Canada's granting councils — the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council, and the Social Sciences and Humanities Research Council — have adopted the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Second Edition (TCPS2). TCPS2 sets ethical guidelines which apply to any institution that receives funding from any of the three councils. The guidelines require each such institution to establish an independent Research Ethics Board (REB) which reviews the ethics of all "research involving human subjects which is conducted within, or by members of, the institution." Acadia University's REB, established by the University Senate in 1999, draws its membership from among Acadia faculty and students and members of the local community.
TCPS2 defines "research" as "an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation." The following types of research require ethics approval from the Research Ethics Board before the research is begun:
- All research that involves living human subjects, except as stipulated below
- Research involving human remains, cadavers, tissues, biological fluids, embryos, or fetuses
- Research that involves interviewing a human subject to secure identifiable personal information, whether by face-to-face meetings, telephone, videotaping or other electronic encounters, or individualized questionnaires
- Research involving third-party interviews if the third party is approached directly for interviews or for access to private papers
- Research involving naturalistic observation of humans, except as stipulated below
- Research which involves the secondary use of data that was originally collected from human subjects for another purpose, except as stipulated below
The above-mentioned types of research require ethics review regardless of whether the
- research is funded.
- funding is external.
- subjects are from outside the institution.
- subjects are paid.
- research is conducted outside the institution.
- research is conducted in Canada.
- research is conducted by staff or by students.
- research is conducted in person or remotely.
- information is collected directly from subjects or from records not in the public domain.
- research is to be published.
- focus of the research is the human subject or a broader issue.
- research is observational, experimental, correlational or descriptive.
- project has been approved elsewhere.
- research is a pilot study or a fully developed project.
- research is to acquire basic or applied knowledge.
The following types of research do not require ethics approval:
- Research involving naturalistic observation of participants in, for example, political rallies, demonstrations, or public meetings, since it can be expected that the participants are seeking public visibility
- Research about a living individual involved in the public arena, or about an artist, based exclusively on publicly available information, documents, records, works, performances, or archival materials
- The secondary use of pooled data which cannot be traced to the original research subjects
- Quality assurance studies, performance reviews, or testing within normal educational requirements, unless there is an element of research in addition to the assessment
If you have any doubt about whether these conditions apply to a particular project, contact Stephen Maitzen, Chair of the REB.
- Acadia University, by and through the University Senate, has mandated the REB to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human subjects which is conducted within, or by members of, the University, using the considerations set forth in TCPS2 as the minimum standard. The REB reports to the University Senate through the Dean of Research and Graduate Studies.
- Acadia University may not override negative REB decisions reached on grounds of ethics except in accordance with the formal appeal mechanism specified in section 1.11, below. Acadia University may refuse to allow certain research within its jurisdiction, even though the REB has found it ethically acceptable.
- Except for the Dean of Research and Graduate Studies and the Graduate Student Representative, both of whom are non-voting members, the membership of the REB is determined as follows. Community Representatives are nominated by the Senate Nominating Committee and appointed by Senate. Each Faculty Representative is nominated and elected by the relevant individual Faculty. The Chair is nominated and elected by the University Faculty as a whole.
- As mandated by Senate, the membership of the REB (to include both men and women) is as follows:
- The Dean of Research and Graduate Studies, to serve as a non-voting, ex officio member who shall act as liaison to the Senate Research Committee, the Senate Graduate Studies Committee, and Senate;
- One faculty member, knowledgeable in ethics, to serve as Chair;
- One member from the Faculty of Arts with broad expertise in the methods or in the areas of research that are covered by the REB;
- One member from the Faculty of Professional Studies with broad expertise in the methods or in the areas of research that are covered by the REB;
- One member from the Faculty of Pure and Applied Science with broad expertise in the methods or in the areas of research that are covered by the REB;
- One member from the Faculty of Theology with broad expertise in the methods or in the areas of research that are covered by the REB;
- One member from the community having no affiliation with Acadia University and not currently engaged in scientific, legal or academic work;
- One member from the community who has legal knowledge, but having no affiliation with Acadia University;
- One graduate student to have non-voting status, to be appointed by the Student Representative Council.
- The decision of a granting agency to fund the proposed research will be considered by the REB to be sufficient scholarly review. Where no such funding has been awarded, the REB will conduct its own scholarly review or, where the REB lacks the necessary expertise, will consult an ad hoc independent peer-reviewer who will report directly to the REB.
- The extent of scholarly review required for biomedical research which poses no more than minimal risk will vary according to the research being carried out.
- Research in the humanities and social sciences which poses no more than minimal risk will not normally be required by the REB to be peer-reviewed.
- The REB employs a proportionate approach based on the general principle that the more invasive the research, the greater should be the care in assessing the research.
- The REB adopts the definition of minimal risk research contained in TCPS2: "research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research."
1. Full REB review
This level of review is required for all research that the REB regards as posing more than minimal risk (see definition below). The REB may require this level of review for minimal-risk research as well if it judges that aspects of the research warrant doing so.
2. Delegated review by a Faculty Representative on the REB
Ethics applications filed with the REB normally receive delegated review by a Faculty Representative if the REB regards the research as posing only minimal risk. The Faculty Representative must report the results of such review for ratification by the full REB at a regular meeting.
3. Department-level delegated review of minimal-risk research in courses
The department, school, or program may review research that undergraduate or graduate students conduct to fulfill non-thesis course requirements, provided that the research poses only minimal risk. Reviews must adhere to TCPS2. An annual report shall be emailed to the Chair of the REB by June 30, giving details of the review procedures used and listing all research projects approved during the previous twelve months. Research posing more than minimal risk and research by students as part of a faculty member's research program must be reviewed by the REB.
4. Department-level delegated review of minimal-risk Honours research
The department, school, or program may review minimal-risk Honours research. Reviews must adhere to TCPS2. The department, school, or program must report the results of such reviews to the Chair of the REB by June 30 of each year, giving details of the review procedures used and listing all Honours projects approved during the previous twelve months. The department, school, or program may decline to conduct reviews, either in general or in individual cases, directing applications to the REB instead. Research posing more than minimal risk and research by students as part of a faculty member's research program must be reviewed by the REB.
(a) Graduate thesis research must be reviewed by the REB. Review of such research is not delegated to the department, school, or program.
(b) The national Secretariat on Research Ethics has ruled that if a realistic prospect exists that a faculty member will co-author a paper based on a student's research project, then the project must be reviewed by the REB. Review of such research is not delegated to the department, school, or program.
Definition of "minimal risk"
"For the purposes of this Policy, 'minimal risk' research is defined as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research." [TCPS2, Chapter 2, Section B]
The members of the REB meet formally once each month, September through July. See the dates of meetings. The REB expects regular attendance by its members and will construe frequent unexplained absences as a notice of resignation. A quorum for meetings consists of five voting members, including at least one community member.
- The agendas and minutes of all REB meetings are prepared and maintained by the Chair. The minutes document the REB's decisions as well as any dissents and the reasons given for dissenting.
- The REB considers its minutes to be confidential documents. Subject to the preservation of their confidentiality, the minutes will be accessible to representatives of Acadia University who have been authorized by Senate to examine them. Researchers and funding agencies will also be given access to those portions of the minutes which specifically concern them, again subject to the preservation of confidentiality.
- Applications, minutes, correspondence, and associated materials will be retained in locked storage or in a password-protected network folder for a minimum of five (5) years.
- The REB will function impartially, provide a fair hearing to those involved and provide reasoned and appropriately documented opinions and decisions. The REB shall accommodate reasonable requests from researchers to participate in discussions about their proposals, but researchers may not be present when the REB is making its decisions.
- All complete applications received by the appropriate deadline, including those that have received delegated review (as in section 1.6, above), will be discussed and formally voted upon. A simple majority of the REB's voting members is necessary and sufficient for ethics approval or for ratification of a previously granted expedited approval.
- The REB will notify applicants of its decisions by means of a formal letter from the Chair. Notifications of delegated approval, pending ratification by the full REB, will normally be sent electronically by the faculty representative reviewing the application.
- When the REB declines to approve a research proposal, it will provide the researcher with all the reasons for doing so and give the researcher an opportunity to reply before making a final decision.
TCPS2 Article 6.18 gives researchers the right to request, and the REB an obligation to provide, reconsideration of decisions affecting a research project.
- Before any appeal is made, it is expected that both parties will have abided by the process of reconsideration referred to in 1.10, above.
- When a final decision has been made and a project has been rejected, appeals will be considered only on procedural grounds or when there is a significant disagreement over interpretation of TCPS2.
- Provided that its composition conforms to TCPS2 Article 6.4, the REB of Mount Allison University will serve as the appeals board for Acadia University in a reciprocal relationship. Both universities have entered into this relationship by means of a memorandum of agreement.
- The decision of the appeals board shall be final.
If the REB is reviewing research in which a member of the REB has a personal interest (e.g., as a researcher or supervisor), the member shall not be present during the REB's discussion or decision-making with regard to the research. In cases of disagreement over conflicts of interest, both the REB member in alleged conflict and the researcher may present evidence and offer a rebuttal concerning the nature of the conflict of interest. The other members of the REB will make a final decision regarding how to proceed.
Ongoing research is subject to continuing ethics review. The Chair of the REB must be notified of any significant proposed changes to the research plan or research protocol before such changes are implemented.
- Ethics approvals have a maximum term of one (1) calendar year from the date of approval. Extension of that term requires a written request from the researcher to the Chair of the REB.
- In accordance with TCPS2 Article 6.14, the REB must be promptly notified when an approved project concludes. An email notification sent to the REB Chair is sufficient for this purpose.
As stated in section 1.2, above, the REB has jurisidiction over all human-subjects research conducted within, or by members of, Acadia University. This jurisidiction is unaffected by the involvement of other institutions in such research. Applicants whose proposals have received ethics approval elsewhere are welcome to submit documentation of the approval, which the REB will review carefully. However, the REB will conduct its own ethics review and will not consider itself bound by the results of other reviews. Nor does the REB expect that its approval or rejection of research will automatically determine how the research will be evaluated elsewhere.
Research to be performed outside the jurisdiction of Acadia University or outside Canada shall undergo prospective ethics review both by the Acadia University REB and by the REB, where such exists, with the legal responsibility and equivalent ethical and procedural safeguards in the country or jurisdiction where the research is to be done.
Research may occur only if the free and informed consent of participants, or their authorized third parties, has been obtained and is maintained throughout the research process. TCPS2 Article 3.7 provides for exceptions to this requirement in limited circumstances.
Free and informed consent must be voluntarily given, without manipulation, undue influence or coercion.
REB review is not required for research involving the observation of people in
public places where:
(a) it does not involve any intervention staged by the researcher, or direct interaction
with the individuals or groups;
(b) individuals or groups targeted for observation have no reasonable expectation
of privacy; and
(c) any dissemination of research results does not allow identification of specific
Subject to applicable legal requirements, individuals who are not legally competent shall be asked to become research subjects only when
- the research question can only be addressed using individuals within the identified group(s); and
- free and informed consent will be sought from their authorized representative(s); and
- the research does not expose them to more than minimal risks without the potential for direct benefits for them.
For research involving incompetent individuals, the REB shall ensure that, as a minimum, the following conditions are met:
- The researcher shall show how the free and informed consent will be sought from the authorized third party, and how the subjects' best interests will be protected.
- The authorized third party may not be the researcher or any other member of the research team.
- The continued free and informed consent of an appropriately authorized third party will be required to continue the participation of a legally incompetent subject in research, so long as the subject remains incompetent.
- When a subject who was entered into a research project through third-party authorization becomes competent during the project, his or her informed consent shall be sought as a condition of continuing participation.
Where free and informed consent has been obtained from an authorized third party, and in those circumstances where the legally incompetent individual understands the nature and consequences of the research, the researcher shall seek to ascertain the wishes of the individual concerning participation. The potential subject's dissent will preclude his or her participation.
- Subject to all applicable legislative and regulatory requirements, research involving emergency health situations shall be conducted only if it addresses the emergency needs of individuals involved, and then only in accordance with criteria established in advance of such research by the REB. The REB may allow research that involves health emergencies to be carried out without the free and informed consent of the subject or of his or her authorized third party if all of the following apply:
- A serious threat to the prospective subject requires immediate intervention; and
- Either no standard efficacious care exists or the research offers a real possibility of direct benefit to the subject in comparison with standard care; and
- Either the risk of harm is not greater than that involved in standard efficacious care, or it is clearly justified by the direct benefits to the subject; and
- The prospective subject is unconscious or lacks capacity to understand risks, methods and purposes of the research; and
- Third-party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so; and
- No relevant prior directive by the subject is known to exist.
- When a previously incapacitated subject regains capacity, or when an authorized third party is found, free and informed consent shall be sought promptly for continuation in the project and for subsequent examinations or tests related to the study.