Year : 2018 | Volume
: 5 | Issue : 3 | Page : 70--71
Ethics committee in an academic institute
Ravindra B Ghooi
Director, Scientia Clinical Services, Pune, Maharashtra, India
Director Ravindra B Ghooi
Director, Scientia Clinical Services, Pune, Maharashtra
|How to cite this article:|
Ghooi RB. Ethics committee in an academic institute.J Dent Res Rev 2018;5:70-71
|How to cite this URL:|
Ghooi RB. Ethics committee in an academic institute. J Dent Res Rev [serial online] 2018 [cited 2019 Mar 19 ];5:70-71
Available from: http://www.jdrr.org/text.asp?2018/5/3/70/245685
“Should academic research be subjected to ethical scrutiny like new drug trials?” Is a question that is often asked. Investigators hope that the answer is negative. They are often irked by the requirement of voluminous documents by Ethics Committees (ECs), and often by EC members who believe their main role is to control research. However, the World Medical Association (WMA) while introducing the concept of independent ethical review did not differentiate between “academic” and “regulated research.” While one cannot read what was in their minds when the members met in Tokyo, in 1975, one can but guess what the reasons were.
The mid-seventies were turbulent times for scientific research. Exposes of the Tuskegee studies (this was incidentally a noninterventional, observational study), the Willowbrook study and Human Radiation Experiments teased the healing wounds caused by Nazi experiments. Although the Nuremberg Code was lauded by all as a foundation for medical research ethics, it had no legal force behind it. The Declaration of Helsinki remained a guideline, and scientists had very little will to follow it. The most disturbing observation was that maximum abuse of research participants took place at the hands of investigators. The persons who could have been the greatest protectors of individuals were found to be the main violators.
It became clear to the WMA that one could not depend on investigators to treat the participants ethically. There was a need for another mechanism, providing oversight that would prevent unethical research and permit only ethical studies. Thus, the WMA proposed a multisectoral, independent body called the Institutional Review Board. The nomenclature of this body has changed; however, the basic function remains the same. Over the last few years, Ethics Committees have become so successful in protecting participants, that regulators are offloading more and more responsibilities on them.
Currently, all research involving human participants needs clearance from a duly constituted Ethics Committee. Clinical research involves human participants, and these participants expect to be protected. By participating in research, they are doing science favor, and protecting them against harm, whether physical, mental, psychological, social, or financial is but an act of repaying them for their services. Very often the investigators, especially when they are young students may not realize the harm they cause to the participants; hence, oversight by a mature group of people (such as EC members) is necessary. The government has added more layers of protection, and these include the registration of Ethics Committees with the regulatory authority.
Those opposing EC scrutiny point out that the most academic studies are descriptive and observational; hence, injury to the participants is very rare. Nonetheless, it is recognized that even descriptive studies could harm participant, they often affect participants in unexpected ways. The common refrain that postgraduate students' research be kept out of reach of the EC to make life easier for the students misses the point that the rights and well-being of participants take precedence over all considerations. When research projects are in part fulfillment of the requirements of qualification, there is no reason to reduce the emphasis on research. It would be better to have no research rather than have research without ethical review.
Postgraduate studies are but a stepping stone for medical or dental practice. Laxity in any part of the study is bound to affect the quality of qualifying students. Since these are the people who will manage the health of the nation, a few years hence, no compromise should be allowed on quality of education imparted to them. That high-quality education yields high-quality doctors and dentists, is an axiom, it needs no proof. Medical and dental students have contributed to tremendous advances in science, it should be remembered that Charles Best was a medical student when he helped Fredrick Banting discover insulin. One never knows when another Best may emerge through the portals of the institute.
The role of an Ethics Committee is not only to control research but also to facilitate ethical research. A small tweak in the trial design can help a trial overcome the ethical pitfalls, and that is what is expected of the Ethics Committee. The composition of the EC should be such that it can provide guidance to make research ethical, and only when this happens, will investigators stop seeing the EC members as adversaries. Working together the EC and investigators can raise the bar of research, which every institute and university looks forward too. One, therefore, cannot overemphasize the importance of careful selection of Ethics Committee members.
Students who conduct research would like to see their research published in journals, and editors of most good journals, demand that papers should be based on projects that have ethical clearance. If for nothing else, only for the sake of publication, all projects should undergo ethical scrutiny. If this is not done, we would be left with either no publications, or publications in journals now known as predatory journals. Such paid publications often cause more harm than good to the students' cv. They also need to realize that a single publication in Lancet or New England Journal of Medicine can do more for them, than what a handful of godfathers could.
Academic institutes are crucibles where professionals are molded. It would be to the advantage of these professionals as well as the lay public if academic institutes were to inculcate ethics in their students; mere inclusion of a few lectures on ethics is inadequate. Ethics has a far wider application, beyond research; its reach extends to routine practice and other areas of life. The products of such institutes should not only practice ethically but also have ethics ingrained in every action of theirs. If more and more people understand ethics and practice it in their daily life, the earth would be a better place to live in.
One final reason why ethics is so important in research is the need for continued new drug research. Despite the great advances of medicine over the last century, we still do not have safe and effective drugs for many diseases. The drugs that are safe are ineffective and those that are effective are unsafe. There should be no slackening of the pace of new drug development. For accelerated drug development, we would need the cooperation of healthy volunteers and patients; however, they will not volunteer unless they are assured that their rights, safety, and well-being will be protected, and that is what the ECs are mandated to do.
Research should not only be ethical but also be seen to be ethical, and this is one area where we, as scientists have failed miserably. The lay people do not trust medical research; they look down upon drug trials as a shady activity. They even call trial volunteers guinea pigs. We have failed to convey and to convince the population at large that medical research is an extremely ethical activity, and a research participant receives better care than an average patient.