Institutional Review Board

 All research in human subjects is now guided by the principles enshrined in the Declaration of Helsinki. This is also the basis of good clinical research practices (GCP) adopted by the international conference on harmonization (ICH). The Indian Council of Medical Research (ICMR) has also issued ethical guidelines for research on human subjects.

Chest Research Foundation (CRF), Pune, was established as an institution devoted to clinical research in the field of respiratory diseases. Consequently, it conducts research involving human subjects, either patients or healthy volunteers. It was therefore necessary to form this IRB to ensure that the research carried out at CRF meets both the international and the local ethical standards, and thus complies with the principles of GCP thereby protecting the rights and safety of human subjects.

SCOPE

Although this IRB is formed primarily to review the proposals for research to be done at CRF, it will offer its services to investigators working in other institutions, and also to independent investigators, who do not have access to an IRB. However, the applications for review received from such investigators should expressly declare that they and the administrators of the institutions in which they are working, if that be the case, accept the authority of this IRB to lay down conditions for approving a research proposal, to oversee its conduct, and to demand its termination if the IRB detects any misconduct, fraud, violation of the approved protocol, or any reason that exposes the study subjects to unacceptable risk. Further, the Principal Investigator will need to be present at the meeting of the Board, in which his/her proposal is to be discussed, to offer clarifications on the project if necessary, unless for justifiable reasons this condition is waived by the Board.

GUIDING PRINCIPLES                                                            

  • Schedule Y (Drugs and Cosmetic Act 1940; amendment 20th January 2005). 
  •  ICMR’s Ethical Guidelines for Biomedical Research on Human Participants (2006).
  • WHO Operating Guidelines for Ethical Review Board that Review Biomedical Research (2000).
  • International Conference on Harmonization - Good Clinical Practices (ICH-GCP) Guidelines (1996).
  • Notification- Ministry of Health and Family Welfare (Department of Health), 30 January 2013.
  • Notification- Ministry of Health and Family Welfare (Department of Health), 08 February 2013.

 

MEMBERSHIP

A constituent meeting of the IRB, chaired by Dr. Sundeep Salvi, Director of CRF, was held on 16 November 2002, in which the following policies were adopted:

  1. The constituent meeting shall elect the Chairperson and members to form the IRB.
  2. The IRB will be multi-sectorial and multidisciplinary in composition.
  3. The IRB will have 8-12 members.
  4. The constitution of the Board will be as recommended by ICMR Ethical guidelines as follows:
    1. Chairperson
    2. One - two persons from basic medical science area (preferably pharmacologist)
    3. One - two clinicians from various Institutes
    4. One legal expert or retired judge
    5. One social scientist/ representative of non-governmental voluntary agency
    6. One philosopher/ ethicist/ theologian
    7. One lay person from the communityMember Secretary
  5. Each member shall attend or shall have attended an orientation program on GCP, with special reference to the responsibilities and functions of an IRB.
  6. Each member will have to sign a letter of acceptance of IRB membership in response to an invitation letter sent by the chairperson.
  7. The IRB will appoint a chairperson who is not from the institution to maintain the independence of the IRB. The Member- Secretary will be from the institution and will be responsible for administrative matters of the IRB.
  8. Other members will be a mix of medical/non-medical, scientific and non-scientific persons including lay persons and appropriate gender representation.
  9. The members representing medical scientists and clinicians should have Post Graduate degree and adequate experience in their respective fields and aware of their roles and responsibilities as committee members.
  10. Each member shall sign a Confidentiality agreement with CRF that he or she shall treat as confidential all information and documents made available to him or her by the IRB.

For further queries please feel free to contact us at ethics@crfindia.com

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