COMPOSITION OF ETHICS COMMITTEE

MODULE 2

Ethics committees (EC) are of mainly two types :

  1. Institutional Ethics Committee – also known as Institutional Review Board (IRB)
  2. Independant Ethics Committee (IEC)

ECs should be multidisciplinary and multisectorial in composition. Independence and competence are the two hallmarks of an IEC. The number of persons in an ethical committee should be kept fairly small (7-9 members). It is generally accepted that a minimum of five persons is required to compose a quorum. There is no specific recommendation for a widely acceptable maximum number of persons but it should be kept in mind that too large a Committee will make it difficult in reaching consensus opinions. 12-15 is the maximum recommended number.

The Chairperson of the Committee should preferably be from outside the Institution and not head of the same Institution to maintain the independence of the Committee. The Member Secretary who generally belongs to the same Institution should conduct the business of the Committee. Other members should be a mix of medical / non-medical scientific and non-scientific persons including lay public to reflect the differed viewpoints.

The composition may be as follows :-

  1. Chairperson
  2. 1-2 basic medical scientists.
  3. 1-2 clinicians from various Institutes
  4. One legal expert or retired judge
  5. One social scientist / representative of non-governmental voluntary agency
  6. One philosopher / ethicist / theologian
  7. One lay person from the community
  8. Member-Secretary

The ethical committee at any institution can have as its members, individuals from other institutions or communities if required. There should be adequate representation of age, gender, community, etc. in the Committee to safeguard the interests and welfare of all sections of the community / society. Members should be aware of local, social and cultural norms, as this is the most important social control mechanism. If required, subject experts could be invited to offer their views, for example for drug trials a pharmacologist, preferably a clinical pharmacologist, should be included. Similarly, based on the requirement of research area, for example HIV, genetic disorders etc. specific patient groups may also be represented in the Committee. The membership of IEC will include Epidemiologist(s), Sociologist(s), Lawyer(s), Theologian, Statistician(s), Clinician(s), Basic scientists, Pharmacist(s)/Clinical Pharmacologist(s) etc. They should be appointed by the Head of the Institute based on their competencies and integrity, and could be drawn from any public or private Institute from anywhere in the country.

IEC should be constituted in the following pattern :

  1. A Chairperson
  2. A Deputy Chairman if need be,
  3. A Member Secretary,
  4. 5-15 members from different Departments / Specialties / disciplines or areas
    etc..
  5. Authority under which IEC is constituted:

The Institutional Head constitutes the IEC.

Membership requirements:

  1. The duration of appointment is initially for a period of 2-3 years
  2. At the end of 2-3 years, as the case may be, the committee is reconstituted, and 50% of the members will be replaced by a defined procedure.
  3. A member can be replaced in the event of death or long-term nonavailability or for any action not commensurate with the responsibilities laid down in the guidelines deemed unfit for a member.
  4. A member can tender resignation from the committee with proper reasons to do so.
  5. All members should maintain absolute confidentiality of all discussions during the meeting and sign a confidentiality form.
  6. Conflict of interest should be declared by members of the IEC

Quorum requirements:

The minimum of 5 members are required to compose a quorum. All decisions should be taken in meetings and not by circulation of project proposals.

Members Responsibilities

The Chairperson will conduct all meetings of the IEC. If for reasons beyond control, the Chairperson is not available, the Deputy Chairperson or an alternate Chairperson will be elected from the members by the members present, who will conduct the meeting. The Member Secretary is responsible for organizing the meetings, maintaining the records and communicating with all concerned. He/she will prepare the minutes of the meetings and get it approved by the Chairman before communicating to the researchers with the approval of the appropriate authority.

Independent consultants

IEC may call upon subject experts as independent consultants who may provide special review of selected research protocols, if need be. 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 or ethnic minorities. They are required to give their specialized views but do not take part in the decision making process which will be made by the members of the IEC .