(Hereafter known as the Advisory Committee on Research Ethics Boards at Queen's University)
Preamble
Queen's University is committed to ensuring the highest level of ethical conduct for research involving humans and to following the guidelines outlined in the Tri-Council policy statement Ethical Conduct for Research Involving Humans.
Dr. Suzanne Fortier, Vice-Principal (Research) established an Advisory Committee to report by May 1999 on issues related to the implementation of the Tri-Council Policy at Queen's University. Membership and terms of reference of this committee are attached. Consultation with the broader university community was sought, as was consultation with the Principal, Vice-Principals, Deans and Department Heads of the University.
Existing Structure
Queen's University currently has one recognized university-level Research Ethics Board (REB), which reviews all protocols for the Faculty of Health Sciences and the affiliated teaching hospitals. The balance of protocols requiring research ethics approval is reviewed at the departmental or faculty level. A survey of departments has ascertained that there is a wide range of processes in place. Additionally, the number of REBs varies among Faculties. For instance, the Faculty of Arts and Science has a number of REBs, but the Faculty of Education has only one.
Assessment of Existing Structure vs. Tri-Council Policy
The existing Health Sciences REB will need to make some changes to conform with the guidelines outlined in the Tri-Council Policy Statement, primarily in areas of membership and appeal process; however, any changes required will be minor in nature. Meeting the guidelines is already on the Board's agenda and progress is being made towards compliance.
None of the existing Departmental and Faculty processes surveyed is consistent with the new policy. Typically, they do not meet regularly, do not meet face to face, do not have an appropriate mix of members and do not have appeal processes in place.
Recommendations
Because of the level of detail and reporting required in establishing and maintaining an REB to conform with the Tri-council policy statement, it is recommended that the University support a General University Research Ethics Board to review all of the non-health sciences protocols. The implementation of a second committee is based on the premise that each committee would handle roughly equal numbers of protocols. Should this not turn out to be the case, the existence of a two-committee structure will be reviewed at the end of two years.
Cost Implications
The Health Sciences REB currently requires the administrative support of about 0.75 of one full-time equivalent staff person.
It is estimated that the implementation of the General University Research Ethics Board will require the addition of a 0.75 full-time equivalent staff person, at a cost of approximately $31,500 per annum, including benefits. In addition, office supplies and a computer will be required at an initial cost of $4,000. Ongoing costs are estimated at approximately $500.00 per annum.
It is recognized that the Chairs of the University Ethics Boards will be required to make a substantial time commitment, which may have cost implications for the University.
Policy for Research Involving Humans
1. Number of Research Ethics Boards
The University requires two University-wide research ethics boards. The constituency and mode of operation of both REBs operated by the University on behalf of its researchers will be in accordance with the guidelines set out in the Tri-Council Policy Statement for Ethical Conduct for Research Involving Humans and in accordance with its overriding philosophy of balancing the harms and benefits of any research involving humans. The REBs must be vested with the requisite authority to adequately perform its functions. Thus it is proposed that the Principal of Queen's University invests in each Research Ethics Board, the authority to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human participants which is conducted within, or by members of, Queen's University. The Board is to use the considerations set forth in the Tri-Council policy statement as a minimum standard on which to base its decisions and to ensure that decisions are made in accordance with prevailing University policies.
1.1 The proposed membership and terms for a REB are:
Members of the Research Ethics Boards, including their Chairs, are to be appointed by the Principal, on the advice of the Vice-Principal (Research), for a period of three years and shall be eligible for reappointment. In the case of the Health Sciences Research Ethics Board, appointments shall be recommended by the Vice-Principal (Research) in consultation with the Vice-Principal (Health Sciences) and other members of the South Eastern Ontario Health Sciences Centre. The University Research Ethics Boards shall be accountable to the Principal and shall provide advice to the Principal through the Vice-Principal (Research).
REBs shall normally have no more than fifteen regular members. In accordance with Article 1.3 of the Tri-Council policy statement, each REB shall consist of at least five members, including both men and women, of whom:
- at least two members have broad expertise in the methods or in the areas of research that are covered by the REB
- at least one member is knowledgeable in ethics
- for biomedical research, at least one member is knowledgeable in the relevant law
- at least one member has no affiliation with the institution, but is recruited from the community served by the institution.
As the size of a Research Ethics Board increases beyond the minimum of five members, the number of community representatives should also increase proportionately. The REB Chair is able to nominate appropriate ad hoc members for any review in which the Board feels it requires specific expertise not available from its regular members. Should this occur regularly, the membership of the REB should be modified.
Current Membership of the Health Sciences REB
The current membership of the Health Sciences Research Ethics Board is appointed by the Principal with consultation by the teaching Hospitals. Current membership is:
| Dr. A.F. Clark | Head and Professor, Department of Biochemistry, Professor, Department of Pathology, Faculty of Health Sciences, Queen's University (Chair) |
| Dr. B. Appleby | Departmental Assistant, Bioethics, Kingston General Hospital Instructor, Department of Family Medicine, Queen's University |
| Dr. M. Godwin | Associate Professor, Department of Family Medicine, Queen's University Associate Professor, Department of Community Health & Epidemiology Research Director, Department of Family Medicine, Queen's University |
| Dr. S. Irving | Psychologist, St. Mary's of the Lake Hospital |
| Ms. S. Laschinger | Assistant Professor, School of Nursing, Queen's University |
| Dr. J. Low |
Professor, Department of Obstetrics and Gynaecology, |
| Ms. F. O'Heare | Director, Risk Management Services, Kingston General Hospital Assistant Professor (Adjunct) School of Nursing, Queen's University |
| Dr. J. Parlow | Associate Professor, Department of Anaesthesia, Assistant Professor, Department of Pharmacology & Toxicology, Queen's University |
| Dr. W. Racz | Professor, Department of Pharmacology & Toxicology, Queen's University |
| Dr. J. Rapin | Assistant Professor, Department of Emergency Medicine, Queen's University |
| Dr. M. Schumaker | Professor, Department of Religious Studies, Queen's University |
| Dr. L. Seymour |
Co-Director, IND Program, Canadian Cancer Trials Group |
| Dr. S.J. Taylor | Bioethicist, Faculty of Health Sciences, Queen's University and Kingston General Hospital; Assistant Professor, Department of Family Medicine, Queen's University |
|
Dr. G. Torrible |
Community Member |
This mix of members includes one legal representative, three bioethics specialists and one community member. In order to bring full compliance with the guidelines, at least one and possibly two community members will need to be added to the committee.
Suggested membership for the General University REB;
Any department that has a protocol to be reviewed by one of the University committees has an option to put forth a nomination for membership on the REB. In the first instance, the Vice-Principal (Research) will seek nominations through written communication with the Deans of the University. Membership will initially be struck in accordance with the Tri-council suggestions as outlined above, with the one exception being that membership will include a representative from the graduate student body.
1.2 Scope of the REBs
All research that involves living human participants requires review and approval in accordance with the Tri-Council Policy statement, before the research is started, except as stipulated below.
Research about a living individual involved in the public arena, or about an artist, based exclusively on publicly available information, documents, records, works, performances, archival materials or published third-party interviews, is not required to undergo ethics review. Such research only requires ethics review if the participant is approached directly for interviews or for access to private papers, and then only to ensure that such approaches are conducted according to professional protocols.
Quality assurance studies, performance reviews or testing within normal educational requirements should also not be subject to REB review.
The REB has a responsibility for encouraging appropriate awareness of the need for ethics review amongst the research community of Queen's University.
1.3 Allocation of Protocols
Research whose primary application is in the health sciences will be referred to the Health Sciences Research Ethics Board. All research involving human remains, cadavers, tissues, biological fluids, embryos or fetuses shall be reviewed by the Health Sciences Research Ethics Board. All research conducted on patients in the teaching hospitals must be referred to the Health Sciences Research Ethics Board.
Research whose primary application falls in any other discipline at Queen's University will be directed to the General University Research Ethics Board for review.
In a case where a protocol is submitted to a University REB that feels it does not have the necessary expertise to review the protocol, the Chair of that Board has the authority to refer the protocol to the more appropriate Board.
2. Expedited Review
A proposal, once received by the REB Chair, may be considered for expedited review if requested or if it is deemed by the Chair that the proposed research is of low ethical concern. Necessary conditions for low ethical concern include, but are not limited to, protocols that meet the requirements for free and informed consent, protect privacy and confidentiality, adhere to guidelines of conflict of interest and inclusion, and are of minimal risk. Minimal risk means that potential participants can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the participant in his or her everyday life.
The Chair may also effect expedited review in the event that a protocol is a renewal or continuation of a research program that has already been reviewed by the full Board. In any case where expedited review has been granted, the Chair will report the decision to the Board at its next meeting.
2.1 Faculty, School or Departmental REBs
Faculty, School or Departmental (referred hereafter as Unit) Research Ethics Boards may be established with the recommendation and approval of the relevant University Research Ethics Board to review Unit protocols. For student protocols, the Unit REB may either approve the protocol as one of low ethical concern or forward the protocol to one of the two University Boards for review. The Unit Board must use the definition of low ethical concern as outlined in Article 2 of this policy as a benchmark on which to determine approval or referral of a protocol.
For faculty protocols, Unit REBs will consider the protocol and forward the proposal to the University REB with a recommendation for either a) expedited review or b) full review. The Unit Boards will submit a quarterly report to one of the University Boards based on the normal assignment process of protocols. This report will include a justification for any protocols that were approved by the Unit Board. Any complaints received by a Unit REB will automatically be reported to one of the University REBs. From time to time the University Board will monitor the operations of the Unit Boards.
In the absence of a Unit REB, all protocols are to be automatically forwarded to one of the two University REBs
3. Review Procedures for Ongoing Research
Ongoing research shall be subject to continuing ethics review. Normally, continuing review should consist of at least the submission of a succinct annual status report to the REB. The REB shall be promptly notified of adverse events, changes in protocols and when the project concludes.
The REB must review and renew each protocol annually. This may be conducted by expedited review if, in the assessment of the Chair, the protocol is of low ethical concern, or remains unchanged from the original protocol.
4. Appeal Process
The REB shall accommodate reasonable requests from researchers to participate in discussions about their proposal, but the researchers shall not be present when the REB is making its decision. When an REB is considering a negative decision, it shall provide the researcher with all the reasons for doing so and shall give the researcher an opportunity to reply before making a final decision. The Board may provide for a face-to-face meeting with the researcher.
The Chair should monitor the REB's decisions for consistency, ensure that these decisions are recorded properly, and ensure that researchers are given written communication of the REB's decisions (with reasons for negative decisions) as soon as possible.
In cases where an REB has completed its process and researchers and an REB cannot reach agreement through discussion and reconsideration, an appeal may be made to the alternate REB on Queen's Campus.
5. Conflicts of Interest
If an REB is reviewing research in which a member of the REB has a personal interest in the research under review, conflict of interest principles require that the member must disclose their conflict and not be present when the REB is discussing or making its decision except as provided for under Article 4.
6. Operational Procedures:
Operational procedures will be developed by each Research Ethics Board consistent with the needs of the relevant research communities. Terms of reference are to be in accordance with prevailing University Policies and the guidelines outlined in the Tri-Council policy statement Ethical Conduct for Research Involving Humans.