INDEPENDENT ETHICS COMMITTEE  or Institutional Review Borad or IRB

Introduction

The Independent Ethics Committee also referred to as Institutional Review Board (IRB) in many countries, serves as an independent representative and competent body to review, evaluate and decide on the scientific and ethical merits of research proposals. The primary purpose of this committee is to protect the rights, safety and well being of human subjects who participate in a research project. The Ethics Committees are entrusted with the initial review of the proposed research protocols prior to initiation of the projects and also have a continuing responsibility of regular monitoring of the approved programmes till the same are completed. Such an ongoing review is in accordance with the Declaration of Helsinki and all the international guidelines for biomedical research.

Basic Responsibilities

The basic responsibility of an IEC is to ensure a competent review of all ethical aspects of the proposals received and free from any bias and influence that could affect their objectivity. IECs should ensure the scientific soundness of the proposed research projects through appropriate Scientific Review Committees and provide advice to the researchers on all aspects of the safety and welfare of the research participants. In smaller institutions the Ethics Committees may take up the dual role of Scientific and Ethical Review, the scientific evaluation should ensure technical excellence of the proposed study.

The responsibilities of an IEC can be defined as follows:

  1. To protect the dignity, rights and well being of the potential research participants.
  2. To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs.
  3. To assist in the development and the education of a research community responsive to local health care requirements.

Composition

IECs should be multidisciplinary and comprise of members from different sectors of society. Independence and competence are the two hallmarks of an IEC.

The number of persons in an Ethics Committee should have at least seven members; however a minimum of five persons is required to compose a quorum. Twelve to fifteen is the maximum recommended number.

The Chairperson of the Ethics Committee should preferably be from outside the institute to maintain the independence of the committee. The Member Secretary generally belongs to the same institution to conduct the business of the committee. Others members should be a mix of medical/non-medical, scientific and non-scientific persons including lay public to reflect the different 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

In any case, the ethics committee must include one member who is independent of the institution/trial site and one member whose primary area of interest/ specializiation is nonscientific. Also, there should be adequate gender representation of the Committee. Subject experts may be invited if required. Further, depending on the requirement of the research projects, for example HIV/AIDS, genetic disorders etc, specific patient groups may also be represented in the committee. Members should be aware of local, social and cultural norms.

Only those Ethics Committee members who are independent of the sponsor and clinical trial should vote/provide opinion in matters related to the study.

Terms of Reference

The IEC members should be made aware of their roles and responsibilities as committee members. They should be kept aware of all the national and international developments and any change in the regulatory requirements should be brought to their notice. Each committee should have its own operating procedures which are updated from time to time.

Review Procedures

The Ethics Committee should review every research proposal on human subjects to evaluate the possible risks to the subjects. The EC should evaluate the adequacy of documents for ensuring privacy, confidentiality and justice issues. It should ensure that a research proposal has been scientifically reviewed before an ethical review is taken up. The ethical review should be done through formal meetings and decisions not taken through circulation of proposals.

The researcher should submit an appropriate application along with the study protocol. The protocol should include the following:

  1. The title with signature of Principal Investigator (PI) and Co-investigators as attestation for conducting the study.
  2.  Clear research objectives and rationale for undertaking the investigation in human participants in the light of existing knowledge.
  3. Recent curriculum vitae of the Investigators indicating qualification and experience.
  4. Participant recruitment procedures and brochures, if any.
  5.  Inclusion and exclusion criteria.
  6. Precise description of methodology of the proposed research, including sample size (with justification), type of study design (observational, experimental, pilot, random ized, blinded etc.), intended intervention, dosages of drugs, route of administration, duration of treatment and details of invasive procedures if any.
  7. Plan to withdraw or withhold standard therapies in the course of research.
  8. Plan for statistical analysis of the study.
  9. Procedure for seeking and obtaining informed consent with sample of patient information sheet and informed consent forms in English and local languages.
  10. Safety of proposed intervention and any drug or vaccine to be tested, including results of relevant laboratory, animal and human research.
  11. For research involving more than minimal risk, an account of management of such risk or injury.
  12. Proposed compensation and reimbursement of incidental expenses and management of research related and unrelated injury/ illness during and after research period.
  13. An account of storage and maintenance of all data collected during the trial.
  14. Plans for publication of results - positive or negative - while maintaining the privacy and confidentiality of the study participants.
  15. A statement on probable ethical issues and steps taken to tackle the same like justification for washout of standard drug, or the use of placebo control.
  16. All other relevant documents related to the study protocol like investigator's brochure for trial on drugs/ devices/ vaccines/ herbal remedies and statement of relevant regulatory clearances.
  17. Agreement to comply with national and international Good Clinical Practices (GCP) protocols for clinical trials.
  18. Details of Funding agency/ Sponsors and fund allocation.
  19. For international collaborative study details about foreign collaborators and documents for review of Health Ministry's Screening Committee(HMSC) or appropriate Committees under other agencies/ authority like Drug Controller General of India (DCGI)
  20. For exchange of biological material in international collaborative study a MoU/ Material Transfer Agreement between the collaborating partners.
  21. A statement on conflict-of-interest (COI), if any.

Decision making process

The IEC should meet at periodically to review new proposals, evaluate the progress of ongoing tirals, review serious adverse event (SAE) reports and assess final reports of all research activities. The committee should have a previously scheduled agenda. The decision making process is an important task and following points should be considered while doing so :

  1. The decision to recommend/ reject/ suggest modification must be taken by a broad consensus after the quorum requirements are fulfilled.
  2. A member having conflict-of-interest (COI) should submit in writing before the review meeting and it should also be recorded in the minutes.
  3. If one of the members has her/his own proposal for review or has any COI then s/he should withdraw from the IEC while the project is being discussed not participate in the voting process.
  4. A negative decision should be supported by clearly defined reason
  5. It the IEC receives information that may affect the risk/benefit ratio, it may decide to reverse its positive decision on a study.
  6. The IEC would order the trial be discontinued if it finds that the goals of the trial have already been achieved midway or unequivocal results are obtained.
  7. In case of premature termination of study, notification should include the reasons for termination along with the summary of results conducted till date.
  8. The IEC should be informed under following circumstances:
  • Any amendment to the protocol with proper justification
  • Serious and unexpected adverse events
  • Any new information that may influence the study
  1. The applicant/investigator may be invited to present the protocol or offer clarifications in the meeting if it deemed necessary.
  2. Subject experts may be invited to express their views but should not take part in the voting process.
  3. Meetings are to be minuted and should be approved and signed by the Chairperson.

Review Process:

      Periodic review

The ongoing research may be reviewed at regular intervals of six months to one year

as may be specified in the SOP of the ethics committee.

 

      Continuing review

The IEC has the responsibility to continue reviewing approved projects for continuation, new information, adverse event monitoring, follow-up and if required later after completion.

      Interim review

An interim review can be carried out by a sub-committee instead of waiting for the scheduled time of the meeting like re-examination of a proposal already examined by the IEC or any other matter; however the IEC should decide the circumstances and the mechanism under which it is permitted. Further, the decisions taken during interim review should be brought to the notice of the main committee.

 

 

Monitoring

Once a project is approved, it is the duty of the IEC to monitor the approved studies. The investigator must be asked to submit periodic status reports at appropriate intervals and this should be specified in the SOP of the IEC. The IEC reviews the SAE reports from the site as well as other sites and accordingly takes appropriate action.

Record keeping

According to written procedures, all documentation and communication of an IEC are to be dated, filed and preserved. Strict confidentiality is to be maintained during access and retrieval procedures. The following records should be maintained for the following:

  1. constitution and composition of the IEC;
  2. latest curriculum vitae of all IEC members (dated and signed);
  3. standing operating procedures of the IEC;
  4. national and International guidelines;
  5. copies of protocols submitted for review;
  6. all correspondence with IEC members and investigators regarding application, decision and follow up;
  7. agenda of all IEC meetings;
  8. minutes of all IEC meetings with signature of the Chairperson;
  9. copies of decisions communicated to the applicants;
  10. record of all notification issued for premature termination of a study with a summary of the reasons;
  11. final report of the study including microfilms, CDs and Video recordings.

 

As per ICMR Guidelines, it is recommended that all records must be safely maintained after the completion/termination of the study for a period of 3 years if it is not possible to maintain the same for more than that due to resource crunch and lack of infrastructure.

Special considerations

All the above requirements are applicable to biomedical research as a whole, there are certain specific concerns applicable to specific areas of research which require additional safeguards/ protection and the IEC should take note of these specific considerations. For example research involving children, pregnant and lactating women, vulnerable participants and those with limited autonomy. In such instances, the observations and suggestions of IEC should given in writing in unambiguous terms.

Refrences:

  1. Ethical Guidelines For Biomedical Research On Human Participants
  2. Good Clinical Practice for Clinical Research In India
  3. Schedule “Y”, Drugs and Cosmetics (IInd Amendment) Rules, 200

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 Disclaimer : This is not a original article or a review and sections from various articles [as referenced] are been compiled to prepare  an overview. All credit belongs to the original authors.

Compiled by Neelam Jhangiani  neelam-jhangiani