Research & Innovation Services

Terms of Reference: 

1. To ensure the ethical treatment of research subjects in accordance with the Research Policy of the General Faculties Council and to disallow research that has not been approved or does not continue to follow the ethical guidelines applied by the Human Subject Research Committee (HSRC) at the time of approval.
2. To conduct or cause to have conducted, in a timely manner, a review, for the purposes of approval, of the features of the proposal that involves the personal rights and welfare of the subjects. At the discretion of the HSRC any such reviews may be delegated to other bodies which in turn communicate the results of the review to the HSRC. Such bodies could include faculty review committees, where they exist. Any such faculty review committee must be created according to approved faculty council procedures to review research within that faculty and must operate according to Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans policies regarding membership and procedures. The faculty review committee must report annually to the HSRC.
3. In addition to item number 1 above, where required by an external agency, to conduct or cause to have conducted an ethical review of a research proposal in accordance with the requirements of the agency, and to notify the agency of the results.
4. The HSRC will accept submissions (i.e., proposals for approval, questions, comments, complaints) that relate to the ethical treatment of research subjects whether they come from the researchers themselves, participants in the research, or third parties.

Membership: (should include both men and women)

Membership Terms:

Quorum = 4 (members present must possess the range of background and expertise stipulated in Article 1.3 of the Tri-Council Policy Statement)

The appropriate Dean/Director will appoint faculty members for a two-year term. The Committee will appoint the community member, for a two-year term. Terms will overlap for purposes of continuity and may be renewed. The Committee Chair will be elected by the Committee annually. The Committee reports to General Faculties Council.

Policies and Procedures:

Research Requiring Ethics Review:

• All research that involves living human subjects requires review and approval by the HSRC in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, before the research is started, except as stipulated below.
• Research involving human remains, cadavers, tissues, biological fluids, embryos or foetuses shall also be reviewed by the HSRC.
• 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 third-party interviews, is not required to undergo ethics review. Such research only requires ethics review if the subject 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 and to Article 2.3 of the Tri-Council Policy Statement.
• Quality assurance studies, performance reviews or testing within normal educational requirements should also not be subject to HSRC review.

Authority of the HSRC:

The HSRC is mandated 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 of Lethbridge, using the considerations set forth in the Tri-Council Policy Statement as the minimum standard. In making a decision with respect to a particular proposal the HSRC may also consult any of numerous extant statements of ethical principles as well as individuals who are familiar with the ethical questions of the affected research area.

It is recognized that, while the HSRC is responsible for ensuring ethical practice in research carried on within or by members of the University of Lethbridge, the researcher(s) cannot abdicate his/her/their responsibility for ethical practice in research and continue to retain that responsibility independently of a decision by this or any other committee.

Part of the responsibility of the researcher(s) is to ensure that the HSRC be made aware of all research projects involving human subjects along with the information required to make an informed review of the procedures involved in that research. The investigator bears a further responsibility to ensure the HSRC be made aware of any changes in the procedure of an approved project that would have an impact on the ethical treatment of the subjects.

All research involving human subjects as defined in Article 1.1 of the Tri-Council Policy Statement and involving either researchers or subjects associated with the University of Lethbridge must be reviewed by the HSRC.

Student research involving human subjects, for class projects or individual projects which involve data gathering with the intent to publish (including that which is accessible outside the classroom), should be reviewed by the HSRC. Minimal risk protocols will be given expedited review. Student research which has already been approved under another protocol will not require a separate review, if the procedures involving human subjects are the same. In all cases, the instructor is responsible for ensuring that ethical standards are followed.

Research Projects Involving Special Cultural Groups:

Researchers who are proposing a research project involving special cultural groups (e.g. Aboriginal Peoples, communal groups) should detail how they will ensure that their project is carried out in a culturally and linguistically appropriate manner. The proposal should address such issues as informed consent, who can speak for whom, intellectual property, advocacy, and dissemination of information. These issues should be addressed in a way that is responsive to cultural dynamics and values, social norms and mores, and issues of power. The research process should facilitate local indigenous participation in decision-making--including local ethical review and research licenses, where appropriate. In cases where the subject of study is the group itself (e.g., a First Nation) or a significant portion of that group, rather than simply individuals from that group, the researcher should detail how consent will be obtained from the group (e.g., the respective Council of the First Nation).

Application Process:

Application for approval of a research project should be made, using the Application for Ethical Review of Human Subject Research which is available via this link or from Research Services.

Minimal Risk Research and Expedited Review:

The HSRC will adopt a proportionate approach based on the general principle that the more invasive the research, the greater should be the care in assessing the research. It is recognized that a distinction may be drawn between minimal risk research (see C1 of the Tri-Council Policy Statement) on the one hand and research with some potential risk to the participant on the other. Research of the latter type places increased responsibility on the investigator and on the review committee to ensure that all risks to the subjects are minimized as much as possible and that the potential benefits of the research are sufficiently important to outweigh the potential costs and risks to the subjects.

Research involving minimal risk may be reviewed and approved by one member of the HSRC and the HSRC Chair who subsequently reports such decisions to the entire HSRC. In the event that these two reviewers disagree on the outcome of the review, the protocol will be submitted to the entire HSRC for review.

Where research involves more than minimal risk, the merit and scholarly standards of the research will be assessed by the HSRC. Normally, an independent, peer review will be the evidence on which the HSRC's assessment of merit and scholarly standards will be based.

Meetings and Attendance:

The HSRC shall meet regularly to discharge their responsibilities.

Record Keeping:

Minute of all HSRC meetings shall be prepared and maintained by the HSRC. The minutes shall clearly document the HSRC's decisions and any dissents, and the reasons for them. In order to assist internal and external audits or research monitoring and to facilitate reconsideration or appeals, the minutes will be accessible to authorized representative of the University of Lethbridge, researchers and funding agencies.

A numbered log will be kept of all human subject research protocols. Protocols approved by expedited review will be minuted as Items for Information. Researchers will be informed by e-mail or memo about the results of their protocol review. An annual report, detailing all protocols reviewed, will be submitted to General Faculties Council.

Decision-making:

The HSRC shall meet face-to-face to review proposed research that is not delegated to expedited review. HSRC review shall be based upon fully detailed research proposals or, where applicable, progress reports. The HSRC shall function impartially, provide a fair hearing to those involved and provide reasoned and appropriately documented opinions and decisions. The HSRC shall accommodate reasonable requests from researchers to participate in discussions about their proposals, but not be present when the HSRC is making its decision. When the HSRC is considering a negative decision, it shall provide the researcher with all the reasons for doing so and give the researcher an opportunity to reply before making a final decision.

The HSRC will normally attempt to make decisions by consensus and will work with the researcher to attempt to resolve any perceived shortcomings in the research protocol. If disagreements persists, majority vote will prevail with the HSRC Chair's vote serving as a tie-breaker. The decision will be recorded properly and the researcher will be given written communication of the HSRC's decision (with reasons for both positive and negative decisions) as soon as possible.

The researcher has the right to request, and the HSRC has an obligation to provide, reconsideration of decision affecting a research project.

Appeals:

In cases when a researcher and the HSRC cannot reach agreement through discussion and reconsideration, review should be permitted by the Human Subject Review Appeal Committee (HSRAC), which is a standing committee of the University of Lethbridge. Membership of the HSRAC follows the same composition, independence, etc. as that of the HSRC. The Vice-President (Academic) will serve on the HSRAC in an ex-officio, non-voting capacity. The HSRAC Chair will be elected by the HSRAC.

A researcher must submit an appeal within 30 days of notification of the HSRC's decision and must provide a basis for which the decision may be appealed. All documentation submitted to the HSRC for review, along with documentation regarding their decision, will be submitted to the HSRAC for their review.

Conflict of Interest:

If the HSRC is reviewing research in which a member of the HSRC has a personal interest in the research under review (e.g., as a researcher or as an entrepreneur), conflict of interest principles require that the member not be present when the HSRC is discussing or making its decision. The HSRC member may disclose and explain the conflict of interest and offer evidence to the HSRC provided the conflict is fully explained to the HSRC, and the proposer of the research has the right to hear the evidence and to offer a rebuttal.

Review Procedures for Ongoing Research:

• Ongoing research shall be subject to continuing ethics review. The rigour of the review should be in accordance with a proportionate approach to ethics assessment.
• As part of each research proposal submitted for HSRC review, the researcher shall propose to the HSRC the continuing review process deemed appropriate for that project. The reporting requirements will be determined at the time of approval.
• Approval will normally be for the life of the project that has been approved. In accordance with the Tri-Council Policy Statement, a succinct annual status report should be submitted and the HSRC should be promptly notified when the research is concluded. In the absence of substantial changes in community standards over the time period involved, approval of ongoing research will be pro forma.

Review of Multi-Centered Research:

 The researcher should provide a list of all the HSRCs who will be reviewing the same research project, in order to coordinate review of multi-centred projects and to facilitate the communication of any concerns. The other HSRCs reviewing the same research project will be sent a copy of our HSRC's decision (and any pertinent comments), and will be asked to send a copy of their decision to our HSRC.

Review of Research in Other Jurisdiction or Countries:

 Research to be performed by the University of Lethbridge researchers outside the jurisdiction or country of the University of Lethbridge shall undergo prospective ethics review both (a) by the University of Lethbridge HSRC; and (b) by the HSRC, 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.

In the case of research involving researchers or subjects associated with the Chinook Health Region and requiring review by the Regional Ethics Committee of the Chinook Health Region, the University of Lethbridge HSRC will do its usual review then, rather than approving or denying the project at that point, it will send its comments along with a representative to the Regional Ethics Committee meeting when it meets on the proposal. At that point the approval/denial/responses to the researcher will be handled by the Regional Ethics Committee, with the awareness of the University of Lethbridge representative. The decision of the Regional Ethics Committee will then be communicated back to the Univeresity of Lethbridge HSRC and, under ordinary circumstances, become the decision of the University of Lethbridge HSRC.

Requirement for Free and Informed Consent:

 Research governed by the Tri-Council Policy Statement (See Article 1.1) may begin only if (1) prospective subjects, or authorized third parties, have been given the opportunity to give free and informed consent about participation, and (2) their free and informed consent has been given and is maintained throughout their participation in the research. Articles 2.1(c), 2.3 and 2.8 of the Tri-Council Policy Statement provide exceptions to Article 2.1(a).

Evidence of free and informed consent by the subject or authorized third party should ordinarily be obtained in writing. Where written consent is culturally unacceptable, or where there are good reasons for not recording consent in writing, the procedures used to seek free and informed consent shall be documented.

The REB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent, provided that the REB finds and documents that:

• The research involves no more than minimal risk to the subjects;
• The waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects;
• The research could not practicably be carried out without the waiver alteration;
• Whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation; and
• The waivered or altered consent does not involve a therapeutic intervention.

In studies including randomization and blinding in clinical trials, neither the research subjects nor those responsible for their care know which treatment the subjects are receiving before the project commences. Such research is not regarded as a waiver or alteration of the requirements for consent if subjects are informed of the probability of being randomly assigned to one arm of the study or another.

Voluntariness:

Free and informed consent must be voluntarily given, without manipulation, undue influence or coercion.

Naturalistic Observation:

HSRC review is normally required for research involving naturalistic observation. However, research involving observation of participants in, for example, political rallies, demonstrations or public meetings should not require HSRC review since it can be expected that the participants are seeking public visibility.

Informing Potential Subjects:

Researchers shall provide, to prospective subjects or authorized third parties, full and frank disclosure of all information relevant to free and informed consent. Throughout the free and informed consent process, the researcher must ensure that prospective subjects are given adequate opportunities to discuss and contemplate their participation. Subject to the exception in Article 2.1(c) of the Tri-Council Policy Statement, at the commencement of the free and informed consent process, researchers or their qualified designated representatives shall provide prospective subjects with the following:

• Information that the individual is being invited to participate in a research project;
• A comprehensible statement of the research purpose, the identity of the researcher, the expected duration and nature of participation, and a description of research procedures;
• A comprehensible description of reasonably foreseeable harms and benefits that may arise from research participation, as well as the likely consequences of non-action, particularly in research related to treatment, or where invasive methodologies are involved, or where there is a potential for physical or psychological harm;
• An assurance that prospective subjects are free not to participate, have the right to withdraw at any time without prejudice to pre-existing entitlements, and will be given continuing and meaningful opportunities for deciding whether or not to continue to participate; and
• The possibility of commercialization of research findings, and the presence of any apparent or actual or potential conflict of interest on the part of researchers, the University of Lethbridge or sponsors.

Competence:

Subject to applicable legal requirements, individuals who are not legally competent shall only be asked to become research subjects when:

• The research question can be addressed using individuals within 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 HSRC 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.

Research in Emergency Health Situations:

 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 HSRC. The HSRC may allow research that involves health emergencies to e 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.

Informed Consent Involving Special Cultural Groups:

Researchers are encouraged to consult the Tri-Council Policy Statement Article 2.1 (b) and Section 6 (Research Involving Aboriginal Peoples) when their research involves special cultural groups (e.g. Aboriginal Peoples, communal groups).

Approved by General Faculties Council - June 7/04

Links:

Application for Ethical Review of Human Subject Research

Human Subject Research Sample Letter of Consent

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)