CLICK HERE TO DOWNLOAD TIREC APPLICATION FORM ...
CLICK HERE TO VIEW APPROVALS..
OBJECTIVES & FUNCTIONS OF T.I.R.E.C
Objectives: TIREC was created with the vision of a quality assessment of research protocols and insurance of ethical and moral sanctity. Hence with this as the basis TIREC was given the following modules for operation
1. TIREC shall provide independent, competent and timely review of the ethics of proposed studies
2. TIREC shall provide sanctions for the research protocols before the commencement of a study
3. TIREC shall regularly monitor the ongoing studies for the insurance of the ethical and moral sanctity of the research work.
4. TIREC shall review and approve all research proposals involving human participants with a view to safeguard the dignity, rights, safety and well being of human participants irrespective of the source of funding.
5. TIREC shall not allow the goals of research, however important, to override the health and well being of the research subjects.
6. TIREC shall ensure that all four cardinal principles of research ethics namely - Autonomy, Beneficence, Non-maleficence and Justice are observed in the planning, conduct and reporting of a proposed study.
7. TIREC shall evaluate the applicability and substance of an informed consent process, risk benefit ratio, distribution of burden/benefit and provisions for appropriate compensations wherever required.
8. TIREC shall review the proposals before start of the study as well as monitor the research throughout the study until and after completion of the study through periodic reports, final report and site visits.
9. TIREC shall also ensure compliance with all regulatory requirements, applicable guidelines and laws under the Government of State of Tamilnadu and Government of India.
10. TIREC shall review and record all needed documents to ensure moral and ethical values of the study, permissibility and feasibility of the protocol, consents forms for participants, and consents of the performing departments and co-operating departments.
Composition of TIREC: TIREC shall be multidisciplinary and multisectorial in composition. The number of members in the committee are to be kept at 12 member. The external members shall be in majority to ensure the independence of the committee. The Chairperson and Vice Chairperson and 6 members of the committee shall be from outside the Institute. The Member Secretary and three other members are drawn from TVMC for the conduct of businesses of the Committee. Of the 9 members, 5 shall be from medical profession and 4 from non-medical, non-medical scientific and non-scientific persons including general public and legal profession to reflect the differed viewpoints.
The composition may be as follows:-
2. Vice Chair Person
- Biomedical Scientists (External)
- Non Medical Non Scientific Representative (External)
- Legal expert (External)
- Social scientist/representative of NGO (External)
- General Medical Practitioner (External)
- Consultant Medical Practitioner (External)
- Faculty Member, TVMC
- Faculty Member, TVMC
TIREC shall have majority of its members from outside TVMC and are drawn from any
public or private institute from anywhere in the state. There shall provide adequate representation of age, gender, community etc. in the Committee to safeguard the interests and welfare of all sections of the society. The Committee shall have a fair representation of men and women.
Constitution of IEC: The Dean, Tirunelveli Medical College, Tirunelveli shall constitute the TIREC, in consultation with the FAÇADE (College Council). The committee will be normally reconstituted every 2 years.
Membership Duration and Responsibilities: The duration of the membership will be 2years. There will be no bar on the members serving for more than one term but it is desirable to have around one third fresh members. A member can be replaced if he/she are absent for three consecutive meetings. Authority to replace the member shall be with the Dean. Members should maintain confidentiality of all discussions during the meeting and sign a confidentiality form at the start of their term. Each member of the committee will submit a declaration to maintain the confidentiality of the documents submitted to them during their membership period. Conflict of interest if any shall be declared by members of the TIREC at the beginning of every meeting.
1. All proposals should be submitted in the prescribed application form, copies of which will be available with the COLLEGE OFFICE / DOWNLOADS .
2. All relevant documents should be enclosed with application.
3. The required number of copies of the proposal along with the application and documents in
prescribed format duly signed by the PI and Co-investigators/Collaborators should be forwarded by the Head of the Department.
4. The Member Secretary will acknowledge the receipt and indicate any lacunae. Missing information should be supplied within two weeks.
5. The date of meeting will be intimated to the PI who should be available to offer clarifications if necessary.
6. The decision of IEC will be communicated in writing.
7. If revision is to be made, the revised document in required number of copies should be submitted within a stipulated period of time as specified in the communication.
DOCUMENTATION: All research proposals should be submitted with the following documents:
1. Title of the project
2. Names of the PI and Co-investigators with designation.
3. Name of any other Institute/Hospital/Field area where research will be conducted.
4. Approval of the Head of the Department.
5. MOU with the Cooperating Department (s)
6. Protocol of the proposed research.
7. Ethical issues in the study and plans to address these issues.
8. Proposal should be submitted with all relevant annexure like proforma, case report forms, questionnaires, follow-up cards, etc. to be used in the study.
9. Patient information sheet and informed consent form in English/Hindi and local language(s) should be enclosed. The patient information sheet should provide adequate and complete information in understandable language. It should also assure that any new information that becomes relevant during the trial and is related to their participation will be given to them. The consent form should be as per schedule Y published in Gazette of India (2005).
10. For any drug/device trial, all relevant pre-clinical animal data and clinical trial data from other centers within the country/other countries, if available.
11. Any regulatory clearances required. Copy of clearances if obtained. This is necessary for new drug/device not approved for marketing in India, justification for sending of biological samples outside India and use of radioactive pharmaceuticals in clinical studies.
12. Source of funding and Budget along with the supporting documents.
13. Indemnity issues including insurance for the compensation to the participants etc.
14. An undertaking to immediately report Serious Adverse Events (SAE) to IEC.
15. Statement of conflicts of interest, if any. Plans for publication of results-positive or negative-while maintaining the privacy and confidentiality of the study participants.
16. Any other information relevant to the study.
17. Agreement to submit annual progress report and final report at the end of study.
18. The PI should provide the details of other ongoing research projects (Title of the project, Date of starting and duration, source and amount of funding).
CONDUCT OF MEETINGS & APPROVALS:
1. A minimum of 5 members including at least three external members is required for quorum.
2. All decisions should be taken in meetings and not by circulation of project proposals.
3. The Chairperson will conduct all meetings of the TIREC. If for reasons beyond control, the Chairperson is not available, the Vice Chairperson shall preside.
4. The Member Secretary will be responsible for organizing the meetings, maintaining the records and communicating with all concerned. He/she will prepare the minutes of the meetings and get them approved by the Chairperson before communicating to the Principal Investigators.
5. TIREC may call upon subject experts as consultants for review of selected research protocols. These
experts may be specialists in ethical or legal aspects, specific diseases or methodologies, or represent specific communities, patient groups or special interest groups e.g. cancer patients, HIV/AIDS positive persons. These consultants shall not take part in the decision making process.
6. Meetings of TIREC shall be held on scheduled intervals as prescribed (once in 3 months, for which the dates will be decided at the end of previous meeting). Additional meetings will be held as and when necessary.
7. The proposals will be sent to members at least 2 weeks in advance.
8. Decisions will be taken by consensus after discussions, and voting will be done if necessary.
9. PI should be available during the meeting and may be invited to offer clarifications.
10. The decisions of the meeting shall be recorded in the minutes book and shall be confirmed during the next meeting with signature of Chairperson at each page.
11. Decision Shall evaluate
- Scientific design and conduct of the study
- Approval of scientific review committee and regulatory agencies.
- Assessment of predictable risks/harms and potential benefits.
- Procedure for selection of subjects including inclusion/exclusion, withdrawal criteria
- Sample size and advertisement details.
- Management of research related injuries, adverse events and compensation provisions.
- Justification for placebo, if any.
- Availability of products to the trial subjects after the study, if applicable.
- Patient information sheet and informed consent form in English/Tamil or other local language.
- Protection of privacy and confidentiality of subjects.
- Involvement of the community, wherever necessary.
- Protocol and proforma of the study including the consent form.
- Plans for data analysis and reporting.
- Adherence to all regulatory requirements and applicable guidelines.
- Competence of investigators, research and supporting staff.
- Facilities and infrastructure.
12. Proposals which are recommended for minor revisions shall be reviewed by a select sub-committee
appointed by the TIREC for clearance and approved by the Chairperson. The approvals will be reported in the next TIREC meeting by Member Secretary.
13. The revised form of proposals requiring major changes will be reviewed at the next ethics committee meeting.
14. Rejected proposals may be reconsidered only if a very strong case is made out with required documentary evidence and review by an expert is provided.
15. A member shall withdraw from the meeting during the decision procedure concerning an application where a conflict of interest arises. This shall be indicated to the chairperson prior to the review of the application and recorded in the minutes.
16. Only members will make the decision. The decisions shall be taken in the absence of investigators, representatives of sponsors, consultants.
17. Decision may be to approve, reject or revise the proposals. Specific suggestions for modifications and reasons for rejection should be given.
18. Revised proposals may be subjected to an expedited review.
19. All approved proposals will be subject to the following standard conditions. Additional conditions may be added by the TIREC.
20. PI should submit annual report of the ongoing project on format prescribed by the Institute, to the TIREC. The final report of the completed study should be submitted by PI. The PI should highlight the changes in the protocols/brochures/informed consent form etc. being amended from the previous documents while submitting amended documents to TIREC.
21. Decision will be communicated to PI by the Member Secretary in writing. Suggestions for modifications and reasons for rejection shall be communicated to the PI.
Memorandum of Understanding and Indemnity for Sponsored Drug/Device/Collaborative Trials
After the approval from TIREC, the sponsor/CRO will submit the clinical trial agreement/Memorandum of Understanding and Indemnity Agreement document on Rs. 100 stamp paper separately (two copies) to the Institute which will be signed by sponsor and the Dean, TVMC with the counter signature of PI. As per existing policy of the Institute, there will be 25% overhead charges to the total cost of the trial/per patient cost. The drug trial shall be started by the PI after the agreement is signed by both the parties as well as
DCGI and required regulatory approvals are available for the concerned trial.
Follow up Procedures: Annual report should be submitted by the PI on prescribed format along with comments. Final report should be submitted at the end of study on prescribed format including a copy of the report which has been sent to sponsoring agency. All SAEs and the interventions undertaken should be intimated immediately to IEC. The PI should submit the SAEs reported by other centers from time to time to the Member Secretary for information to TIREC along with comments if any action is required in the current study. Protocol deviation, if any, should be informed with adequate justifications. Any amendment to the protocol should be submitted for approval. Any new information related to the study should be communicated to TIREC. Premature termination of study should be notified with reasons along with summary of the data obtained so far. Change of investigators should be done with the approval of TIREC.
RECORD KEEPING & ARCHIVING OF T.I.R.E.C
1. Curriculum Vitae (CV) of all members of TIREC.
2. Minutes of all meetings duly signed by the Chairperson. Copy of all correspondence with
members, researchers and other regulatory bodies.
3. Copy of existing relevant national and international guidelines on research ethics and laws
along with amendments.
4. All study related documents (study protocols with enclosed documents, progress reports, and
SAEs.) should be archived for minimum of ten years after the completion of study. A copy of
filled CRF shall remain with the PI for minimum of fifteen years.
5. Final report of the approved projects.