Ethics Committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international laws. Central Drugs Standard Control Organization, the national drug regulatory authority has published various regulations applicable for Ethics Committee in India. New Drugs and Clinical Trial Rules, 2019 specifies the requirements for registration, functioning, proceedings, record management of ethics committees in India.

In India, Ethics Committees are broadly classified into following types:

  1. Ethics Committee for clinical trial, bioavailability and bioequivalence study
  2. Ethics Committee for Biomedical and Health Research

 

These two types of ethic committees are governed through separate set of rules and regulations as embedded in the New Drugs and Clinical Trial Rules, 2019.

In the current article, we shall be discussing about the regulatory requirements for the functioning of Ethics Committee for clinical trial, bioavailability and bioequivalence study.

The Ethics Committee for clinical trial, bioavailability and bioequivalence study are further classified into following:

  1. Institutional Ethics Committee: The clinical trial site/ hospital having their own ethics committee.
  2. Independent Ethics Committee: Ethics Committee which is not a part of any hospital/ clinical trial site.

Whoever intends to conduct clinical trial or bioavailability study or bioequivalence study shall be required to have approval of an Ethics Committee. 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).

What is the Constitution of Ethics Committee for Clinical Trial?

The Ethics Committee shall have a minimum of seven members from medical, non – medical, scientific and non – scientific areas with at least:

  • one lay person;
  • one woman member;
  • one legal expert;
  • one independent member from any other related field such as social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian.

The Ethics Committee shall consist of at least fifty percent of its members who are not affiliated with the institute or organization in which such committee is constituted. The committee shall include at least one member whose primary area of interest or specialization is non- scientific and at least one member who is independent of the institution.

Who will be 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. 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.

What are 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 time. 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 Chairperson. 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.

 

How to register an Ethics Committee relating to clinical trial, bioavailability and bioequivalence study?

Ethics Committee shall make an application for grant of registration to the Central Licensing Authority in Form CT-01.

While making an application, following information shall be furnished as per Table 1 of Third Schedule of New Drug and Clinical Trial Rules, 2019:

  1. Name of the ethics committee.
  2. Authority under which the ethics committee has been constituted, membership requirements, the term of reference (TOR), conditions of appointment and the quorum required.
  3. The procedure for resignation, replacement or removal of members.
  4. Address of the office of the ethics committee.
  5. Name, address, qualification, organisational title, telephone number, fax number, email, mailing address and brief profile of the Chairperson.
  6. Names, qualifications, organisational title, telephone number, fax number, e-mail and mailing address of the members of the ethics committee. The information shall also include member’s specialty (primary, scientific or non-scientific), member’s affiliation with institutions and patient group representation, if any.
  7. Details of the supporting staff.
  8. The standard operating procedures to be followed by the committee in general.
  9. Standard operating procedures to be followed by the committee for vulnerable population
  10. Policy regarding training for new and existing committee members along with standard operating procedures.
  11. Policy to monitor or prevent the conflict of interest along with standard operating procedures.
  12. If the committee has been audited or inspected before, give details.

The Central Licensing Authority shall scrutinize the information and documents furnished with the application and if found satisfactory, then may grant registration to Ethics Committee in Form CT-02.

In case,  the Central Licensing Authority is not satisfied with the compliance of these rules by the applicant Ethics Committee, it may, reject the application, for reasons to be recorded in writing.

 

Ethics Committee Registration Process in India

 

Can Someone apply for reconsideration of the rejection of ethics committee registration?

An applicant Ethics Committee aggrieved by the decision of rejection of the application by the Central Licensing Authority may file an appeal before the Central Government in the Ministry of Health and Family Welfare within sixty working days from the date of the receipt of order of such rejection. The Central Government may, after such enquiry, as considered necessary, and after giving an opportunity of being heard to the appellant, shall dispose of the appeal filed within a period of sixty working days from the date on which the appeal has been filed.

 

What is the validity period of registration of Ethics Committee for clinical trial?

The registration granted in Form CT-02 shall remain valid for a period of five years from the date of its issue, unless suspended or cancelled by the Central Licensing Authority.

How to renew the registration of Ethics Committee for clinical trial?

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.

 

What are the functions 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 intervals. 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 analyze 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 subject. 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

 

What is 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.

Can ethics committee hire services of an expert for any specialized protocol?

Yes, 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.

What are the requirements to be fulfilled in case there is a change in constitution of the ethics committee?

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.

 

What are 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

References:

New Drugs and Clinical Trial Rules, 2019