GUIDELINES FOR GOOD PRACTICE IN THE CONDUCT OF CLINICAL TRIALS IN HUMAN PARTICIPANTS IN SOUTH AFRICA

8. Ethics Committees - Contents

8.1 Responsibilities
8.2 Composition, Functions and Operations
8.3 Procedures
8.4 Records
8.5 Disclosure of Potential Conflict of Interest

  1. ETHICS COMMITTEES
8.1 RESPONSIBILITIES

An ethics committee should safeguard the dignity, rights, safety, and well-being of all trial participants. Special attention should be paid to trials that may include vulnerable participants.

The ethics committee should obtain the following documents: trial protocol(s)/amendment(s), written informed consent form(s) and consent form updates that the investigator proposes for use in the trial, subject recruitment procedures (e.g. advertisements), written information to be provided to participants, Investigator's Brochure (IB), available safety information, information about payments and compensation available to participants, the investigator’s current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the ethics committee may need to fulfil its responsibilities.

The ethics committee should review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed and the dates for the following:

  • approval;
  • modifications required prior to its approval;
  • disapproval; and
  • termination/suspension of any prior approval.

The ethics committee should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the ethics committee requests.

The ethics committee should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human participants, but at least once per year.

When a non-therapeutic trial is to be carried out with the consent of the subject’s legally acceptable representative the ethics committee should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials.

Where the protocol indicates that prior consent of the trial subject or the subject’s legally acceptable representative is not possible, the ethics committee should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials (i.e. in emergency situations).

The ethics committee should review both the amount and method of payment to participants to assure that both neither present problems of coercion or undue influence on the trial participants. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject.

The ethics committee should ensure that information regarding payment to participants, including the methods, amounts, and schedule of payment to trial participants, is set forth in the written informed consent form and any other written information to be provided to participants. The way payment will be prorated should be specified.

8.2 COMPOSITION, FUNCTIONS AND OPERATIONS

The ethics committee should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the ethics committee must be:

  • Be representative of the communities they serve and reflect the demographic profile of the population of South Africa;
  • have a minimum membership of at least seven members;
  • have a chairperson;
  • include members of both gender and not more than 70% of its members must be men or women;
  • at least one lay person with no affiliations with the institution, not currently involved in medical, scientific or legal work and who are preferably from the community;
  • at least one member with knowledge of, and current experience in areas of research that are regularly considered by the ethics committee;
  • at least one member with knowledge of and current experience in the professional care, counselling or treatment of people (e.g. medical practitioner, psychologist, social worker, nurse); and
  • at least one member who is legally trained.

The ethics committee should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s).

Ethical review should be done in compliance with the Regulatory Authority checklist as outlined in Appendix B.

An ethics committee should make its decisions at announced meetings at which at least a quorum, as stipulated in its written operating procedures, is present.

Only members who participate in the ethics committee review and discussion should vote/provide their opinion and/or advise.

The investigator may provide information on any aspect of the trial, but should not participate in the deliberations of the ethics committee or in the vote/opinion of the ethics committee.

An ethics committee may invite nonmembers with expertise in special areas for assistance.

8.3 PROCEDURES

The ethics committee should establish, document in writing, and follow its procedures, which should include:

  • Determining its composition (names and qualifications of the members) and the authority under which it is established.
  • Scheduling, notifying its members of, and conducting its meetings.
  • Conducting initial and continuing review of trials.
  • Determining the frequency of continuing review, as appropriate.
  • Providing, according to the applicable regulatory requirements, expedited review and approval of minor change(s) in ongoing trials that have the approval of the ethics committee.
  • Specifying that no subject should be admitted to a trial before the ethics committee issues its written approval of the trial.
  • Information to be provided to participants.
  • The way payment will be prorated should be specified.
  • Specifying that no deviations from, or changes of, the protocol should be initiated without prior written ethics committee approval of an appropriate amendment, except when necessary to eliminate immediate hazards to the participants or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone number(s)).
  • Specifying that the investigator should promptly report to the ethics committee:
  1. Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial participants
  2. Changes increasing the risk to participants and/or affecting significantly the conduct of the trial
  3. All adverse drug reactions (ADRs) that are both serious and unexpected. These should also be reported to the regulatory authority.
  4. New information that may affect adversely the safety of the participants or the conduct of the trial.
  • Ensuring that the ethics committee promptly notify in writing the investigator/institution concerning:
  1. Its trial-related decisions.
  2. The reasons for its decisions.
  3. Procedures for appeal of its decisions.
8.4 RECORDS

The ethics committee should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 5 years after completion of the trial and make them available upon request from the regulatory authority(ies).

The ethics committee may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists.

8.5 DISCLOSURE OF POTENTIAL CONFLICTS OF INTEREST14

Institutions including organisations sponsored to conduct clinical trials and Ethics Committees must have clearly formulated policies regarding conflicts of interest.

These institutions or organisations must formulate and advertise to their staff all policies and procedures regarding appropriate disclosure of affiliation with, or financial involvement in, any organisation or entity with a direct interest in the subject matter or materials of researchers. These procedures must cover the full range of potential interest, including the direct benefits such as sponsorship of the investigation or indirect benefits such as the provision of materials or facilities or the support of individuals such as provision of travel or accommodation expenses to attend conferences. Such disclosure should cover any situation in which the conflict of interest may, or may be perceived to, affect decision regarding other people.

The procedures should require disclosure to editors of journals, to the readers of published work, and to external bodies from which funds are sought.

Principal investigators have an obligation to disclose at the time of reporting, proposing research, or seeking approval from Ethics Committee or other regulatory authorities any conflict of interest which has a potential to influence the trial and its conduct.

Member of ethics committees must withdraw from the committee when discussion on their own projects are taken and must not use their membership on the committee to gain a favourable advantage

Individual members of ethics committees may also have a conflict of interest in accepting undue or excessive honoraria for their participation in for example, private ethics committees. Care must be taken to ensure financial and administrative independence of ethics committees so as to enable them to adequately fulfil their duties.

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Footnotes

[14] Joint NH& MRC.AVCC Statement and Guidelines on Research Practice. Australia, 1990; Canadian Code of Ethical Conduct for Research Involving Humans, May 1997

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