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Journal of Postgraduate Medicine, Vol. 48, Issue 2, 2002 pp. 91 Do All Projects Require Ethics Committee Clearance? Urmila M. Thatte, MD Department of Clinical Pharmacology, TN Medical College, Mumbai - 400 008, India. Code Number: jp02030 When a manuscript is submitted to a journal for publication, one of the first things a referee will look at is whether an Ethics Committee has approved the study (be it a study in humans or now even animals) and whether written informed consent has been taken from the subjects participating in the study or their guardians (of course only relevant for human studies!). The dilemma comes when these have not been done. In 2002 when, at the global level the International Conference for Harmonisation for Good Clinical Practice and at the national level both the Indian Council for Medical Research1 and the Central Drugs Standard Control Organisation (Directorate General of Health Services)2 have clearly laid down guidelines for doing clinical research this should not be a dilemma at all. Clearly all and any research in humans must be preceded by permission from an Ethics Committees be it an Institutional Review Board or an Institutional Ethics Committee or an Independent Ethics Committee whichever is accessible. The type of research could be prospective or retrospective, could be an invasive, experimental study involving a new drug or new device (or even an old drug or device) or a "simple" questionnaire based study, in normal subjects or in patients, a study looking at histopathology specimen or serum samples, a company sponsored project or a Government sponsored one, an academic project or a student's thesis. As long as it involves research on human beings, the investigator must obtain Ethics Committee permission. If we want research to be internationally acceptable, papers have to conform to international guidelines. What does an Ethics Committee look at when it reviews a project? In general, the following: Is the research in human subjects absolutely essential, how are the subjects participating in the study going to be informed about the study and how will their "voluntary" participation be assured, whether any subject is being exploited, whether the confidentiality and privacy of a patient is being protected, whether due care is being taken at all steps to ensure minimal risk to the patients, is the study being conducted by competent individuals, is the data generated from the study being recorded accurately in a transparent manner, will the results obtained from this research be applicable to the community from where the subjects are drawn, have all institutional and legal aspects been addressed, how will the results of the research be publicised, and are the GCP and ethical guidelines being followed in spirit and letter? If for any reason Ethics Committee permission was not obtained prior to conduct of the study it is obvious that unless the paper has some "real" message and is of great importance to patient care to merit its publication (after taking post-facto Ethics Committee permission) it has to be rejected. Sometimes slightly ridiculous and somewhat vacuous arguments are offered when authors are confronted with this issue e.g. similar studies have been done elsewhere in the country without Ethics Committee permission, or that there are publications in other Indian journals describing similar studies- so the authors should be permitted to publish their paper without Ethics review. But one wrong should not perpetuate another if at all, it must be corrected. We are not concerned with other trials. We are after all only concerned with the trial being reported in the paper sent for publication. If authors have not obtained Ethics Committee clearance for this trial, the paper gets rejected on this ground itself. Beyond just taking Ethics Committee permission another issue that comes up is "Has written informed consent been obtained from the subject?" This is also not a topic for "debate". Informed consent has to be taken and must be documented. An informed consent is not just a piece of paper rather it is a whole process and the process has to be documented. The patient information sheet and informed consent document is reviewed meticulously by Ethics Committees and their input always enriches the informed consent document and protects the patient. Ethics after all, is the application of values and moral rules to human activities and bioethics is a part of applied ethics that uses ethical principles and decision making to solve actual or anticipated dilemmas in medicine and biology. Ethics seeks to find reasoned, consistent, and defensible solutions to moral problems. Indeed, there can very few arguments against the need for ethical review of protocols for human research before starting them.
Urmila M. Thatte, MD Department of Clinical Pharmacology, TN Medical College, Mumbai - 400 008, India.
References
This article is also available in full-text from http://www.jpgmonline.com/ © Copyright 2002 - Journal of Postgraduate Medicine |
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