Guidelines

Guidelines

INSTITUTIONAL ETHICS COMMITTEE

It is mandatory, as per the Chapter II of the ICMR Ethical Guidelines for Biomedical Research On Human Participants that all proposals on biomedical research in Heartfulness Institute involving human participants should be cleared by an appropriate the Institutional Ethics Committee to safeguard the welfare and the rights of the participants. The IEC is entrusted not only with the initial review of the proposed research protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring of the approved programmes to foresee the compliance of the ethics during the period of the project.

The basic responsibility of the IEC is to ensure a competent review of all ethical aspects of the project proposals received by it in an objective manner. IEC will provide advice to the researchers on all aspects of the welfare and safety of the research participants after ensuring the scientific soundness of the proposed research through appropriate Scientific Review Board.

The major aspects that IEC focusses on are as follows:

  • To ensure that any research using human beings as participants in Heartfulness shall follow the standards and principles prescribed for such trials in the ICMR Ethical Guidelines for Biomedical Research on Human Participants, 2006; and
  • To protect the dignity, rights and well-being of the potential research participants.
  • To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs.
  • To assist in the development and the education of a research community responsive to local health care requirements.

Review Procedures

The IEC shall review every research proposal for biomedical research on human participants in accordance with the SOPs to be formulated, prior to initiation of the research. It shall ensure that a scientific evaluation has been completed before ethical review is taken up. The Committee shall evaluate the possible risks to the participants with proper justification, the expected benefits and adequacy of documentation for ensuring privacy, confidentiality and the justice issues. The IEC’s member-secretary or secretariat shall screen the proposals for their completeness and depending on the risk involved categorize them into three types, namely, exemption from review, expedited review and full review (See Ethical Guidelines for Biomedical Research on Human Participants,2006 Page 11-15).
An investigator cannot decide that her/his protocol falls in the exempted category without approval from the IEC. All proposals will be scrutinized by the secretariat to decide under which of the three categories it will be considered.

Submission of applications

Applications for ethical committee clearance and Scientific Review Board clearance should be submitted simultaneously. The applications will be then scrutinized by the Chairperson and the Member Secretary and categorize it among the three categories as described above. The applications shall be then forwarded to IEC members who will have a minimum period of 3 weeks for review. IEC will immediately (in a week’s time) conduct a meeting for ethical clearance to the projects that have obtained technical clearance.

Download the prescribed format for proposals

 

 

For more details, contact

Institutional Ethics Committee

R.Sathyanarayanan
Member Secretary, Institutional Ethics Committee,
Plot 37, 4 th Street, Krishna Nagar,
Virugambakkam, Chennai 600 092.
E-mail:iec@heartfulness.org