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research governance framework for health and social care

  • Health and social care

Research governance framework for health and social care: second edition

Sets out principles, requirements and standards that apply to research relating to responsibilities of each UK health departments.

This publication was withdrawn on 7 November 2017

The updated policy framework is on the HRA website.

Applies to England

research governance framework for health and social care

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research governance framework for health and social care

Research governance framework for health and social care: annex (updated September 2008)

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The research governance framework for health and social care sets out the broad principle of good research governance.

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research governance framework for health and social care

Clinical research governance

Mrc policy on the uk policy framework for health and social care research.

To ensure that health and social care research in the NHS is conducted to high scientific and ethical standards, the  UK policy framework for health and social care research defines broad principles of good research governance . The UK policy framework was released in October 2017 by the Health Research Authority to replace the previous research governance frameworks of England, Wales, Scotland and Northern Ireland.

The Medical Research Centre’s (MRC) policy on the UK policy framework details our requirements of MRC-funded researchers in universities or other research organisations undertaking work in the NHS or with NHS partners.

These requirements, which focus mainly on research sponsorship, are part of MRC’s terms and conditions for research funding.

There is a different policy for  sponsorship of clinical trials of medicines .

Requirements for MRC-funded research by other organisations

UKRI expects the host institution, the research organisation, to nominate itself as sponsor or to make alternative arrangements.

All new grant and fellowship applications for clinical research funding must include details of the sponsorship arrangements made by the research organisation.

Sponsorship of clinical research in MRC institutes and requirements for directors

UKRI will accept sponsorship responsibilities under the UK policy framework for clinical research led by UKRI employees at MRC institutes.

Institute directors are authorised to accept sponsorship responsibilities on behalf of UKRI. An MRC institute should not accept sponsorship responsibilities if they rightly belong elsewhere.

There is a different policy for  sponsorship under the clinical trials regulations .

Under the UK policy framework sponsorship is project-specific and does not automatically extend to new work which has not been assessed by the MRC. However, it does accommodate reasonable changes within the scope and duration of the approved project or those required by research ethics committees.

Institute directors may agree to co-sponsor clinical research projects with another research organisation under certain circumstances, subject to appropriate agreements and controls, and providing that:

  • another organisation is not better placed to undertake the sponsor’s duties
  • one or more UKRI employees act as principal investigator and accept responsibilities for the design or conduct (or both) of the study
  • the research proposal has been peer reviewed and approved for funding by the MRC
  • an MRC institute is able to exercise the sponsor’s duties.

Directors of MRC institutes must ensure that there is clear and systematic documentation of all projects for which the institute has sponsorship responsibilities. This includes approvals of the study and any amendments by regulatory authorities and research ethics committees. This information should be immediately available on request.

Directors of MRC institutes must ensure that quality, risk management and monitoring systems are in place.

MRC institutes should have appropriate research governance systems, in which responsibilities are allocated, accepted and carried out within a sound research and project management framework.

Agreements and systems should be in place and documented with NHS organisations and other collaborative or partner organisations, including commercial organisations.

Naming UKRI as sponsor on ethics committee applications

If the conditions are met, MRC institutes should:

  • name UKRI as the sponsor on Research Ethics Committee applications;
  • provide relevant details for a member of staff within the institute who is responsible for sponsorship (the sponsor representative).

Further guidance on how MRC institutes should implement sponsorship responsibilities can be found on the  MRC Regulatory Support Centre’s sponsorship and indemnity page .

Contact the MRC Regulatory Support Centre

Email:  [email protected]

Last updated: 17 June 2022

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Research governance framework for health and social care.

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Replacing the Research Governance Framework

As part of the work underpinning the development of the UK Policy Framework for Health and Social Care Research - the replacement for the 4 Research Governance Frameworks (RGF) - the HRA conducted a number of exercises to obtain a better understanding of the current systems in place for research governance. Further information on these projects can be found below.

Social care scoping exercise

The HRA has a duty under section 111 of the  Care Act 2014  to coordinate and promote regulatory practice; in particular, the HRA must promote the co-ordination and standardisation of practice in the United Kingdom relating to the regulation of health and social care research; and it must, in doing so, seek to ensure that such regulation is proportionate.

Subsection 3 imposes a further duty on the HRA to promote the coordination and standardisation of practice in relation to the regulation of health and social care research giving it the lead role in removing duplication and streamlining the regulation of health and social care research across the regulatory system.

As part of the development of a new UK Policy Framework for Health and Social Care Research , we conducted a scoping exercise to obtain a better understanding of the current systems in place for research governance for social care research. The HRA conducted a series of interviews across the UK which included:

  • policy leads
  • research governance leads
  • ethics leads
  • other stakeholders

The HRA used the findings from this exercise to inform the development of the replacement to the RGF. The UK Policy Framework for Health and Social Care Research was reviewed at the HRA Board meeting on 21 January 2015 prior to a public consultation .

Perception of risk in research

We carried out a piece of work to consider the perception of risk in research and whether there is a differing perception between different groups.

As part of this project, the HRA sent a questionnaire to two groups; Research Ethics Committee members and Patient and Public Involvement representatives. The questionnaire gave summaries, with differing levels of detail, regarding a number of studies or scenarios. The individual was then asked to give an opinion on whether the study should go ahead despite certain ethical issues.

Other work areas:

  • How the NHS supports educational research
  • Risks to research because of perceived risks of research
  • Serious breach notifications and safety reporting
  • Seeking informed consent for simple and efficient trials
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Research governance: where did it come from, what does it mean?

For a variety of historical and social reasons, research has become increasingly formalized and regulated. This change has potential benefits (reduction in fraud and misconduct, protection of vulnerable groups, financial probity) but also disadvantages (increased paperwork, time delays, constraints on research freedom).

The terms ‘research’ and ‘governance’ mean different things in different contexts. Even with explicit guidance, ambiguities must be resolved by human judgement. Variation in the nature and outcome of approval decisions is therefore a fact of life.

The type of approval needed for a research study depends on the official remit of the approval body, the question to be addressed; the methods to be used; the context in which the work will take place; the level of analysis and interpretation; and the plans for how the findings will be presented and used.

INTRODUCTION

In many countries, research has moved from being a largely unregulated endeavour undertaken by interested individuals working independently of external controls to a highly formalized, regulated and institutionalized activity. 1 This change has a number of historical and social causes, including an increase in the scale of research and national funding to support it, the expectation for greater accountability in the public sector; the active input of service users (e.g. gay men and AIDS 2 ), and the exposure of fraud and misconduct in research—especially on groups who have lacked the ability or opportunity to give informed consent (Box 1). 3

Box 1 Fraud and misconduct in medical research: disproportionate impact on vulnerable groups

Minority ethnic groups

Between the 1930s and 1960s in Tuskegee in the South of America 400 poor, Black men from rural areas were recruited without their knowledge or consent into a long-term follow-up trial of the prognosis of untreated syphilis; effective treatments were withheld from them for decades. 26 Jews, Gypsies and Slavs were included within human experiments throughout the Holocaust, particularly those relating to warfare such as the testing of effects of gas attacks, battle injury or surviving freezing temperatures subjected to a range of experimentation [Ref. 3 ].

Institutionalized groups

Prisoners [Refs 3 , 27 ] and military personnel [Ref. 3 ] have not always been given the opportunity to give full informed consent or opt out of research without changes in their care or status.

Developing countries

Poor communities in developing countries have occasionally been targeted by pharmaceutical companies for trials of medicinal products that would not meet stringent restrictions in the countries where the company is based [Refs 28 , 29 ].

Socially excluded groups

Studies of ‘treatments’ for homosexuality up to the 1970s can, with the wisdom of hindsight, be classified as ideologically driven research that supported and perpetuated social prejudice and exclusion [Ref. 30 ].

The recently dead

The Alder Hey Hospital scandal highlighted the removal and retention of children’s organs and body parts for scientific study without full parental consent or knowledge [Ref. 31 ].

In the UK, the rapid growth of systems and procedures for research management and governance has generated confusion and resentment in the research community. They bemoan the rising burden of paperwork, the curtailment of research freedom, expensive delays caused by lengthy application procedures, inconsistent decisions, and in some cases, the halting of entire research programmes by allegedly heavy-handed but misinformed ethics committees. 4 – 7 The BMJ recently launched a campaign to revitalize academic medicine which aims to promote better public understanding of research and ensure that high quality studies that will benefit patients are supported rather than suppressed.

This is the first in a series of three papers that look at research governance from both a theoretical and a practical perspective. We consider definitions of research and governance from different standpoints and attempt to clarify and explain (but not to defend uncritically) the current systems for regulating research. Our main example is the UK National Health Service, but we draw on examples from other countries and sectors. Papers two and three in the series will explore issues of risk, indemnity, and ethics.

WHAT IS RESEARCH?

Implicit in the human condition is an insatiable curiosity and the desire to acquire and analyse knowledge. For instance:

  • A teenager might look for information on the Internet to complete a piece of homework
  • A manager might review attendance figures at a sexual health clinic with a view to changing clinic times to increase accessibility
  • A public health consultant might study data on the incidence of breast cancer in her locality following the introduction of mammography screening
  • An oncology nurse might collect data from patients entered in a trial of a new cancer drug
  • A social scientist might analyse the messages from a public access Internet discussion about the safety of vaccines.

All these activities might be perceived as research by the person undertaking them (Box 2). Whether a study is research in the sense that it requires formal regulation and monitoring (e.g. approval from a research ethics committee) depends on: ( a ) the defined remit of the regulatory body; ( b ) the specific question being addressed; ( c ) the method(s) chosen to address the question; ( d ) the context in which the work takes place; ( e ) the nature and depth of analysis and interpretation; and ( f ) the plans for publication and the use to which the findings will be put.

WHAT IS GOVERNANCE?

Governance is the system of administration and supervision through which research is managed, participants and staff are protected, and accountability is assured. Governance is not the remit of any single institution (indeed, a guiding principle is that it is everyone’s business). It is therefore not surprising that tensions exist (and always will exist) between regional, national or international (e.g. European Union) codes of practice; national and European law; and professional standards, norms and values.

Box 2 Definitions of research

The lay person’s definition...

Research is about asking a question and systematically looking for the answer [Ref. 32 ].

The medical editor’s definition...

Research is concerned with discovering the right thing to do and audit is about ensuring that it is done right [Ref. 33 ].

The World Medical Association’s definition...

The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease [Ref. 17 ].

The OECD’s definition...

Research is creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of man, culture and society, and the use of this stock of knowledge to devise new applications [Ref. 34 ].

The hospital’s definition...

Research is about creating new knowledge about what works and what doesn’t. It provides the foundations for national and/or local agreement about the kind of clinical treatment and care we should be providing, i.e. helps to answer the question ‘what is best practice?’ [Ref. 35 ].

The taxman’s definition...

Research and development for tax purposes takes place when a project seeks to achieve an advance in science or technology [Ref. 36 ].

The social scientist’s definition...

Research is a codified, scholarly and professional mode of knowledge production that has its prime institutional loci in universities, policy analysis units of government departments or international organizations and private research institutes and produced by academics, think-tank experts and development professionals [Ref. 37 ].

In the UK, the main reference point is the Research Governance Framework for Health and Social Care, 8 whose stated purpose is to enhance ethical and scientific quality, promote good practice, reduce adverse incidents and ensure lessons are learned. The Framework, which reflects EU regulations (see below) sets out the responsibilities of the individuals and organizations involved in research, including funders, researchers, organizations employing researchers, and healthcare organizations 8 and goes some way to dispelling the persistent view of research management as something separate from the science of research.

GAINING APPROVAL FOR A RESEARCH STUDY

Different regulatory and approval bodies have different remits and agendas. The question ‘does my study need approval by a particular body?’ must be answered with reference to what that body considers within its remit, rather than in relation to what the researchers themselves consider to be the key ethical and scientific issues. The different definitions of research used by different bodies reflect their particular agendas and priorities (e.g. pure versus applied, biomedical versus psychosocial, wet versus dry), and are sometimes couched in oppositional terms (that is, describing what research, for their purposes, is not ). 9

Box 3 Overview of processes for governing research in selected countries

Canada and USA

  • Both countries have nationally coordinated and regulated ethics committee structures and procedures and additional provision for review of multi-centre studies. Whereas Canadian Research Ethics Boards are responsible for reviewing and approving clinical trial protocols and informed consent forms for research with human subjects, US Institutional Review Boards formally review all research activities involving human subjects
  • Both appear to have other institutional arrangements in place to review, for instance, legal and contract matters, liability or billing issues
  • Governmental and regulatory agencies concerned with the conduct of research include the US Office for Human Research Protections and the Canadian Institutes for Health Research. The Canadian national policy statement is notable in acknowledging that studies employing social science methods may require different procedures to those used for clinical or intervention studies.
  • NHS Research Ethics Committees (RECs) review all research involving NHS patients, premises, staff and tissue samples. The same form is used for review of all research projects, with RECs required to provide a decision within 60 working days
  • Other committees, such as those in universities, also review health-related research
  • Research of this kind must also gain formal NHS management approval from the relevant local NHS trust(s) where the study is taking place and all clinical trials of new medicinal products must now gain a European Clinical Trials Database reference before proceeding.
  • No national ethical review process is in place but individual committees with voluntary processes appear to be developing on an ad hoc and voluntary basis
  • No legal or formal system of ethical or research management approval appears to be available through which research involving human subjects can proceed, although international collaborative projects should seek approval from their centre (e.g. in the USA or the UK).

In practice, however, projects often prove difficult to classify even with explicit written guidance. 10 For example, many types of applied research (action research, 11 evaluation of services, 12 quality improvement research, 13 and so on) seek to generate new knowledge as well as providing direct benefits to patients and practitioners locally, so it is meaningless to state which is the ‘main’ purpose of the project. The inherently fuzzy nature of much contemporary research means that algorithmic tools (in which a flow chart of questions leads to one of two categories: ‘research’ or ‘not research’; 14 ‘trial’ or ‘not trial’, 15 etc.) may have limited potential for removing ambiguity.

If an official research approval body (such as a local research ethics committee in the UK) deems a particular project outside its remit (e.g. if the study does not involve NHS staff, patients or tissue samples and takes place off NHS premises), this does not mean the project team can pursue their work unrestrained. It would be highly unusual if the study did not fall within the remit of at least one (and possibly several) other regulatory bodies. Clinical audit, for example, will be the remit of the acute or primary care trust under clinical governance arrangements. 13 , 16 A student PhD study based in a UK university, but with all fieldwork conducted abroad, will be covered by the university under its internal supervision and ethics procedures. A survey of school pupils generally needs approval from the school’s board of governors. And so on. In addition, researchers are professionally (though not legally) bound by generic codes of practice (e.g. Declaration of Helsinki 17 ). And, of course, we all have responsibility to obey the law and behave decently towards our fellow citizens—e.g. following ethical principles of respect for human dignity, beneficence, non-malefience and justice. 18

There are instances when official regulations appear to have obvious ambiguities. For instance, an investigative journalist employed by a TV company and an academic researcher employed by a university might both collect the narratives of people taking an antidepressant drug. But, whereas the journalist must do no more than stay within the law (e.g., the Data Protection Act), the researcher is bound by an additional set of formal and statutory procedures by virtue of the classification of the study as academic research.

Where there is doubt as to the status of a proposed study, it is quite in order to ask advice from the Central Office for Research Ethics Committees who may also liaise with relevant committee/s (see [ www.corec.org.uk ] for contact details). Judgement will be applied on a case-by-case basis, drawing on local precedent and the definitions in Box 2.

RESEARCH GOVERNANCE IN AN INTERNATIONAL CONTEXT

Box 3 gives examples of the broad systems for reviewing and approving research involving human participants outside the UK. They are the product of the prevailing social, healthcare and research environments in different countries and will inevitably vary in focus and aims. 19 Some carry legal weight or are formalized in some other way, others have looser terms of reference or are entirely voluntary. Similarly, professional codes and guidance vary widely within and across countries. 19

This international variation is more than a curiosity. Although international standards for research have been encouraged since Nuremberg, for studies that span several countries, governance requirements in the partner centres may still differ to such an extent that it is impossible to achieve a single common protocol for recruiting participants, gaining informed consent, managing the project, and storing data. 6 As with all complex research studies, time must be built into the planning and preparation stage for multiple applications to be processed.

Where systems are not in place or appear inadequate for the task at hand, researchers may find it useful to refer to generic guidance (e.g. Declaration of Helsinki, 17 International Conference on Harmonisation of Good Clinical Practice, 20 MRC Guidelines on Research in Developing Countries 21 —see Box 4 for further examples). However, these recommendations are not always legally binding and may be differently interpreted (or prove impossible to implement) in different countries. For example, all the international guidelines relating to health research recommend local ethical review, but ethics committees have yet to become a worldwide phenomenon.

Member countries of the European Union are increasingly encouraged to work together to achieve convergence of policies in a number of fields including research and development. An EU Directive on 1 May 2004 introduced new legal restrictions on the testing of medical products, including an onus on the lead researcher to register all pharmaceutical trials at inception and ensure that appropriate insurance arrangements are in place. 22 The implementation process has been a cause for concern, not least in questioning whether important publicly funded research may falter due to the rising complexity and costs associated with increased bureaucracy.

IMPLICATIONS FOR SERVICE ORGANIZATIONS

In the UK, a healthcare organization that hosts research (that is, allows research to be undertaken on its premises) has a number of statutory responsibilities including duty of care to all patients, ensuring scientific review of proposals and monitoring research 8 . It incurs additional responsibilities for the initiation, management and conduct of a research project if it decides to act as a research sponsor 8 . The NHS R&D Forum (see Box 4) provides a list of NHS institutions who act as research hosts and/or sponsors.

Box 4 Regulations and guidance relating to health research

International / EU codes and regulations relating to health research

  • The first major international code of ethical principles in medical research was the Declaration of Helsinki, produced by the World Medical Association in 1964. The Declaration was last up-dated in 2000 [ www.wma.net/e/policy/b3.htm ] with related documents [ www.wma.net/e/ethicsunit/helsinki.htm ]
  • Council for International Organizations of Medical Sciences (CIOMS) established by WHO and UNESCO has provided international guidelines for biomedical research involving human subjects [ www.cioms.ch/frame_guidelines_nov_2002.htm ]
  • The Council of Europe produced the Convention on Human Rights Protection and Biomedical Science and more recently a protocol on Biomedical research [ www.coe.int/T/E/Com/Files/Themes/Bioethics/default.asp ]
  • The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) promotes the harmonization of the regulation of pharmaceutical drugs. 1996 Good Clinical Practice guidelines [ www.ich.org ] under guidelines and efficacy topics
  • The World Health Organization has an ethics programme and associated publications [ www.who.int/ethics/en ]
  • European Union Clinical Trials Directive 2001/20/EC relates to the conduct of clinical trials on medicinal products for human use and new legislation implemented in Member States in May 2004 [ http://europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf ].

Guidance on conducting research in developing countries

  • The Medical Research Council has published an ethics guide on research involving human participants in developing societies [ http://www.mrc.ac.uk/pdf-devsoc.pdf ]
  • The European Group on Ethics in Science and New Technologies published their discussions of the ethical aspects of clinical research in developing countries [ http://europa.eu.int/comm/european_group_ethics/docs/tb1oc_en.pdf ]
  • The Nuffield Council on Bioethics has produced a report on The Ethics of Research Related to Healthcare in Developing Countries [ http://www.nuffieldbioethics.org/go/ourwork/developingcountries/introduction ].

UK Research Governance and Ethics

  • The Medical Research Council Ethics and Best Practice pages include guidelines on clinical trials, ethics and peer review [ http://www.mrc.ac.uk/index/publications/publications-ethics_and_best_practice.htm ]
  • The Department of Health Research Governance pages include information on the development of policy, guidance on specific issues and implementation plans [ http://www.dh.gov.uk/PolicyAndGuidance/ResearchAndDevelopment/ResearchAndDevelopmentAZ/ResearchGovernance/fs/en#4840302 ]
  • The NHS R&D Forum have produced a documentation guide for research governance which provides links to all relevant sites [ http://www.rdforum.nhs.uk/workgroups/primary/pcinfoguide/introduction.htm ] and provides a list of contact details in order to obtain local NHS R&D approval for research [ http://www.rdforum.nhs.uk/links/locallinks.htm ]
  • The Central Office for Research Ethics Committees (COREC) provides the most up-to-date information and forms relating to NHS ethical review, including New Operational Procedures [ http://www.corec.org.uk/ ]
  • Ethics Research Information Catalogue (ERIC) holds a collection of articles related to the ethics of medical research on humans at [ http://www.eric-on-line.co.uk/index.php ]
  • The Medicines and Healthcare products Regulatory Agency (MHRA) provides information on the Clinical Trials Directive [ http://www.mhra.gov.uk/ ] and a joint site between the DH and MHRA has a Clinical Trials Toolkit [ http://www.ct-toolkit.ac.uk/ ]
  • Each university in the UK has its own rules, regulations and processes [ http://www.scit.wlv.ac.uk/ukinfo/ ].

These new infrastructure requirements place a high burden on NHS organizations. Historically, little emphasis was placed on the management and administration of research studies, which tended to be seen as the creative pursuits of individual clinicians. To some extent, then, service organizations must undergo a cultural change as well as invest in the necessary infrastructure to support research. Recent surveys have shown that most health service staff feel positive about the principles and aspirations of the Research Governance Framework but find them confusing and difficult to implement in practice. 1 , 5 , 8

There is also the issue of proportionality—i.e. the punishment should fit the crime. The principles, structures and systems associated with research governance apply whether undertaking a large multi-centre clinical trial or a small local project. In secondary care (e.g. acute hospital trusts), considerable research infrastructure already exists, and the implementation of research governance has been fairly non-contentious. This has not been the case in primary care, where research has not historically been part of core business and R&D infrastructure is underdeveloped. 23 PCTs who are just beginning to develop a research culture and build research capacity must make considerable short-term investment in the initial setting-up of systems—a step that many will find prohibitive.

IMPLICATIONS FOR INDIVIDUAL RESEARCHERS

Table 1 draws on Richard Doll’s 50-year longitudinal study of the outcome of smoking in British doctors to explore how the research process and governance procedures have changed over time. 24 It points to several areas relating to research governance and ethics that researchers must consider before commencing a study, many of which are established features of good research practice, but until recently only the individual researcher was officially accountable for them.

The research process explored through 50 years of observations on smoking in British doctors

Some of the changes highlighted in Table 1 have raised concerns about over-regulation, 4 , 6 and the creation of additional and unwelcome layers of bureaucracy across the research environment. Doll himself was willing to go to prison in defiance of new regulations, believing they are suffocating clinical medical research. Many of these areas will be discussed in more detail in papers two and three of this series.

Only time will tell if research governance procedures will achieve the goal of raising standards, protecting participants and assuring quality—and whether the inevitable constraints on research freedom will be worth the candle. Nevertheless, the procedures are now official, and cutting corners constitutes fraud and/or professional misconduct. Depending on the particular regulations breached, the researcher may face criminal charges, removal or restriction of professional privileges, loss of institutional indemnity, or dismissal from employment. Where genuine ambiguity exists about the status of a proposed study, it may be a false economy to try to sell it as non-research in order to avoid having to complete the paperwork, since if the work is subsequently submitted to an academic journal, confirmation of research ethics approval may be a condition for publication.

On a positive note, NHS research ethics committees are now required to deliver decisions on valid applications within 60 working days, with similar arrangements throughout the EU 6 . They are also being encouraged to move from an ethos of policing research to one of quality assurance and facilitation. The UK Department of Health is reviewing the barriers to research caused by new governance systems. 25 Hopefully, this will lead to a slackening of red tape, streamlining of procedures, and specific measures in research fields for which current regulations have proved unworkable.

Acknowledgments

Our thanks go to the late Sir Richard Doll for his comments on this paper.

This is the first in a series of three articles on research governance.

Research governance: implications for health library and information professionals

Affiliation.

  • 1 School of Business Information, Faculty of Business and Law, Liverpool John Moores University, UK. [email protected]
  • PMID: 12641525
  • DOI: 10.1046/j.1471-1842.2003.00413.x

The Research Governance Framework for Health and Social Care published by the Department of Health in 2001 provides a model of best practice and a framework for research in the health and social care sector. This article reviews the Department of Health Research Governance Framework, discusses the implications of research governance for library and information professionals undertaking research in the health- and social-care sector and recommends strategies for best practice within the information profession relating to research governance. The scope of the Framework document that covers both clinical and non-clinical research is outlined. Any research involving, amongst other issues, patients, NHS staff and use or access to NHS premises may require ethics committee approval. Particular reference is made to the roles, responsibilities and professional conduct and the systems needed to support effective research practice. Issues such as these combine to encourage the development of a quality research culture which supports best practice. Questions arise regarding the training and experience of researchers, and access to the necessary information and support. The use of the Framework to guide research practice complements the quality issues within the evidence-based practice movement and supports the ongoing development of a quality research culture. Recommendations are given in relation to the document's five domains of ethics, science, information, health and safety and finance and intellectual property. Practical recommendations are offered for incorporating research governance into research practice in ways which conform to the Framework's standards and which are particularly relevant for research practitioners in information science. Concluding comments support the use of the Research Governance Framework as a model for best practice.

Publication types

  • Benchmarking
  • Biomedical Research / ethics*
  • Ethics, Institutional*
  • Ethics, Research*
  • Health Services Research / ethics*
  • Libraries, Medical / organization & administration*
  • Organizational Culture
  • Program Development
  • State Medicine
  • United Kingdom

Strengthening data governance in US public health agencies

Data and information management, including data governance, has emerged as a top ten policy and technology priority for state chief information officers (CIOs) in recent years. 1 Data and information management appeared among state CIOs’ top ten policy and technology priorities for 2021, 2022, and 2023. For more, see “Resource center,” National Association of State Chief Information Officers (NASCIO), accessed February 26, 2024. This ranking highlights the greater focus organizations are placing on the use of data to support faster and richer insight generation.

Data governance can be especially critical for enabling the functions of state public health agencies. For example, a single, unified framework can enable earlier detection of public health threats, a more coordinated response to public health emergencies, better-informed daily decision making, and an increased ability to manage risks. In our experience, public health agencies may benefit from focusing on four key dimensions (based on the McKinsey DRIVE framework) as they develop and implement their data governance approach: data strategy, impact case, and road map; information architecture and technology; value, operating model, and governance for public health; and ethics, talent, and culture. To help agencies get started with this approach, this article offers eight insights and relevant examples drawn from existing efforts across US state agencies.

To read the full article, download the PDF here .

Connor Norwood , a senior adviser in McKinsey’s Chicago office, formerly served as the chief data officer of the Indiana Family and Social Services Administration; Saumya Singh is an associate partner in the New Jersey office; Keerthana Sundar is a consultant in the Chicago office; and Hrishika Vuppala is a senior partner in the Southern California office.

The authors wish to thank Ellen Feehan, Jessica Kahn, Mihir Mysore, Adam Ng, Anthony Nguyen, and Bryan Petzold for their contributions to this article.

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Part 1. Overview Information

National Institutes of Health ( NIH )

National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS )

National Institute of Mental Health ( NIMH )

National Institute on Minority Health and Health Disparities ( NIMHD )

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research ( OBSSR )

Sexual and Gender Minority Research Office ( SGMRO )

Office of Nutrition Research ( ONR )

R01 Research Project Grant

  • March 12, 2024 Pre-Application Webinar for RFA-NR-24-005: Strategies to Improve Health Outcomes and Advance Health Equity in Rural Populations (R01 Clinical Trial Optional). See Notice NOT-NR-24-008
  • August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice  NOT-OD-22-198 .
  • August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice  NOT-OD-22-189 .

See Part 2, Section III. 3. Additional Information on Eligibility.

The purpose of this initiative is to support research to improve health and promote health equity in rural populations. Rural populations experience high rates of many causes of morbidity and disability, and high and increasing rates of premature death. Meaningful and sustained improvements in the health of rural populations require effective solutions to address the underlying causes. Applications responding to this Notice of Funding Opportunity (NOFO) should develop, adapt, or implement intervention strategies addressing social determinants of health (SDOH) to improve health and promote health equity in rural populations. This funding opportunity encourages studies that use a wide range of methodological approaches that enhance access to, and acceptability and effectiveness of, interventions in rural populations, such as community-engaged research approaches that build on the strengths of rural communities.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.

Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .

30 days prior to the application due date

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Not Applicable

It is critical that applicants follow the instructions in the Research (R) Instructions in the  How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  • Use the NIH ASSIST system to prepare, submit and track your application online.
  • Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
  • Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section i. notice of funding opportunity description.

Rural Americans make up around 20% of the U.S. population. By multiple measures, adults and children living in rural areas have worse health than those living in more urbanized areas. Adults are more likely to die from the five U.S. leading causes of death (heart disease, cancer, accidental injuries, chronic lower respiratory disease, and stroke) than their urban counterparts. Children in rural areas are less likely to be vaccinated and their parents are more likely to report difficulties meeting basic needs. Many resources to protect and improve health across the lifespan are less available to rural populations than more urbanized populations. Rural communities across the U.S. are diverse and vary greatly in multiple ways that impact health.

Social determinants of health (SDOH) ( https://www.ninr.nih.gov/researchandfunding/nih-sdohrcc#tabs2 ), or the conditions in which people are born, grow, learn, work, play, live, and age, and the wider set of structural factors shaping the conditions of daily life, vary across geographies from neighborhoods to regions and nations. SDOH include the quality and affordability of available food and housing, access to healthcare, employment opportunities that provide a living wage, and telecommunication and transportation infrastructures that facilitate access to resources needed to support health, wellbeing, and economic prosperity. These and other SDOH influence individual and family circumstances like low income and food insecurity that, through a variety of pathways, influence health in rural communities and contribute to health inequities for marginalized rural populations, including people of color, immigrants, sex and gender minority people, and people with disabilities.

Understanding that social determinants of health can promote, maintain, or hinder health, research is needed to advance solutions that leverage those factors that have positive impacts, as well as mitigate or eliminate factors with negative impacts on rural health. Many interventions that address social determinants of health are developed, tested, and implemented only in urbanized areas. Relatively few researchers seek to develop, adapt, and/or implement interventions designed specifically to meet the needs of people living in rural communities.

The 2021 National Academies report on Population Health in Rural America focused attention on the changing demographics and social determinants of health in rural America. The need for implementation of evidence-based strategies to improve rural health was highlighted, and there was a call for research that addresses social factors and health needs, as well as the gaps in the healthcare system. Other recent reports in the health research literature, and the NIH Rural Health Day Seminars ( https://videocast.nih.gov/watch=48966 ), have emphasized the need for research to incorporate innovative research designs and approaches relevant to rural communities.

Research Objectives

This funding opportunity will support research to develop, adapt, or implement intervention strategies addressing SDOH to improve health and promote health equity in rural populations. Research must address social determinants of health, along with community priorities, needs, and preferences, in the development, adaptation, or implementation of interventions. Interventions or implementation strategies seeking to either mitigate or eliminate the impacts of adverse social determinants of health and/or bolster positive social determinants of health are of interest. Investigators are encouraged to leverage community strengths in intervention design. Community-based participatory research (CBPR) or other community-engaged approaches may be useful for understanding community priorities, needs, and preferences, as well as for leveraging strengths of and knowledge embedded in rural communities.  

Research studies should seek to improve health outcomes and must be guided by a conceptual framework that identifies hypothesized pathways between the intervention and health outcome(s). The primary outcome may reflect health or functional status, health conditions, quality of life, well-being, morbidity and mortality, and/or health behaviors. Individual-, population-, system-, and multi-level interventions could be responsive to this NOFO. Successful, evidence-based interventions may be adapted to specific rural communities and tested for acceptability and efficacy or effectiveness. Pragmatic and implementation studies are welcome, including hybrid effectiveness/implementation studies of adapted interventions or intervention bundles.

Examples of topics of interest include, but are not limited to:

  • Intervention studies focused on improving outcomes in conditions or risks that occur at higher rates in rural populations
  • Development, adaptation, and implementation of interventions that address social determinants of health ( https://www.ninr.nih.gov/research/nih-sdohrcc#tabs2 ) in marginalized populations living in rural or remote areas of the United States such as migrant workers, immigrants, people with disabilities, racial and ethnic minority groups, people of low income, and sexual and gender minority groups
  • Implementation studies to advance the reach, effectiveness, and sustainability of evidence-based interventions in rural communities or in identified marginalized rural populations
  • Adaptation of technologies to address structural barriers to health in rural areas (e.g., healthcare resource shortages and telecommunication limitations that affect access to specialty care or pharmacy services)
  • Interventions that seek to improve health by addressing limited access to healthy foods, places for physical activity, or housing options in rural communities
  • Studies that develop, test, and/or implement firearm injury prevention intervention(s) to address the disproportionate burden of morbidity and mortality due to firearm injury in rural communities
  • Service and care models that build upon places of social interaction in rural communities, such as churches, schools, libraries, and grocery stores 

Non-Responsiveness Criteria

Applications that are deemed non-responsive will not be reviewed. This includes:

  • Applications that do not include a Plan for Enhancing Diverse Perspectives
  • Applications to study populations or regions outside the United States
  • Research projects that do not include a U.S. rural population. For the purposes of this NOFO, rural population is defined as: individuals living or working in a rural area, or communities or systems located in a rural area. Rural areas are defined according to the Health Resources & Services Administration (HRSA) definition : All non-metro counties, as defined by the Office of Management and Budget; all metro census tracts with Rural-Urban Commuting Area (RUCA) codes 4-10; and large area metro census tracts of at least 400 square miles in an area with population density of 35 or less per square mile with RUCA codes 2-3; and outlying metro counties without a UA. For more detail on the addition of outlying metro counties, read the Federal Register Notice, Revised Geographic Eligibility for Federal Office of Rural Health Policy Grants . The HRSA Rural Health Grants Eligibility Analyzer can be used to determine which counties and locations are rural areas. HRSA also provides data files to identify rural areas by county, census tract, and those using a zip code approximation. Remote areas, defined by USDA Frontier and Remote (FAR) Area Code 4, are considered both rural and remote; therefore, the definition of rural above will be used for eligibility. The USDA provides data files and maps using the FAR codes. Rural and remote areas may include American Indian and/or Alaska Native Tribal populations.
  • Research projects that do not include a health outcome as the primary outcome
  • Research projects that do not address social determinants of health as conceptualized by the NIH
  • Applications that do not include a conceptual framework that identifies hypothesized pathways between the intervention and outcome(s)
  • Construction and major renovations costs are unallowable through this RFA. Applications that propose to use grant funds to support construction or major alteration and renovation projects will be considered non-responsive.

Areas of Interest of Participating Institutes, Centers, and Offices (ICOs)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. Research areas include rheumatology, orthopaedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. In the context of this NOFO, the NIAMS is interested in applications that support the exploration of strategies to address social determinants of health to improve quality of health and promote equity in rural populations in the NIAMS mission-relevant disease areas. Research in community health care settings is particularly encouraged. Clinical trial applications will not be supported for this NOFO. Applicants interested in clinical trials should visit the NIAMS clinical research website where a list of current NIAMS clinical trials specific NOFOs is available:   https://www.niams.nih.gov/grants-funding/conducting-clinical-research/investigator-clinical-trial-policies . Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.

National Institute of Mental Health (NIMH)

The National Institute of Mental Health (NIMH) is interested in applications relevant to priorities described in this RFA and that support the NIMH Strategic Plan for Research. For the purposes of this RFA, NIMH is particularly interested in (but not limited to) projects that:

  • Develop and test new mental health preventive, treatment, and services interventions and/or strategies for implementing interventions with established effectiveness, with a focus on the challenges faced in rural areas as primary mechanisms (factors that impact the useability of evidence-based practice, cultural fit of these practices, implementation and access barriers, and service/system challenges, such as workforce limitations).
  • Develop and test multi-level mental health interventions that address structural, system and policy challenges that contribute to mental health disparities.
  • Identify rural area factors that mediate or moderate intervention and/or implementation effectiveness.
  • Examine/adapt parameters of evidence-informed lethal means safety interventions (e.g., dose, duration, method of administration) that impact generalization of efficacious interventions to rural practice settings.
  • Investigate whether and to what extent financing mechanisms, policies, regulations, and healthcare system rules optimize patient-level outcomes, and identify mutable factors and policy interventions that can improve mental health outcomes in rural areas.

All applications that propose clinical trials should follow the NIMH’s experimental therapeutics approach to intervention development and testing (see https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml ). That is, the scope of work should include specification of targets/mechanisms (for intervention testing) and societal factors/system factors (for service and implementation studies) and assessment of intervention induced changes in the presumed targets/mechanisms/societal/system factors that are hypothesized to account for the intervention’s outcomes and access to the intervention. 

Depending on the research question, a variety of methodologically rigorous approaches may be indicated. For example, for studies that involve testing and comparing alternative strategies, designs may include randomized controlled trials (RCTs) and variants (e.g., stepped wedge cluster randomized trial designs), quasi-experimental designs with non-randomized comparison groups, time-series designs, and other designs of equivalent rigor and relevance. Considerations for selecting a research design for the proposed study include the scientific question that the study is designed to answer, practical constraints, ethical issues, and the tradeoff between maximizing internal and external validity; the design that is proposed should be justified, accordingly, in the application.

NIMH is committed to supporting research that reduces disparities and advances equity in mental health interventions, services, and outcomes. Accordingly, this NOFO encourages research studies that examine approaches that can be used to reduce disparities for racial and ethnic minority groups, individuals limited by language or cultural barriers, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons, persons living with disabilities, and other underserved groups.

NIMH encourages a deployment-focused model of intervention and services design and evaluation that takes into account the perspective of relevant stakeholders (e.g., service users, providers, administrators, payers) and the key characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows) that are intended to implement optimized mental health interventions. This attention to end-user perspectives and characteristics of intended clinical and/or community practice settings is intended to ensure the resultant interventions and service delivery strategies are acceptable to consumers and providers, the approaches are feasible and scalable in the settings where individuals are served, and the research results will have utility for end users.

NIMH encourages research on potentially scalable preventive, therapeutic, and services interventions that focuses on practice-relevant questions. Accordingly, collaborations between academic researchers and clinical or community practice partners or networks are encouraged. Studies should capitalize on practice infrastructure, including but not limited to SAMHSA-supported 988 Suicide and Crisis Lifeline services and training infrastructure, and when possible, NIMH encourages applications that leverage existing research resources (e.g., practice-based research networks such as the NIMH-sponsored Mental Health Research Network (MHRN), NIMH-supported ALACRITY and Practice-based Suicide Prevention Research Centers , institutions with Clinical and Translational Science Awards). To facilitate the ultimate translation into practice, NIMH encourages research and clinical approaches that incorporate the use of routinely collected data (e.g., electronic medical records, patient registries, other administrative databases) to increase the efficiency of participant recruitment (i.e., more rapid identification and enrollment) to facilitate the collection of practice-relevant data (e.g., clinical characteristics; stakeholder-relevant outcomes, including mental health and general health care utilization; data on longer-term outcomes; data regarding the value and efficiency of intervention approaches).

AIDS-related applications will not be considered by NIMH for this RFA.

National Institute on Minority Health and Health Disparities (NIMHD)

The mission of NIMHD is to lead scientific research to improve minority health and reduce health disparities in populations that experience health disparities. Of specific interest are intervention studies that focus on the intersectionality of race/ethnicity and/or low SES with rural populations. See https://jamanetwork.com/journals/jama-health-forum/fullarticle/2812750 for more information. NIMHD encourages projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities in accordance with NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html .

Sexual & Gender Minority Research Office (SGMRO)

The SGMRO coordinates research and activities related to the health and well-being of sexual and gender minority (SGM; defined for NIH research in NOT-OD-19-139 ) populations by working directly with the NIH institutes and centers (ICs) and serves as a liaison for the research community to ensure SGM populations are considered and represented in research activities across the agency. The SGMRO does not have grant-making authority and can only support grants deemed meritorious after review by one of the ICs participating in this announcement and after a co-funding request is initiated through the IC. Please reach out to the relevant Scientific/Research Contact(s) identified in this announcement with any questions about IC-specific research priorities and funding. More SGM- and SGMRO-specific information is available in the NIH Strategic Plan to Advance Research on the Health and Well-being of Sexual and Gender Minorities FY 2021-2025 and on the Office’s Research Resources webpage .

For this NOFO, SGMRO encourages research across the life course that explores and addresses the health needs of SGM populations living in rural settings to support the maintenance or improvement of health and health outcomes among SGM communities and SGM people who are members of other populations that experience health disparities and inequities. When appropriate, SGMRO encourages consideration and incorporation of relevant concepts (e.g., minority stress, social safety, intersectionality, stigma), research strategies (e.g., community-led or -engaged research, trauma-informed research, strengths-based approaches), and frameworks (e.g., SGM Health Disparities Research Framework , NIMHD Research Framework ).

Plan for Enhancing Diverse Perspectives

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310 , submitted as Other Project Information as an attachment (see Section IV).

Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material . The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.  

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Renewal of RFA-NR-20-001

The  OER Glossary  and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The National Institute of Nursing Research (NINR) intends to commit $3,000,000 in FY 2024 to fund 3-4 awards, depending on receipt of meritorious awards and availability of funds.  

Application budgets are limited to less than $500,000 per year in direct costs, and need to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities , NOT-OD-22-019 .

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide .

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application . This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see  NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications ).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the  How to Apply - Application Guide  except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Weiqun Li, M.D. Chief, Scientific Review Branch DESP, NINR Telephone: 301-594-5966 Fax: 301-480-8260 Email: [email protected]  

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

SF424(R&R) Other Project Information

Other Attachments:

  • In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.
  • The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate.
  • Where possible, applicant(s) should align their description with these required elements within the research strategy section.
  • The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
  • The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review.

Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

  • Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
  • Description of any planned partnerships that may enhance geographic and regional diversity.
  • Plan to enhance recruiting of women and individuals from groups historically underrepresented in the biomedical, behavioral, and clinical research workforce.
  • Proposed monitoring activities to identify and measure PEDP progress benchmarks.
  • Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
  • Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
  • Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
  • Publication plan that enumerates planned manuscripts and proposed lead authorship.
  • Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp

SF424(R&R) Senior/Key Person Profile

R&R or Modular Budget

PEDP implementation costs

  • Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm ).

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan

All instructions in the  How to Apply - Application Guide must be followed, with the following additional instructions:

The Research Plan should indicate how the application addresses issues that are meaningful to rural communities, systems, or people. The Research Plan should also describe the study team's expertise in conducting research in rural settings, as well as whether and how the team members from different backgrounds are included to enhance the success of the proposed research within rural communities. 

The research plan must describe how social determinants of health and community priorities, needs, and preferences are integrated into the development, adaptation, or implementation of health interventions. The Research Plan should also describe the conceptual framework and hypothesized pathways between the intervention and improved health outcomes. 

Finally, the Research Plan should address the feasibility of the proposed approach within the rural setting and the acceptability of the approach to rural populations.  

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the  How to Apply - Application Guide .

Other Plan(s):  Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:  Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I.  contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide .

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide . Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide .

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Institute of Nursing Research (NINR), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular NOFO, note the following:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this NOFO:

  • How well does this project address issues that are meaningful to rural communities, systems, or people?
  • To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?  

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

  • What expertise is included on the team regarding conducting research in the rural setting?
  • Does the application address the inclusion of team members from different backgrounds that will lead to successful conduct of the study in the rural setting?
  • To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

  • To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

  • Are the proposed approaches specifically adapted to research in rural communities?
  • How well does the approach address feasibility in the rural setting and acceptability to rural people?
  • How well have social determinants of health been incorporated into the development, adaptation, or implementation of the health intervention(s)?
  • How well have community priorities, needs, and preferences been incorporated into the development, adaptation, or implementation of the health intervention(s)?
  • To what extent are the hypothesized pathways between the intervention and health outcomes in the conceptual framework likely to lead to improved health outcomes?
  • Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?  

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Specific for this NOFO:

  • To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects .

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research .

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Renewals, the committee will consider the progress made in the last funding period.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms ) or the rationale for not sharing the resources, is reasonable.

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Nursing Research (NINR), in accordance with NIH peer review policies and practices , using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Nursing Research. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the  eRA Commons . Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the  NIH Grants Policy Statement Section 2.4.4 Disposition of Applications .

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the  NIH Grants Policy Statement . This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website ( https://register.clinicaltrials.gov ). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities , including of note, but not limited to:

  • Federalwide Standard Terms and Conditions for Research Grants
  • Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
  • Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance ( HHS-690 ). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website .

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement . Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the  Research Performance Progress Report (RPPR)  annually and financial statements as required in the NIH Grants Policy Statement .

Awardees will provide updates at least annually on implementation of the PEDP.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement . NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online:  https://www.era.nih.gov/need-help  (preferred method of contact) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources) Email:  [email protected]  (preferred method of contact) Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace) Contact Center Telephone: 800-518-4726 Email:  [email protected]

Karen A. Kehl, PhD, RN National Institute of Nursing Research (NINR) Telephone: 301-594-8010 Email: [email protected]  

Christopher Barnhart, PhD Sexual & Gender Minority Research Office (SGMRO) Telephone: 301-594-8983 Email: [email protected]

Holly Nicastro, PhD, MPH Office of Nutrition Research (ONR) Phone: (301)-435-0383 Email: [email protected]

Priscah Mujuru, DrPH, RN National Institute on Minority Health and Health Disparities (NIMHD) Phone: 301-594-9765 E-mail: [email protected]

Patricia Anne Arean, Ph.D.  National Institute of Mental Health (NIMH) Phone: 301-827-4878 E-mail: [email protected]

Juliette Claudine Mcclendon, Ph.D.  NIMH - NATIONAL INSTITUTE OF MENTAL HEALTH Phone: 301-379-0413 E-mail: [email protected]

Charles H Washabaugh, PhD NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES Phone: 301-496-9568 E-mail: [email protected]

Weiqun Li, MD National Institute of Nursing Research (NINR) Telephone: 301-594-5966 Email: [email protected]

Kelli Oster National Institute of Nursing Research (NINR) Telephone: 301-594-2177 Email: [email protected]  

Priscilla Grant, JD NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES Phone: 301-594-8412 E-mail: [email protected]

Tamara Kees National Institute of Mental Health (NIMH) Telephone: 301-443-8811 Email: [email protected]

Erik Edgerton NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES Phone: 301-594-7760 E-mail: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts . All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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In the commune of Nsélé in Kinshasa, Democratic Republic of the Congo

A person holding up a card

Mitigating the socioeconomic impacts of COVID-19

With a cash transfer in peri-urban Kinshasa, Democratic Republic of the Congo

Girl in Madagascar in front of their classroom ravaged by a cyclone

Prospects for Children: A Global Outlook 2024

Cooperation in a Fragmented World: Discover the eight trends that will define the year ahead for children and young people.

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Data Must Speak: Chad

Reports and project briefs

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Data Must Speak: United Republic of Tanzania

Areas of work.

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Adolescent participation and civic engagement

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Child protection

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Education and human capital

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Health and well-being

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The State of the World’s Children

UNICEF’s flagship report – the most comprehensive analysis of global trends affecting children

Changing Childhood Project

What is childhood like today?

Prospects for Children: Global Outlook

An annual analysis of trends shaping the world and their impact on children

Report Card

Understanding child well-being everywhere

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UNICEF Innocenti works for and with children and young people to seek solutions to their most pressing challenges. As we focus on the rights and lives of children and young people, we always ask: Who else can we include? Will this work cause unintended harm? Are there events that could surprise us? Does this work drive change?

Events and insights

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Celebrating women in education

A closer look at female teachers and school leaders

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As they move

Child and youth experiences of migration, displacement and return in Afghanistan

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Parenting programmes can reduce violence against children

UNICEF, Prevention Collaborative and Equimundo launch three new evidence briefs

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Refugee youth-led organisations

The under-explored impact and potential

A group of adolescent girls wearing brightly coloured saris in India playing in a field of yellow flowers

Launch of UNICEF's Youth Foresight Playbook

28 November 2023, Dubai Future Forum

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Expert consultation on age-related public expenditure

12-13 April 2023

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The Third Annual KIX Symposium

12-13 October 2022

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UNICEF at the International SBCC Summit 2022

5-9 December 2022

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IMAGES

  1. Clinical Governance and Research Governance Frameworks

    research governance framework for health and social care

  2. What is clinical governance [+ what are the 7 pillars?]

    research governance framework for health and social care

  3. Framework on governance of health research

    research governance framework for health and social care

  4. Research Governance Framework For Health And Social Care

    research governance framework for health and social care

  5. Shared Governance Structure

    research governance framework for health and social care

  6. Research Governance Framework For Health And Social Care

    research governance framework for health and social care

VIDEO

  1. Health and Social Care Workforce debate 13.07.23

  2. Course Project

  3. Research Governance: Keeping Research Safe for Everyone

COMMENTS

  1. PDF Research Governance Framework for Health and Social Care

    Second edition, 2005. Research Governance Framework for Health and Social Care. Foreword. The Research Governance Framework outlines principles of good governance that apply to all research within the remit of the Secretary of State for Health. Research governance is one of the core standards for health care organisations.

  2. UK Policy Framework for Health and Social Care Research

    Last updated on 6 Sep 2023. This policy framework sets out principles of good practice in the management and conduct of health and social care research in the UK. These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate ...

  3. UK Policy Framework for Health and Social Care Research

    A policy framework that sets out principles of good practice in the management and conduct of health and social care research, taking account of legal requirements and other standards. It covers the scope, implementation, responsibilities and audience of the policy framework, as well as the principles and responsibilities for different types of research.

  4. [Withdrawn] Research governance framework for health and social care

    This publication was withdrawn on 7 November 2017 and the updated policy framework is on the HRA website. It sets out the broad principle of good research governance for research relating to health and social care in England.

  5. MRC policy on the UK policy framework for health and social care research

    To ensure that health and social care research in the NHS is conducted to high scientific and ethical standards, the UK policy framework for health and social care research defines broad principles of good research governance.The UK policy framework was released in October 2017 by the Health Research Authority to replace the previous research governance frameworks of England, Wales, Scotland ...

  6. 29

    Research governance framework. Research is essential to the successful promotion of health and well-being. Many of the key advances in the last century have depended on research, and health and social care professionals and the public they serve are increasingly looking to research for further improvements.

  7. PDF Research Governance Framework for Health and Social Care

    Research Governance Framework for Health and Social Care Second edition, 2005 - Annex

  8. Research Governance Framework For Health and Social Care

    The framework is offered as a model for the governance of research in other areas where poor practice could have a direct impact on the health or wellbeing of the public. Standards: ethics, science, information, health and safety, finance, quality research culture. Responsibilities and accountability: agreements, specific responsibilities.

  9. Research governance framework for health and social care

    Research use and support needs, and research activity in social care: a cross-sectional survey in two councils with social services responsibilities in the UK. Cooke J, Bacigalupo R, Halladay L, Norwood H. Health Soc Care Community, 16(5):538-547, 01 Apr 2008 Cited by: 7 articles | PMID: 18384359

  10. Research governance framework for health and social care

    This document sets out a framework for the governance of research in health and social care. The framework applies to all research that relates to the responsibilities of the Secretary of State for Health; that is, research concerned with the protection and promotion of public health, research undertaken in or by the Department of Health, its non-Departmental Public Bodies and the NHS, and ...

  11. Research governance framework for health and social care

    2003. TLDR. It is considered whether the new Research Governance Framework for Health and Social Care and the new arrangements for research ethics committees will provide counterbalance to greater commercial interests into the NHS through research networks involving both public and private interests. 20.

  12. The Research Governance Framework for Health and Social Care

    The Research Governance Framework for Health and Social Care is a framework of responsibilities and quality checks formulated by the English Department of Health for researchers and others. Primary care trusts were required to comply with the RGF by April 1, 2003.

  13. Research governance framework for health and social care: annex

    The Research Governance Framework for Health and Social Care sets out principles, requirements and standards for the governance of research in health and social care. The framework applies to all research that relate to the responsibilities of the Secretary of State for Health; that is, research concerned with the protection and promotion of public health, research undertaken in or by the ...

  14. Research governance framework for health and social care

    Shareable Link. Use the link below to share a full-text version of this article with your friends and colleagues. Learn more.

  15. Replacing the Research Governance Framework

    The HRA is coordinating and promoting the development of a new UK Policy Framework for Health and Social Care Research, which will replace the 4 Research Governance Frameworks (RGF) for research in health and social care. The HRA has conducted various exercises to understand the current systems and practices for research governance in health and social care, and to inform the development of the new policy framework.

  16. Active Health Governance—A Conceptual Framework Based on a Narrative

    The framework emphasizes research on the social determinants of health, promoting policies for protecting health rather than simply improving health care, and intervening at the level of health systems rather than health professionals . From this point, this framework on active health governance ought to be viewed as a "proactive" strategy ...

  17. Research governance: where did it come from, what does it mean?

    In the UK, the main reference point is the Research Governance Framework for Health and Social Care, 8 whose stated purpose is to enhance ethical and scientific quality, promote good practice, reduce adverse incidents and ensure lessons are learned.

  18. UK Policy Framework For Health and Social Care Research

    The The UK Policy Framework for Health and Social Care Research outlines the principles of good governance for all research within the remit of the Secretary of State for Health. ... The RGF has been replaced by UK Policy framework for Health and Social Care Research in 2017. A number of different individuals and organisations are involved in ...

  19. PDF Research Governance Framework for Health and Social Care Research

    Authority's (HRA) UK policy framework for health and social care research1 and will be guided by procedures developed by the HRA, to ensure a consistent approach to co-ordinating and standardising regulatory practice. This will achieve compatibility between the UK and Isle of Man for the management and conduct of health and social care ...

  20. Research governance framework for health and social care

    Research governance framework for health and social care. Research governance framework for health and social care Health Soc Care Community. 2002 Jan;10(1):6-9. doi: 10.1046/j.0966-0410.2001.00336.x. Author Marc Taylor 1 Affiliation 1 NHS R & D Funding, Department of ...

  21. PDF Research governance policy

    activity, staff should ensure compliance by following the NICE research governance framework. Responsibilities 11. NICE's Science Policy & Research (SP&R) Programme is responsible for managing the NICE research governance policy, providing advice on its implementation and managing the research register (the central database

  22. Research governance: implications for health library and ...

    The Research Governance Framework for Health and Social Care published by the Department of Health in 2001 provides a model of best practice and a framework for research in the health and social care sector. This article reviews the Department of Health Research Governance Framework, discusses the i …

  23. Research governance framework for health and community care

    A framework for the governance of research in health and community care is presented. The principles underpinning the framework apply to all research which relates to the responsibilities of the Minister for Health and Community Care. That is, research concerned with the protection and promotion of public health, research undertaken in or by the Scottish Executive Health Department, (SEHD ...

  24. Strengthening data governance in US public health

    Data governance can be especially critical for enabling the functions of state public health agencies. For example, a single, unified framework can enable earlier detection of public health threats, a more coordinated response to public health emergencies, better-informed daily decision making, and an increased ability to manage risks.

  25. Strategies to Improve Health Outcomes and Advance Health Equity in

    In the context of this NOFO, the NIAMS is interested in applications that support the exploration of strategies to address social determinants of health to improve quality of health and promote equity in rural populations in the NIAMS mission-relevant disease areas. Research in community health care settings is particularly encouraged.

  26. UNICEF

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