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Ethics approval: responsibilities of journal editors, authors and research ethics committees

Luchuo engelbert bain.

1 Athena Institute for Research on Communication and Innovation in Health and Life Sciences, Vrije Universiteit, Amsterdam, The Netherlands

Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers’ money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

Meaningful progress of medicine depends on research that must ultimately involve human subjects [ 1 ]. The researcher carries the responsibility to respect the highest ethical standards to protect research participants even after consent is obtained [ 1 ]. The amount of research on human subjects inundating the world is taking geometric proportions and the trend is almost irreversible. The Declaration of Helsinki requires that all medical researches be submitted to and approved by an ethics committee. It states: “ the research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins ” [ 1 ]. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. Good research involves risks taken by research participants and most of the time uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. How can the young researcher respect ethical standards, without any prior research ethics knowledge or training, not to talk of knowing what an ethics approval is all about? Of 174 theses on Human Immuno Virus (HIV) in Cameroon, only 17 out of these had documented ethics approvals [ 2 ]. Out of 217 reviewed full length articles in the health sciences, 57.53% of these reported having obtained ethical approval [ 3 ]. Seven items generally constitute the research ethics review agenda for most protocols [ 4 ]. Social value; scientific validity; fair subject selection; independent review; informed consent; respect for enrolled subjects; favorable risk-benefit ratio. Most researchers mistake scientific clearance or approval for ethical clearance. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. Most Research Ethics Committees (RECs), or elsewhere, Institutional Review Boards (IRBs) are transdisciplinary in constitution to properly ascertain the diverse dimensions of the research question under investigation. This reduces the bias of looking at the “black bird” from a single direction. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks of the research participants. It is important to highlight the fact that risk is not only physical, but certain exposures to the research task might have far reaching psychosocial consequences. In laboratory, genetic medicine, biobank research and disaster response, core ethical concerns seen in broad consent might be erroneously omitted at the beginning of the study, or fail to be sought from participants for instance during initial sample collection phase. RECs could be helpful to highlight these issues to the research team. Obtaining ethics approval is a core component of good science. Publication pressure is a key contributor to falsification of research findings, as well as bypassing ethics approval, especially among young researchers. Failure to properly ascertain the importance of ethical approval by researchers and journals could indirectly fuel research misconduct and predator publication [ 5 , 6 ]. Researchers could shy away from submitting ethically charged protocols for review, or go for “low quality or less stringent” RECs. Complexities of the protocol review process in terms of money, time and requirements could scare researchers from engaging into the endeavor to obtain ethical approval [ 7 ]. With the already worrisome publish or perish syndrome, low quality ethics review, or complete avoidance and consequent opting for predator journals becomes the way out for these researchers. Many, if not all respected journals require an ethics statement. The editors and reviewers routinely check if ethical approval was obtained for research on human subjects.

Though a duty for the reviewers to be sensitive to the ethics of the manuscript under consideration, it is the sole responsibility of the author or researcher to ensure that he obtains ethics approval if need be. Obtaining ethics approval does not in itself render the research work ethical. Competence of the RECs to review specific types of research need to be continuously questioned and defined by the respective National Ethics Committees (NECs). Capacity building in research ethics should remain a priority. Researchers must themselves recognize the importance of obtaining ethical clearance. In cases of doubt whether to obtain approval or not, advice from the ethics committee, research ethics specialists should be systematically sought. The future might compel the creation of national and international data bases of RECs, for rapid cross checking of the validity of provided ethical approval references or copies provided by authors. Many authors could declare having obtained ethical approval, while in practice, no ethical approval in effect was actually obtained. It is a subject of discussion to systematically provide references or copies of the ethical approvals to journal editorial boards to be sure these were obtained. NECs have the responsibility to have a data base of smaller RECs, define their scope of competence and ensure capacity building [ 7 ]. Lack of coordination could make ethically charged researchers to go to small inexperienced RECs for more rapid approvals. Training and capacity building remains a key challenge, and students must receive compulsory research ethics courses as researchers of tomorrow. It is only in this light that they shall develop the moral responsibility as researchers to systematically reflect on obtaining ethical approvals before delving into the research process. Most researchers and students erroneously self-evaluate specific studies not to be ethically charged and find ethical approval an idle venture. However, the ethical waiver decision or advice preferably should come from the ethics committee. The challenges for RECs remain persistent.

Most functioning on altruistic grounds, hold meetings once in a month that delay the review process, and thus scare scientists from seeking ethical approval. Governments must support the functioning and encourage capacity building of these ethics committees. Research malpractice is here and it shall be scientific hypocrisy to think this could be eliminated by the good will of researchers. Ethical “policing” through requests of ethical approval references or copies for eventual verification should be considered. Should it be a mandatory task for reviewers to ask for copies/references of ethical approvals before going on to publication of research involving human subjects? Should reviewers trust the declarations of scientists on grounds of mere ethics statements? How can the validity of assertions of having obtained ethical approval be verified? Is it the duty/role of the reviewer to check if ethics approval was effectively obtained? It is time for NECs to think of National REC repositories, where authenticity of ethics approvals could be verified. This could be helpful in case of allegations of unethical research or exploitation that could potentially arise. Verification of ethics approval authenticity could serve as a nudge to promote ethical sound research. Obtaining ethical approval is above all, the responsibility of the author or researcher. Reviewers have a mandate to verify these ethics statements. Research ethics education and capacity building remain key action areas that have not received the attention they righty deserve in the past. Including ethics statements in reports could encourage researchers to seek for ethics approval, and thus carryout ethical research [ 8 ]. This statement on its own, is simply a means, and not an end itself. Ethical approval must become part of researchers? daily practice and requires to be systematically checked by reviewers before publication of research involving human subjects. A discussion on whether or not to verify the authenticity of provided ethics approval references or copies, as well as the establishment of Research Ethics Committee Repositories at National and International Levels looks promising. This could indirectly facilitate collaborative research, as well as arouse the need to systematically obtain ethics approval among researchers. Institutional support to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approval.

Competing interests

The author declare no competing interest.

• Research article
• Open access
• Published: 05 December 2019

Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study

• Yanni Wu 1   na1 ,
• Michelle Howarth 2   na1 ,
• Chunlan Zhou   ORCID: orcid.org/0000-0001-8537-2679 1 ,
• Mingyu Hu 1 &
• Weilian Cong 1  

BMC Medical Ethics volume  20 , Article number:  94 ( 2019 ) Cite this article

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Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals.

This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review.

A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “ consent was obtained from participants or participants agreed to join in the research ”. Furthermore, whilst most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received (all P  < 0.05).

The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required.

Peer Review reports

Given the importance of protecting human subjects in clinical research, there is now greater scrutiny of researchers to ensure that ethical principles have been met during the process [ 1 , 2 ]. The World Medical Association issued the Declaration of Helsinki in 1964 and established the international ethical regulations for medical studies involving human subjects with subsequent updates [ 3 ]. The Declaration of Helsinki highlighted two aspects of ethical considerations: that all of the participants have the right to be informed about the study, by giving informed consent, and that an ethics committee approval should have got to ensure the appropriateness of design before initiating a research [ 4 ]. Furthermore, journals and publishers, have a responsibility to act as “gate-keepers”, and are obliged to scrutinize whether ethical approval of human research has been obtained priori to submission of papers [ 5 ]. This responsibility mirrors the requirement of the Declaration of Helsinki that “ Researchers, authors, sponsors, editors and publishers all have ethical obligations……Reports of research not in accordance with the principles of this Declaration should not be accepted for publication ” [ 4 ]. This duty of journals and publishers is supported by the International Committee of Medical Journal Editors (ICMJE) [ 6 ] and adopted by journal editors and publishers. Following this, the Nuremberg Code [ 7 ], the World Association of Medical Editors (WAME) [ 8 ], and the Committee of Publication Ethics (COPE) [ 9 ] established ethical principles to protect human right in medical research. For example, COPE stipulated that journals should provide guidance to support the reporting of ethical approval and informed consent when publishing human research.

However, the reporting of ethical considerations still less than ideal in human research though it is acknowledged that some progress has made in recent years. For example, Yank and Rennie [ 1 ] investigated the ethical protections of clinical trials published in top five medical journals including The Lancet, JAMA, BMJ, The New England Journal of Medicine, and Annals of Internal Medicine and found that 31 and 26% articles published before 1997 did not report ethical approval and informed consent, respectively. Furthermore, 18% of publications in these five journals after 1997 did not report ethical approval and informed consent. More recently, similar findings were identified by a range of authors, suggesting that this is a common challenge faced by journals [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ]. For example, Schroter, Plowman [ 10 ] reviewed five general medical journals and reported that 47 and 31% of human research did not describe whether informed consent and ethical approval have obtained. More recently, the increasing concern on human rights protection has influenced this and ethical transgressions have improved. This was illustrated by Bridoux, Schwarz [ 18 ], who reported that 92.2% of surgical trials described informed consent and 87.7% stated ethical approval. However, publications that are not in accordance with the principles of ethical reporting remains common [ 19 , 20 , 21 , 22 ]. For example, Murphy, Nolan [ 20 ] identified that 42.9 and 49.9% of clinical research published in three leading European Otolaryngology periodicals did not report informed consent and ethical approval, respectively.

Nursing research has progressed rapidly during the last three decades and supported the development of efficient and high-quality care. This is observed in a number of nursing academic journals, increased volume of nursing research, and professors in nursing [ 23 , 24 , 25 ]. The growth in nursing research presents a range of challenges, not least because of the vulnerable groups that nursing research includes and the capability and capacity of nurses to conduct ethically sound research. Worryingly, it is acknowledged that many nurses receive inadequate education, often compounded with lack of ethical awareness and knowledge when conducting clinical research [ 26 , 27 , 28 , 29 ]. This was reflected in findings reported by Negarandeh and Gobady [ 30 ] who identified that 70.8% of nurses and midwives lack of education on ethical issues. These challenges within nursing research has raised concerns and the International Council of Nurses Code of Ethics for Nurses [ 31 ] has founded to regulate research ethics in the nursing profession. Therefore, it is essential to identify the extent to which ethical review is reported in nursing publications to both regulate and monitor ethics in nursing research involving human subjects.

Currently, the majority of ethics investigation have focused on reports in medical journals. In order to identify the extent to which ethical approval on human research is reported in nursing journals, we conducted a study to explore the ethical considerations among 12 Chinese top nursing journals. Our findings identified that only 51.8 and 25.9% of clinical trials reported informed consent and ethical approval, respectively [ 32 ]. The purposes of this study were to assess the rates of reporting of ethical considerations in five leading international nursing journals following the work of Yank and Rennie [ 1 ].

Study design and inclusion criteria

This is a retrospective observational study adhered to STROBE guidelines. All publications that reported clinical research in five high ranked nursing journals, according to the 2017 SCI Journal Citation Reports’ impact factor between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. These journals, with a high impact factor, were International Journal of Nursing Studies (3.755), European Journal of Cardiovascular Nursing (2.763), Journal of Family Nursing (2.537), Nurse Education Today (2.533), and Birth-issues in Perinatal Care (2.518). Publications were included if the following criteria were met: (1) Clinical research articles: as described by previous studies [ 10 , 11 , 13 , 20 ], the sample frame selected included all original research articles involving human participants or human tissue. (2) Full-text articles. Supplement published studies, protocols, laboratory and animal studies, reviews, letters, editorials, discussion papers, erratum/corrigendum, commentaries, and news were excluded.

Data extraction

Data were extracted between August 2017 and July 2018. The contents and full-text PDFs of the five top nursing journals between 2015 and 2017 were extracted and downloaded from the Wiley Online Library or the ScienceDirect through the university subscription. Two authors (W.C and M.H1) independently reviewed the articles published in the five nursing journals in keeping with the standardized eligibility criteria to ensure the accuracy and credibility of the process. All of the articles were identified and reviewed based on the contents of each issue of journal. The full text of each included article was carefully read and the results were recorded in a standardized data extraction form. Disagreements were resolved by consensus or the third person (Y.W). Following this, articles that did not report ethical review were checked again by the third person (Y.W).

The primary outcome of our study was to ascertain the rates of reporting informed consent and ethical approval. We included papers with any of the following types descriptions (with examples). (1) Informed consent – a. written informed consent obtained (“ the written informed consent was obtained from participants or the legally authorized representative ”), b. oral informed consent obtained (“ the oral/verbal consent was obtained from participants ”), c. other consent type (has been categorized as “ the participants’ consent was indicated by the completion and returning of the questionnaire ”, “ consent was obtained through providing information and finishing consent section or a consent form within the online portal ”, and “ the informed consent was indicated by participants take part in evaluations ”), d. the consent type not reported (only described that “ consent was obtained from participants or participants agreed to join in the research ”, but did not indicate the way to get the consent), and e. consent was waived or not required (“ informed consent was exempted or not required due to the policy or the law of the government or the type of the research ”). The dates on informed consent in the study were collected on prospective studies only [ 20 ]. (2) Ethical approval – we checked to determine if the study reported that it was approved by the ethics committee in the hospital or other institutions before undertaking the research. We also examined whether the name of the ethical committee and ethical approval reference number was reported.

The secondary outcomes of our study included the rates of reporting other details related to ethical approval and informed consent including ethical statement. For example, whether the author declared that the research conformed to the Declaration of Helsinki, and if the research participants had been told that they have the right to withdraw from the study at any time without reprisal. There was excellent agreement on the two primary outcome measures between two authors (W.C and M.H1) (reporting of informed consent and ethical approval) ( k  > 0.95 for all).

We collated additional information that included the study type, funding sources, and nationality of publishing institution to enable subgroup analysis. Firstly, the type of research was categorized as either prospective or retrospective based on prior studies [ 11 , 13 , 15 ]. Following this, the prospective studies were divided into randomized controlled trial (RCT), nonrandomized trial, observational study (including audit, surveys, quality assurance activities, prospective cohort study, and qualitative study), single-arm, specimen, and mixed methods study. The retrospective studies were divided into specimen, chart review, and database analysis. Secondly, data were gathered on whether research received financial support following the work of Yank and Reinnie [ 1 ], regardless of the type of funding. Finally, given the different clinical ethical dilemmas in different countries [ 33 ], we identified the nationality of publishing institution of each study, defined as the country of the research conducted institution.

Data analysis

Data was analyzed using SPSS 20.0 software (IBM, USA). The rates of informed consent and ethical approval between year, study types, funding sources, and different countries were compared by use of Chi-square tests or Fisher’s exact tests (where cell size was less than 5). All P values were two-sided, and a value of P <  0.05 was indicated significant.

Study selection

A total of 2041 citations were identified from the contents of all the five leading nursing journals published between 2015 and 2017. From these, 757 were screened out using the data extraction process. These were: 335 reviews, one laboratory investigation, one research protocol, and 420 other types (letters, editorials, discussion papers, erratum/corrigendum, commentaries, and news). In total, 1284 clinical papers were included to extract the data of ethical review (see Fig.  1 ).

PRISMA Flow Diagram

• Informed consent

Of the 1284 clinical studies, 99 were retrospective studies and 1185 were prospective studies. Of the 1185 prospective studies, 1037 (87.5%) mentioned informed consent. However, only 549 (52.9%) of those reported that written informed consent had been obtained, and only 37 (3.6%) of these had reported oral consent. Interestingly, 70 (6.8%) of studies had used other ways to indicate participants’ consent, such as ‘assent’ through the completion and return of the questionnaire in surveys, or finishing online consent section, or implied by participants attend research evaluations. Notably, a small number 375 (36.2%) described that “ consent was obtained from participants or participants agreed to join in the research ” but did not elaborate on the methods used to gain consent. Furthermore, six (0.5%) studies stated that the informed consent from participants were waived or not required due to the policy or the law of the government or the type of the research (Table  1 ). In addition, the rates of reporting informed consent between different publication years and evidence of research funding demonstrated no statistical significance (all P  > 0.05) but variances were observed between different country ( P  < 0.001) (Table  2 ).

• Ethical approval

Our results indicate that 1203 (93.7%) of 1284 clinical studies reported ethical approval in the main text of the paper. Of the 1203 studies, 1144 (95.1%) reported that ethics committee approval was obtained before the study was undertaken and 59 (4.9%) of studies stated that the ethical approval for the study was not required or waived under the local or national laws. Notably, of the 1144 studies that reported ethical approval had been obtained, a larger number, 1058 (92.5%) of studies stated the name of ethical committee, however, only 424 (37.1%) of studies included the ethical approval reference number. A small number, 181 (14.1%) of studies stated that ethical considerations of the research conformed to the Declaration of Helsinki (Table 1 ). Furthermore, no statistically significant differences were found between 2015 and 2017 in relation to the rates of reporting ethical approval ( P  > 0.05). Notably, the rates of reporting ethical approval were different between different study type, country, and whether mentioning financial support (all P  < 0.05). The rates of reporting ethical approval in prospective studies was much higher than retrospective studies (94.6% vs 82.8%). Moreover, the reporting of ethical approval in the studies that had financial support, was much higher than those who did not receive funding (95.2% vs 91.9%) (Table 2 ).

Our findings revealed a relative progression in the reporting of ethics as compared with prior studies such as Yank and Rennie [ 1 ], Schroter, Plowman [ 10 ], Pitak-Arnnop, Sader [ 14 ], and Fitzgerald [ 19 ]. For example, we identified that 87.5% of prospective clinical studies reported informed consent and 93.7% of clinical studies stated that ethical approval had been obtained. This is similar to Bridoux, Schwarz [ 18 ] findings that reported 87.7 and 92.2% of surgical trials stated ethical approval and informed consent, respectively. However, the reporting rates of ethics were much higher than most of other studies. For example, informed consent and ethical approval were reported in 53 and 69% in five general medical journals, 68.5 and 71% in six leading anesthesia journals, 36 and 39.3% in four major orthodontic journals, 57.1 and 50.1% in three leading European Otolaryngology journals, as well as 16 and 54% in three paediatric surgical journals, respectively [ 10 , 11 , 19 , 20 , 22 ]. Furthermore, the reporting of ethical considerations in the five leading international journals was more frequent than the twelve top Chinese nursing journals we previously investigated in 2017. These earlier findings highlighted that only 51.8 and 25.9% of clinical trials stated informed consent and ethical approval, respectively [ 32 ]. This more recent increase may have been influenced though the rapid development of medical technology which has enriched the content of nursing clinical research. However, it is acknowledged that China’s higher nursing education developed slowly because of civil wars and external invasion until 1949 and still need more efforts to improve the knowledge and awareness of ethics among nursing researcher [ 34 ].

Importantly, our findings indicated that the reporting of ethical approval in leading international nursing journals is less than ideal and work is needed to develop a standardized approach. Whilst our research illustrates a welcome progression, equally, the reporting of ethical approval is now recognized by leading journals as an essential pre-publication requirement. However, the detail of what is reported needs to be developed to enable readers and editors to understand that the reporting of consent was more than just ‘consent’ and that it was truly informed, thus reflecting the autonomous rights of the research participants. Merely stating fact that ‘informed consent’ was obtained, does not necessarily mean that consent was actually informed [ 1 ]. Signing a consent form or explicitly negotiated verbal consent presents two traditional methods in which participants’ informed consent is obtained [ 3 ]. With the rapid development of network techniques, using electronic methods to obtain informed consent is now considered to be a convenient as compared to other ways especially in some online questionnaire survey research. Furthermore, based on the 375 studies that did not describe the way to get the consent, determining whether the ethical considerations reported were implemented as challenging. Moreover, the reason for exemption should be declared by the authors which should include a rationale for absence of informed consent and/or ethical approval. For example, lack of informed consent maybe as a result of fully anonymised samples or legal reasons [ 15 ]. In our study, only 59 (4.9%) of studies stated that the ethical approval for the study was not required or waived under the local or national laws. Of the studies that have been identified as not reporting ethical considerations, we are unable to report whether the ethical protections of these studies were deemed unnecessary or if the researcher did not consider it. Therefore, the reporting of ethical protection of clinical research in leading nursing journals needs to be transparent and standardized.

Furthermore, our study identified progression in the reporting of ethical approval, however, only 37.1% of studies mentioned the ethical approval reference number. Although the ethical principles of the Declaration of Helsinki and the ICMJE do not stipulate that authors report the name of ethics committee and the approval number in the text, it has been recommended by many researchers [ 1 , 20 , 35 ]. Similar reporting expectations are included in the author instructions in numerous medical journals such as the BMJ , the European Journal of Cardiovascular Nursing , and the Journal of Family Nursing . This conflict in reporting of ethical committees and references numbers could be explained by the following two reasons. Firstly, the inclusion of the ethics committee details and reference helps to regulate ethical statement and to make sure that the ethical approval is authentic. Secondly, there is strong evidence to show the different effectiveness and practice between different local committees, stating the name of ethics committee could also help readers or others make decisions on the ethical protections of the study [ 36 , 37 ]. In addition, our study, only five clinical studies stated the organizational approval to conduct the research including the approval from the dean’s office, the school management, and the head of the department. Though this may be due to the organization policy, this approach does not comply with the principles of the Declaration of Helsinki which states that the research should be approved by an independent ethics committee. Therefore, the statement of the ethics committee approval in clinical studies still need to be standardized and improved.

It was surprising that there was no difference between publication year on ethical considerations in leading international nursing journals, which is contrary to the results on twelve Chinese nursing journals demonstrated a sharp improvement previously identified between 2013 and 2016 [ 32 ]. This may have been influenced by recent higher education institution, the ethics committee, and the nursing journals efforts in China in recent years.

Furthermore, our research demonstrated that the rates of reporting ethical approval in prospective studies was much higher than retrospective studies (94.6% vs 82.8%). Specifically, RCTs showed a relatively high reporting rates whereas the study type of database and single-arm need more attention to improve the reporting of ethical considerations. This is supported by Block [ 13 ] who found that the RCTs showed a high proportion in reporting of ethical approval. Most of researchers obtained ethics committee approval for RCTs and were not realized that approval still required for studies that do not enroll human participants such as retrospective studies on chart or database review [ 15 ]. Moreover, although we only retrieved the rates of reporting informed consent in prospective studies in line with prior studies [ 13 , 20 ], we are aware that neither retrospective studies published in the five leading international nursing journals stated the informed consent. The Declaration of Helsinki states that if informed consent for medical research using existing human data or material is impracticable to obtain, the research could be done after approval of an ethics committee. Furthermore, some researchers also stated that the informed consent is not required to the retrospective studies because this kind of study meet the criteria that “ the research involves no more than minimal risk to the subjects ” [ 13 ].

In summary, nursing journals assume an extremely important social, moral and ethical responsibility to improve and regulate the reporting of ethical considerations in clinical research. The reporting of ethics in the five leading international nursing journals showed some progress, but effort is still required to standardize the transparency and detail of ethical reporting.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

The Committee of Publication Ethics

The International Committee of Medical Journal Editors

Randomized controlled trials

The World Association of Medical Editors

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Acknowledgements

Not applicable.

The project was funded by the China Editology Society of Science Periodicals (CESSP) of China Association for Science and Technology (No. castqk2017-qnkt-01). The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Author information

Yanni Wu and Michelle Howarth contributed equally to this work.

Authors and Affiliations

Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, People’s Republic of China

Yanni Wu, Chunlan Zhou, Mingyu Hu & Weilian Cong

The School of Health & Society, University of Salford, Greater Manchester, UK

Michelle Howarth

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Contributions

YW, MH2, and CZ were responsible for protocol design of the research. YW, WC and MH1 extracted and analyzed the data from the five leading nursing journals. YW wrote the first draft of the manuscript and MH2 helped with the revisions of the article. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Chunlan Zhou .

Ethics declarations

Ethics approval and consent to participate.

The study is exempt from review by the Ethics Committee of Nanfang Hospital based on the basis that this type of study is non-human subject research, and waived the need for informed consent.

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The authors declare that they have no competing interests.

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Wu, Y., Howarth, M., Zhou, C. et al. Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study. BMC Med Ethics 20 , 94 (2019). https://doi.org/10.1186/s12910-019-0431-5

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Received : 27 November 2018

Accepted : 27 November 2019

Published : 05 December 2019

DOI : https://doi.org/10.1186/s12910-019-0431-5

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• Publication ethics and research integrity: policy guidelines for authors

We all want to ensure that the research you publish with us meets strict quality guidelines. Your reputation, and ours, depends on it. So does the reputation of your research institution on the global stage.  

Here you will find guidance on policies that help us achieve this, and what we ask of you to comply with them. We also recommend taking a look at the guidelines provided by The Committee on Publication Ethics (COPE)  

Declaration of conflicting interests

If you’ve received research funding, or been paid for attending a talk related to your work, these may be interpreted as competing interests. You should declare anything relevant, and we’re here to help you to do so easily by providing sample wording for typical scenarios.

What do I need to declare? How do I make a declaration? Further information

Funding statements

All research articles need a funding statement, so here’s a quick guide to writing one.

Writing a funding statement Industry-funded articles

Ethics approval and informed consent statements

Guidance on preparing ethics statements in support of research findings, with multiple examples of scenarios and statements to get you started.

Studies involving humans Studies involving animals Studies not involving humans or animals Global research ethics and inclusion

If you’ve received research funding, or been paid for attending a talk related to your work, these may be interpreted as conflicting interests. You should declare anything relevant, and we’re here to help you to do so easily by providing sample wording for typical scenarios. This guidance also applies to you if you are an editor or guest editor writing any editorial to be published in one of our journals.

COPE states in its Guidelines on Good Publication Practice that:

‘Conflicts of interest arise when authors, reviewers, or editors have interests that are not fully apparent and that may influence their judgments on what is published. They have been described as those which, when revealed later, would make a reasonable reader feel misled or deceived.’

A potential competing interest may arise from relationships, allegiances or hostilities to particular groups, organizations or interests, which may influence your judgments and impact objectivity. The issue is particularly sensitive when such interests are private and/or may result in personal gain. We ask our Authors, Reviewers, Guest Editors and Editors to declare any potential competing interests in a “Declaration of conflicting interests” statement.

Examples include:

• Having received fees for consulting
• Having received research funding
• Having been employed by a related company
• Holding stocks or shares in a company which might be affected by the publication of your article
• Having received funds reimbursing you for attending a related symposia, or talk.  

What do I need to declare?

In your Contributor Agreement you will be asked to certify that:

• All financial support is acknowledged in your article.
• Any commercial or financial arrangements related to your article have been discussed with your Editor, who will advise whether details should be declared.
• You have not signed an agreement with any sponsor that might compromise the impartial reporting of data.

Not all SAGE journals require a declaration of conflicting interests alongside your article, so check on your individual journal page if they do, and what they require of you, as this will vary.

Submissions will be evaluated fairly and will not necessarily be rejected when any competing interests are declared. 

How do I make a declaration?

If you are publishing in a journal that requires a declaration of conflicting interests it should be added under the heading ‘Declaration of conflicting interests’ after any Acknowledgments and before Funding, Notes and References.

If there are no conflicting interests, we’ll publish this statement: ‘The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article’.

Further information

• Guidelines published on good publication and the Code of Conduct by the Committee of Publication Ethics (COPE).
• guidelines published by the International Committee of Medical Journal Editors (ICMJE).
• Common Standard for Conflict of Interest Disclosure published by Center for Science in the Public Interest.

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All research articles need a funding statement, so here’s a quick guide to writing one. It should appear under the heading ‘Funding’ after any Acknowledgments and Declaration of conflicting interests, and before Notes and References.

This should comprise the text in bold in the example below, followed by the full name of the funding agency, and the grant number in square brackets:

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Medical Research Council [grant number xxx].

Multiple grant numbers should be separated by commas, multiple agencies by semicolons.

What if your research was supported indirectly by grants available to your institution, but not to you personally? In this case, simply include this statement:

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Note: If you have any concerns that the information you give may compromise your anonymity prior to the peer review process, you can choose to wait until you submit your final accepted manuscript.

Industry-funded articles

We can only consider industry-funded articles if funding is fully declared within the manuscript, together with any role in the design of the study or in the analysis and interpretation of data played by the funder.

Both direct and indirect funding must be declared, whether funding is in full or in part. Indirect funding includes organisations associated with the research and/or authors receiving funding from one of the industries below, or any industry where the funder could be seen to have a vested interest in the results of a study.

Industries include but are not limited to:

• Pharmaceuticals
• E-cigarettes

Failure to declare industry-specific funding can lead to the rejection of your article at submission, or retraction of the whole article if the oversight comes to light after publication.

How do we make sure that we maintain high ethical standards in publishing? By including clear statements in support of results reported in articles. Here is guidance, with examples of sample statements, for:

Studies involving humans

All studies involving humans, for example including patients, their samples, data or any other study involving human participants must be evaluated by a suitably qualified research ethics committee prior to undertaking the research in line with the Declaration of Helsinki .

All studies involving people, whether patients or research participants, must be evaluated by a qualified research ethics committee prior to undertaking the research in line with the Declaration of Helsinki .

Ethics statements should be included in the methods section of all relevant submissions (unless the journal you’re submitting to publishes them under a separate heading – the journal’s submission guidelines will make this clear) and must include the name and location of the review board, approval number and date, as in the examples below.

Ethics approval statements

These examples can be used If ethics approval was obtained:

This study was approved by the XXXX Research Ethics Committee (approval no. XYZ123) on Month DD, YYYY.

This study received ethical approval from the XXXX IRB (approval #XYZ123) on Month DD, YYYY.

Examples of ethics approval statements suitable for different scenarios:

The XXXX Ethics Review Committee at XXXX University approved our interviews (approval: XYZ123) on Month DD, YYYY. Respondents gave written consent for review and signature before starting interviews.

This study received ethical approval from the XXXX IRB (approval #XYZ123) on Month DD, YYYY. This is an IRB-approved retrospective study, all patient information was de-identified and patient consent was not required. Patient data will not be shared with third parties.

The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of XXXX (no. XYZ123) on Month DD, YYYY, with the need for  written informed consent waived. 

This study was conducted in accordance with the Declaration of Helsinki. Approval was granted on Month DD, YYYY. The Institutional Review Board (IRB) at XXXX acted as the central IRB, whose review was accepted by all participating institutions’ IRBs (Ref. XYZ123). The central IRB determined that this research involved minimal risk and approved a waiver for informed consent.

This study was approved by the Ethics Committee of XXXX University (Ethics Code: XYZ123) on Month DD, YYYY. All participants provided written informed consent prior to enrolment in the study. This research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki.

The ethics review committee of the XXXX University approved this study on Month DD, YYYY. Number: XYZ123. Date: Month DD, YYYY. Written informed consent for inclusion in this research was obtained from the patients prior to surgery.

The experimental protocols were approved by the Institutional Review Board (IRB) of the XXX University (No. XYZ123) on Month DD, YYYY. All research activities complied with ethical regulations and were performed in accordance with regulations of each hospital. Informed consent to use histopathological samples and pathological diagnostic reports for research purposes was obtained from all patients prior to surgery. They were given the option to refuse to participate by opting out.

These examples can be used if ethics approval and patient consent were waived:

The Ethics Committee of the XXXX waived the need for ethics approval and patient consent for the collection, analysis and publication of the retrospectively obtained and anonymised data for this non-interventional study.

The study was approved by the Danish Data Protection Agency. According to Danish legislation, neither ethics  approval nor patient consent is required for registry linkage studies [23].

Case reports

Ethical approval to report this case (or case series) was obtained from *name of ethics committee or institutional review board (approval number/ID)*.  

Our institution does not require ethical approval for reporting individual cases or case series.

Patient or participant consent

In all cases, it’s important to state that consent has been granted to use any personal information, and how that consent has been gathered. Informed consent includes three key components:  

• Communication of information  
• Comprehension of information  
• Voluntary participation

For research articles, you need to state in the methods section whether the participants provided written or verbal informed consent. This statement should include whether the participants provided consent to conduct the study, publish the study, and have their photos or other images used . If information has been anonymized, that should be clearly stated too. If you are publishing on an open access basis, patients or participants must be aware that the article will be available to anyone with an internet connection.

The American Psychological Association (APA) recommends that for those who are legally incapable of giving informed consent, researchers should:  

• Provide an appropriate explanation  
• Seek the individual's assent  
• Consider the person’s preferences and best interests  
• Obtain appropriate permission from a legally authorized person, if such a substitute consent is permitted or required by law  

If the law doesn’t permit or require a legally authorized person to provide consent, you’ll need to show that you’ve taken reasonable steps to protect the individual's rights and welfare.   Participants should be informed about:  

• The purpose, duration, and procedure of the research  
• Their right to decline to participate and how to withdraw from the research along with the possible consequences  
• Factors that may be expected to influence their willingness to participate, such as potential risks, discomfort, or adverse effects  
• Prospective research benefits and incentives for participation  
• Limits of confidentiality  
• Whom to contact for questions about the research and research participants’ rights.  

You can access Sage’s Participant Consent Form here . Authors should not submit completed consent forms alongside the manuscript files unless specifically requested to do so, owing to potential legal/privacy issues with sending and receiving confidential information. Instead, they should confirm in the relevant section of the – e.g. manuscript – text that the individual(s) or their proxy has provided written informed consent for the publication of this information in the present work.

Informed consent for ethnographic research  

Ethnographic research requires similar ethics approvals from an International Review Board or independent local, regional, or national review body as well as participant consent to conduct and publish the research. Consent should obtained before the research is conducted and it should be part of the project design, implementation, and other parts of the research process. Consultation with groups or communities affected by the studies and consideration of their input on the study design should happen throughout the entire research period. If consent is not obtained before the study perhaps because of the research context, process, or researcher/participant relations, you can seek to obtain it retroactively if necessary.  

Participants should also understand that there is a possibility that confidentiality might be compromised, despite best efforts. This is especially important to note for small communities where participants may be more easily identifiable.

Examples below if consent was obtained:

1.      Written informed consent

The study was approved by the XXXX (Ethical Clearance Reference Number: XYZ123) on Month DD, YYYY. All participants provided written informed consent prior to participating.

Written informed consent was obtained from a legally authorised representative for anonymised patient information to be published in this article.

2.      Verbal informed consent

Informed consent was obtained verbally before participation. The consent was audio-recorded in the presence of an independent witness.

3.      Patient consent for studies involving minors

Written informed consent to participate in this study was provided by the participants’ legal guardians/next of kin.  

4.     Patient or participant consent for use of images including faces

Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.

If patient consent was not obtained:

Informed consent for information published in this article was not obtained because [please state the reason].

Studies involving animals

All studies involving animals, particularly vertebrate animals, must be evaluated by a qualified animal ethics or welfare committee. Ethics statements should include the name and location of the reviewing committee, approval number and date, as in these examples:

Protocols for animal experiments were approved by the Animal Experimental Ethics Committee of the XXXX University (Approval no. XYZ123) on Month DD, YYYY, in compliance with the National Institutes of Health guidelines for the care and use of laboratory animals.

All animals were cared for in strict accordance with the Guide for the Care and Use of Laboratory Animals (NIH Publication No. 85-23, revised 1996), and the experimental design was approved by the Ethics Committee of XXXX (Approval no. XYZ123) on Month DD, YYYY.

If IACUC approval was obtained you can use the example below:

The XXX Institutional Animal Care and Use Committee approved the experimental procedures used in this study (approval no. XYZ123) on Month DD, YYYY.

An example on animal welfare:

All animal housing and experiments were conducted in strict accordance with the institutional Guidelines for Care and Use of Laboratory Animals at [insert name of institution where the research was conducted and/or where the author is based].

Studies not involving humans or animals

These statements can be used in situations where a study did not involve human or animal participants as well as non-research articles such as reviews:

This article does not contain any studies with human or animal participants.

There are no human participants in this article and informed consent is not required.

Global research ethics and inclusion

If your article reports on global research, you should follow the TRUST Code . We recommend including a statement in your methods section describing how your work adheres to the Articles in the Code. Some journals may require a statement under the separate heading ‘Global research ethics and inclusion’ at the end of your article. This should cover the following:

• Confirm that the research has local relevance and has been designed and conducted in collaboration with local communities. Note that contributors meeting the requirements of authorship as per the ICMJE Guidelines must be listed as authors. Sometimes research is conducted in low- and middle-income countries in partnership with researchers from higher income countries. In these cases it is expected that local researchers are listed in first and/or last authorship positions to reflect the significant contribution they will have made. Joint first and/or joint senior authorship is an option here.
• Confirm that local ethics review was sought and if not, explain the reasons why.
• Where research involvement presented any kind of risk to participants e.g. discrimination, incrimination or risk to personal health and safety, describe the special measures taken to ensure their safety and wellbeing that were agreed with local partners.
• Explain how communication was tailored to the requirements of local participants to ensure that informed consent was freely given, and any feedback on findings was comprehensible to local communities. Describe how any potential cultural sensitivities were explored in advance.
• Confirm that all research was conducted to the highest possible ethical standards, regardless of the requirements of the local setting.

We also recommend the guidance provided by Consensus statement on measures to promote equitable authorship in the publication of research from international partnerships (Morton, B. et al, 2022) .

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