What are the MCI guidelines for clinical research?
Regulation 6.8 “Code of conduct for doctors in their relationship with pharmaceuticaland allied health sector industry” of the MCI Code of Ethics Regulations 2002 hasissued the following guidelines regarding clinical research or trials.
6.8.1 (e) Medical Research: A medical practitioner may carry out, participate in, workin research projects funded by pharmaceutical and allied healthcare industries. Amedical practitioner is obliged to know that the fulfillment of the following items (i) to(vii) will be an imperative for undertaking any research assignment / project fundedby industry – for being proper and ethical. Thus, in accepting such a position amedical practitioner shall:-
- Ensure that the particular research proposal(s) has the due permission fromthe competent concerned authorities.
- Ensure that such a research project(s) has the clearance of national/ state /institutional ethics committees / bodies.
- Ensure that it fulfils all the legal requirements prescribed for medical research.
- Ensure that the source and amount of funding is publicly disclosed at thebeginning itself.
- Ensure that proper care and facilities are provided to human volunteers, ifthey are necessary for the research project(s).
- Ensure that undue animal experimentations are not done and when these arenecessary they are done in a scientific and a humane way.
- Ensure that while accepting such an assignment a medical practitioner shallhave the freedom to publish the results of the research in the greater interestof the society by inserting such a clause in the MoU or any other document /agreement for any such assignment
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Thanks for publishing this article.Is the risk and benefit same to all the researches or the primary responsibility of the Primary Investigator /Secondary Investigator? What is the resonsibility of additional sites?