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What are the MCI guidelines for clinical research? |
Medico Legal Corner
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What are the MCI guidelines for clinical research?
Dr KK Aggarwal & Advocate Ira Gupta,  12 August 2019
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Regulation 6.8 “Code of conduct for doctors in their relationship with pharmaceutical and allied health sector industry” of the MCI Code of Ethics Regulations 2002 has issued the following guidelines regarding clinical research or trials.

6.8.1 (e) Medical Research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical 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 funded by industry – for being proper and ethical. Thus, in accepting such a position a medical practitioner shall:-

  1. Ensure that the particular research proposal(s) has the due permission from the competent concerned authorities.
  2. Ensure that such a research project(s) has the clearance of national/ state /institutional ethics committees / bodies.
  3. Ensure that it fulfils all the legal requirements prescribed for medical research.
  4. Ensure that the source and amount of funding is publicly disclosed at the beginning itself.
  5. Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research project(s).
  6. Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way.
  7. Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document /agreement for any such assignment
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