Institutional Ethics Committee shall be multidisciplinary and multi-sectorial in composition notified by the head of the institute as per the ICMR National Ethical Guidelines as below:
1. There should be adequate representation of age and gender.
2. Preferably 50% of the members should be non-affiliated or from outside the institution.
3. The number of members in an EC should preferably be between 7 and 15 and a minimum of 5 members should be present to meet the quorum requirements.
4. The EC should have a balance between medical and non-medical members/technical and non-technical members, depending upon the needs of the institution.
5. So as to maintain independence, the head of the institution should not be part of the EC but should act as an appellate authority to appoint the committee or to handle disputes.
6. The Chairperson and Member Secretary could have dual roles in the ethics committee. They could fulfil a role based on their qualifications (such as that of the clinician, legal expert, basic scientist, social scientist, layperson, etc.) in addition to taking on the role of Chairperson or Member Secretary.
7. The EC can also have a set of alternate members who can be invited as members with decision-making powers to meet the quorum requirements. These members have the same TORs as regular members and can attend meetings in the absence of regular members.
8. The EC can maintain a panel of subject experts who are consulted for their subject expertise, for instance, a paediatrician for research on children, a cardiologist for research on heart disorders, etc. They may be invited to attend the meeting to give an expert opinion on a specific proposal but will not have decision-making power/voting rights.
9. The EC may invite subject experts as independent consultants or include a representative from a specific patient group as a member of the EC or special invitee, for an opinion on a specific proposal, for example, HIV, genetic disorders, or cancer, with appropriate decision-making power.
10. As far as possible a separate scientific committee should priorly also review the proposal before it is referred to EC. EC can raise scientific queries besides ethical ones as both good science and ethics are important to ensure the quality of research and participant protection.
| S. No. |
Members of EC |
Definition/description |
| 1. |
Chairperson/ Vice Chairperson (optional) Non-affiliated
Qualifications –
A well-respected person from any background with prior experience of having served/serving in an EC |
Conduct EC meetings and be accountable for the independent and efficient functioning of the committee
- Ensure active participation of all members (particularly non-affiliated, non-medical/ non-technical) in all discussions and deliberations
- Ratify minutes of the previous meetings
- In case of anticipated absence of both Chairperson and Vice Chairperson at a planned meeting, the Chairperson should nominate a committee member as Acting Chairperson or the members present may elect an Acting Chairperson on the day of the meeting. The Acting Chairperson should be a non-affiliated person and will have all the powers of the Chairperson for that meeting.
- Seek COI declaration from members and ensure quorum and fair decision-making.
- Handle complaints against researchers, EC members, conflict of interest issues and
requests for use of EC data, etc.
|
| 2. |
Member Secretary/ Alternate Member Secretary (optional) Affiliated
Qualifications-
- Should be a staff member of the institution
- Should have knowledge and experience in clinical research and ethics, be motivated and have good communication skills
- Should be able to devote adequate time to this activity which should be protected by the institution
|
- Organize an effective and efficient procedure for receiving, preparing, circulating and maintaining each proposal for review
- Schedule EC meetings, prepare the agenda and minutes
- Organize EC documentation, communication and archiving
- Ensure training of EC secretariat and EC members
- Ensure SOPs are updated as and when required
- Ensure adherence of EC functioning to the SOPs
- Prepare for and respond to audits and inspections
- Ensure completeness of documentation at the time of receipt and timely inclusion in agenda for EC review.
- Assess the need for expedited review/exemption from review or full review.
|
| 3. |
Basic Medical Scientist(s) Affiliated/ non-affiliated
Qualifications-
- Non-medical or medical person with qualifications in basic medical sciences
- In case of EC reviewing clinical trials with drugs, the basic medical scientist should preferably be a pharmacologist
|
- Scientific and ethical review with special emphasis on the intervention, benefit-risk analysis, research design, methodology and statistics, continuing review process, SAE, protocol deviation, progress and completion report
- For clinical trials, pharmacologist to review the drug safety and pharmacodynamics.
|
| 4. |
Clinician(s) Affiliated/ non-affiliated
Qualifications-
- Should be individual/s with recognized medical qualifications, expertise and training
|
- Scientific review of protocols including review of the intervention, benefit-risk analysis, research design, methodology, sample size, site of study and statistics
- Ongoing review of the protocol (SAE, protocol deviation or violation, progress and completion report)
- Review medical care, facility and appropriateness of the principal investigator, provision for medical care, management and compensation.
- Thorough review of the protocol, investigator’s brochure (if applicable) and all other protocol details and submitted
documents.
|
| 5. |
Legal expert/s
Affiliated/ non-affiliated
Qualifications-
- Should have a basic degree in Law from a recognized university, with experience
- Desirable: Training in medical law.
|
- Ethical review of the proposal, ICD along with translations, MoU, Clinical Trial Agreement (CTA), regulatory approval, insurance document, other site approvals, researcher’s undertaking, protocol specific other permissions, such as stem cell committee for stem cell research, HMSC for international collaboration, compliance with guidelines etc.
- Interpret and inform EC members about new regulations if any
|
| 6. |
Social scientist/ philosopher/ ethicist/theologian
Affiliated/ non-affiliated
Qualifications-
- Should be an individual with social/ behavioral science/ philosophy/ religious qualification and training and/or expertise and be sensitive to local cultural and moral values. Can be from an NGO involved in health-related activities
|
- Ethical review of the proposal, ICD along with the translations.
- Assess the impact on community involvement, socio-cultural context, religious or philosophical context, if any
- Serves as a patient/participant/ societal/Community representative and brings in ethical and societal concerns.
|
| 7. |
Lay person(s)
Non-affiliated
Qualifications-
- Literate person from the public or community
- Has not pursued a medical science/ health-related career in the last 5 years
- May be a representative of the community from which the participants are to be drawn
- Is aware of the local language, cultural and moral values of the community
- Desirable: involved in social and community welfare activities
|
- Ethical review of the proposal, ICD along with translation(s).
- Evaluate benefits and risks from the participant’s perspective and opine whether benefits justify the risks.
- Serve as a patient/participant/ community representative and bring in ethical and societal concerns.
- Assess on societal aspects if any.
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