Human Research Ethics Committee: Composition and Documentation of Activities

Human Research Ethics Committee: Composition and Documentation of Activities

Standard Operating Procedure

Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town

Human Research Ethics Committee: Composition and Documentation of Activities

Policy

The Faculty of Health Sciences has appointed a Human Research Ethics Committee to oversee the safety, rights and welfare of human participants in research. The composition and functions of the Committee must meet standards laid down in the Department of Health’s Ethics in Health Research: Principles, Structures and Processes, 2004, and requirements specified in the US Federal Wide Assurance. The Committee aims to meet these requirements as far as reasonably possible.

Purpose

The purpose of this policy is to outline measures for appointing the Chairperson and committee members, to describe their responsibilities and to define the Committee’s operational procedures.

Chairperson: Selection and Responsibilities

The Chair is appointed by the Dean of the Faculty of Health Sciences on the recommendation of the Deputy-Dean of Research for a three-year renewable term of office.

Qualities and Responsibilities

The Chair should:

·  Play a leadership role in developing and implementing sound Human Research Ethics Committee policies and procedures.

·  Possess a comprehensive knowledge of national and international research ethics and regulation, institutional policies and relevant legislation.

·  Have leadership and management skills to facilitate and direct discussion at convened meetings. This includes the ability to foster open and collegial discussion among all Human Research Ethics Committee members whilst maintaining focus on the issues at hand (i.e. enabling the systematic review of protocols).

·  Have respect for committee members from diverse backgrounds, perspectives and sources of expertise, in particular the contributions of non-scientists.

·  Be able to function in a team, often under stressful circumstances.

·  Be able to promote a culture of respect within the research community for the Human Research Ethics Committee process and for research ethics in general.

·  Have the courage and confidence to uphold Human Research Ethics Committee judgements that may not be popular with investigators, the research community or University officials.

·  Pursue continuing education in research ethics.

The Chair’s responsibilities are to:

·  Conduct monthly Human Research Ethics Committee meetings.

·  Conduct expedited reviews or delegate this task to suitably qualified individuals who may or may not be Committee members.

·  With the assistance of the Deputy, select reviewers with necessary expertise to perform initial and ongoing protocol reviews.

·  Advise and consult with researchers on research ethics-related issues.

·  Prepare an annual report for the Dean summarising the nature and volume of the Human Research Ethics Committee’s activities.

·  Participate in non-compliance investigations.

·  Contribute to the development of Human Research Ethics Committee policies and procedures.

·  Serve as a liaison between the Human Research Ethics Committee, investigators, the Research Directorate and Dean and other relevant stakeholders.

·  Ensure that the committee receives appropriate and sufficient administrative support, meeting space and resources to function efficiently, and report deficiencies to the Deputy-dean of Research in the Faculty of Health Sciences.

·  Assist the Human Research Ethics Committee administration to prepare the agenda before meetings, and to review the minutes after meetings.

·  Review and sign letters to researchers conveying the Committee’s decisions relating to their protocols.

·  Consult with Chairs from human research ethics committees across the campuses of the University of Cape Town to encourage and facilitate cross-disciplinary research.

·  Consult with Chairs from other human research ethics committees through-out the country in order to:

o  Improve participants’ welfare and safety, particularly in multicentre trials.

o  Develop and promote best practices in research ethics oversight.

Deputy-chairperson: Selection and Responsibilities

The Deputy-chairperson is nominated and selected by members of the Human Research Ethics Committee for a three-year renewable term of office. Potential nominees must be voting members of the Committee.

The deputy-chair’s responsibilities include:

·  Performing functions delegated by the Chair, including expedited review.

·  General responsibilities which accompany committee membership.

The Committee may appoint several deputies to discharge various functions such as oversight of serious adverse events or amendments.

Human Research Ethics Committee Composition

The primary mandate of the Human Research Ethics Committee is to protect the rights and welfare of human participants in research. In fulfilling this brief, the Committee requires diverse membership in order to provide expertise in and sensitivity to a broad range of scientific and ethical considerations.

Human Research Ethics Committee members are appointed by the Dean on the recommendation of the Chair for three-year renewable terms. New appointments are staggered to ensure appropriate balance and maintain continuity. Members will receive a formal letter of appointment.

Human Research Ethics Committee membership is continuously monitored to ensure appropriate representation. The Chair and Deputy perform an annual review of the composition, expertise and contribution of members. When a member resigns from the committee, the choice of a replacement takes into account the overall balance of the committee and specific expertise that is needed.

The University will provide legal protection in respect of liabilities that may arise when members are acting in good faith whilst performing their Human Research Ethics Committee activities.

In keeping with US federal regulations, the Administrative Manager will report any changes in the committee’s membership to the Office for Human Research Protections.

In line with Department of Health requirements as laid down in ‘Ethics in Health Research: Principles, Structures and Processes’ 2004, the Human Research Ethics Committee membership must satisfy the following requirements:

·  Collectively possess sufficient qualifications and experience to review the science, health and ethical aspects of proposed research.

·  Reflect the demographic profile of the population of South Africa.

·  Include a balance of males and females.

·  Include at least nine members, with 60% constituting a quorum.

·  Have at least two lay persons who have no affiliation with the University, are not currently involved in medical, scientific or legal work and are preferably from the community in which the research will take place.

·  Include at least one scientific member with expertise in areas of research regularly reviewed by the committee.

·  Include at least one member with knowledge and experience in care, counselling or treatment such as a nurse or psychologist.

·  Include at least one legal person with legal training.

Members’ responsibilities include:

·  Attending meetings on a regular basis and not leaving until meetings are adjourned.

·  Maintaining strict confidentiality regarding protocol information, reviews and decisions and all matters discussed at committee meetings.

·  Disclosing conflicting interests and where a conflict does exist with respect to a study, not reviewing the protocol or leaving the room during discussion of and voting on the protocol.

·  Respecting each other’s views and the deliberative process.

·  Deciding independently if the design and conduct of proposed studies will protect participants’ safety, rights and welfare.

·  Remaining impartial and objective when reviewing protocols.

·  Serving as main reviewers for research in their areas of expertise.

·  Serving as general reviewers of all research discussed at full committee meetings.

·  Deciding by vote or consensus, whether to approve, require revisions, not approve or defer studies following deliberation at full committee meetings.

·  Performing expedited reviews of minimal risk research.

·  Keeping up-to-date with national and international research ethics and regulatory guidance.

·  Taking part in research ethics-related continuing education.

·  [Members must indicate with a tick on the attendance register that they will maintain confidentiality of all proceedings and declare any conflicts of interest.]

Alternate Membership

The Human Research Ethics Committee encourages the use of alternate membership. Alternates substitute for core (primary) members when the latter are unable to attend full committee meetings. Core and alternate members have equal standing on the committee.

Alternate members increase the functional capacity and administrative flexibility of the committee. The use of alternates makes it easier for the Human Research Ethics Committee to meet its diversity requirements without increasing the number of voting members needed for a quorum. A strategy of rotating meeting attendance between members and their alternates also reduces the attendance burden for specialised categories of members. The names of alternates must appear on the Committee membership list with a clear indication that they are alternate members. Ad hoc substitutions for core Human Research Ethics Committee members are permitted provided the composition of the Committee meets national and Common Rule requirements (when applicable) as far as reasonably possible.

Generally, the Human Research Ethics Committee will appoint two members (the core and the alternate) for a given roster position. However, in some cases, it may be desirable to have more than two people who alternate in providing the committee with a specific type of representation. For example, to approve US federally-funded research at a full-committee meeting, federal regulations require at least one voting member whose primary concerns are non-scientific. To increase its flexibility, the Committee may appoint several people to serve as alternates for the non-scientific voting member position. This approach increases the chances of having a non-scientific member present at all full-committee meetings. (Non-scientific members are those whose training, background and occupation incline them to view research activities from a standpoint outside a biomedical or behavioural research framework).

The appointment process for alternate members is the same as for regular members. Alternate members must:

·  Vote on protocols at full-committee meetings only in the absence of the primary members whom they replace.

·  Receive the same material for review that the primary member would have received.

Consultants or Ad Hoc Reviewers

The Human Research Ethics Committee may use consultants or ad hoc reviewers where additional or specialised expertise is needed to review specific protocols. Consultants may be asked to review an individual protocol or attend a meeting to provide education on any issue of general interest. Consultants do not count as part of a quorum or vote.

The committee or the Chair may invite consultants from inside or outside the Faculty of Health Sciences who have special expertise to act as consultants or ad hoc reviewers of human research. Reasons for seeking additional or special competence may include but are not limited to the need for:

·  Additional scientific, clinical or scholarly expertise.

·  Particular knowledge about potentially vulnerable populations.

·  Broader understanding of gender or cultural issues.

·  Greater sensitivity to community perceptions.

·  A statistical opinion.

Potential consultant resources include:

·  Various specialty clinical departments in the Faculty of Health Sciences.

·  The University of Cape Town’s Bioethics Centre.

·  Representatives of community advisory boards.

·  Representatives of specific participant populations.

Consultants and ad hoc reviewers:

·  Must have access to all documents submitted to the Human Research Ethics Committee relevant to the specific study under review.

·  May take part in deliberations and may make recommendations concerning a study but they may not vote.

·  Must affirm that they have no conflict of interest with respect to the specific studies they are invited to review.

·  Must maintain strict confidentiality with respect to the specific protocol and the meeting’s proceedings.

·  May provide information about a specific study by written report, attending the meeting, or both.

Observers and Guests

Observers and guests may attend a full Human Research Ethics Committee meeting at the Chair’s discretion or invitation. Guests and observers are individuals with an interest in research ethics and the review process and may or may not attend regularly. Guests and observers:

·  Do not count as part of the quorum.

·  Must maintain confidentiality with respect to protocols and proceedings during the meeting.

·  May not observe the final discussion and vote for any protocols in which they have a potential or actual interest.

Observers with a special interest or expertise in research ethics and who regularly attend monthly meetings will be invited to join the Committee as alternate members as vacancies arise. Observers can also put themselves forward for nomination. In this way, the Committee will serve a capacity-building and mentorship role in research ethics more generally. In turn, the Committee will be able to appoint new members with experience of the review process and a demonstrated commitment to encouraging ethical research in the Faculty.

Ex-officio Members

Ex-officio member means an individual is an automatic Committee member by virtue of the individual’s status. Ex officio members:

·  May take part in the Committee’s deliberations to provide information and expertise.

·  May not vote on any Committee decision.

·  Must comply with the Committee’s conflict of interest requirements.

Permanent ex-officio representatives on the Human Research Ethics Committee are the:

·  Dean of the Faculty of Health Sciences

·  Deputy-dean of the Research Directorate in the Faculty of Health Sciences.

Quorum Requirements and Voting at Human Research Ethics Committee Meetings

Except when an expedited procedure is used, the Human Research Ethics Committee must review initial and continuing studies at full-committee meetings at which a quorum is present.

Quorum and voting requirements:

·  A quorum must include at least 60% of members.

·  When a primary member and his or her alternate both attend a meeting, only one member may vote.

·  The Chair and Deputy count towards the quorum.

·  A quorum must be maintained for each vote. If a quorum fails, further studies cannot be approved and must be held over until the next convened meeting.

·  Any member with a conflict of interest with respect to a specific study must leave the room during deliberations and decision-making relating to the study. This member may not vote on the study.

·  Any person not listed on the official Committee membership roster, as a regular or alternate member, may not vote.

·  Voting by proxy is not allowed.

·  Consultants, ad hoc reviewers and ex officio members may not vote.

·  Generally, decision-making at full-committee meetings is by consensus. At the Chair’s discretion, voting may be decided by a show of hands.

·  All full-committee decisions relating to studies regulated by the US Common Rule are decided by a vote and must include at least one member whose primary concerns are non-scientific. A licensed physician must be present for decisions relating to FDA-regulated studies.