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 Table of Contents  
VIEWPOINT
Year : 2018  |  Volume : 10  |  Issue : 4  |  Page : 105-107

Should lack of ethical committee's approval of human research lead to rejection of resulting manuscripts?


1 Center for Diabetes and Endocrinology, Institute of Medicine, Sheikh Khalifa Medical City, Abu Dhabi, United Arab Emirates
2 Department of Medicine, Hamad Medical Corporation, and Weill Cornell Medicine-Qatar, Doha, Qatar
3 Department of Pediatrics, United Arab Emirates University, Al Ain, United Arab Emirates
4 Department of Surgery, The Ohio State University, Columbus, OH, USA

Date of Web Publication3-Aug-2018

Correspondence Address:
Dr. Salem A Beshyah
Institute of Medicine, Sheikh Khalifa Medical City, P. O. Box. 59472, Abu Dhabi
United Arab Emirates
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijmbs.ijmbs_42_18

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How to cite this article:
Beshyah SA, Ibrahim WH, Aburawi EH, Elkhammas EA. Should lack of ethical committee's approval of human research lead to rejection of resulting manuscripts?. Ibnosina J Med Biomed Sci 2018;10:105-7

How to cite this URL:
Beshyah SA, Ibrahim WH, Aburawi EH, Elkhammas EA. Should lack of ethical committee's approval of human research lead to rejection of resulting manuscripts?. Ibnosina J Med Biomed Sci [serial online] 2018 [cited 2021 Mar 9];10:105-7. Available from: http://www.ijmbs.org/text.asp?2018/10/4/105/238525




  Context Top


Compliance with ethical principles in clinical research is a vital aspect of scientific publication.[1] It is particularly important because the published data may directly affect human health.[2] There have been some concerns about the extent of adherence to ethical principles that lead to increased scrutiny of publication ethics, policies, and practices in various regions and disciplines.[3],[4] These infringements involve knowledge and behavior of authors, competence and complacency of editors, and adequacy of regulatory provisions.

Recently, the Ibnosina Journal of Medicine and Biomedical Sciences received few clinical research manuscripts that seemed, on their face value, exciting and have contributing valuable knowledge to their subject. Surprisingly, these submissions had no mention of formal ethical approval despite involving human subjects. On further inquiry, it was readily revealed that no ethical review was undertaken. The authors furnished different arguments for such ethical oversight including ignorance about the need for such approvals or lack of Institutional Review Boards (IRBs) in their setting. We were particularly alarmed that some of these authors hold high qualifications from established universities and were employed in academic positions in their institutions. Unfortunately, they failed to recognize the mandatory nature of the formal prior ethical review of human research.[1],[2] Hence, in this viewpoint, we consider the core principles of good practice in scientific publishing, emphasize ethics as a core value in research, and highlight ethical pitfalls by authors, editors, and institutions.


  Publication: An Ethical Imperative Top


Publication of clinical research is both a monitor of the researcher's ethics and an audit of the local and regional ethics committees that approved it.[5] Peer-reviewed biomedical journals are expected to publish accurate and vital information. In the process, numerous ethical issues may arise from within both the editorial and research communities. The general ethical issues include what constitutes authorship, fair and serious peer-review processes, avoidance of duplicate or repetitive publication, and declaration of potential conflict of interest.[6] Issues of authorship include multiple authorship, misconduct among coauthors, guest and honorary authorship, the order of authorship, and credit for those not qualifying for authorship. Peer reviews attempt to ensure that what is published is valid.[7] Ethical issues of peer reviews include confidentiality of the manuscript, potential editor and reviewer bias, and conflict of interest on the part of the reviewer. Duplicate or repetitive publication, in which the same information is reported two or more times, can damage a journal's reputation for publishing new and vital information and can waste its resources. Conflict of interest, in which financial and personal considerations may affect the investigator's judgment, can severely damage the integrity of the author and the journal.[7]


  Why Ethical Approval is Required for Research Publications? Top


Opinions may differ about what is ethically allowable in clinical and benchtop medical researches. Ethical permission and ethical monitoring of medical research are subject to a hierarchy of pyramidal controls, starting in the hospital and ending with the local, institutional, or regional ethical committees. Such committees function with varying degrees of efficiency and quality of output, and with differing viewpoints on many ethical issues.[8] Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee commonly known as IRBs. Journals continue to receive submissions from authors who have failed to obtain such approval.[9] The IRB is an independent body constituted of medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in clinical research. IRBs do their role by, among other things, reviewing, approving, and providing continuing review of the research protocol and amendments and the methods and materials to be used in obtaining and documenting informed consent of the research subjects in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guideline.[2] Four justifications for requiring ethical approval before publication include the following: first, IRB approval adds legitimacy to the research; second, the process of obtaining IRB approval can improve the quality of an intervention being investigated; third, obtaining IRB approval can help mitigate harm; and lastly, obtaining IRB approval demonstrates respect for persons.[9]


  Pitfalls and Solutions for Authors and Editors Top


The growing emphasis on the importance of publishing scientific findings in the academic world has led to increasing discovery of potentially significant publications in which scientific and ethical rigor may be questioned. This has hindered research progress but also eroded public trust in all scientific advances. Due to the increasing concern and the complexity of research misconduct, the Committee on Publication Ethics (COPE) was established in 1997 to manage cases with ethical implications.[10] COPE is a professional body providing a discussion forum and advice for scientific editors; it aims to find practical ways to deal with the publishing issues and to develop good practice. It is essential to customize and outline the best practice in the ethics of scientific publishing. These strategies of COPE are valuable for all those involved in clinical research. Scholarly trustworthiness should be actively encouraged in all medical and scientific courses of study and should be used to inform publication ethics and prevent misconduct. It is with that in mind these guidelines have been produced.[11] COPE publishes cases referred to it with its verdict and advice to the editors on its website. For this editorial, we present the summary of selected real-life instances published by COPE under the subheading “ethical oversight questionable/unethical research.”[11] They all demonstrate the inappropriateness and potential risk to human subjects posed by research being conducted without prior ethical approval. The examples presented here give a wide range of scenarios from utter ignorance of the regulation, lack of rules, and lack of structure to making false assumptions [Box 1]. Many more ethical issues are available on the COPE website and are worth a careful consideration by those with an interest and they can be used for educational sessions to stimulate discussion around the subject.




  Ethical Compliance is a Responsibility for All Top


The advancement of medical science and practice relies on research that must eventually involve human subjects. Therefore, obtaining ethical approval should be a moral reflex for researchers. Unfortunately, this is not the case with too many researchers bypassing the ethics approval procedure, or perhaps unaware of its fundamental importance. Research expectedly involves risks taken by the research participants and uses health-care funds from public, private, or charitable sources in the process. These mandate the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science.[12] Some researchers may confuse scientific clearance or even worse administrative approval with ethical approval. For a study to be ethically sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. The researcher has the responsibility of systematically consulting with IRB for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to evaluate the ethical soundness of manuscripts submitted for review systematically. Capacity building in research ethics and institutional support for IRBs to speed up protocol review could reduce the incentive of researching human subjects without ethical approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from IRBs functioning purely on altruistic grounds. Building capacity for researchers in research ethics, institutional reforms, and support for IRBs appear not to have received the attention they truly deserve.[12] In developing countries, IRBs may be seen as luxury rather than necessity components of institutions. IRB members may be called upon to join based on personal interest with no protected time to undertake the necessary review work. Lack of administrative support may make difficult for researchers to submit applications and burden IRB members with unnecessary administrative tasks.

Finally, it is essential that academicians make their utmost effort to maintain the integrity of scientific research and uphold its ethical standards. Authors, editors, journals, and institutions have to work together to this end. Authors must adhere to the spirit and letter of the international research ethics guidelines and journal instructions, while editors should play a gatekeeper role to protect research participants, uphold scientific integrity, and maintain public trust in the experimental process and profession. Medical journals should inspect ethical review more critically. Names of IRB bodies granting the approvals as well as reference code numbers (rather than accepting a generic statement) should be incorporated in the manuscript. Institutions should enforce the provisions for ethical approvals for all kinds of research by putting in place rules and regulations and clear pathways spanning the full range of research work from student projects to pharma-sponsored studies.

Authors' Contributions

All authors contributed to the drafting and revisions of the manuscript and approved its final version.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Compliance with ethical principles

Not applicable.



 
  References Top

1.
ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf. [Last accessed on 2018 Jun 16].  Back to cited text no. 1
    
2.
International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals (excerpts). J Am Coll Dent 2014;81:23-30.  Back to cited text no. 2
    
3.
Xuemei L, Youping L, Shangqi S, Senlin Y, Williams S. Ethical review reporting of Chinese trials records in WHO primary registries. J Med Ethics 2011;37:144-8.  Back to cited text no. 3
    
4.
Belhekar MN, Bhalerao SS, Munshi RP. Ethics reporting practices in clinical research publications: A review of four Indian journals. Perspect Clin Res 2014;5:129-33.  Back to cited text no. 4
[PUBMED]  [Full text]  
5.
Roberts J. An author's guide to publication ethics: A review of emerging standards in biomedical journals. Headache 2009;49:578-89.  Back to cited text no. 5
    
6.
Pearn J. Publication: An ethical imperative. BMJ 1995;310:1313-5.  Back to cited text no. 6
    
7.
Kempers RD. Ethical issues in biomedical publications. Hum Fertil (Camb) 2001;4:261-6.  Back to cited text no. 7
    
8.
Gollogly L, Momen H. Ethical dilemmas in scientific publication: Pitfalls and solutions for editors. Rev Saude Publica 2006;40:24-9.  Back to cited text no. 8
    
9.
Newson AJ, Lipworth W. Why should ethics approval be required prior to publication of health promotion research? Health Promot J Austr 2015;26:170-5.  Back to cited text no. 9
    
10.
Foo JY, Wilson SJ. An analysis on the research ethics cases managed by the committee on publication ethics (COPE) between 1997 and 2010. Sci Eng Ethics 2012;18:621-31.  Back to cited text no. 10
    
11.
Committee on Publication Ethics (COPE). Research” Without Ethics Committee Approval. Available from: https://www.publicationethics.org. [Last accessed on 2018 Jun 15].  Back to cited text no. 11
    
12.
Bain LE. Ethics approval: Responsibilities of journal editors, authors and research ethics committees. Pan Afr Med J 2017;28:200.  Back to cited text no. 12
    



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