2. Constitution of Institutional review board, CIHSR
The CIHSR IRB was established as part of the institute’s commitment for ensuring quality research done ethically for the purpose of good evidence based medicine as well as promotion of high quality standard in patient care, professional education, research and community consideration.
2.2 Policies for researchers
- The researcher should have the appropriate qualifications and competence in research methodology and should be aware of and comply with the scientific, medical, ethical, legal and social requirements of the research proposal.
- The researchers and the team are responsible for protecting the dignity, rights, safety and well-being of the participants enrolled in the study.
- The proposal should be submitted in the prescribed format as specified by IRB SOP.
- All proposals are required for presentation in both scientific and ethical committee meeting for discussion and decision making.
- All researchers are required to read and comply with the ‘responsible conduct of research’ given in section 3 of National ethical guidelines for biomedical and health research involving human participant by ICMR, 2017 2
- As the institute also conduct DNB and family medicine teaching programme, students/candidates under the teaching programme are to complete all necessary requirements for approval of thesis proforma by IRB within a period of 3 months after commencing of the course.
- Leave or absence of principle investigator for 3 months or more mandates the transfer of PI responsibility to qualified onsite co-investigators formally appointed by amendment in the research project.
2.3 Policies for IRB members
- The IRB members includes a scientific committee and an ethical committee both having specific functions. Refer to table 1 for specific ethics member functions and responsibilities.
- The CIHSR IRB should provide competent and timely reviews of all research proposals submitted to ensure that the study is within the standard norms of national and international guidelines, and the ethical conduct of all such research within the ethical norms laid down by the latest revisions of national ethical guidelines for biomedical and health research involving human participants of the Indian Council for Medical Research (ICMR) and other relevant guidelines. And to ensure that applicable local laws and regulations are also met.
- The submitted research proposals are reviewed under broad heading of benefit-risk assessment, informed consent process, privacy and confidentiality, distributive justice, payment for participation, compensation for research-related harm, policy for monitoring and preventing conflict of interest, selection of vulnerable and special groups as research participants, community engagement and post research access and benefit sharing.
- Suggest strategies to improve research proposals that fall short of the expected scientific and ethical standards.
- Refuse approval of research proposals that do not meet the expected scientific and ethical standards.
- Provide ongoing monitoring of all research that it approves, including site visits and audits of procedures and documentation of adverse events.
- Require periodic reports and final reports of all research that it approves.
- The IRB SOP and its policies should be revised for all IRB members at least once yearly
2.4 Composition of IRB members.
The scientific committee is selected by the institute for the purpose of reviewing submitted research protocols to ensure that the novelty in what is looked for, the rationality behind the research and the justification for the same are answered.
The ethical committee composition:
- IRB should be multidisciplinary and multi-sectoral in Committee is composed of a minimum of 7, and maximum of 15 members. It includes scientific and non-scientific members, clinicians and non – clinicians, members of the community, a lawyer/expert in ethics, a social worker / layperson / patient representative to represent different points of view in accordance with chapter IV of the New Drugs and Clinical Trial Rule, 2019 1.
- Committee will comprise of a Chairperson, a Member Secretary, and other 5-11 active members who represent an appropriate balance of professional, ethical, legal, cultural, educational, and community
- In addition to the members the committee will have a list of experts who will contribute to the proposals by providing their suggestions in their respective fields.
Table 1 showing the various EC title and their job description. This is an adaptation from national ethical guidelines for biomedical and health research involving human participants by ICMR, 2017 2.
EC title and their job description
|S.No||Members of EC||Definition / Description|
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 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 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 conflict of interest 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.
|2|| Member Secretary|
• 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.
• Assess the need to obtain prior scientific review, invite independent consultant, patient or community representatives.
• Ensure quorum during the meeting and record discussions and decisions.
|3|| Basic Medical Scientist(s)|
• Non-medical or medical person with qualifications in basic medical sciences.
|• 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.|
Affiliated/ non-affiliated Qualifications - • Should be individual/s with recognized medical qualification, 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 protocol, investigators brochure (if applicable) and all other protocol details and submitted documents.
|5|| Legal expert/s|
Desirable: Training in medical law.
| • Ethical review of the proposal, ICD along with translations, MoU, regulatory approval, insurance document, other site approvals, researcher’s undertaking, protocol specific other permissions such as multisite research studies, HMSC and MTA for international collaboration.|
• Interpret and inform EC members about new regulations if any.
|6|| Social scientist/ philosopher/ ethicist/theologian|
• 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 impact on community involvement, socio–cultural context, religious or philosophical context, if any
• Serve as a patient/participant/ societal / community representative and bring 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.
2.5 Appointment of EC members
- The Director of CIHSR is responsible for appointing all EC members, including the chairperson.
- In the appointment letter issued to the members, the following should be specified:
- Term of reference of CIHSR- IRB.
- Specific role and responsibilities.
- Duration of appointment.
- Conditions of appointment.
- The duration of EC members is for a minimum period of 3 years. The duration can be extended depending upon the need of the institute IRB with proper notification.
- Adherence to the procedure of appointment of IRB is to be followed to allow continuity, maintenance and development of the required expertise as well as input of new and innovative approach and ideas.
- There is no limit to the number of times the membership is renewed.
- The director of the institute with recommendations from the chairperson and member secretary shall decide the continuation of each IRB member.
- The appointment of chairperson or member secretary shall be appointed 6 months prior to the resignation or termination of the present member.
- The other EC members shall be appointed 1 month prior to the resignation or termination of the present member.
2.5.3 Resignation/replacement procedure
In case a regular member wishes to resign, a written application should be made dated 30 calendar days from the next scheduled IRB meeting notifying to the Director of CISHR, member secretary and chairperson of CISHR IRB. The same authority will follow the prescribed protocol for replacement/removal of IRB member falling in the same category.
2.5.4 Termination/removal procedure
The following are the reasons an IRB membership can be terminated or relieved.
- IRB member failing to attend more than three consecutive meetings (not applicable for external member). His/her membership shall be reviewed to see if he/she is a regular defaulter and if necessary the Director of CIHSR, member secretary and Chairperson can terminate the membership.
- If a regular IRB member relocates to a new city/country where it will impede his/her involvement or attendance in IRB meetings, the Director of CIHSR will issue a letter of termination of membership.
- All activities of termination of membership are to be recorded in the next IRB meeting whereby the roster of IRB members will be revised.
2.6 Criteria for selecting EC members
- The members should be selected in their personal capacities based on their qualifications, experience, interest, commitment and willingness to volunteer the required time and effort. See table 1 for further details.
- The members are appointed to the CIHSR IRB for a particular role and they cannot substitute the role of any other members who is absent for a meeting. The role of chairperson/member secretary is an additional activity to their primary responsibility based on his/her qualification. Hence if the chairperson has a PhD in sociology he/she can serve both as the social scientist as well as the chairperson.
2.7 Requirements for IRB members
- Provide a recent signed CV and training certificates on Good clinical practice (GCP), this is applicable for both scientific and EC committee members.
- Either be trained in GCP at the time of induction or must undergo training and submit training within 6 months of appointment.
- EC members should be willing to undergo training or update his/her skills/knowledge during their tenure as an IRB member.
- The EC members should sign a confidentiality and conflict of interest agreement.
- The EC members should be aware of the relevant guidelines and regulations.
- The EC members should understand, accept and follow the conflict of interest policy of CIHSR IRB.
- The EC members should be willing to place his/her full name, profession and affiliation of the EC in the public domain.
- The EC members should be conversant, committed and have an understanding of the need for research in the institute and for ensuring protection to research participants in research.
2.8 Quorum requirement for EC meeting.
- A minimum of five members should be present in the meeting room for discussion of research proposals.
- The quorum should include medical, non-medical or technical or/and non-technical members.
- Minimum of one non-affiliated member should be part of the quorum.
- The lay person should preferably be part of the quorum.
- No decision is valid without fulfilment of the quorum.
2.9 Decision making
- Decision is arrived by consensus, if consensus is not possible voting is carried out and a decision is reached by simple majority.
- Opinions and recommendations of absent members are transmitted via email for consideration by the attending members during discussion but will not be counted as votes or quorum for formally convened full board meetings.
- All conflict of interest with any committee members in the research proposal should be declared and such committee members should not be made part of the deliberation and decision making process of the research proposal. The events should me recorded in the meeting minutes.
- The decisions regarding acceptance or requirement of modifications should be intimated with the Principle investigator via email.
- In case of rejection of the proposal, reason should be stated clearly to the Principle investigator.
2.10 Payment of EC members.
The EC members may be given a reasonable honorarium for attendance at the meeting.
2.11 IRB Secretariat
Secretariat is composed of the member secretary, research coordinator and administrative staff of CIHSR-IRB.
The secretariat shall have the following functions:
- Organizing an effective and efficient tracking procedure for each proposal
- Preparation, maintenance and distribution of study
- Organizing IRB meetings
- Preparation of agenda and minutes of the
- Maintaining IRB documentation and
- Communicating with IRB members and P
- Arrangement of training for personnel and IRB
- Providing necessary administrative support for IRB related activities to the member secretar
- To receive IRB processing fees and issue official receipts for the sa
3.12 Training of IRB members
- The institute is responsible for making sure the EC members are trained in Good clinical practice, EC function and SOPs, attending ICMR conferences and be involved with regional forums for discussing ethical issues.
- The IRB members will be encouraged to attend workshop at least once every year as part of on-going training.
- The IRB will conduct workshops from time to time to impart training to the IRB members as well as the institute researchers. The training programs should be scheduled and spread over the calendar year.
3.13 Induction of new members
New members are allowed to be an observer in the his/her first committee meeting before being made part of the quorum for decision making.
At the time of induction, the member secretary shall give a briefing on the CIHSR IRB policies. Enumerated below are the issues/topics covered.
- CIHSR IRB history and background.
- Introduction of the national ethical guidelines for biomedical and health research involving human participants by ICMR.
- Introduction to New Drug and Clinical Trial Rule 20191.
- The present committee members and their roles in CIHSR IRB.
- Introduction to the general ethical issue related to research with human participants.
Soft copy of the IRB SOP should be given to each member at the time of induction. A period of 2 months is given to each member for familiarizing with the SOP and made to sign a declaration stating the acceptance and understanding of the SOP.
Online certificate courses for GCP following ICH guidelines are an acceptable part of training requirement.
3.13 Prepare annual report for submission to Director, CIHSR.
The following reports are to be prepared
- Quantitative evaluation of the committee in the last 1 year.
- A list of the proposals including its status in the last 1 year.