Ethics in Clinical Research

Role and Composition of Ethics Committee (EC)

Ethics as much talked about, is arduous to understand and interpret. One always tries to interpret ethics in his or her own way. So how can we justify as to what is ethical and what not? Seems like a real googly, isn’t it? In similar sense, think about how ethics committees justify their decisions with regards to new clinical trials, subject safety etc. To understand the role of ethics committee (EC), we need to step in its shoes. However, still the question remains, how do they do it?

There is a normal way, which is to follow – the guidelines, the regulations and may be as a matter of fact, Standard operation procedures (SOPs). Well inspite of all righteous compliance we may be far from achieving an ethical outcome.

Arduous role of Ethics Committee (EC):
According to Mark P. Aulisio and Robert M. Arnol in their article on “Role of the Ethics Committee” they quoted “Ethics committees arose in response to a clinical need for a formal mechanism to address some of the value conflicts and uncertainties that arise in contemporary health-care settings”…

Basic role of Ethic Committee can be summed as:
• To protect the rights, safety and well being of patients; by
– Prevent studies that pose an unacceptable risk of harm to participants
– Ensure that all participants in research are aware about the pros and cons for their participation and have given appropriate Informed Consent.
• To promote fair ethical policies and procedures which will maximize the likelihood of achieving good and patient-oriented outcomes;
• To enhance the ethical tenor between health care professionals and organisations conducting clinical trials.
• Overview and monitor thoroughly, compliance of sites with Standard Operating Procedures (SOPs), regulations, guidelines and ETHICS.
• Offering due consideration to community views.

Composition of Ethics Committee: (as per Schedule Y)

• There should be a heterogeneous group of at least 7 members (5 as per ICH-GCP). The EC members should be – Qualified, experienced in their professional field and proficient enough to review and evaluate both scientific & ethical aspects (familiar with GCP).
• Adequate representation of age, gender etc is maintained.
• Maximum of 15 members are recommended
– Chairperson : Outsider (Not from the institution if its Institution Review Board)
– Member – Secretary
– Member list must include at least each one of the following– a basic medical scientist, clinician, legal expert, social worker, philosopher/priest, & a lay person.
– Experts from different arenas may be also invited for scientific review.
– A representative of Patient groups like for HIV, may also be included.

To conclude that we say; an ethics committee should have a composition which will function in a manner that it will justify not only right V/s wrong decision but also will be instead competent enough in judging various right V/s right situations.

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