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• Volume 47, Issue 5
• Process of risk assessment by research ethics committees: foundations, shortcomings and open questions
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• http://orcid.org/0000-0002-1953-9909 Pranab Rudra ,
• Christian Lenk
• Institute of the History, Philosophy and Ethics of Medicine , Ulm University , Ulm , Baden-Württemberg , Germany
• Correspondence to Pranab Rudra, Institute of the History, Philosophy and Ethics of Medicine, Ulm University, Ulm, Baden-Württemberg 89073, Germany; rudrapranab{at}gmail.com

Risks and burdens in the study participation, as well as an adequate risk-benefit balance, are key concepts for the evaluation of clinical studies by research ethics committees (RECs). An adequate assessment and continuous monitoring to ensure compliance of risks and burdens in clinical trials have long been described as a central task in research ethics. However, there is currently no uniform and solid theoretical approach to risk assessment by RECs. Regulatory standards of research ethics such as the Declaration of Helsinki provide only minimal guidance on how risk decisions are considered. Due to discrepancies in the existing literature and guidance documents, adequate risk assessment by RECs remains to be elusive. In this article, we address current definitions of risk and present our own concept of aggregate risk definition. Moreover, we highlight the concept of benefit, the standard of reasonableness with respect to ethics literature and different approaches of risk-benefit assessment. In order to present a comprehensive theoretical approach of risk assessment by RECs, further understanding of the definitions of risk may improve adequate decision-making tasks by RECs. To improve the process of risk assessment by RECs, a dynamic framework will be illustrated, showing step-by-step risk assessment functions. This approach may be a promising tool to ensure adequacy in risk assessment by RECs.

• research ethics
• clinical ethics
• clinical trials
• ethics committees/consultation
• technology/risk assessment

https://doi.org/10.1136/medethics-2019-105595

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Introduction

The concept of risk within the clinical research community is considered to be a central element and is frequently mentioned in scientific publications, guidelines and regulations. 1–8 Over the last two decades, increased globalisation of clinical research paved its path to the increased expansion of clinical trials. 9 Although regulatory documents for every clinical research addressing benefit and harm comparison are helpful, there is no uniform methodology inherent on how research ethics committees (RECs) should use the heterogeneous information on risks and burdens gathered from clinical studies. Lacking, however, is a comprehensive and systematic framework for risk-benefit evaluations based on the relevant literature and on guidance documents. As a result, the role of RECs in risk evaluation and monitoring is not clearly understood, particularly in terms of the ongoing clinical trial. This issue is highlighted by Rid and Wendler: “The regulations seem to leave those charged with assessing the risks and potential benefits of medical research with only their own intuitions to guide them. However, while normative judgment is a crucial part of ensuring that medical research is ethical, these assessments should be based on a systematic evaluation of the risks and benefits posed by individual research studies, not based on mere intuition regarding which procedures and studies are, and are not, excessively risky”. 2 This critical description of the framework of risk assessment by RECs is supported by a number of further publications. 5 10–12 On the one hand, research ethics looks back at a long and fruitful discussion concerning the criteria of risk assessment. On the other hand, there are still uncertainties on how to use these criteria in the field of clinical trials in a regular and systematic manner in order achieve adequate risk monitoring and patient protection.

The importance of a rigid risk assessment and monitoring in clinical trials was dramatically demonstrated by a Dutch study in pregnant women that had to be terminated after fatal results during summer 2018. Due to a decision of the Data Safety and Monitoring Board of the Dutch Strider Trial, the risk-benefit ratio of the trial was regarded no longer acceptable. The data revealed that 17 infants born to women given the drug sildenafil (Viagra) had lung problems, and 11 of those infants died, in comparison to 3 infants with lung problems in the placebo group, where no infants died. 13 The study’s goal was to find an effective treatment against fetal growth restriction, where the published study design of the drug sildenafil proved to be effective and successful in a number of animal and preclinical studies. 14 In case an ongoing trial fails to show a significant beneficial effect or shows a signal of harm, RECs may decide to stop the trial and allow detailed review and validation of the findings before any further exposure of the given drug occurs. 15 The dramatic chain of events that took place in the Dutch study stands as an alarming example of possible weaknesses of monitoring and constant risk-benefit assessment in clinical trials. Reports of the deaths of research subjects raise serious concerns regarding the system and processes by which the participant’s safety is monitored.

This article considers three especially contested areas of research risk. First, we will review the concept of risk and benefits used in the relevant literature with respect to clinical practice (see section ‘Understanding risks and benefits in clinical studies’). Second, we will review the term ‘reasonable risk’ using different evaluation procedures that RECs may rely on when weighing the risks and benefits of medical research (see section ‘Reasonable risks as a common standard for clinical research’). Finally, we illustrate a new approach for risk assessment in clinical trials, which can be applied to the different study phases with respect to different kinds of risks at different time points (see section ‘Process of risk assessment’). We argue that such a comprehensive model may assist RECs and physicians to improve the monitoring of clinical trials as well as patient safety. In this article, we do not focus exclusively on pharmacological studies, but want to present concepts usable for all kinds of clinical studies.

Understanding risks and benefits in clinical studies

Regarding the international regulation and monitoring of clinical research, we find a well-defined system for the classification of pharmaceutical risks and medical devices, but no comparable provisions in other fields (eg, other interventional studies in medicine, surgery or psychology). This leaves out subjective and emotional burdens as well as additional physical or social risks for patients and study participants. At present, it is an open question, how the pharmacological understanding of risk can be complemented by risks and burdens of additional research procedures such as performing biopsies, spinal taps or experimental surgical interventions.

A systematic literature research review 3 5 16–19 reflects a widely endorsed definition of risk—a product formula for possible harm that may occur, expressed as chance (probability), and severity (magnitude) of the envisioned harm, denoting to the formula

In the economic sciences, it is widely accepted that the second factor, ‘severity of damage’, can be adequately described as the amount of financial damage (eg, the damage of a house, the loss of a car or the compensation for an injury). Evidently, such a concept of risk is in the end not very well suited for medicine and research ethics. As King and Churchill explain, ‘[b]oth potential benefits and risks of harm should always be examined and characterized, to the extent possible, according to their nature, magnitude (size and duration), and likelihood’. 20

Based on this definition, we propose an extended concept of risk and benefit and a comprehensive understanding of risk which does not only cover pharmacological risks and burdens in clinical trials. We define the extended clinical risk as the product of the frequency, the kind of harm and the magnitude (size and duration) of the expected side effect ( Box 1 , (2)). For example, it could be known that a drug causes in the case of 1%–10% of the treated patients impaired vision to a severe degree, but that this is a transient condition. Such a description would be adequate from a medical ethics’ perspective. The frequency of risk and benefit can be deduced from the former experience with a therapeutic intervention. In the case of common medical interventions, the rate of side effects is often published in medical guidelines.

Definitions of risk, types of risk and types of benefit

Economic concept of risk: risk=frequency×severity of damage

Example: risk of dying in a car crash=10 deaths p.a./100 000 vehicles=0.0001%

Extended concept of risk and benefit (King and Churchill 2008): risk=frequency×[(kind of harm+magnitude (size+duration)] benefit=frequency×[kind of benefit+magnitude (size+duration)]

Examples:risk=1%–10% of treated patients×(impaired vision+severe+transient) benefit=10% of treated patients×(6 months higher life expectancy+median quality of life )

Comprehensive understanding of risk: The overall risk and burden of study participation consists in the aggregate of partial risks and burdens (drug risk, additional physical risks/burdens, social risk, psychological risk/burden)

Additionally, to develop a comprehensive understanding of burden and risk in a clinical study, we come to the definition of comprehensive risk in Box 1 , (3). The overall risk and burden in a clinical study is then the sum of partial risks and burden in four different areas ( figure 1 ): first, the drug risk, which contains adverse events and side effects. Second, there are the burdens of study measurements like additional X-rays or spinal taps. Third, genetic examinations can also include some social risks, and the same is true for psychiatric or psychological examinations which strongly intrude into the privacy sphere of the participants. Finally, there exist psychological risks and burdens, for example, when psychiatric patients are questioned about sexual abuse in their childhood.

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Different types of risk in clinical studies.

In general, this is contrasted with three forms of benefit ( figure 2 ): first, the direct clinical benefit, that is, when the patient directly profits from a new therapy in a study. Second, the group benefit, that is, when the patient herself or himself does not directly profit from the intervention, but future patients having the same disease, and third the scientific benefit, that is, to provide generalisable knowledge which is normally produced in all studies of basic research. 20 These three forms of benefit are also incorporated in the Declaration of Helsinki and are connected to the acceptability of risk, that is, larger forms of risk are only acceptable when study participants have the chance to realise a direct clinic benefit. When the study participation bears only the chance for a group benefit, only minor risk is seen as acceptable (Art. 16–18). 4 From our point of view, with these definitions and descriptions of benefit and risk, research ethics has the necessary concepts and terminology to carry out an adequate benefit-risk assessment, over and above the reductionist understanding of pharmacological risk alone.

Different types of benefit in clinical studies.

Reasonable risks as a common standard for clinical research

International conventions and guidelines, as well as national law, usually demand an ‘adequate’ risk assessment and a ‘weighing’ of risks and benefits for the individual participant. From the participant’s point of view, it has to be determined, that in her or his situation, the probability and amount of harm in a clinical trial is acceptable or appropriate and does not exceed defined ethical, legal and medical thresholds (eg, pain, fear or toxicity). 21 The amount of risk for a special intervention (ie, the application of a new drug or an innovative surgical intervention) is often difficult to determine even for medical experts and has to be concluded—among other sources—from detailed statistical analysis and the available literature. A clinical trial has the aim to show the superiority or at least the non-inferiority between two or more different and prima facie equivalent medical interventions (the so-called clinical equipoise). When dealing with patient populations, risks are compared with those of the existing standard of care, which may itself involve a great deal of risk and the level of risk tolerance may therefore be quite high; when no such effective treatment or procedure exists, the benefits and risks of an innovative treatment approach are often compared with placebo. In this context, a comparable problem exists in the case of placebo use in a clinical trial when study participants are at risk of disease progression due to the placement in the placebo group. 22 23 However, there are currently no clearly defined criteria and procedures on how this should be organised. Therefore, the implementation of risk evaluation for RECs still remains a challenge. In the international research ethics literature, there are especially three approaches that discuss possible and adequate forms of risk assessment:

Weijer and Miller wanted to make RECs’ decisions more understandable and objective, and therefore suggested component analysis in the evaluation of clinical research. The component analysis divides the individual research interventions included in a given study into two groups: therapeutic and non-therapeutic. The approach involves an independent risk assessment of each research intervention or procedure involved in a study (eg, drawing blood, performing CT scan, taking liver biopsy). 24 25 According to Weijer, therapeutic procedures are justified in terms of the clinical benefits of the participants, that is, clinical equipoise must be met. In contrast, non-therapeutic procedures are regarded as justified when the procedure in the study includes knowledge gain (ie, administered solely for the purpose of answering scientific questions and the potential to advance society’s interests) provided that the risk is acceptable and does not or only slightly exceed risks of daily life.

In response to Weijer’s component analysis, Wendler and Miller developed the ‘net risks test’ that assesses the risk-benefit profile of each intervention by comparing its risks with the potential clinical benefits and then comparing them with existing alternatives. 26

The direct benefit assessment is used in risk assessment by RECs, which is derived from the US guidance documents for medical research on humans. 27 This assessment instrument offers a possibility to avoid the therapeutic and non-therapeutic distinction and takes the direct clinical benefits of a study for the participants as the deciding criterion for ethical considerations.

Concerning the three shortly described approaches, it catches one’s eye, that they do not give a clear and substantial definition of ‘reasonable risk’. The criteria are always relative or proportional to possible clinical or scientific benefits. Therefore, these instruments do not give a direct answer of what is meant by a ‘reasonable’, ‘justified’ or ‘balanced’ relation of risk and benefit. Rather, they can be regarded as decision aids for experts with longstanding experience in the field. It remains an open question, whether such approaches can ensure a homogeneous level of regulation based on similar decisions from different RECs and in the assessment of different clinical trials. Additionally, especially the Belmont Report and the different versions of the Declaration of Helsinki take up a stance regarding an adequate risk assessment. The different aspects of risk assessment in clinical research studies from the Declaration of Helsinki are compiled in table 1 .

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Criteria for risk assessment in clinical studies according to the Declaration of Helsinki

A closer look at these criteria of risk assessment in table 1 reveals that there are in general two different kinds of ‘reasonable risk’: first, we find a relative or proportional understanding of risk in the majority of passages in the cited documents. This suggests that it is asked or stated that an existing risk might be acceptable in comparison to the clinical benefit for the concerned patient, the benefit for society or in comparison with existing alternatives ( table 1 , (1–3)). We can call this a proportional understanding of risk, because it results in the point of view that the existing risk must be proportional to an aspired good or benefit. For example, when the patient suffers from only a minor disturbance of health and well-being, it would be irrational to accept major risks and burdens for the treatment of this condition. However, in the case of severe or untreatable diseases, it is rational to accept larger risks and burdens in the treatment of the disease. Such an understanding of risk seems to be adequate for medical research, but maybe produces further questions in some situations, for example, when patients suffer from a potentially lethal disease with no existing treatment options. Where is then the limit in such a relative understanding of risk and what is acceptable for such patients in the research for new therapies? The proportional perception of risk comes here to the conclusion, that also the sacrifice of important patient interests could be acceptable in such cases. From the ethical point of view, such a result is a dilemma of benefit-risk assessment (for further problems with the ‘weighing’ of risks and benefits, see King and Churchill 20 ). Given that such patients are an especially vulnerable group in research ethics, alternative approaches would be necessary to solve this dilemma.

Second, one can notice an absolute or definite understanding of ‘reasonable risk’ in the quotations number 4 and 5 from the Declaration of Helsinki ( table 1 , (4 and 5)). The first quotation number 4 refers to vulnerable patients who have no direct clinical benefit when participating in a research project. Art. 28 of the Declaration of Helsinki claims that in such cases only ‘minimal risk and minimal burden’ is acceptable. This indicates an absolute understanding of risk. Quotation number 5 refers to placebo studies and studies where standard treatment is withheld. According to the Declaration ‘additional risks of serious or irreversible harm’ must be excluded in such cases, which indicates an absolute understanding of risk as well. Apart from these two articles, the relative or proportional understanding of risk is seen as adequate or reasonable. The term absolute represents a predetermined or fixed risk level to ensure clinical safety for the participants. For example, exposing a group of children or individuals to the burdens of study participation (ie, an additional blood sampling) would not violate the requirements of patient protection when the study has the potential to promote the health of this patient group with minimal risk and burden. In such cases, Kopelman proposes an upper limit for risk, which ‘(a) represents no more than a minimal risk for children with conditions who are enrolled in studies and (b) be no more than a minor increase over minimal risk for healthy children were they enrolled’. 28 This constitutes an absolute standard of risk which is applied to children and other vulnerable groups.

Process of risk assessment

It remains unclear whether the models proposed in the literature are already used by RECs when making decisions in interdisciplinary consultations. The common risk-benefit approaches, namely component analysis, net risk test and direct benefit assessment do not give a complete account of risk-benefit assessment of medical research. 2 18 24–26 Most importantly, none of them accounts for risk identification on a continuous basis throughout the clinical trial. An ideal risk assessment process should start at the protocol design so mitigation can be built into the protocol and monitoring documents.

In the following, we describe the different steps in the assessment procedure of RECs, as it is portrayed in figure 3 . So far, the internal process of risk assessment has not been adequately described in relation to the different components of clinical trials (initiation phase, start of trial, conduct, reporting, end of trial). Our description refers to the processes as they are currently practised by RECs and other responsible authorities (eg, the respective national body responsible for the market approval of new drugs, ie, the Food and Drug Administration in the USA, the Medicines and Healthcare products Regulatory Agency in the UK and the Federal Institute for Drugs and Medical Devices in Germany). Additionally, the description includes the proposal of the extended concept of risk and benefit (see section ‘Understanding risks and benefits in clinical studies’) and a systematic order of REC risk assessment at different points in time in the course of the clinical trial. Therefore, the description represents a normative or idealised risk assessment procedure for RECs.

The process of risk assessment by research ethics committees. DSURs, Development Safety Update Report; EMA, European Medicines Agency; SAEs, Serious Adverse Events; SUSARs, Suspected Unexpected Serious Adverse Reaction; t1, Evaluation of Risk before Trial Start; t2-t3, Reporting in the Course of the Trial; t4, Foreseen End of Trial.

The process begins with the initiation phase of the clinical trial ( figure 3 , (1)) and the submission of the study protocol together with clinical and preclinical data and further documents to the official authorities and to the responsible RECs. In the assessment of the clinical trial by the REC, risks are identified and compared ( figure 3 , (2)) with standard treatment (insofar there is an established standard treatment). To come to a comprehensive understanding of risk, as described above, the different types of risk ( figure 1 ) have to be examined. It follows ( figure 3 , (3)) the proof of the risk classification, that is, what is to date known regarding the frequency of risk. The frequency at which the risk occurs is an important factor in classifying risk according to its weight. The European Medicines Agency guidelines classify drug risks according to the likelihood and severity of adverse events (ranging from very common to very rare). The risk-benefit assessment demands knowledge and a proper understanding of setting priorities in terms of risk identification and classification ( figure 3 , (4)). Considerations such as what can go wrong or the probability of a negative outcome occurring or trial subject’s safety, well-being and rights are all part of the assessment process. Different criteria of risk-benefit assessment profile of clinical trials, drug trials, first-in-human use, children, vulnerable groups and individuals according to Declaration of Helsinki are taken into account. 29

In summary, the concerned REC and the respective national body assess the information for a well-founded risk-benefit balance and take possible steps to reduce the risk to an acceptable level ( figure 3 , (5)). Once the right risk-benefit balance has been determined, the authorities finally decide on whether the clinical trial is allowed to start ( figure 3 , (5 and 6)). The regular reports of expected and unexpected adverse events ( figure 3 , (7)) during the trials are used to classify the risks appropriately (ranging from mild risk to the death of a participant). According to the international drug regulations, adverse events in drug trials have to be regularly communicated to the RECs and the responsible authorities. By systematic documentation of the adverse events, RECs gain insight into the existing risks and burdens in a clinical trial. This is complemented by annual reports of the researchers regarding the safety of the trial. In the course of the continued risk observation and assessment, the question arises, whether the original risk-benefit assessment at the trial start (t1) was accurate in comparison with the later on reported types and level of risk (t2–t3) ( figure 3 , (8)). At the present point of time, it is not defined in the Declaration of Helsinki or other documents (at least in the European Union) how much effort RECs should invest into this task of risk monitoring in clinical trials. However, as the above-mentioned example of the Strider Trial shows, this task is of extreme importance. In case of a fundamental deviation from the previously expected risk level and an excess of severe adverse events, the responsible authorities have the possibility of a termination of the clinical trial ( figure 3 , (9)). Otherwise, the trial reaches its foreseen end as it was defined in the study protocol ( figure 3 , (10)).

From our point of view, this systematic approach to risk assessment in clinical trials can facilitate better and more informed decision-making and make an important contribution to a steady and continuous improvement of patient safety. Although the approach presented here is an evolving framework, the concept is expected to benefit the RECs how and to what degree of transparency the information is shared. One should also consider that numerous values ground risk judgements and that a more comprehensive approach towards risk assessment will be more sensitive to the different needs and burdens of study participants. Additionally, a more systematic approach can strengthen the coherence of REC decisions and therefore the trust between researchers and the institution of the REC as such. Such an approach could also identify remaining elements of uncertainty in the concept of a research project, where more assertive measures from the REC could be needed. It is, however, in the responsibility of all involved parties to best contribute to the delivery of an effective risk assessment in research studies.

The task of risk-benefit assessment by RECs is a complex endeavour. To better understand this assessment, we took initiative to explore the literature definition and reasonableness of risk in clinical studies. We summarised how authors from ethics literature perceive risk and benefit definitions. A key part of the assessment process is to understand what reasonable risk means. Generally, with the term ‘reasonable risk’ we understand a proportionality of risks and benefits while for vulnerable groups there should only be minimal risks with the exclusion of any irreversible risks. In any case, a systematic approach where the definition and reasonableness of risk are uniform and its heterogeneity addressed promises to reduce unreliable decisions made by RECs. A model system to articulate the process of risk has been proposed here which provides a compelling dynamic foundation for a framework for assessing risk in clinical studies. The model may prove effective for continuous risk assessment in different clinical studies while maintaining a ‘homogenous approach’ by the RECs. The appropriate conduct of the risk assessment process suggested here may ensure step-by-step compliance with regulations and can prevent—in the given limits of risk assessment—major unjustified risks to participants in the study. When following the systematic framework, the RECs will be able to indicate any amendments related to risks and can, therefore, respond to them accordingly, timely, accurately and effectively.

To sum up, by looking at the theoretical aspects of risk in all dimensions, in particular, definition and reasonableness, we can better identify the problems of discrepancies and strategise consolidated solutions of risk assessment. Following the described process of risk assessment would be fruitful for RECs to conflate ethical considerations and risk-benefit tasks, thereby improving the functioning and the ethical consultation of RECs. As described above, the aim of a responsible risk-benefit assessment cannot be reached by only punctual and intuitive activities. Instead, a steady and systematic approach by RECs is needed, particularly in improving ongoing or intermediate clinical trials and patient safety. Next to that, our description of the domain of risk assessment in clinical trials shows that there should be more efforts for the establishment of absolute risk thresholds, for example, in the case of specific diseases (ie, cancer research, dementia research). This could lead to a more homogeneous risk assessment between different RECs, also in international comparison. Such an approach may be extremely important especially in the case of patients with severe and incurable diseases, where up to now a proportionate approach for risk assessment is not possible.

Acknowledgments

The authors would like to thank the two anonymous reviewers for their helpful comments, which have been incorporated into this article.

• Van Ness PH ,
• National Commission
• World Medical Association Declaration of Helsinki
• Kimmelman J
• EU Expert Group
• ↵ Regulation (EU) NO 536/2014 of the European Parliament and of the Council: clinical trials on medicinal products for human use, and repealing directive 2001/20/EC 2014 .
• Grinnell F ,
• Sadler JZ ,
• McNamara V , et al
• Emanuel EJ ,
• Alfirevic Z , et al
• Ganzevoort W ,
• Palmboom GG ,
• Willems DL ,
• Janssen NBAT , et al
• Engel-Glatter S
• Lantos JD ,
• Wendler D ,
• Septimus E , et al
• Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada
• Churchill L
• Emanuel E ,
• Kopelman LM
• European Commission

Contributors All authors contributed significantly to this article.

Funding This paper was written with support from the Medical Faculty of Ulm University.

Competing interests None declared.

Provenance and peer review Not commissioned; externally peer reviewed.

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Understanding Potential Risks for Human Subjects Research

As part of their ethical duty to participants, all researchers are required to properly identify, minimize, and disclose any potential harm or discomforts that may come to participants. These harms and discomforts are labeled as “ risks, ” and should be minimized, according to the beneficence principle of the Belmont Report . Any risks that may potentially befall participants must be disclosed in the informed consent , and participants should be given the choice of whether or not to participate in research. 

Additional risks may also be encountered in light of a catastrophic event (e.g., a natural disaster, epidemic, terrorist attack, pandemic, etc.). During these times, researchers with active protocols must review their study activities to identify and mitigate any new risk. For example, prior to the COVID-19 pandemic and depending on the topic, TC IRB typically considered in-person surveys with adults competent to consent as low risk. Under COVID-19 circumstances, however, studies with in-person components are now reviewed as higher risk, as person-to-person exposure is the most frequent route of transmission for infectious viruses. The IRB is required to assess the level of risk involved in a research study when making a determination for review requirements. Some items factoring into the IRB’s risk assessment include possible risk to a subject’s psychological wellbeing, or the risk to a subject if their confidentiality is compromised. The more risk involved in a study, the higher the level of review and the more human subject protections required by the IRB.

Examples of Potential Risks & Suggestions for Mitigation

Reviewing potential risks to participants requires a knowledge of various types of harm or discomfort that participants may encounter. The Teachers College research community is largely composed of behavioral and social researchers. The following examples and suggestions for minimizing risks are likely to be encountered in behavioral science research, though they may also extend to biomedical and other types of research as well. 

Loss of Time : Researchers are required to include the estimated time of each study activity and the total time of completion on the informed consent (parent permission or assent form). Researchers should: 

• Estimate study completion time based on pilot tests.
• Consider the reading level of participants (e.g., 3rd grade readers vs. post-secondary students) when calculating the time necessary to complete the study.
• Reasonably overestimate times to account for participants that may take longer.
• Prepare for potential time delays when using online software (e.g., Zoom ) or introducing new activities.

Traumatic Events: Recalling traumatic or distressing events can be uncomfortable, and in some cases, harmful to an individual.  Traumatic events are defined as events that are shocking, scary, or dangerous (e.g., natural disasters, acts of violence, accidents, etc.). While it is not always possible to identify what types of questions may trigger participants, researchers should identify and disclose questions or activities pertaining to traumatic events. Researchers should: 

• Disclose any topics, study activities, or questions that may be triggering in the informed consent. For example, if the study includes questions about a traumatic event (e.g., 9/11), provide a trigger warning such as “The next section will include questions that may be uncomfortable to you. This study is voluntary. You can choose to stop the study at any time or skip any question.” 
• Monitor the participant during each study activity and after, if possible. While the participant may appear fine during a study,  recalling traumatic events may lead to flashbacks, insomnia, trouble concentrating, or higher levels of anxiety, sadness, or anger for a prolonged period of time.
• Provide participants with a list of community resources, or offer free counseling services (if appropriate), should the need arise.
• Consider options such as recruiting a trained professional to be available to help debrief the participants if they start to experience symptoms of distress.

Unwanted Stimuli: Exposure to unwanted or distressing stimuli during a study’s activities may bring harm and discomfort. Participants should not be exposed to distressing stimuli (e.g., pornography, smoking, suicide) without first providing their clear consent. Researchers should:

• Know the risks associated with exposing participants to unwanted stimuli (e.g., increased sadness or irritability), and implement additional safeguards throughout their study, such as debriefing participants after the study activities are finished.
• Refrain from exposing high-risk groups to unwanted stimuli. For example, study activities including heavy drinking or intoxication should screen out recovering substance users.  

Labeling: Participants unfamiliar with clinical terminology may begin to identify with disorders or personalities outlined in study measures. For example, someone taking a scale labeled “Depression Scale” may begin to identify as having depression without receiving a clinical diagnosis. Researchers should:

• Reduce participant confusion by appropriately and clearly naming scales or removing measure names altogether. 
• Examine tiles of studies for potential bias and risk to participants.

Environmental Stimuli: Environmental stimuli, such as the research location, building layout, lighting, or external noise, is not always considered in the research design. However, some stimuli may be triggering for participants, and should be eliminated, if possible. Researchers should:

• Examine their research space for any environmental allergens or health issues, such as dust and flickering lights, prior to inviting participants.
• Remain mindful of possible food allergies (e.g., nuts, shellfish, gluten) when serving snacks or refreshments.
• Ensure that the space is safe, secure, hygienic , and, if applicable, private.
• Review the CDC's detailed instructions on how to clean and disinfect workspaces, along with their list of EPA-approved disinfectants .

Minor Emotional Risk: Typical common, but minor, risks include mental fatigue, embarrassment, discomfort, or frustration. Researchers should:

• Review their study activities from the perspective of the participant in order to determine if these emotions might be encountered. For example, a 5-minute survey on personal food preferences is unlikely to cause frustration. However, a study activity in which participants must solve complex mathematical equations in front of peers may cause embarrassment or frustration. 
• Always disclose any anticipated distressing emotions in the consent form.

Participant Relationships: Putting strain on participants’ relationships (e.g., causing a fight between a dating couple) will likely cause harm or discomfort to a participant. Researchers should: 

• Disclose study activities in the consent form that may cause relationship distress.
• Distinguish between study activities that may cause relationship distress  (e.g., this study will examine household spending habits between partners) from unintentional relationship distress perpetuated in error by the researcher. In the latter’s case, the researcher should gauge the situation and take steps to ensure respect, participant autonomy, and care.

Exercise & Repetitive Movements : Studies involving exercise or movement have an inherent risk of physical injury to the participants. Researchers should:

• Disclose all activities at the beginning of the study that may cause physical discomfort.
• Evaluate or discuss the participants’ physical health and ability based on the study activity (e.g., able to lift 20 pounds without assistance).
• Gauge the health of the participant to engage in the activities. For example, does the participant have any underlying health conditions that might impact their ability to participate? (e.g., a study requiring intense cardio exertion might want to screen for asthmatic participants).
• Disclose health risks on the consent form.

Personal Information: A sking questions about private information such as income, health habits, illegal substance use, etc. may be distressing for participants. Inclusion of these types of questions should be clearly justified to the IRB. Researchers should:

• Clarify confidentiality policies.
• Disclose what identifiers may be disclosed, or are at risk of disclosure (e.g., during focus group sessions, researchers cannot guarantee confidentiality).
• Review  Certificates of Confidentiality (CoC) for human subjects, if applicable.

Viral Illnesses, Spreads, or Pandemics: With the COVID-19 pandemic, person-to-person contact is the most frequent route of viral transmission. Researchers with in-person components in their study must evaluate study activities for points of contact. Exposure is at its highest when people are within approximately 6 feet of one another, and in close contact for 15 minutes or more. Shared spaces, equipment, and surfaces (e.g., office keyboards, writing utensils, etc.) can also be contaminated. To reduce the risk of infection, researchers should:

• Wash hands with soap and water for 20 seconds. If soap and water are not available, use a hand sanitizer that contains at least 60% alcohol.
• Avoid touching one’s face.
• Use face coverings when around other people.
• Cover coughs and sneezes.
• Throw used tissues in the trash.
• Practice social distancing, if possible.
• Clean and disinfect high-touch surfaces daily. This may include tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
• Restrict in-person interactions to ventilated areas, or outside when possible.
• Remain vigilant about taking the steps that reduce exposure.

Requirements for Mitigating Research Risks

When assessing risk and benefits in a study, the IRB can support researchers in determining if a risk is justifiable or should be removed. Generally, risks to participants must be minimized, and any risks in the study should be reasonable when compared to the benefits of the study. 

The IRB also requires that each individual participant provides their informed consent. All consent must be documented and available for review if requested. If a participant is unable to provide their consent (e.g., a minor), their guardian must provide consent, and the participant’s assent should be sought. If a participant is likely to be vulnerable to coercion (e.g., prisoners, cognitively impaired persons, etc.), additional safeguards must be outlined in the IRB application. Additionally, researchers must justify the rationale for conducting their study with vulnerable populations as opposed to general populations (e.g., the study provides an intervention which fills a need for that specific population). For sample consent and application language, please visit our  TC IRB Submission Document Templates & Samples guide.

In the informed consent, the privacy and confidentiality of the participants must be appropriately documented. TC IRB recommends that all data be  de-identified prior to the start of analysis. Finally, the research plan must make provisions for the secure collection and monitoring of data (visit our Data Sharing, Requests, & Encryption  for more information). TC IRB has worked closely with TC Information Technologies (IT) to support researchers working remotely with limited resources and technological capabilities. TC IT should be consulted as the first point of contact if data cannot be secured to the standards outlined in the data security plan.

For COVID-19 related information, risks, and preparation please visit  here.

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Appointments are available by request . Make sure to have your IRB protocol number (e.g., 19-011) available.  If you are unable to access any of the downloadable resources, please contact  OASID via email [email protected] .

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Understanding Risk in Research

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Assessing risk in a research study is one of the primary responsibilities of an IRB and one of its most controversial tasks.  By nature, studying human beings is a complicated process because the subject matter itself is complicated.  The level of risk can vary because of many factors including: the population included in the study, the situations encountered by the participants, and/ or the experience of the researcher or team. Two studies may appear similar but a few factors could make one inherently more risky than the other. 

This section describes what a researcher needs to consider when developing a protocol as well as the risk analysis conducted by an IRB board member. This section does not cover ever scenario nor is it meant to be all inclusive; if you have a specific question about the risks in your study, please  contact  our office for further guidance.

Section Topics

Conducting Risk-Benefit Assessments and Determining Level of IRB Review

Regulatory background.

Investigators should understand the concept of minimizing risk when designing research and conduct a risk-benefit assessment to determine the level of IRB review of the research. In the protocol application the Investigator should:

• Assess potential risks and discomforts associated with each intervention or research procedure;
• Estimate the probability that a given harm may occur and its severity;
• Explain measures that will be taken to prevent and minimize potential risks and discomforts;
• Describe the benefits that may accrue directly to subjects; and
• Discuss and the potential societal benefits that may be expected from the research.

Risks to subjects who participate in research should be justified by the anticipated benefits to the subject or society. This requirement is found in all codes of research ethics, and is a central requirement in the Federal regulations ( 45 CFR 46.111  and  21 CFR 56.111 ). Two of the required criteria for granting IRB approval of the research are:

• Risks to subjects are  minimized  by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
• Risks to subjects are  reasonable  in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB Committee will consider  only those risks and benefits that may result from the research , as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research.

Definitions

Benefit:  A helpful or good effect, something intended to help, promote or enhance well-being; an advantage.

Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant.

Minimal Risk:  A risk is minimal when “the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater in and of themselves than those ordinarily encountered in  daily life of the general population  or during the performance of  routine physical or psychological examinations or tests .” Examples of procedures that typically are considered no more than minimal risk include: collection of blood or saliva, moderate exercise, medical record chart reviews, quality of life questionnaires and focus groups. See Expedited review categories for a complete listing.

Minimal Risk for Research involving Prisoners:  The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults. A risk is minimal when, "the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental or psychological examinations of  healthy persons ."

Privacy:  Privacy is about people and their sense of being in control of others access to them or to information about themselves.

Confidentiality:  Confidentiality is about how identifiable, private information that has been disclosed to others is used and stored. People share private information in the context of research with the expectation that it be kept confidential and will not be divulged except in ways that have been agreed upon.

Types of Risks to Research Subjects

Physical Harms:  Medical research often involves exposure to pain, discomfort, or injury from invasive medical procedures, or harm from possible side effects of drugs, devices or new procedures. All of these should be considered "risks" for purposes of IRB review.

• Some medical research is designed only to measure the effects of therapeutic or diagnostic procedures applied in the course of caring for an illness. Such research may not entail any significant risks beyond those presented by medically indicated interventions.
• Research designed to evaluate new drugs, devices or procedures typically present more than minimal risk and involve risks that are unforeseeable that could cause serious or disabling injuries.

Psychological Harms:  Participation in research may result in undesired changes in thought processes and emotion (e.g., episodes of depression, confusion, feelings of stress, guilt, and loss of self-esteem). Most psychological risks are minimal or transitory, but some research has the potential for causing serious psychological harm.

• Stress and feelings of guilt or embarrassment may arise from thinking or talking about one's own behavior or attitudes on sensitive topics such as drug use, sexual preferences, selfishness, and violence.
• Stress may be induced when the researchers manipulate the subjects' environment to observe their behaviors and reactions. The possibility of psychological harm is heightened when behavioral research involves an element of deception.

Social and Economic Harms:  Some losses of privacy and breaches of confidentiality may result in embarrassment within one's business or social group, loss of employment, or criminal prosecution.

• Areas of particular sensitivity involve information regarding alcohol or drug abuse, mental illness, illegal activities, and sexual behavior.
• Some social and behavioral research may yield information about individuals that could be considered stigmatizing to individual subjects or groups of subjects. (e.g., as actual or potential carriers of a gene; individuals prone to alcoholism). Confidentiality safeguards must be strong in these instances.
• Participation in research may result in additional actual costs to individuals. Any anticipated costs to research participants should be described to prospective subjects during the consent process.

Privacy Risks:  Loss of privacy in the research context usually involves either covert observation or participant observation of behavior that the subjects consider private. It can also involve access and use of private information about the subjects. The IRB must make two determinations:

• Is the loss of privacy involved acceptable in light of the subjects' reasonable expectations of privacy in the situation under study; and
• Is the research question of sufficient importance to justify the intrusion?

Breach of Confidentiality Risks:  Absolutely confidentiality cannot be guaranteed and is always a potential risk of participation in research. A breach of confidentiality is sometimes confused with loss of privacy, but it is a different risk. Loss of privacy concerns access to private information about a person or to a person's body or behavior without consent; confidentiality of data concerns safeguarding information that has been given voluntarily by one person to another. It is important to recognize that a breach of confidentiality may result in psychological harm to individuals (embarrassment, guilt, stress, etc.) or in social harm.

Conducting Risk-Benefit Assessments

Role of the Investigator:  When designing research studies, investigators are responsible for conducting an initial risk-benefit assessment using the steps outlined in the diagram below.

Role of the IRB:  The IRB ultimately is responsible for evaluating the potential risks and weighing the probability of the risk occurring and the magnitude of harm that may result. It must then judge whether the anticipated benefit, either of new knowledge or of improved health for the research subjects, justifies asking any person to undertake the risks. The IRB cannot approve research in which the risks are judged unreasonable in relation to the anticipated benefits. The IRB must:

• Identify the risks associated with the research, as distinguished from the risks of therapies the subjects would receive even if not participating in research;
• Determine that the risks will be minimized to the extent possible;
• Identify the probable benefits to be derived from the research;
• Determine that the risks are reasonable in relation to be benefits to subjects, if any, and the importance of the knowledge to be gained; and
• Assure that potential subjects will be provided with an accurate and fair description (during consent) of the risks or discomforts and the anticipated benefits.

Diagram 1: Steps for Conducting a Risk-Benefit Assessment

Ways to Minimize Risk

• Provide complete information in the protocol regarding the experimental design and the scientific rationale underlying the proposed research, including the results of previous animal and human studies.
• Assemble a research team with sufficient expertise and experience to conduct the research.
• Ensure that the projected sample size is sufficient to yield useful results.
• Collect data from conventional (standard) procedures to avoid unnecessary risk, particularly for invasive or risky procedures (e.g., spinal taps, cardiac catheterization).
• Incorporate adequate safeguards into the research design such as an appropriate data safety monitoring plan, the presence of trained personnel who can respond to emergencies.
• Store data in such a way that it is impossible to connect research data directly to the individuals from whom or about the data pertain; limit access to key codes and store separately from the data.
• Incorporate procedures to protect the confidentiality of the data (e.g., encryption, codes, and passwords) and follow UCLA IRB guidelines on  Data Security in Research .

Levels of IRB Review

Exempt research.

Although the category is called "exempt," this type of research does require IRB review and registration. The exempt registration process is much less rigorous than an expedited or full-committee review. To qualify, research must fall into 8 federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments. For additional information see OHRPP Exempt Guidance .

• Anonymous surveys or interviews
• Passive observation of public behavior without collection of identifiers
• Retrospective chart reviews with no recording of identifiers
• Analyses of discarded pathological specimens without identifiers

Expedited Research

To qualify for an expedited review, research must be no more than minimal risk and fall into nine (9) federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. For additional information see  OHRPP Expedited Guidance .

• Surveys and interviews with collection of identifiers
• Collection of biological specimens (e.g., hair, saliva) for research by noninvasive means
• Collection of blood samples from healthy volunteers
• Studies of existing pathological specimens with identifiers

Full Board Research

Proposed human subject research that does not fall into either the exempt or expedited review categories must be submitted for full committee review. This is the most rigorous level of review and, accordingly, is used for research projects that present greater than minimal risk to subjects. The majority of biomedical protocols submitted to the IRB require full Committee review. For additional information see  OHRPP Full Board Guidance .

• Clinical investigations of drugs and devices
• Studies involving invasive medical procedures or diagnostics
• Longitudinal interviews about illegal behavior or drug abuse
• Treatment interventions for suicidal ideation and behavior

Regulations and References

• DHHS 45 CFR 46.110
• DHHS 45 CFR 46.111(a)(1-2)
• FDA 21 CFR 56.110
• FDA 21 CFR 56.111(a)(1-2)
• OHRP IRB Guidebook, Chapter 3: Basic IRB Review, Section A, Risk/Benefit Analysis

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• Int J Qual Health Care

A framework to support risk assessment in hospitals

Gulsum kubra kaya.

Engineering Design Centre, Department of Engineering, University of Cambridge, Trumpington Street, Cambridge, UK

James R Ward

P john clarkson, associated data, quality problem or issue.

A number of challenges have been identified with current risk assessment practice in hospitals, including: a lack of consultation with a sufficiently wide group of stakeholders; a lack of consistency and transparency; and insufficient risk assessment guidance. Consequently, risk assessment may not be fully effective as a means to ensure safety.

Initial assessment

We used a V system developmental model, in conjunction with mixed methods, including interviews and document analysis to identify user needs and requirements.

Choice of solution

One way to address current challenges is through providing good guidance on the fundamental aspects of risk assessment. We designed a risk assessment framework, comprising: a risk assessment model that depicts the main risk assessment steps; risk assessment explanation cards that provide prompts to help apply each step; and a risk assessment form that helps to systematize the risk assessment and document the findings.

Implementation

We conducted multiple group discussions to pilot the framework through the use of a representative scenario and used our findings for the user evaluation.

User evaluation was conducted with 10 participants through interviews and showed promising results.

Lessons learned

While the framework was recommended for use in practice, it was also proposed that it be adopted as a training tool. With its use in risk assessment, we anticipate that risk assessments would lead to more effective decisions being made and more appropriate actions being taken to minimize risks. Consequently, the quality and safety of care delivered could be improved.

Introduction

Across the world, healthcare has devoted substantial attention to ensuring safety [ 1 – 4 ]. A number of studies have been published, such as in relation to safety culture [ 4 ] and the reduction of harm [ 5 – 8 ]. Through continuing efforts to improve safety, reforms have been proposed that have been driven by safety–critical industries (e.g. nuclear and aviation), such as the implementation of risk management system [ 9 ]. So far, however, such reforms have largely prioritized the investigation of incidents over their prevention in the first place [ 3 ]. An approach which focuses on risk assessment [ 10 – 12 ] could complement this reactive practice. Risk assessment, as a part of the overarching process of risk management, aims to identify, analyse and evaluate risks that may have a negative influence on the quality and safety of the care delivered [ 11 , 13 – 16 ].

In the National Health Service in England (NHS England), hospitals assess a range of risks, including wrong medication, delayed discharge, patient claims and failure to comply with requirements. In so doing, hospitals provide risk assessment guidelines and training to support their staff—often frontline and risk management staff—and external authorities support and investigate hospitals to deliver safe care [ 15 , 17 – 19 ]. However, despite considerable efforts being made, a number of problems have been identified with current practice. For instance, patient safety-related risks can be ignored at the organizational level, and health information technology innovations can be assumed to be safe until something goes wrong [ 20 ]; risk assessment techniques are little-used, and if used, they may be used without training [ 12 , 21 ]; risk register systems can be used as bureaucratic data collection rather than to diagnose potential problems [ 19 ]; there can be a lack of consultation with a sufficiently wide group of stakeholders including patients [ 22 ]; risk assessment practice is criticized as lacking in consistency and transparency [ 17 ]; and the risk evaluation guidance provided is insufficient, which may lead to poor decisions being made [ 15 ]. Consequently, risk assessment may be underutilized when attempts are made to ensure safety.

Many of the problems stem from the foundations of risk assessment, including how to express risk, how to analyse it and how to use risk assessment as a tool to improve patient safety [ 14 ]. One way to address such problems is through providing good guidance on the fundamental aspects of risk assessment [ 10 , 23 ]. This paper, therefore, reports the design process for—and content of—a risk assessment framework (RAF). The RAF aims to guide healthcare staff on risk assessment as well as to address current challenges by learning from prescribed good risk assessment practice and the experience of healthcare staff (e.g. doctors, nurses and managers).

Study design

This study adopted a V system developmental model [ 24 , 25 ] (see Fig. ​ Fig.1) 1 ) to design the proposed RAF through the consideration of user needs, requirements, multiple design concepts and the evaluation of the selected concept.

V system developmental model applied for the design of the RAF.

Semi-structured interviews were conducted with healthcare staff from different professions in multiple acute hospitals in NHS England to understand user needs in risk assessment (see Table ​ Table1). 1 ). A purposive sampling strategy was used to ensure participants had sufficient experience of risk assessment. All potential participants were known to the research team, and we received permission to interview 12 individuals. The inclusion criterion was to select participants who had been involved in at least one risk assessment. Interview questions were developed based on the literature findings, with further input from the research team and were then piloted with a healthcare researcher. Participants were asked questions in relation to their understanding of risk assessment (e.g. why and how to assess risks), their practical experience in risk assessment (e.g. which methods to use and how to prioritize risks), their recommendations on how to improve risk assessment practice (e.g. participants’ views on the terminology and methods used), their views on their own organizational risk assessment guidelines, their views on good risk assessment practice (e.g. the accessibility and usability of the guidelines they use) and the challenges that they experience when undertaking risk assessment.

The characteristics of the participants in the user needs interview

T, telephone interviews; F, face-to-face interviews.

Requirements for the new RAF were elicited from the interviews, an extensive literature review and analysis of risk assessment-related documents from 100 hospitals and 35 risk assessment standards from other industries. The findings were reviewed by the authors to ensure that there were no conflicting or inconsistent requirements. From this, the authors identified 23 requirements to design the RAF (see Table ​ Table2 2 ).

Requirements for the design of the RAF

Using the refined list of requirements, through multiple discussions the authors developed a range of design concepts, which were finally refined into a single concept. The authors then evaluated the framework through the use of a scenario as follows:

In a hospital setting, a neurorehabilitation unit will be moved from an old building to a new building, and the standards of the patient rooms will be changed. Since there is a change in the system, a risk assessment will be conducted to assess risks in the new neurorehabilitation unit before the move occurs. As a part of this, a risk assessment will be conducted to assess all risks in relation to the patient’s accommodation in a single-bed patient room.

User evaluation was conducted with 10 participants (8 were new participants) (see Table ​ Table3). 3 ). The evaluation interviews comprised two parts. In the first part, the author (G.K.K.) explained the how the RAF could work with the risk assessment scenario given above. In the second part, each participant discussed their views on the 17 predetermined statements. A Likert scale was then used by the participants to rate their level of their agreement to each statement. The average rating was calculated by assigning a score to each Likert scale (i.e. ‘strongly agree = 5,’ ‘agree = 4, neutral = 3,’ ‘disagree = 2’ and ‘strongly disagree = 1’) in order to aid numerical analysis. In addition to the responses of the user evaluation statements, participants provided brief comments on two open-ended questions to improve the initial version of the framework: ‘what is familiar and what is new about the RAF?’ and ‘what changes would you recommend to improve the RAF?’ and were given additional space to add further comments.

The characteristics of the interview participants for the evaluation

a Participants who had also been involved in the previous interview process.

The design of the RAF was then developed iteratively to improve its usefulness and usability based on the comments given and discussions between the authors.

Risk assessment framework

Having considered all requirements, an RAF was designed by the authors, consisting of a risk assessment model, explanation cards and a risk assessment form.

The risk assessment model comprises four phases (identify, analyse, evaluate and manage), and each phase comprises four steps (see Fig. ​ Fig.2 2 ).

Risk assessment model.

Each step is described on an A5 size double-sided explanation card (see Appendix 1 ), which provides a number of prompts. Table ​ Table4 4 summarizes these prompts at each risk assessment step. These cards are designed to assist healthcare staff in undertaking risk assessment since they bring together the key principles of risk assessment. The risk assessment form is provided to document the risk assessment findings (see Fig. ​ Fig.3 3 ).

A brief summary of the prompts provided for each assessment step

Risk assessment form.

In the identify phase, the system is described, potential undesired events are defined, their contributory factors are determined and their potential consequences are identified. This phase seeks to answer the question: ‘what might happen?’.

In the analyse phase, current controls are examined, and the severity of the consequence, the likelihood of occurrence and the level of risk are estimated. This step aims to address the question: ‘what is the level of risk?’.

In the evaluate phase, the estimated risk level is compared with the risk criteria (e.g. up to a risk score of 9 is generally tolerable) to decide whether or not the risk is tolerable and if there is any need to take any action. Any controls required are listed, and findings of the assessment are documented as well as shared. This phase, therefore, aims to address the question: ‘is there any need for action?’.

In the manage phase, which interacts with all the phases of risk assessment, a team is assembled, historical data are reviewed, techniques to be used in risk assessment are identified, and all activities related to these should be managed. Thus, this phase coordinates the management of all steps to conduct effective risk assessment by seeking to answer the question: ‘how to manage?’.

Evaluation of the RAF

The authors evaluated the framework by conducting a risk assessment through the use of the predetermined scenario. The authors identified 20 potential undesired events (e.g. patient falls); described a wide range of contributory factors (e.g. staff tiredness) and multiple consequences for each potential undesired event (e.g. treatment delay); examined current controls; estimated risk levels; evaluated their tolerability; listed required controls (e.g. replacement of the bed rails) and defined actions associated with the controls (e.g. responsibilities for implementation). This allowed the authors to crudely evaluate the usefulness of the framework, and, therefore, to develop the initial version of the framework iteratively. For instance, the initial version of the framework encouraged risk sources to be identified first, followed by risk scenarios. Subsequently, this was reversed, with the identification of undesired events coming first and then contributory factors, which are considered as risk sources. This was due to the fact that it was easier to identify the undesired event first. Indeed, undesired events are often known in healthcare [ 20 ] and it is more challenging to identify risk sources [ 10 ].

Each interview for the user evaluation lasted approximately 80 min. Results are shown in Table ​ Table5 5 .

Results from the user evaluation statements (RAF = risk assessment framework)

RAF, risk assessment framework.

Regarding the open-ended questions, all participants responded to the first question. For example, I10 stated, ‘The general framework is familiar. However, it builds in a more robust and comprehensive approach to risk assessment and risk control.’ I5 highlighted the reduced jargon and technical terms and found it very useful. Similarly, I8 pointed out that ‘the methodology is presented in much more user-friendly terms than by experts such as ISO 31 000 and the Health and Safety Executive . ’ I9 did not find the RAF to be significantly different to current standards, but highlighted that the inclusion of the contributory factors was the part she found the most useful. She also added ‘I would see my primary use of the RAF as a training aid used during face to face training sessions, with staff then able to use the RAF as a post-training prompt to remind them of the steps they need to follow when carrying out a risk assessment.’ Other participants also claimed that the RAF is familiar to them in terms of its main steps (i.e. identify, analyse and evaluate), but they found the details to be different, systematic and helpful.

Seven of the participants responded to the second question. I9 provided three recommendations: to have stronger linkages between contributory factors and controls/actions, to consider estimating a target risk score as well as the actual risk score and to clarify to what extent to follow the RAF and when to do so. I8 recommended stronger links to objectives and that the framework should allow opportunities to be assessed as well as downside risks. I10 suggested there should be more explanation of what ‘system’ means. I7 suggested adding technique cards to explain a number of techniques to support risk assessment, whereas I4 claimed that adding such cards would make it too complicated. I2, I3 and I6 recommended developing specific cards for different users and use-cases (such as medical devices, and clinical and organizational risk assessments).

Seven participants provided further comments. I7 stated that the RAF closely follows their new risk management training handbook. I4 found the framework to be well presented and simple to understand and stated that it could be used as a teaching aid. I2 found it very accessible and easy to follow. I5 stated that they would like to implement it, I6 found it to be a useful tool, and I1 found the team approach necessary and found the RAF to be ‘really good’. I10 also appreciated the work by stating, ‘I think this is an excellent framework that will help many people’.

Based on the findings from the interviews, the authors further developed the initial design by providing additional guidance on the estimation of likelihood and consequence; developing a ‘abridged’ version of the explanation cards; colouring each phase with a different colour and numbering each card.

This study presented an RAF to guide healthcare staff in undertaking risk assessment. The framework was designed to be systematic and compatible with existing risk assessment practice. In essence, the framework simplifies the risk terminology used, and it brings together the principles of national and international risk assessment standards as well as a number of techniques (e.g. failure mode and effects analysis (FMEA), root cause analysis (RCA) and bow-ties). However, the framework should be tailored to the specific needs of the assessment. For example, local hospital requirements might require a slightly modified set of risk criteria or the use of a more specific contributory factors list. Additionally, we believe the framework could readily be used in different healthcare settings (e.g. primary care), in the UK and worldwide, since it provides guidance on the fundamental aspects of risk assessment.

The framework has the potential to identify a large number of risks through consideration of the system to be assessed, its parts and their interactions, and it has the potential to determine a wide range of contributory factors. In healthcare, contributory factors are often determined following an incident by the use of RCA. Yet, too often only a single cause is identified [ 26 ] despite the provision in the healthcare literature of a number of lists of multiple potential contributory factors [ 27 – 29 ]. Identifying many contributory factors not only helps to understand potential undesired events but also helps to set up effective controls in the system in order to prevent, detect or reduce the severity of the undesired events. However, it should also be noted that identifying many risks does not necessarily lead to better risk controls [ 30 ]. Even a good risk assessment does not lead to safe systems if the findings of the risk assessment are not implemented.

Furthermore, the framework suggests determining the tolerability of a risk through the consideration of multiple factors, including risk scores, organizational and regulatory requirements and the potential benefits of leaving the risk in place, and the framework urges its potential users to assemble a multidisciplinary team to undertake risk assessments. In the English NHS, organization-wide risks tend to be evaluated by individuals through the use of risk matrices in which consequence and likelihood axes are used and categorized, each with a score from 1 to 5 [ 15 ]. However, the use of risk matrices, and thus risk scores, has been criticized in the literature. To gain (or avoid) attention, lower risk scores can be artificially recategorized to a higher risk level (or vice versa), and risk scoring itself can be subjective [ 15 , 31 , 32 ] and can lead to biased judgements about the management of the risks [ 33 , 34 ]. However, taking into account multiple factors to determine the tolerability of a risk would help minimize the limitations of the use of risk matrices, and the involvement of a multidisciplinary team would help to minimize subjectivity in risk scoring.

While the RAF has been shown to offer great value in supporting effective risk assessment, there are some limitations to this study. First, the list of requirements is not intended to be exhaustive and constitutes only one approach to addressing the problems identified in this paper.

Second, the framework is built on the Safety I approach, whereas the Safety II approach might make a significant contribution to the current risk assessment practice, by considering success rather than only undesired events [ 35 , 36 ]. However, this approach has not yet been widely used and there are a number of criticisms regarding its usability and adoptability [ 37 – 39 ].

Third, the evaluation of the RAF was limited. The evaluation interviews were not designed to provide duplicating and reversing questions to establish the reliability of the responses. Additionally, participants’ views on the proposed RAF could have been biased since they evaluated the framework based on the explanations presented rather than on their experience of using it. While the authors of this paper aimed to minimize such limitations by conducting regular review meetings, a control study could be conducted to see the real impact of the framework in comparison to typical current risk assessment practice in hospitals.

Risk assessment supports decisions made in relation to potential undesired events. Despite significant efforts of healthcare professionals and organizations, there is a potential to improve current risk assessment practice in hospitals. In this paper, we designed an RAF to guide healthcare staff in risk assessment and to address existing challenges of risk assessment. This was subsequently evaluated to investigate its practical use.

The framework brings the principles of risk assessment together and learns from the experience of healthcare staff in risk assessment. It uses simplified risk terminology to minimize misconceptions and encourages: convening a multidisciplinary team, describing the system to be assessed, defining potential undesired events based on the system description, determining a wide range of contributory factors, considering all potential consequences, determining tolerability of a risks by considering multiple factors and considering control actions to minimize the potential undesired events defined.

The framework can be used as a training tool to guide in effective risk assessment as well as a tool to assess risks in healthcare settings. We believe that the framework can contribute to the quality and safety of care when it is used effectively and the assessment findings are implemented.

Supplementary Material

Supplementary data.

This work was funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, at Cambridgeshire and Peterborough National Health Service Foundation Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

Stochastic Environmental Research and Risk Assessment

Stochastic Environmental Research and Risk Assessment (SERRA) publishes research papers, reviews and technical notes on stochastic (i.e., probabilistic and statistical) approaches to environmental sciences and engineering, including the description, modelling and prediction of the spatiotemporal evolution of natural and engineered systems under conditions of uncertainty, risk assessment, interactions of terrestrial and atmospheric environments with people and the ecosystem, and environmental health. Its core aim is to bring together research in various fields of environmental, planetary and health sciences and engineering, providing an interdisciplinary forum for the exchange of ideas, for communicating on issues that cut across disciplinary barriers, and for the dissemination of novel stochastic techniques used in various fields. Contributions may cover measurement, instrumentation and probabilistic / statistical modelling approaches in various fields of science and engineering

• Andreas Langousis

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Multivariate stochastic vasicek diffusion process: computational estimation and application to the analysis of \(co_2\) and \(n_2o\) concentrations.

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Natural resource development, economic policy uncertainty and urban residents’ consumption in China: a nonlinear ARDL and time-varying parameter vector autoregressive with stochastic volatility approach

• Tianxiang Long
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Dynamic clustering of spatial–temporal rainfall and temperature data over multi-sites in Yemen using multivariate functional approach

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Determination of the surface roller length of hydraulic jumps in horizontal rectangular channels using the machine learning method

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• Statistical Considerations for Premarketing Risk Assessment - 05/16/2024

Virtual | Virtual

Event Title Statistical Considerations for Premarketing Risk Assessment May 16, 2024

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

This presentation will:

• Describe important statistical considerations in the premarketing assessment of drug safety. The safety profile of a drug evolves over time through gained experience and increased exposure. The use of diligent planning for safety and rigorous assessment of maturing safety data optimizes the ability to characterize the safety profile of a drug
• Cover the importance of planning for the safety assessment of a drug. A focus will be on planning to assess key risks in confirmatory trials to improve the quality and reliability of the safety data collected for these risks. Such a task requires clear specification of the key risks, operational definitions of the risks and plans to ascertain them, and other trial design and conduct considerations to facilitate their assessment at trial completion
• Address statistical considerations in the analysis of safety data, primarily adverse event data. Analysis of adverse outcomes is not a simple calculation of crude proportions of the number of participants experiencing the event. Rather, it requires careful consideration about the approach to analysis, including topics such as handling of treatment discontinuation, using data from multiple trials, defining summary measures of incidence, and choosing statistical methods to estimate the incidence and corresponding uncertainty

INTENDED AUDIENCE

• Pharmaceutical regulatory scientists, clinical reviewers, medical professionals, data scientists, statisticians, statistical programmers, medical writers working on clinical trial safety analyses for new drug marketing applications
• We will not discuss trial data for generic drug applications

TOPICS COVERED

• How trial design can enhance the assessment of safety data
• The importance of tailoring the analysis of safety to align with trial design
• The use of appropriate statistical analysis approaches, including topics such as the choice of metric for estimating risk, handling treatment discontinuation, and integrated analyses

LEARNING OBJECTIVES

• Identify how trial design can enhance the assessment of safety data
• Cite the importance of tailoring the analysis of safety to align with trial design
• Explain appropriate analysis approaches to assess causal relationships between drug and adverse outcomes

Gregory Levin, Ph.D. Associate Director for Statistical Science and Policy Office of Biostatistics (OB) Office of Translational Science (OTS) Center for Drug Evaluation and Research (CDER) | FDA

Mat Soukup, Ph.D. Deputy Director Division of Biometrics VII OB | OTS | CDER | FDA

FDA RESOURCES

• FDA Guidance Benefit-Risk Assessment for New Drug and Biological Products (October 2023)
• FDA Guidance Premarketing Risk Assessment (March 2005)
• ICH Guidance E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions (March 1995)
• ICH Guidance E9 Statistical Principles for Clinical Trials (September 1998)

CONTINUING EDUCATION (CE)

This event has been approved for 1.5 contact hours of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. Participants may obtain a certificate of attendance which can be used in support of CEs for the following professional organizations: RAPS, SOCRA, SQA, and ACRP. Certificates are only available during the two weeks post-event. For more information, see details below.

*Registration and real-time attendance via available online rooms is required.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• Please contact [email protected] for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.

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Risk Assessment and Prevention of Falls in Older Community-Dwelling Adults : A Review

• 1 Division of Geriatrics, Duke University, Durham, North Carolina
• 2 Durham VA Geriatric Research Education and Clinical Center, Durham, North Carolina
• 3 Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston
• 4 Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
• 5 Marcus Institute for Aging Research & Department of Medicine, Hebrew SeniorLife, Boston, Massachusetts
• JAMA Clinical Guidelines Synopsis Guidelines on Falls Prevention in Older Adults Peggy B. Leung, MD; Jason T. Alexander, MD; Karin E. Ouchida, MD JAMA

Importance   Falls are reported by more than 14 million US adults aged 65 years or older annually and can result in substantial morbidity, mortality, and health care expenditures.

Observations   Falls result from age-related physiologic changes compounded by multiple intrinsic and extrinsic risk factors. Major modifiable risk factors among community-dwelling older adults include gait and balance disorders, orthostatic hypotension, sensory impairment, medications, and environmental hazards. Guidelines recommend that individuals who report a fall in the prior year, have concerns about falling, or have gait speed less than 0.8 to 1 m/s should receive fall prevention interventions. In a meta-analysis of 59 randomized clinical trials (RCTs) in average-risk to high-risk populations, exercise interventions to reduce falls were associated with 655 falls per 1000 patient-years in intervention groups vs 850 falls per 1000 patient-years in nonexercise control groups (rate ratio [RR] for falls, 0.77; 95% CI, 0.71-0.83; risk ratio for number of people who fall, 0.85; 95% CI, 0.81-0.89; risk difference, 7.2%; 95% CI, 5.2%-9.1%), with most trials assessing balance and functional exercises. In a meta-analysis of 43 RCTs of interventions that systematically assessed and addressed multiple risk factors among individuals at high risk, multifactorial interventions were associated with 1784 falls per 1000 patient-years in intervention groups vs 2317 falls per 1000 patient-years in control groups (RR, 0.77; 95% CI, 0.67-0.87) without a significant difference in the number of individuals who fell. Other interventions associated with decreased falls in meta-analysis of RCTs and quasi-randomized trials include surgery to remove cataracts (8 studies with 1834 patients; risk ratio [RR], 0.68; 95% CI, 0.48-0.96), multicomponent podiatry interventions (3 studies with 1358 patients; RR, 0.77; 95% CI, 0.61-0.99), and environmental modifications for individuals at high risk (12 studies with 5293 patients; RR, 0.74; 95% CI, 0.61-0.91). Meta-analysis of RCTs of programs to stop medications associated with falls have not found a significant reduction, although deprescribing is a component of many successful multifactorial interventions.

Conclusions and Relevance   More than 25% of older adults fall each year, and falls are the leading cause of injury-related death in persons aged 65 years or older. Functional exercises to improve leg strength and balance are recommended for fall prevention in average-risk to high-risk populations. Multifactorial risk reduction based on a systematic clinical assessment for modifiable risk factors may reduce fall rates among those at high risk.

Read More About

Colón-Emeric CS , McDermott CL , Lee DS , Berry SD. Risk Assessment and Prevention of Falls in Older Community-Dwelling Adults : A Review . JAMA. Published online March 27, 2024. doi:10.1001/jama.2024.1416

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© 2024

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The Columbia-Suicide Severity Rating Scale (C-SSRS) is a unique suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions that anyone can ask. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs. Users of the C-SSRS tool ask people:

• Whether and when they have thought about suicide (ideation)
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The first step in effective suicide prevention is to identify everyone who needs help. The C-SSRS was the first scale to address the full range of suicidal thoughts and behaviors that point to heightened risk. That means it identifies risk not only if someone has previously attempted suicide, but also if he or she has considered suicide, prepared for an attempt (for example, buying a gun, collecting pills, or writing a suicide note), or aborted plans for suicide because of a last-minute change of heart or a friend’s intervention.

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Boring is better when conducting risk assessments

By John Hintze

R isk assessments can swallow up many hours of bank executives’ precious time. But if they result in flashing red lights about unexpected risks, then banks have probably done something wrong throughout the year.

Khouri spoke on a panel that was part of the ABA/ABA Financial Crimes Enforcement Conference . Also on the panel were Carl Francois, BSA and fraud officer at Southern First Bank, a community institution with $4 billion in assets, and Rebecca Schauer Robertson, deputy BSA officer and financial crimes manager at Blue Ridge Bank, with $3.3 billion in assets, who served as moderator.

The bankers discussed risk assessments from several angles, including the extent to which first-line employees at the bank provide input; the role of a bank’s internal audit, upper management and board of directors; and whether various risks are combined into a single assessment. The panel participants agreed that while risk assessments’ rewards may not seem to warrant the load of work they entail, they are nevertheless essential documents.

Khouri’s statement was in response to Schauer Robertson asking how frequently the two banks conduct their risk assessments and whether they actively consult the assessments throughout the year or, practically speaking, set them aside until the next annual review.

Francois noted the plain-vanilla nature of his bank, without exotic financial products or acquisitions, and that Southern First’s annual risk assessment is conducted by a third party. However, he’s the one, given the bank’s relatively small size, who gathers all the necessary information from different parts of the organization.

“I’m involved from start to finish, which helps me identify changes in this year’s responses compared to last year’s and whether there’s anything different,” Francois said. “Even though we outsource it, it still takes up a lot of my time, and it’s an important exercise.”

Ally, instead, completes the exercise fully in-house, producing a main “programmatic” annual assessment that looks at all the different business lines and their inherent risks, the control environment and finally the residual risk. The bank uses a software tool to help gather the information, provide supporting documentation, do the calculations, and it has a team member primarily focused on the task.

Khouri said he monitors the process to ensure he isn’t “spending too much time and resources just to validate the information. But in the end it’s a good exercise.” He added that Ally also performs “mini” risk assessments in the event of significant developments such as an acquisition or regulation impacting a business line.

The risk assessment exercise brings together input from first-line bank employees all the way to internal audit and the board of directors. Khouri said his team works closely with first-line bank employees who provide much of the necessary data about customers and products.

“As we continue to expand, we’ve had our own data team try to pull that information for us, so it’s less of a burden on the front line,” he said. “But much of the time we must work closely with them.”

Francois said he works with IT resources to pull the required data, and given the bank’s straightforward business model and “clean” data, relatively few first-line employees must be contacted.

Asked whether the panel participants receive feedback on their risk assessments from business management teams, Khouri said the assessment first seeks input from the risk committees of the business lines, the first-line of defense. Then the results are presented to the corporate AML oversight committee, where they are escalated up the chain. A summary goes to a compliance-risk-management committee. Then up to the board once a year.

Francois meets monthly with “operational directors” to discuss any potential risks that may require a mitigation plan and may be incorporated in the annual risk assessment. “It’s good to have the opportunity to present it to them, on the chance anything there needs to be addressed,” he said, adding that the bank’s CEO and president sit in on those meetings.

In terms of his bank’s board, Francois said, members get the full risk-assessment report but they typically scrutinize a heat map summary and ask questions about red issues they may be unfamiliar with.

“It’s a good thing if there’s nothing that scares folks,” he said. “In reality, you want it to be boring.”

Khouri agreed, noting his team’s heat map at the top level of the organization, where each line of business is rated for its inherent risk, control environment and residual risk. In addition, one page is devoted to AML and another for the Office of Foreign Assets Control. Each notes whether there are year-over-year changes to the overall risk score. Then there’s a page for each line of business to explain in more detail any concerns. All the supporting documentation can be accessed through the risk-assessment software tool.

“We don’t believe the final report should be extensive. All these pages are combined in one deck that goes up through the chain of management for review,” Khouri said.

Both bankers said their institutions combine BSA, including AML and OFAC in one risk assessment, rather than separate these.

“In a community bank, I’m the BSA and OFAC officer, and a lot of those data points go together,” Francois said. “It creates efficiencies to just do it all at one time.”

Khouri said Ally’s compliance tool assesses AML separately from OFAC and displays the information in separate dashboards. But they are combined into one risk assessment. Both banks approach fraud separately from their BSA/AML risk assessments.

Francois noted that Southern First Bank’s fraud-related suspicious activity reports exceed those for AML, and that fraud is among the eight national AML/combating-the-financing-of-terrorists (CFT) priorities that the Financial Crimes Enforcement Network first announced in June 2021, indicating that a fraud risk assessment is important.

“It’s something we’re going to do in 2024, but we haven’t decided yet whether to do it in-house or partner with someone to map it out,” Francois said.

Asked whether their institutions have incorporated these priorities into their risk assessments, both bankers said they have considered them but are waiting for guidance before making significant risk-assessment changes.

“I was asked the same question by my FDIC examiner about a month ago, and when I said I’m waiting on more guidance, he responded, ‘That’s fine; I’m not going to put the cart before the horse,’” Francois said.

John Hintze frequently writes for the ABA Banking Journal.

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