PREAMBLE

Maganbhai Adenwala Mahagujarat University undertakes many research activities in the field of Public Health. The University places utmost value to Human Ethics hence all the Public Health Research proposals of the University or its constituent institutes involving human subjects are examined and reviewed by duly constituted Institutional Ethics Committee of the University. The present “Ethics Committee, Maganbhai Adenwala Mahagujarat University has been constituted in January 2023 for the period of January 2023 to January 2028 after getting registered. It is going to handle regular meetings every year to review the research proposals submitted for ethical clearance. The IEC, MAM UNI has been formed in accordance with the terms of reference of ICMR, New Delhi and follows the Ethical Guidelines for Biomedical Research on Human Participants designed by ICMR, New Delhi. Initiatives have also been taken to get it registered with the central Drug Control Organization, DGHS, Ministry of H & FW, GOI. The present Ethics Committee of MAM University is comprised of ten members representing various sections of the community like Doctors, Academicians, Scientist, Public Health Specialist, Public Health Specialist, Social Scientist, NGO workers, Minority Representatives, Lawyer, Statisticians etc.

As per the directives from the Vice Chancellor, MAM University Institutional Ethics Committee of Maganbhai Adenwala Mahagujarat University has been framed as follows.

No.NameDesignationCategoryAffiliationContact number
1Dr. Nikhil KharodChairpersonA well-respected personNon-affiliated98253 28749
2Prof. Dr. Barna GangulyMemberBasic Medical Scientist(s)Non-affiliated97129 06493
3Dr. Tejalben SoniMemberBasic Medical Scientist(s)Non-affiliated96109 04294
4Dr. B.H. ShelatMemberClinicianAffiliated84870 15255
5Prof. Dr. Ganga HadimaniMemberClinicianAffiliated87800 67570
6Prof. Dhval DholakiaMemberClinicianAffiliated89809 25520
7Dr. Pradip VaishnavMemberLegal ExpertAffiliated99795 05150
8Shri Moraridas MaharajshriMemberSocial scientist/ philosopher/ Ethicist/theologianNon- affiliated99255 18750
9Mr.Umeshbhai DaghatMemberLegal ExpertNon Affiliated98251 84266
10Shri Hinaben JaniMemberLay PersonNon-affiliated92657 46720
11Prof. Dr.Manish PatelMember SecretaryA well- experienced personAffiliated99795 89865
12Prof Dhara VyasCo Member SecretaryClinicianAffiliated85111 04356

Function and responsibilities of Ethics Committee

The Ethics Committee for clinical trial shall perform the following functions for a person, institution or organization:

  1. Review and accord approval to a clinical trial, bioavailability or bioequivalence study protocol and other related documents, as the case may be and oversee the conduct of clinical trial to safeguard the rights, safety and wellbeing of trial subjects in accordance with the New Drug and Clinical Trial Rules, 2019, Good Clinical Practices Guidelines and other applicable regulations;
  2. Ongoing review of the clinical trials for which it has accorded approval at appropriate Such review may be based on periodic study progress reports furnished by the investigators or monitoring and internal audit reports furnished by the sponsor or by visiting the study sites;
  3. Indicate the reasons that weighed with it while rejecting or asking for a change or notification in the protocol in writing and a copy of such reasons shall also be made available to the Central Licensing Authority;
  4. Shall analyse the relevant documents pertaining to any serious adverse event happened to a trial subject or to study subject during clinical trial or bioavailability or bioequivalence study. The report shall be forwarded to the Central Licensing Authority and comply with the provisions of Chapter VI of New Drug and Clinical Trial Rules, 2019;
  5. The committee shall order for discontinuation or suspension of the trial, in case it comes to a conclusion that the trial is likely to compromise the right, safety or wellbeing of the trial The same shall be intimated to the head of the institution conducting clinical trial and the Central Licensing Authority;
  6. Shall allow any officer authorized by the Central Licensing Authority to enter, with or without prior notice, to inspect the premises, any record, or any documents related to clinical trial, furnish information to any query raised by such authorized person, in relation to the conduct of clinical trial and to verify compliance with the requirements of New Drug and Clinical Trial Rules, 2019, Good Clinical Practices Guidelines and other applicable regulations for safeguarding the rights, safety and well-being of trial subjects;
  7. Shall comply with the requirements or conditions in addition to the requirements specified under the Drugs and Cosmetics Act and New Drug and Clinical Trial Rules, 2019 as may be specified by the Central Licensing Authority with the approval of the Central Government, to safeguard the rights of clinical trial subject or bioavailability or bioequivalence study

The minimum number of attendees required for reviewing any clinical trial or BA/BE protocol
The clinical trial or bioavailability or bioequivalence protocol and related documents shall not be reviewed by an Ethics Committee unless at least five of its members as detailed below are present, namely:

  • Medical scientist (preferably a pharmacologist);
  • clinician;
  • Legal expert;
  • Social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian or a similar person;
  • Lay

The Ethics Committee may constitute one or more sub-committees of its members to assist in the functions assigned to it.

The Ethics Committee may associate such experts who are not its members, in its deliberations but such experts shall not have voting rights, if any.

Any change in the membership or the constitution of the registered Ethics Committee shall be intimated in writing to the Central Licensing Authority within thirty working days.

The records to be maintained by the ethics committee The Ethics Committee shall maintain data, record, registers and other documents related to the functioning and review of clinical trial or bioavailability study or bioequivalence study, as the case may be, for a period of five years after completion of such clinical trial. The records to be maintained are as follows:
  1. Constitution and composition of the Ethics Committee
  2. The curriculum vitae of all members of the Ethics Committee
  3. Standard operating procedures followed by the Ethics Committee
  4. National and international guidelines followed by the Ethics Committee
  5. Copies of the protocol, data collection formats, case report forms, investigators brochures,submitted for review
  6. All correspondence with committee members and investigators regarding application, decision and follow up
  7. Agenda of all Ethics Committee meetings and minutes of all Ethics Committee meetings with signature of the Chairperson
  8. Copies of decisions communicated to applicants
  9. Records relating to any order issued for premature termination of study with a summary of the reasons thereof
  10. Final report of the study including microfilms, compact disks or video recordings
  11. Recommendation given by Ethics Committee for determination of compensation
  12. Records relating to the serious adverse event, medical management of trial subjects and Compensation.

Ethics Committee Registration 
The said Ethics Committee has to be registered under Rule 8 of New Drugs and Clinical Trial Rules, 2019 and the application for registration is to be made to the Central Licensing Authority

i.e. Drugs Controller General of India (CDSCO).

Renewal process of the registration of Ethics Committee
On expiry of the validity period of registration, an Ethics Committee may make an application for renewal of registration in Form CT-01 as per the procedure defined earlier, ninety days prior to the date of the expiry of the registration. If the application for renewal of registration is received ninety days prior to the date of expiry, the registration shall continue to be in force until an order is passed by the said authority on such application.

This is to be noted that fresh set of documents shall not be required to be furnished, if there are no changes in such documents furnished at the time of grant of registration, and the applicant renders a certificate to that effect indicating that there is no change.

The chairperson and other office bearers of the ethics committee
Any member of the Ethics Committee who is not affiliated with the institute or organization shall be the Chairperson. A well-respected person from any background with prior experience of having served/serving in an EC is more preferable.

One member who is affiliated with the institute or organization shall be appointed as Member Secretary of the Ethics Committee by such Institute or organization who will keep records, manage the meetings and follow the code of various other processes of ethics committee as per regulatory norms of Government from time to time.

The requirements for being a member of ethics committee

  1. The members of the Ethics Committee shall follow the provisions of New Drugs and Clinical Trial Rules, 2019, Good Clinical Practices Guidelines and other regulatory requirements to safeguard the rights, safety and well-being of trial
  2. Every member of the Ethics Committee shall undergo training and development programmes as specified by the Central Licensing Authority from time to Any member, who has not successfully completed such training and developmental programmes, shall be disqualified to hold the post of member of the Ethics Committee and shall cease to be a member of such
  3. The members representing medical scientists and clinicians shall possess at least post graduate qualification in their respective area of specialization, adequate experience in the respective fields and requisite knowledge and clarity about their role and responsibility as committee
  4. As far as possible, based on the requirement of research area such as Human Immunodeficiency Virus (HIV) or genetic disorder, specific patient group may also be represented in the Ethics
  5. No member of an Ethics Committee, having a conflict of interest, shall be involved in the oversight of the clinical trial or bioavailability or bioequivalence study protocol being reviewed by it and all members shall sign a declaration to the effect that there is no conflict of While considering an application which involves a conflict of interest of any member of the Ethics Committee, such member may voluntarily withdraw from the Ethics Committee review meeting, by expressing the same in writing, to the The details in respect of the conflict of interest of the member shall be duly recorded in the minutes of the meetings of the Ethics Committee.

Composition, affiliation, qualifications, roles & responsibilities of Ethics committee
As per the Indian Council of Medical Research, the Composition, affiliation & qualifications of Ethics Committee at MAM University has been constituted as follows.

No. Designation Qualifications Affiliation Roles & Responsibilities
1 Chairperson / Deputy Chairperson A well-respected person from any background with prior experience of having served/ serving in an EC Non- affiliated 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 deliberation
  • 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
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
Affiliated
  • 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) Member
  • 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
Affiliated/ Non- affiliated
  • 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 Member Should be individual/s with recognized medical qualification, expertise and training Affiliated/ Non- affiliated
  • 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 car, management and compensation.
  • Thorough review of protocol, investigators brochure (if applicable) and all other protocol details and submitted documents
5 Legal Expert Member
  • Should have a basic degree in Law from a recognized university, with experience
  • Desirable: Training in medical law
Affiliated/ Non- affiliated
  • Ethical review of the proposal, ICD along with translations, MoU, Clinical Trial Agreement (CTA),regulatory approval, insurance document, other siteapprovals, researcher’s undertaking, protocol specificother permissions, such as, stem cell committee for stemcell research, HMSC for international collaboration, compliance with guidelines etc.
  • Interpret and inform EC members about new regulations if any
6 Social scientist/ philosopher/ ethicist/theol ogian Member Should be an individual with social/ behavioural 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 Affiliated/ Non- affiliated
  • 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 Member
  • 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
Non- affiliated
  • 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.
  • Serve as a patient/participant/ community representative and bring in ethical and societal concerns.
  • Assess on societal aspects if any.