INSTITUTIONAL ETHICS COMMITTEE
STANDARD OPERATING PROCEDURES:
This Institutional Ethics Committee for Human Research (IECHR) has been constituted under the authority of the Dean, RVS Institute of Medical Sciences, Chittoor – 517127 and will function with the functions and duties underlined below.
- FUNCTIONS AND DUTIES
- To provide independent, competent and timely review of the ethics of proposed studies.
- To contribute to safeguarding the dignity, rights, safety and well-being of all actual or potential research participants.
- To take into consideration the principle of justice-which requires that the benefits and burdens of research be distributed fairly among all groups and classes in society, taking into account age, gender, economic status, culture, and ethnic consideration.
- IECHR will be independent from political, institutional, professional, and market influences.
- To ensure that there is regular evaluation of the ethics of ongoing studies that received a positive decision.
- The IECHR will have due regard for the requirements of relevant regulatory agencies and applicable laws.
- MEMBERSHIP REQUIREMENTS AND TERMS OF APPOINTMENT
This Executive Committee (EC) is multidisciplinary and multi-sectorial in composition, and includes individuals with relevant scientific expertise, balanced age and gender distribution, and laypersons representing the interests and the concerns of the community.
- This EC has been constituted by direct invitation and appointment of members by the office of the Dean, RVSIMS.
- There has been no conflict of interest in making these appointments.
- The tenure of this EC is two years.
- The appointments will be renewed at the end of two years by consensus.
- Disqualification Procedure: Members who remain absent for 3 consecutive meetings without prior notice and permission of the Chairperson, can be considered for disqualification.
- Resignation Procedure: A member of EC committee may resign his membership by writing under his hand to the chairperson for the reason found fit by him. Resignation will be accepted by the chairperson depending upon the reasons cited in the resignation and he may notify it to the members.
- Replacement Procedure: A casual vacancy in the EC shall be filled by the member of the same category by nomination and acceptance of EC. Mere existence of any vacancy or any defect in the constitution of the EC shall not be a ground for questioning any act done by the EC.
- CONDITIONS OF APPOINTMENT
- A member should be willing to publicize his/her full name, profession and affiliation;
- all reimbursement for work and expenses, if any, within or related to an EC should be recorded and made available to the public upon request;
- A member should sign a consent form and provide a brief bio-data for record.
In accordance with the ICMR [Indian Council of Medical Research] guidelines for the composition of Institutional Ethics Committee (IEC), the Chairperson of the IECHR is a member who is from outside the Institution and not head of the same Institution to maintain the independence of the Committee. The Member Secretary is from the same Institution and should conduct the business of the Committee. There are 14 other members who are a mix of medical/ non-medical, scientific and non-scientific persons including lay persons to represent the differed points of view. The composition is as follows:
- Two persons from basic medical science area (Pharmacy and Pharmacology)
- Six clinicians from RVSIMS.
- Two legal experts
- One social scientist
- Representative of non-governmental voluntary agency
- One philosopher/ ethicist/ theologian
- One lay person from the community
- Member Secretary
- QUORUM REQUIREMENTS
The minimum number of members required to compose a quorum are as follows:
- One clinician
- One legal expert or retired judge
- One social scientist/ representative of non-governmental organisation/philosopher/ ethicist/ theologian or a similar person.
- One lay person from the community.
- INDEPENDENT CONSULTANTS
- A subject expert will be called to offer expertise as and when required. The IECHR will establish a standing list of independent consultants to provide special expertise to the EC on proposed research protocols. These consultants may be experts in specific diseases or methodologies or they may be representatives of communities, patients or special interest groups.
- EDUCATION OF EC MEMBERS
- EC members have a need for initial and continued education regarding the ethics and science of biomedical research. The EC members will be encouraged to keep abreast of all national and international developments in ethics through orientation courses on related topics by its own members or regular training organized by constituted bodies.
- REGISTRATION OF IECHR
- IECHR has been registered with regulatory authority i.e., Drug Controller General of India, Directorate General of Health Services, New Delhi.
- SCIENTIFIC REVIEW
- The protocols will be reviewed by the Scientific Review Committee for looking at the scientific aspects of the proposal under consideration. RVSIMS will receive protocols for approval only after approval from Scientific Review Committee.
- The scientific review of the protocols will be performed by a committee of nine members who belong to the medical discipline. When required, experts of the related disciplines might be invited. Investigators are advised to submit a protocol checklist as per CONSORT checklist. This checklist enumerates the elements required for scientific review.
- SUBMITTING AN APPLICATION
The IECHR, RVSIMS will review only protocols involving studies to be conducted in the Medical College. External protocols will be accepted only in the case of Government funded or approved projects.
The IECHR has established well-defined requirements for submitting an application for review of a biomedical research project.
- This includes a Protocol checklist and Plain language Summary (non technical language) which should accompany each protocol submitted for review.
- An application should be submitted by a qualified researcher responsible for the ethical and scientific conduct of the research.
- Applications should be submitted to the Member Secretary at least 2 weeks prior to the proposed date of the meeting.
- Regarding the number of copies to be submitted to ethics committee, initially 9 copies to be submitted for scientific review and later, 16 copies to be submitted for ethical review. If there are no changes suggested by Scientific Review Committee, 11 copies would be sufficient for IECHR, as 5 members are common.
- Incomplete applications will be returned to the investigator. In cases where the EC requests supplementary information or changes to documents from the applicant, the application will be reviewed in the next meeting.
- Investigators will be notified of the decision of the review within a period of 2 weeks.
- A processing fee of Rs. 35000/- will be charged per application.
- APPLICATION REQUIREMENTS
- Signed and dated application form;
- The protocol of the proposed research (clearly identified and dated), together with supporting documents and annexes;
- Plain language summary in prescribed format;
- A protocol checklist in prescribed format;
- Case report forms, diary cards, and other questionnaires intended for research participants;
- When the research involves a study product (such as a pharmaceutical or device under investigation), an adequate summary of all safety, pharmacological, pharmaceutical, and toxicological data available on the study product, together with a summary of clinical experience with the study product to date (e.g. recent investigator’s brochure, published data, a summary of the product’s characteristics).
- Investigator(s)’s curriculum vitae (updated, signed, and dated);
- Material to be used (including advertisements) for the recruitment of potential research participants;
- A description of the process used to obtain and document consent;
- Informed consent form (clearly identified and dated) in the language(s) understood by the potential research participants and, when required, in other languages;
- A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants.
- A description of the arrangements for indemnity, if applicable.
- A statement of agreement to comply with ethical principles set out in relevant guidelines.
- All significant previous decisions (e.g. those leading to a negative decision or modified protocol) by other ECs or regulatory authorities for the proposed study (whether in the same location or elsewhere) and an indication of modification(s) to the protocol made on that account. The reasons for previous negative decisions should be provided.
- All the investigators shall submit disclosure of the financial aspect to ethics committee with the proposal.
- As per the recent DCGI guidelines, investigators shall not recruit subjects in more than three clinical trials simultaneously at any given time. Investigator should ensure the same before submitting an application.
- REVIEW MEETINGS
- Meetings will be held once in two months and more in case there are more than 5 proposals for review.
- EC members will be given 2 weeks time to read through the applications.
- Meetings will be minuted and these minutes approved at the subsequent meeting.
- The applicant, sponsor, and/or investigator may be invited to present the proposal or elaborate on specific issues.
- In case where an application under review has been submitted by a member of the EC, the member will not be permitted to take part in the decision making process.
- EXPEDITED REVIEW
The proposals presenting no more than minimal risk to research participants may be subjected to expedited review. The Member- Secretary and the Chairperson of the IEC or designated member of the Committee or Subcommittee of the IEC may do expedited review only if the protocols involve:
- Minor deviations from originally approved research during the period of approval (usually of one year duration).
- Revised proposal previously approved through full review by the IEC or continuing review of approved proposals where there is no additional risk or activity is limited to data analysis.
- Research involving clinical materials (data, documents, records, or specimens) that have been collected for non-research (clinical) purposes.
- When in emergency situations like serious outbreaks or disasters a full review of the research is not possible, prior written permission of IEC may be taken before use of the test intervention.
- Clinical studies of drugs and medical devices only when – i. research is on already approved drugs except when studying drug interaction or conducting trial on vulnerable population or ii. Adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of minor nature is reported.
FULL REVIEW: All research presenting with more than minimal risk, proposals/ protocols which do not qualify for exempted or expedited review and projects that involve vulnerable population and special groups shall be subjected to full review by all the members.
- EXEMPTION FROM REVIEW
- Research on educational practices such as instructional strategies or effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- DECISION MAKING
- A member will be asked to withdraw from the meeting for the decision procedure concerning an application where there arises a conflict of interest; the conflict of interest should be indicated to the chairperson prior to the review of the application and recorded in the minutes;
- Decisions will only be made at meetings where a quorum is present;
- Only members who participate in the review will participate in the decision;
- Decisions be arrived at through consensus, where possible; when a consensus appears unlikely, the EC will vote;
- In cases of conditional decisions, clear suggestions for revision and the procedure for having the application re-reviewed will be specified;
- A negative decision on an application will be supported by clearly stated reasons.
- The decision will be communicated in writing to the applicant according to EC procedures, preferably within two weeks’ time of the meeting at which the decision was made
- ECs should receive notification from the applicant at the time of the completion of a study;
The investigators will be asked to provide a follow-up and progress of the trial under the following situations:
- Any protocol amendment likely to affect the rights, safety, and/or well-being of the research participants or the conduct of the study;
- Serious and unexpected adverse events related to the conduct of the study or study product, and the response taken by investigators, sponsors, and regulatory agencies;
- Any event or new information that may affect the benefit/ risk ratio of the study;
The Committee will give its opinion on the projects in one of the following ways:
- Modification before Approval (Conditional Approval)
- Discontinuation of previously Approved project
- MONITORING OF TRIALS:
To safeguard the rights of the human subject participants and as recommended by Drug Controller General of India, New Delhi, this ethics committee would supervise the trials which are approved by this ethics committee. The ethics committee would appoint one or few persons from the members of the ethics committee to monitor and supervise the trials. If required, committee may appoint one person having experience in clinical research to help in this process of monitoring and supervision of the trials as a support staff for the ethics committee.
- DOCUMENTATION AND ARCHIVING
- All documentation and communication of an EC will be dated, filed, and archived according to written procedures. Documents will be archived for a minimum period of 3 years following the completion of a study.
- Other documents to be archived will be: SOPs, minutes and agenda of meetings, biodata of members, annual report of the EC, annual accounts, one copy of application and materials submitted for review, correspondence with applicants, copy of decision, documentation received during follow-up, final summary and report of the study.
A copy of the EC composition and operating procedures can be made available to any member of the Hospital/Institute for filing of research projects, upon written request for the same to the EC.
- PROCEDURE FOR CONDUCT OF THE MEETING
- Please refer section 11.
- PROCEDURE FOR MAINTAINING INCOME AND EXPENDITURE
At the end of the working year (January to December), the statement of Income and expenditure along with the balance amount will be circulated to all members.
- SUBSTITUTION OF MEMBERS AND POWERS and DUTIES OF CHAIRPERSON, CO-CHAIRPERSON AND MEMBER SECRETARY.
As per ICMR Ethical Guidelines for Biomedical Research on Human Particpants, ICMR, 2006
- INFORMED CONSENT VULNERABLE GROUPS (Children/pregnant women/terminally ill)
As per Ethical Guidelines for Biomedical Research on Human Particpants, ICMR, 2006.
Chairperson Member Secretary
- DUTY of EC IN CASE OF AN SAE: The members unanimously decided the following criteria for reporting of SAEs relating to trials.
- any SAE to be informed to EC within 24 hours
- Copy of full report in prescribed format to be submitted along with.
- Each death to be reviewed by a full committee meeting within 5 working days.
- PI to be informed not to recruit further patients until clearance received from EC.
- No backdated SAE reports to be accepted by Member Secretary.
- With respect to current status report, a meeting to be called on 9th July 2010 to discuss the deaths in ongoing trials No. 8,10, 14. The PIs of these trials to be called to offer their explanation on the SAEs.
- FUNDING OF TRIALS: Full details of funding of all trials to be made mandatory for submission to EC. All protocols and related documents to be preserved for 3 years after completion of trial by the PI as well as EC.
- All trials are to be notified to Medical Superintendent SSG Hospital Baroda and permission sought prior to patient recruitment.
ADDITION MADE IN MEETING:
It was decided that the following protocols will be exempt from processing fees.
- Government sponsored protocols that come through the Dean, RVSIMS, Chittoor.
- Any individual non-funded research by staff or members.
Prior permission of EC should be taken before exemption of processing fees.
1) ICMR Ethical Guidelines for Biomedical Research on Human Particpants, ICMR, 2006.
2) Operational Guidelines for Ethics Committees that Review Biomedical Research, WHO, 2000.
|1||DR. L.C.OBULESU, M.D.,||DEAN, MEDICAL COLLEGE||CHAIRMAN|
|2||DR.V.MOHAN RAO, M.S.,||MEDICAL SUPERINTENDENT||Secretary|
|3||DR.A.KISHORE, M.D.,||PROF&HOD, MICROBIOLOGY||Member|
|4||DR. R.SELVARAJ, M.D.,||PROF&HOD, PHARMACOLOGY||Member|
|5||DR. G.VISHNU PRIYA||ASST.PROF, PHARMACOLOGY||Member|
|6||DR.I.SUBRAMANYAM, M.D.,||PROF, GENERAL MEDICINE||Member|
|7||DR.DEEPA, B.V.Sc||VETERINARY MEDICAL OFFICER||Member|
|8||MR.N.JANARDHAN REDDY, M.A, LLB||LEGAL OFFICER||Member|
|9||MR.VIJAY SIMHA REDDY,||LAY MAN||Member|
RESEARCH ACTIVITIES IN THE INSTITUTE :
- RESEARCH DONE ON ““Attitudes towards research among Bachelor of Pharmacy and Doctor of Pharmacy students: A study from tertiary medical institute” – Author(s) Dr. Sai kiran Pasupula, Dr. L. C.Obulesu, Ammajan, Dr. K. Bhaskar Reddy …( Accepted in International Journal of Indian Psychology )