Ethics of Research Involving Human Participants
Memorial University of Newfoundland is committed to the promotion and support of excellence in research and scholarship. The conduct of research must be guided by ethical principles which will protect the rights and welfare of participants.
To ensure that those conducting research at Memorial University achieve a proper balance between respect for the dignity and welfare of the participants on the one hand, and the need for advancement of knowledge on the other.
All research activities involving human participants undertaken by Memorial University faculty, staff and students regardless of the source of financial support and irrespective of the location of the research. Research carried out by external researchers or investigators who access resources or participants at the University is also covered by this policy
CIHR - the Canadian Institutes of Health Research
DRC - Departmental Review Committee
GCREB - the Grenfell Campus Research Ethics Board.
HREA Health Research Ethics Authority
HREB Health Research Ethics Board
ICEHR - the Interdisciplinary Committee on Ethics in Human Research
NSERC - the Natural Sciences and Engineering Research Council of Canada.
Participant - any person who is used as a source of data in the conduct of research.
Research - a systematic investigation or process to establish facts, principles, or generalizable knowledge.
Researcher or Investigator - any individual who is involved in the intellectual direction, control and/or conduct of the research activity. This individual may be a faculty member (including sessional appointments), visiting scholar, adjunct, emeritus, honorary research professor, or executive in residence. The individual could also be a student in an undergraduate, graduate or postgraduate program, staff member, or a community or industrial partner.
REB - research ethics board.
SSHRC - the Social Sciences and Humanities Research Council of Canada
TCPS2 - the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, second edition (2010), as it is amended from time to time
1.0 RESEARCH INVOLVING HUMAN PARTICIPANTS
The University requires that research involving human participants is designed and carried out in an ethical and responsible manner. This policy requires those conducting research to achieve a proper balance between respect for the dignity and welfare of the participants on the one hand, and the need for advancement of knowledge on the other.
2.0 ADOPTION AND INCORPORATION OF ETHICAL PRINCIPLES AND ARTICLES OF THE TRI-COUNCIL POLICY STATEMENT
CIHR, NSERC and SSHRC (collectively the Tri-Council) have jointly adopted the TCPS2.
The University endorses this Policy Statement and has mandated Memorial's REBs to ensure that all research investigations involving human participants are in compliance with the TCPS2. No research may proceed until ethics approval has been granted by the appropriate REB.
The University's Policy on Ethics of Research Involving Human Participants is deemed to be consistent with the TCPS2 and to either meet or exceed the required standards set out in the TCPS2. It is recognized that the TCPS2 will be amended from time to time. Upon notification of such amendments, the University's policy will be reviewed and revised towards achieving consistency with the TCPS2. Notwithstanding the aforementioned, in the event the TCPS2 is amended, research involving human participants at Memorial University shall be subject to the amended terms of the TCPS2.
In addition, in the Province of Newfoundland and Labrador, the Health Research Ethics Authority Act (The Act) came into force on July 1, 2011. The Act requires all health research done in the province to be reviewed and approved by a local (Newfoundland and Labrador) research ethics review board. The Health Research Ethics Authority (HREA) oversees ethics review of health research by the Health Research Ethics Board (HREB) or an approved health research ethics review body. Consequently, all health research involving human participants at Memorial University must be reviewed and approved by HREB or an REB deemed an approved health research ethics review body by the HREA. It is noted that in carrying out their duties the HREA, the HREB and other approved ethics review bodies apply the TCPS2.
3. GUIDING ETHICAL PRINCIPLES
3.1 Respect for Human Dignity
Conflicts may sometimes arise from the application of these principles in isolation from one another. Researchers and Research Ethics Boards (REBs) must carefully weigh all the principles and circumstances involved to reach a reasoned and defensible conclusion.
3.2 Respect for Free and Informed Consent
3.3 Respect for Vulnerable Persons
3.4 Respect for Privacy and Confidentiality
3.5 Respect for Justice and Inclusiveness
3.6 Balancing Harms and Benefits
This is not to say that harm may not result from research. In some areas of research such as political science, economics or modern history, there may be occasions in which research ethically results in harm to the reputations of organizations or individuals in public life.
There is often uncertainty about the magnitude and kind of benefits or harms that may result from proposed research and a resultant uncertainty about the balance of benefits and harms. This uncertainty imposes an obligation to conduct research at a high level of competency in order to maximize the potential benefits of the research.
3.7 Minimizing Harm
3.8 Maximizing Benefits
4.0 RESEARCH REQUIRING ETHICS REVIEW
4.1 Research Requiring Ethics Review
4.2 Research not Requiring Ethics Review
5.0 AUTHORITY AND MEMBERSHIP OF RESEARCH ETHICS BOARDS (REBs)
Two REBs are constituted at the University:
Generally researchers submit their proposals for ethics review to the appropriate REB according to the criteria listed above or as required to ensure review by a REB with the appropriate expertise. Persons conducting any health research, including but not limited to clinical trials, health intervention studies of greater than minimal risk (human kinetics) or health research in particularly vulnerable populations (abuse victims) must submit to the HREB, or an REB deemed an approved health research ethics review body by the HREA. HREA must be notified of applications for review of health research. REBs have the authority to transfer research proposals to another REB to ensure review by a REB with the appropriate expertise. In addition, research sometimes spans the criteria of more than one REB. In such cases, the appropriate REB is determined by agreement between the Chairs of the relevant REBs. The Chairs may decide that the research must be reviewed by both REBs.
REBs constituted at Memorial report to the Office of the President.
Each REB shall suspend any ongoing research under its purview that it deems to pose an unacceptable risk of harm to participants. Chairs of REBs are authorized to act on behalf of their members in exigent circumstances.
Each REB is responsible for developing procedures for implementing the University's ethics policy that meet particular needs of the disciplines it reviews. Such procedures may be more stringent (but not less stringent) than those described in the University's Policy on Ethics of Research Involving Human Participants. All such procedures must be formalized in writing and made available to researchers, sponsors and funding agencies, and participants.
Research requiring ethics review that has not been submitted to and approved by the appropriate REB cannot be undertaken. Non-compliance with this provision may constitute misconduct as defined by the current Collective Agreement between the University and Memorial University of Newfoundland Faculty Association (Article 19.32(f)).
5.3 Administrative Support
The considerable time commitment of those faculty members who serve on Memorial's three REBs will be appropriately noted by the heads of their academic units. In the case of REB Chairs, the need for teaching release, stipendiary or research support will be taken into consideration in consultation with the appropriate academic unit heads at the time of appointment to the position of Chair.
Adequate administrative support must be provided by the University for the two REBs.
6.0 REB ASSESSMENT, DECISION-MAKING AND PROCEDURES
6.1 Proportionate Approach to Ethics Assessment
6.2 Research undertaken by faculty members
Regardless of the level of the review, the ethical requirements for approval do not change; these requirements are applicable to all research involving human participants.
Expedited review, where the research under consideration is deemed to pose no more than minimal risk to participants, can be undertaken by a committee of the REB designated by the Chair. REBs are authorized to undertake expedited review based primarily on an assessment of the risks posed to participants by the research.
6.3 Research undertaken by students
6.4 Ethics Proposals and Determination of Review Level Required
Ethics review by REBs is based upon fully detailed research proposals. Researchers must submit their proposals for ethics assessment to the committee in the format prescribed by the relevant REB. Either the REB Chair or such person(s) designated by the Chair assesses the level of review required. The Chair or designate(s) determines whether the proposal poses greater than minimal risk and therefore must receive full REB review at a meeting of the REB, or poses no more than minimal risk and therefore may receive expedited review.
In the case of research undertaken as part of course work in an ICEHR or GCREB constituency, the academic unit assesses the level of risk and either undertakes an expedited review internally or forwards the proposal to the appropriate REB for full review, as necessary (see APPENDIX).
6.5 Scholarly Review
REB members must keep in mind that definitive studies are rare; the significance of any individual study, even when viewed in retrospect, is not always immediately apparent and can be trivialized. Accordingly, the benefit of a particular research project should often be judged within the context of a research program, taking into account the expertise and experience of the researchers. An integral part of some research programs is the pilot study, the results of which may be only suggestive but which can provide important indications of how to proceed with the research. The value of pilot studies is often indirect and may be better evaluated in the broader context of a research program.
Research in the humanities and social sciences which poses minimal risk is not normally required by REBs to be peer reviewed in order to determine capacity to address the questions being asked.
Certain types of research, often from social science and humanities disciplines, may legitimately have negative effects on public figures or on organizations. Such research should not be disallowed automatically because of a negative imbalance of benefits and harms. The safeguard for those in the public arena is through public debate and discourse and through action in the courts.
6.6 Decision-Making Standards and Review Procedures
Quorum for REB meetings is, at the minimum, one half of the total number of regular members. Where alternate members are appointed to a REB and these members are present at a meeting, they count in determining whether quorum is met.
REB meetings at which full reviews of proposals are conducted must be face-to-face.
REBs must develop procedures to ensure the impartiality and fairness of both their full and expedited review processes and to avoid conflicts of interest. Members must not be present during REB discussions of research with which they are associated, whether the proposal is from a student, faculty member, or external researcher. Similarly, members must not be involved in the expedited review of research with which they are associated. Members must also not participate in the review of any proposal where the researcher is someone with whom they have or have had a close personal or financial relationship.
Decisions of REBs are reached by consensus wherever possible. If the committee cannot achieve consensus, however, the decision is based on majority vote of those present.
For expedited reviews, the decision to approve must be made by consensus if two or more members conduct the review. Lack of consensus in such cases automatically results in referral of the proposal for full REB assessment unless the applicant chooses to withdraw the proposal.
When a REB identifies factors that may jeopardize the well-being of human participants, such issues should be resolved cooperatively by the committee and the researcher. When review indicates significant problems with the proposal and subsequent correspondence and discussion between the REB Chair and the researcher has not alleviated the concerns of the REB, the researcher may be invited to meet with one or more members of the REB or to attend a meeting of the Committee for discussion of issues.
When a REB decides to deny an application or makes approval contingent on changes to the proposal, it must provide the researcher with written grounds for the decision. When a REB decides to deny an application or makes approval contingent on changes to the proposal, researchers have a right to request, and REBs have an obligation to provide, reconsideration based on the researcher's rebuttal to the concerns identified by the REB. The researcher may be invited to meet with one or more members of the REB or to attend a meeting of the Committee for discussion of issues before a final decision is made.
6.7 Record Keeping
REBs shall maintain a file for each research proposal they consider, either during face-to-face meetings or through expedited review. The file shall contain at minimum one copy of the application form, the review proposal, consent documents, along with any additional documentation relevant to the proposal and/or revisions submitted, and formal correspondence with the researcher.
REBs may establish additional requirements for record-keeping relevant to the constituencies they represent, to granting and regulatory agency requirements, and to legislative requirements. The minimum amount of time that REB records shall be kept is five years beyond the closure of the file. Sponsors may require that records be kept for a longer period.
6.8 Ongoing Research
REBs are guided by TCPS2 recommendations for continuing review procedures but may develop other means of continuing ethics review as needed provided such means are not in conflict with the requirements of the TCPS2. REBs determine the nature of the continuing review process, including the intervals at which the researcher must submit materials, if any, for review. Normally, continuing review consists of at least the submission of a succinct annual status report to the REB documenting any changes in the study. The REB must be notified promptly when the project concludes.
Researchers are required to report to the REB any changes in research design, procedures, instruments, sample characteristics, and so forth that are contemplated after ethics approval has been granted. The REB, through full or expedited review, depending on the nature of the proposed changes, must approve the changes before the modified research can proceed or continue.
Researchers are required to notify the REB immediately if an untoward or adverse event occurs during their research or if data analysis or other review reveals undesirable outcomes for participants.
7.0 APPEALS OF REB DECISIONS
A decision of a REB to allow or disallow research on ethical grounds can be appealed only on the basis of an error in process in accordance with the PROCEDURE TO APPEAL A RESEARCH ETHICS BOARD DECISION
In the case of appeals against a decision of either the ICEHR or the GCREB, these two REBs will serve as an Appeals Board for each other. Researchers wishing to lodge an appeal against a decision of either of these two REBs must submit a letter to the Vice-President (Research), acting for the President of the University, who will advise the two REBs that an appeal has been made. The appropriate REB will consider the appeal and the other Board will have no involvement in the appeal process except to be advised of its final disposition.
In the case of appeals against a decision of the HREB, the appeals process may be reviewed in the HREB Policy Manual of the HREA.
8.0 REVIEW OF OFF-CAMPUS RESEARCH
Research conducted by any of the persons to which this policy applies outside the campuses of the University is subject to review by a REB of the University and by the REB, where such exists, with legal and ethical responsibility for research in the country or jurisdiction where the research is to be done.
9.0 FREE AND INFORMED CONSENT
9.1 Normal Requirements
Free and informed consent must be voluntarily given, without manipulation, undue influence or coercion. Participants have given free and informed consent when they have freely agreed to serve in the study on the basis of their understanding of the objectives of the research. They must be fully informed of all risks and possible benefits of their participation. The participants must have an opportunity to evaluate the relative weight of any risks and benefits of the proposed research. Continuing voluntary participation requires that participants be assured that at any time their withdrawal from the research shall not result in penalty or harm or loss of promised benefits.
Participants must understand their respective obligations and responsibilities in deciding whether or not to participate. The researcher must inform the participant of all aspects of the research that could reasonably be expected to influence the participant's willingness to participate, including aspects that involve financial gain.
Special problems of consent and voluntariness arise when, in addition to being a research participant, there is a second relationship between research participant and a researcher. This may be of the nature of relationship between patient and physician, between student and teacher, between prison administrator and inmate, between employer and employee, and other like relationships. Researchers must evaluate these potential problems and take steps to eliminate them before the research can be undertaken. Consent must be obtained under conditions that do not involve explicit or implicit coercion which would limit the freedom and voluntariness of participation.
9.2 Documentation of Consent
In studies including randomization and blinding, normally neither the research participants nor researchers may know to which condition participants have been assigned. Such methods are not regarded as a waiver or alteration of the requirements for consent if participants are informed of the probability of being randomly assigned to one condition of the study or another and the responsibility of the researcher to un-blind if circumstances warrant.
If the methodological requirements of a study make concealment of the goals of the study or the risk involved necessary, the investigator and the REBs have a special responsibility to determine whether the use of these techniques is justified by the study's prospective scientific, educational, or applied value. The investigator must indicate why the objectives necessitate such concealment, and whether alternative procedures are available that do not use concealment. Studies involving concealment normally must not be conducted if there is greater than minimal risk involved because meaningful prior consent is not possible. Particularly in cases of concealment, it is necessary to advise participants that they can withdraw from the study at any time without penalty and without losing anonymity. In the case of behavioural and questionnaire research where full disclosure about the nature and objectives of the research could bias and invalidate results (for example, in communications intended to change attitudes or in studies in incidental learning), the explanation must be given immediately after data collection or as soon as is consistent with the research design and methods. Participants must be fully informed as soon as possible of the purposes and aims of the research, and any uncertainties must be removed. The investigator must remove any misconceptions that may have been fostered and must attempt to re-establish any trust in the research community which may have been lost, assuring the participant during post-briefing that the research procedures were neither arbitrary nor capricious, but necessary for scientifically valid findings.
Even when fully informed consent has not been obtained for participation, participants can sometimes exercise their consent at the conclusion of the study, following post-briefing. In cases where the participant expresses concerns about the study, the researcher may be able to give the participant the option of withdrawing his or her data (See PROCEDURE FOR OBTAINING INFORMED CONSENT FOR RESEARCH ON HUMANS)
9.4 Participation in Research by Persons who are Not Legally Competent
Researchers must comply with all applicable legislative requirements of the jurisdiction in which participation takes place.
Individuals who are not legally competent must only be asked to become research participants when:
9.5 Consent Requirements for Persons who are Not Legally Competent
9.6 Emergency Health Situations
When a previously incapacitated person regains capacity, full free and informed consent shall be sought for continuation in the study including subsequent examinations or tests related to the study.
10.0 PRIVACY AND CONFIDENTIALITY
Researchers must comply with all applicable privacy legislation of the jurisdiction in which information [collection] takes place. Information regarding the federal Personal Information Protection and Electronic Documents Act (PIPEDA) and the provincial Access to Information and Protection of Privacy Act (ATIPPA) can be found at the following websites: http://www.parl.gc.ca/36/2/parlbus/chambus/house/bills/government/C-6/C-6_4/C-6_cover-E.html and http://www.assembly.nl.ca/legislation/sr/statutes/a01-1.htm.
Where possible, participants must be guaranteed privacy and anonymity and their information must be treated as confidential. If these cannot be assured or granted, potential participants must be made aware of the limitations of privacy protection and of the possible consequences of breach of confidentiality as part of the consent process.
10.1 Primary Collection
Subject to the exceptions in Section 4, researchers who intend to interview participants to obtain personal information shall obtain REB approval for the consent and for the interview procedures and instruments. They shall ensure the free and informed consent of participants. Interview includes face-to-face, telephone or other electronic encounters and individualized questionnaires administered in person, by telephone, electronically or by mail. As noted in Section 4, REB approval is not required for research involving access to publicly available information or materials (including archival documents) and records of public interviews or performances.
Subject to the exception in Section 4, researchers shall require REB approval for obtaining identifiable personal information about participants through interview, questionnaire, direct or indirect observation and through access to records or materials containing personal information. REB approval for such research shall include such considerations as:
10.2 Secondary Use
REB approval is required for secondary use of data in research. These data may be anonymous (e.g., information obtained from a cancer registry about each patient diagnosed with colon cancer in a particular year). Researchers may gain access to identifying information if they have demonstrated to the satisfaction of the REB that:
Depending on the perceived risk of a breach of confidentiality, a REB may also require that a researcher's access to data involving identifying information be dependent on:
Researchers who wish to contact individuals to whom the secondary data refer shall seek the approval of the REB prior to contact. The REB shall ensure the original confidentiality guarantees are respected in making such contacts. Normally the data guardian or a member of the research team collecting the data shall make the first contact.
Linkage of data in which research participants may be identifiable shall be approved by the REB. These techniques provide opportunity for addressing previously unanswerable questions but may also create new threats to privacy. REBs must exercise caution in the creation and use of linked data.
10.3 Safeguards in the Protection of Privacy
REBs shall ensure that the means taken to protect the privacy of research participants is thoroughly documented by the researcher. Privacy protection shall be a priority of continuing ethical review.
11.0 CONFLICT OF INTEREST
Researchers hold trust relationships with research participants, research sponsors, institutions, professional bodies, and society. These trust relationships can be put at risk by conflicts of interest that may compromise independence, objectivity, or ethical duties.
Potential conflicts of interest between researchers and participants include but may not be limited to:
REB members may also have conflicts of interest with researchers or with the research project. Potential conflicts of interest include but may not be limited to:
Researchers and REB members shall disclose actual, perceived or potential conflicts of interest to the REB. REBs shall develop mechanisms to address and resolve conflicts of interest (ref Section 6.4).
12.0 INCLUSION IN RESEARCH
An important aspect of the principle of justice is the fair distribution of benefits and burdens. Members of society should neither bear an unfair share of the direct burdens of participating in research, nor should they be unfairly excluded from potential benefits of research participation.
Where research is designed to survey a number of living research subjects because of their involvement in generic activities (e.g., in many areas of health research or in some social science research such as studies of child poverty or of access to legal clinics) that are not specific to particular identifiable groups, researchers shall not exclude prospective or actual research subjects on the basis of such attributes as culture, religion, race, mental or physical disability, sexual orientation, ethnicity, sex or age, unless there is a valid reason for doing so. Neither women nor men shall be automatically excluded from research solely on the basis of sex or reproductive capacity. These statements are not intended to preclude research focused on a single living individual (such as in a biography) or on a group of individuals who share a specific characteristic (as in a study of an identifiable group of painters who happen to be all of one sex, colour or religion , or of a religious order which is restricted to one sex).
Subject to the provisions in Section 9.4, people who are not competent to consent for themselves shall not be automatically excluded from research which is potentially beneficial to them as individuals, or to the group that they represent.
13.0 RESEARCH INVOLVING ABORIGINAL PEOPLES
Research involving aboriginal communities may raise difficult ethical issues, including over-studying. The investigator must describe in detail to the REB any ethical issues relevant to the particular project proposed. Research begins with community or band consultation, often before the design of the research has been finalized. As well, the community must be given opportunity to learn of, and to respond to, the research results before publication. Disagreements in interpretation among community members, and between the community and the research team must be included in any published report.
14.0 CLINICAL TRIALS
14.1 Clinical Equipoise
14.2 Special Requirements for REB Review of Clinical Trials
In Phase I and II trials, the REB must be satisfied that the appropriate hospital and clinical resources are available for safe conduct of the trial and will require assurance by the relevant hospital ethics/resource committees that such resources are available before approving the protocols.
Normally, REBs requests investigators to identify real or perceived conflicts of interest as part of the application process. The budgets of clinical trials are examined to assure that ethical duties concerning conflict of interest are respected. In keeping with the TCPS2, finders fees are prohibited. Physicians' fees for services rendered as part of a clinical trial or for pre-screening potential participants by the referring physician are limited to the standard rates authorized by the Medical Care Plan (MCP).
14.3 Placebo Controls in Clinical Trials
When a clinical trial involving a placebo control is undertaken, the consent form must indicate that standard therapy is being withdrawn or withheld for purposes of the research, the anticipated consequences of the withdrawing or withholding of the therapy, the type of rescue, e.g, alternative medication or study withdrawal, and the reasons why the investigator deems a placebo-controlled trial to be necessary.
15.0 HUMAN GENETIC RESEARCH
The ability to identify human genes and their mutations has profound social implications. Misunderstanding or misuse of the results of genetic testing has the potential to interfere with an individual's self-identity and sense of self-worth, and to stigmatize the entire group to which that individual belongs. Researchers and the appropriate REB shall exercise care in identifying risks to individuals and groups posed by genetic research.
The genetics researcher must seek free and informed consent from the individual and report results to that individual if the individual so desires. Where appropriate, free and informed consent must also involve the family and/or relevant social structures as far as practical and possible. Researchers retain the right not to perform the genetic analysis if the patient/participant does not want to know the result.
Normally, the researcher and the REB must ensure that the results of genetic testing and genetic counseling records are protected from access by third parties, unless free and informed consent is given by the participant. Family information in databanks shall be coded so as to remove the possibility of identification of subjects within the bank itself.
Researchers and genetic counsellors who involve families and groups in genetic research studies must reveal potential harms to the REB and outline how such harms shall be dealt with as part of the research project.
Genetics researchers and the REB must ensure that the research protocol makes provision for access to genetic counselling for the participants, where appropriate.
Though the banking of genetic material is expected to yield benefits, it may also pose potential harms to individuals, their families and the groups to which they may belong. Accordingly, researchers who propose research involving the banking of genetic material have a duty to satisfy the REB and prospective research participants that they have addressed the associated ethical issues, including confidentiality, privacy, storage, use of the data and results, withdrawal by the subject, future contact of participants, families and groups, and the requirement for further ethics approval.
At the outset of a research project, the researcher must disclose to the REB and the research participant the possibility and/or probability that the genetic material and the information derived from its use may have potential commercial uses.
16.0 RESEARCH WITH HUMAN GAMETES, EMBRYOS OR FOETUSES
16.1 Research Involving Human Gametes
It is not ethical to use in research ova or sperm that have been obtained through commercial transactions, including exchange for service.
It is not ethically acceptable to create, or intend to create, hybrid individuals by such means as mixing human and animal gametes, or transferring somatic or germ cell nuclei between cells of humans and other species.
16.2 Research Involving Human Embryos
It is not ethically acceptable to undertake research that involves ectogenesis, cloning human beings by any means including somatic cell nuclear transfer, formation of animal/human hybrids, or the transfer of embryos between humans and other species.
16.3 Research Involving Foetuses
Research involving the use of foetal tissue must be guided by respect for the woman's dignity and integrity. Researchers must thus obtain the free and informed consent of the woman whose foetal tissue is to be used for research.
17.0 HUMAN TISSUE
17.1 Requirements for Ethics Review
17.2 Requirements for Informed Consent
17.3 Previously Collected Tissue
When collected tissue has been provided by persons who are not individually identifiable (anonymous and anonymized tissue), and when there are no potential harms to them, there is no need to seek donors' permission to use their tissue for research purposes, unless an applicable law so requires. The REB will require documentation of both application to access such tissue and the approval provided by the designated guardian of the banked tissue.
18.0 RESPONSIBILITIES OF RESEARCHERS
Researchers are primarily and ultimately responsible for the protection of human research participants. In order to fulfill this responsibility, researchers must be competent in their area of inquiry. They must be familiar and comply with this policy and with other ethics guidelines relevant to their disciplines. Researchers must ensure that all individuals under their supervision have the training and competence needed to carry out their responsibilities. Principal investigators must ensure that all research personnel are familiar with and comply with this policy and other applicable ethics guidelines. Similarly, instructors who include research components in their courses must ensure that their students are competent to conduct the assigned research and that they are familiar with and comply with this policy and other applicable ethics guidelines. Adequate supervision of student research must be ensured, with greater care required as risk of harm to participants increases. Assistants, students, and others who conduct research under the supervision of others should understand that they are themselves researchers and therefore also bear personal responsibility for the ethical conduct of research with human participants.
Researchers have an ethical obligation to protect the welfare of their assistants, employees, and students by not exposing them to unsafe equipment, materials, and environments during the course of research.
19.0 EDUCATION AND DISSEMINATION
The REBs, through information provided on their respective websites, in conjunction with the Office of Research Services and the Office of the Vice-President (Research) have the primary responsibility for providing education for researchers about the ethical treatment of human research participants in general and about this policy.
The President or his/her designate will also convene an annual meeting of academic heads to discuss institutional ethics matters and on-going or emerging issues of a general ethics nature.
Appendix - Student Research as Part of Course Work