Composition of IEC S-VYASA
Guidelines for Project Submission
Deviation (D)/Waiver (W)-Violation (V) Reporting
List of Approved Project’s
The objective of this Institutional Ethics Committee (IEC) is to contribute to a quality and consistent ethical review mechanism for health and biomedical research as prescribed by the Ethical guidelines for biomedical research on human subjects of Indian Council of Medical Research (ICMR).
Role Of IEC:
IEC will review and approve all types of research proposals involving human participants with a view to safeguard the dignity, rights, safety and well-being of all actual and potential research participants. The goals of research, however important, should never be permitted to override the health and well-being of the research subjects.
The IEC will take care that all the cardinal principles of research ethics viz. Autonomy, Beneficence, Non - maleficence and Justice are taken care of in planning, conduct and reporting of the proposed research. For this purpose, it will look into the aspects of informed consent process, risk benefit ratio, distribution of burden and benefit and provisions for appropriate compensations wherever required. It will 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 appropriate well documented procedures for example annual reports, final reports etc. The committee will also examine compliance with all regulatory requirements, applicable guidelines and laws. All research involving human participants should be conducted in accordance with the basic and general ethical principles.
The mandate of the IECs will be to review all research projects involving human subjects to be conducted at the Institute, irrespective of the funding agency.
|Sl. No||Designation in IEC||As a Representative of||Name of the Representative|
|1||Chair Person||_||Prof. T.V. Rao|
|2||Member Secretary||_||Prof. Ramesh M N|
|3||Members||Basic Medical Scientist||Prof. T R Raju|
|4||Dr. Monali Mathad|
|5||Clinician||Dr. Naveen Kumar|
|6||Legal Expert||Mr Ramesh N K|
|7||Social Scientist||Prof. Anil|
|8||Prof. Sendhil Kumaran|
|9||Clinical Pharmacologist||Dr. Girish Bengalorkar|
|10||Lay Person||Mr. Venkatesh RS|
Submit one Original Hard Copy (01) of the Research Project along with Covering letter and ‘soft copy’ to email with the following information addressing to the Member Secretary, Anvesana Research Laboratory, Ground floor, Prashanti Kutiram, Jigani, Bangalore. Tel: 22639983. The Principle Investigator must submit protocol through Head of Division.
No research project shall be / can be started unless ethics clearance/approval is obtained.
Please bear in mind that no retrospective / post facto ethical clearance can be provided to research projects which were neither submitted nor wetted by the Institution Ethics Committee.
All submissions should be made in the prescribed Format of the Institution Ethics Committee with signatures of all the investigators. The submission must be accompanied with Participant Informed Consent Form (PICF), both in English and Local languages, in an understandable layman’s language before it can be considered for placing before the Institution Ethics Committee. Also ensure that all the pages are numbered.
Project Submission Time: Submissions will be received across the year. Proposals will be processed in the 3 monthly meetings. Projects received one month before the stipulated meeting date will be considered for evaluation in the coming meeting while the others will be processed in the next proposed meeting.
Brief on Deviation (D)/Waiver (W)-Violation (V) Reporting While submitting amendments in protocols a covering letter should be provided clearly stating the changes in a tabulated form and a certificate by the PI that the changes made in the protocol will not hamper the safety of the subject in anyway.
IEC will take up only (9+1) projects per meeting for presentation based on first cum first serve in a sequential order of Project submission Number.
A clear list of projects for ethical approval will be listed in IEC website 10 days prior to presentation. Addressing title of the study with Investigator presenting. A confirmatory mail with presentation date will be sent to the applicants.
The proposals will be reviewed for the following aspects by the members and the chair:
Scientific design and conduct of the study.
Approval of appropriate scientific review committees.
Examination of predictable risks/harms.
Examination of potential benefits.
Procedure for selection of subjects in methodology including inclusion/exclusion, withdrawal criteria and other issues like advertisement details.
Management of research related injuries, adverse events.
Justification for placebo in control arm, if any.
Availability of products after the study, if applicable.
Patient information sheet and informed consent form in local language.
Protection of privacy and confidentiality.
Involvement of the community, wherever necessary.
Plans for data analysis and reporting
Adherence to all regulatory requirements and applicable guidelines
Competence of investigators, research and supporting staff
Facilities and infrastructure of study sites
Criteria for withdrawal of patients, suspending or terminating the study
The meeting of the IEC will be held at regular intervals which will be announced in the academic calendar and on the IEC page of SVYASA website.
The submitted proposals will be sent to members at least 2 weeks in advance. Technical evaluation report of the IRB for all the proposals has to be mandatorily also be submitted by the member secretary. (this helps the IEC to completely focus on only the ethical aspects of the proposals, but this will not curtail the ability of IEC to also dwell into technical aspects)
The committee will assess the projects submitted mainly for the following: (i) possible risk to the study participants, (ii) expected benefit to the participants, (iii) privacy, confidentiality and legal issues, (iv) informed consent and adequacy of information provided to the participants, (v) evaluating need for the study (etc., please add whatever else you can think of)
Whenever the study involves procedures or information that is not within the area of expertise of the IEC members, IEC committee can call upon independent consultants for providing insight on special cases on proposed research projects. The consultant maybe specialist in ethical or legal aspects, specific pathologies, or specific methodology (e.g. stem cell research), or representatives of communities or special interest groups. The Independent consultant cannot vote for decision. The independent consultant has to share their comments in written with attested signature for official documentation.
Researchers will be invited to present their study. The decision on which study needs to be presented to the committee will be suggested by the IRB considering the ethical issues involved in the study. IEC also can add or remove studies to be presented as the recommendations of the IRB on all the proposals will be submitted to IEC prior to calling for presentation of the study.
Decisions will be taken by consensus after discussions, and whenever needed voting will be done. Committee members will share their comments during voting procedure.
Independent consultants/Experts will be invited to offer their opinion on specific research proposals if needed.
The comments will be minuted and sent to the members and chair for approval.
Approved comments will be intimated to the PIs and their clarification will be sought wherever needed.
Clarifications along with the original comments will be sent to the chair and members and their final decision will be sought, which will be further communicated to the PIs.