R1 – Research Involving Human Subjects

Originator: Director, Research & Planning
Approver: President’s Council
Effective: November 16, 2004 (revised September 16, 2008)
Replaces: May 18, 2004

Purpose

This document contains RRC Polytech’s policy and procedures for the review of ethical considerations arising from research involving human subjects.

There is a professional responsibility of researchers to adhere to the ethical norms and codes of conduct appropriate to their respective disciplines. When researchers are engaged in research supported by or conducted at RRC Polytech, the College may, in some circumstances, be liable for research conducted by these researchers. Furthermore, most funding agencies require ethics review of research proposals which involve the use of human subjects. For these reasons, policy and procedures are required to ensure that appropriate safeguards are provided. This policy will enable RRC Polytech to ensure that research conducted on human subjects meets the standards of the major granting agencies and regulatory bodies.

Norms for the ethics of research involving human subjects are developed and refined within an ever-evolving societal context, elements of which include the need for research and the research community, moral imperatives and ethical principles, and the law. All research at RRC Polytech must demonstrate that appropriate methods will be used to protect the rights and interests of the subjects in the conduct of research.

Research involving human subjects is premised on a fundamental commitment to advancing human welfare, knowledge and understanding, and to examining cultural dynamics. Researchers undertake or fund research involving human subjects for many reasons. An ethic of research involving human subjects should address two essential components:

• the selection and achievement of acceptable ends, and
• the acceptable means to those ends.

The first component is directed at defining acceptable ends in terms of the benefits of research for subjects, for associated groups, and for the advancement of knowledge. The second component is directed at ethically appropriate means of conducting research.

RRC Polytech endorses the principles set out in the Tri-Council Policy Statement “Ethical Conduct for Research Involving Humans” and this document describes how RRC Polytech will apply the Tri-Council policy. RRC Polytech uses the Tri-Council Policy Statement (TCPS), as the reference and educational resource in developing and implementing this Policy. These principles and guidelines have been widely adopted by diverse research disciplines. As such, they express common standards, values and aspirations of the research community: respect for human dignity, respect for free and informed consent, respect for vulnerable persons, respect for privacy and confidentiality, respect for justice and inclusiveness, balancing harms and benefits, minimizing harm, and maximizing benefit. Accordingly, this policy is intended to ensure that the highest ethical standards in the conduct of research involving human participants are maintained at RRC Polytech in compliance with the TCPS.

The law affects and regulates the standards and conduct of research involving human subjects in a variety of ways, such as privacy, confidentiality, intellectual property, competence, and in many other areas. Human rights legislation prohibits discrimination on a variety of grounds. In addition, most documents on research ethics prohibit discrimination and recognize equal treatment as fundamental. Research should also respect the spirit of the Canadian Charter of Rights and Freedoms, particularly the sections dealing with life, liberty and the security of the person as well as those involving equality and discrimination.

Definitions

• Research is a systematic investigation to establish facts, principles or generalizable knowledge.
• Human research refers to any project that involves the collection of specimens, data or information from persons, through intervention or otherwise. Included are procedures that have a low degree of invasiveness (e.g. surveys, interviews, naturalistic observations, exercise or psychometric testing, examination of patient records), as well as more invasive procedures (e.g. blood sampling, administration of a substance).
• A subject in human research is a person, who by virtue of his/her involvement in a data-gathering situation or activity, is a source of primary data or information.
• A research ethics protocol is a document submitted by the applicant for consideration by the REB. This document contains a detailed description of the rationale/purpose of the study, procedures to be followed in soliciting participants for the research, obtaining their informed consent when possible, collecting their information or data, protecting their privacy or anonymity, and providing feedback regarding the study at its conclusion.
• Minimal risk means that the risks of harm anticipated in the proposed research are not greater or more likely, considering probability and magnitude, than those ordinarily encountered in life, including those encountered during the performance of routine physical or psychological examinations or tests.

Policy

All research projects involving human subjects undertaken by members of or conducted at RRC Polytech – including all faculty, staff and students, including students carrying out research as part of class assignments – shall fall within the jurisdiction of a committee called the RRC Polytech Research Ethics Review Board (REB), irrespective of the source of financial support (if any) and irrespective of the location of the project, in the latter case, so long as the investigator represents the work as RRC Polytech research. Projects conducted by researchers from outside the RRC Polytech community who access College resources (either equipment or personnel), will also fall within the jurisdiction of the RRC Polytech REB.

The RRC Polytech REB shall apply the principles set out in the TCPS “Ethical Conduct for Research Involving Humans” according to the procedures described in this RRC Polytech document. These procedures may be varied to accommodate future approved amendments to the Tri-Council Policy.

1. Requirement for Ethics Review

Except as provided for in policy section 2, all research projects involving human subjects conducted at, or under the auspices of, Red River College Polytechnic require prior ethics review and approval by the Research Ethics Board (REB). This requirement of prior ethics review and approval applies to:

1.1.

All research involving human subjects conducted by the College’s academic staff, administrative and support staff, or students, persons with adjunct appointments, visiting instructors, visiting professional associates, and research associates.

1.2.

All research carried out on College premises or using College facilities, equipment or human, financial or material resources;

1.3.

Research conducted elsewhere under the auspices of the College;

1.4.

The research activities of formally affiliated organizations as a condition of affiliation; and

1.5.

The research activities of organizations or individuals whether formally affiliated or not, while on College premises or using College facilities, equipment or resources, including off-campus sites. When research takes place in a foreign country, the researcher must also assure that his/her procedures meet all legal requirements of that country, as well as the requirements of this policy.

1.6.

All types of research conducted with human subjects. Specifically, prior ethics review and approval is required when research data are derived from, but not exclusively restricted to:

• Information collected through intervention or interaction with a living individual(s);
• Identifiable private information about individuals;
• Information collected through naturalistic observation of humans, except as stipulated below in item 2.3.
• Human organs, remains, tissues and body fluids, cadavers, embryos or fetuses; and/or
• Written or recorded information derived from individually identifiable human subjects.

1.7.

In addition, ethics review is required for the following categories of research that may be overlooked or raise questions about the necessity for such a review:

• Pilot studies and feasibility studies, even those involving only one human subject, require the same scrutiny as full-scale research projects involving many subjects.
• Projects that involve the secondary use of data on human subjects gathered in earlier projects.
• Research conducted by administrative and academic units that involves the collection of survey replies or the use of records as correlates of survey replies from human subjects, e.g. students, staff and/or faculty members.
• Research projects in which the researcher is a consultant unless the researcher has a strict consulting relationship in which all of the following are true: (a) the researcher is hired on his or her own time; (b) the researcher holds no rights in the work; and (c) neither the researcher nor the College retains any data. If any one of these three criteria is not met, prior ethics review and approval is required.
• All independent student research projects conducted in partial fulfillment of certificate/diploma/degree requirements. Research projects conducted as part of formal course requirements may, in certain instances require REB review and approval. It is incumbent on the instructor to check the applicability of this requirement with the REB Chair.

2. Research Excluded; i.e., Not Subject to REB Review

Prior ethics review and approval from an REB will not normally be required for:

2.1.

A limited type of research most often found within the humanities, fine arts, and in some historical research which involves: (a) a public database where aggregated data that cannot be associated with any individual are obtained; and/or (b) information already in the public domain (e.g. autobiographies, biographies or public archives). Nevertheless, it is the responsibility of the researcher to ascertain that any information used from these sources is presented in an accurate fashion.

2.2.

Archival analysis of records by College departments normally engaged in the collection, maintenance, and analysis of such records. Nevertheless, it is incumbent on such units to ensure that the anonymity of individuals and confidentiality of their records are maintained.

2.3.

Naturalistic observation of participants in, for example, political rallies, demonstrations or public meetings where it can be expected that participants are seeking public visibility.

2.4.

Class research projects which involve human subjects and which are conducted by students on other members of the class as exercises to learn how to conduct research.

2.5.

Evaluations of courses or training programs that are designed to provide feedback.

2.6.

Preliminary, informal interviews or casual conversations that are carried out to help clarify the design of a research project.

• Information gathering procedures in support of the general administration of the College¹, where the primary purpose(s) are: To diagnose problems, identify appropriate solutions, provide advice for operation management, or assess performance.
• To collect data primarily designed to affect the operations of the College through affirming satisfaction with the status quo or leading to quality improvements.

2.7.

Information gathering procedures to collect institutional level data for administrative purposes.

2.8.

Research undertaken as a teaching exercise and entailing minimal risk shall be reviewed by school or department level committee on behalf of the REB as per section 8.6 of this policy.

3. Uncertainty About the Need for REB Review

For research/scholarly work where the researcher is uncertain whether REB review is required, it is the responsibility of the researcher to obtain the written opinion of the Chair of the REB as to whether the research should be subjected to prior ethics review and approval.

4. Academic Freedom

All REBs and all persons involved in the ethics review process shall act in such a manner as to ensure that there is no infringement of the academic freedom of researchers.

5. Compliance

The College requires all faculty members, staff and students, as well as external researchers conducting research at the College to adhere to this policy and the procedures that are derived from it. The College considers the improper treatment of human subjects in research to be a serious offence, subject to severe penalties, including but not limited to the withdrawal of privileges to conduct research involving human subjects or disciplinary action.

6. Responsibilities of Researchers

Whenever research involving human subjects is to be performed under the auspices of Red River College Polytechnic or by any College researcher, the researcher is responsible for meeting the following requirements:

6.1.

Ensuring that the research being conducted is scientifically valid and/or appropriate in a scholarly sense, and that the benefits to knowledge that will result from the research warrant the investment of time, effort and risks to be incurred by the number of human subjects for which the research is planned. Scientifically invalid research or research that is more intrusive or requires more subjects to experience the research procedures than those warranted by the research design is unethical. The researcher shall carefully monitor and assure the validity of the research submitted to the REB.

6.2.

Reading and becoming thoroughly familiar with applicable ethical guidelines.

6.3.

Determining if their proposed research requires ethics review. If there is any uncertainty about whether the research requires ethics review and approval, the researcher shall consult the Chair of the REB for advice and decision.

6.4.

Notifying the REB of the proposed research by submitting a completed Human Subject Research Ethics Protocol accompanied by any supplementary materials necessary for full ethics review, and providing any additional information requested by the REB in a timely fashion.

6.5.

Not involving human subjects in the proposed research until the REB has informed him/her of approval in writing for the use of human subjects in the research.

6.6.

Abiding by all decisions of the REB, including following all modifications required for REB approval and not undertaking the research if it has not been approved.

6.7.

Obtaining free and informed consent from all subjects as outlined in section 7 of this policy.

6.8.

Maintaining the confidentiality of data obtained from subjects in the manner required by the REB and relevant organizations.

6.9.

Promptly reporting to the Chair of the REB any injuries to human subjects, any unanticipated problems which involve risks or unusual costs to the subjects, or other adverse events resulting from the research. Initial reports may be verbal; subsequent reports shall be in the manner required by the REB.

6.10.

Promptly reporting to the Chair of the REB any proposed changes in the research which would result in a significantly different involvement of human subjects and obtaining the approval of the REB prior to the changes being made, except where necessary to eliminate apparent and immediate hazards to subjects.

6.11.

Promptly reporting to the Chair of the REB any proposed involvement of human subjects in research which previously had no plans, or only indefinite plans, for subject involvement and obtaining the approval of the REB prior to the involvement of any subjects.

6.12.

Promptly reporting to the Chair of the REB any serious or continuing non-compliance with the requirements of this policy or of the procedures stipulated by an REB by any individual associated with the research.

7. Free and Informed Consent of Subjects

7.1.

The researcher is responsible for obtaining free and informed consent from all prospective subjects, or authorized third parties, prior to commencing research activities. Free and informed consent must be maintained throughout participation in the research. Free and informed consent must be given voluntarily, without manipulation, undue influence or coercion.

7.2.

Evidence of free and informed consent in the form of a signed document by the subject or authorized third party should be obtained in writing and stored in a secure repository.

7.3.

The REB may approve a consent procedure that differs from that outlined in 7.1 and 7.2 if the REB finds that:

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

7.4

Participants in naturalistic observation studies normally do not give informed consent because they are unaware they are being observed. The REB can approve such projects as long as the research records protect the identities of the subjects, as well as their dignity. If the research environment is staged, however, special care must be taken to ensure the privacy, well being, safety, and dignity of the subjects

7.5

Researchers shall provide prospective subjects or authorized third parties with:

• Information that the individual is being invited to participate in a research project;
• A statement of the research purpose, identity of the researcher, the expected duration and nature of participation and a description of the research procedures;
• A description of the reasonably foreseeable harms and benefits that may arise from research participation, as well as the likely consequences of non-action, particularly in research related treatment;
• An assurance that prospective subjects are free not to participate and have the right to withdraw at any time without prejudice to pre-existing entitlements; and
• The possibility of commercialization of the research findings, and the presence of any apparent or actual or potential conflict of interest on the part of researchers, their institutions or sponsors.

7.6 Research Subjects Who are Not Legally Competent

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

• The research question can only be addressed using individuals within the identified group(s);
• 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.

7.6.2 For research involving legally 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.

7.6.3 When 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.

7.7 Research in Emergency Health Situations

7.7.1 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 the 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 not 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.

7.7.2 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.

8. RRC Polytech Research Ethics Board Terms of Reference

8.1 Responsibilities

The RRC Polytech Research Ethics Review Board is responsible to the President of RRC Polytech for:

8.1.1 Developing policies regarding ethical issues relating to the use of human participants in research and experimental teaching protocols;

8.1.2 Reviewing all protocols requiring the participation of human participants for ethical approval;

8.1.3 Reviewing annually all policies regarding ethical issues relating to the use of human participants in research projects to ensure that policies remain current;

8.1.4 Dealing with matters concerned with human-based research referred to the Board by the President of RRC Polytech;

8.1.5 Preparing an annual report for submission to the RRC Polytech President, as outlined in section 12 of this policy;

8.1.6 Participating in continuing education organized by RRC Polytech research administrators for the College community in matters relating to ethics and the use of human participants.

The policies and practices adopted by the REB will be consistent with the current approved Tri-Council Policy Statement, “Ethical Conduct for Research Involving Humans.”

8.2 Composition of the Board

Standing Membership – Five (5) members: The normal term of office for REB members is three years, with no more than one-third being replaced each year; shorter or longer terms may be necessary from time to time. Members may not serve more than six consecutive years, but are eligible for re-appointment after an interval of one year. These members, including the Chair, shall be appointed by the President accordance with the Tri- Council Policy Statement on Ethical Conduct for Research Involving Humans. The Board shall consist of both men and women, of whom:

• at least two members have expertise in the areas of research covered by the board;
• at least one member is knowledgeable in the area of ethics;
• in the case of biomedical research at least one member must be knowledgeable in the area of biomedical research law;
• at least one community member with no affiliation to the institution;
• at least one member whose primary area of interest is in a nonscientific area.

Substitute membership: As needed, substitute members may be appointed by the President in consultation with the Chair to serve as replacements for standing members when they are unable to attend. Such substitute members must not alter the membership structure and in all cases REB members must be competent to judge the acceptability of proposals and shall be knowledgeable of TCPS.

8.3 Quorum

The quorum shall consist of 50% of duly appointed members of the REB, but decisions are only adopted if the attending members possess the range of background and expertise stipulated in 8.2, above, and Article 1.3 of TCPS. Normally consensus will be sought; when required, decision will be by majority vote of the appointed members.

8.4 Ad Hoc Members

The REB may find it desirable, on occasion, to call on specialists to provide expert advice. In each case, the responsibility for appointing these ad hoc members will rest with the Chair. Such ad hoc members will not be voting members of the REB but may participate in the REB’s deliberations.

8.5 Meetings

The REB members shall meet regularly at dates and times that are publicly announced in advance (preferably for the entire academic year) to discharge their responsibilities. Normally, the REB meets monthly, however this may not be required at certain times of year (July and August). Regularly scheduled REB meetings may be canceled if no protocols have been received by the submission deadlines.

9. Procedural Guidelines for the Review of a Research Proposal

9.1 Submission

While it is not necessary for the REB to review a research proposal before it is submitted to a funding agency, REB approval must be obtained before the work begins. Visiting researchers should contact the chair of the RRC Polytech Research Ethics Board well in advance of the anticipated start date of research. Submissions for review should be submitted to the REB using the appropriate forms and by following the instructions on that form. Prospective applicants may approach the REB chair or any REB member for assistance in selecting the appropriate forms for submission.

9.2 Scholarly Review

9.2.1 In case of research proposals that present more than minimal risk, the design of the project must be peer reviewed to assure that it is capable of addressing the question(s) being asked in the research. Sufficient peer review may be considered to be any one of the following:

• Successful approval by the REB (if research is in the REB’s field of expertise).
• Successful funding of grant proposal by a funding agency.
• Ad hoc independent external review reporting directly to the REB.

9.2.2 The extent of the review required for biomedical research that does not involve more than minimal risk will vary according to the research being carried out.

9.2.3 Research in the humanities and the social sciences, which poses, at most, minimal risk shall not normally be required by the REB to be peer reviewed.

9.2.4 Certain types of research, particularly in the social sciences and the humanities, may legitimately have a negative effect on public figures in politics, business, labour, the arts or other walks of life, or on organizations. Such research should not be blocked through the use of harms/benefits analysis or because of the potentially negative nature of the findings. The safeguard for those in the public arena is through public debate and discourse and, in extremis, through action in the courts for libel.

9.3 Principle of Proportionate

Review The REB will use a proportionate approach based on the general principle that the more invasive the procedures involved in the research, the more diligent the assessment of the perceived risks inherent in the study procedures must be.

9.4 Normal Review Process

9.4.1 The REB shall normally meet face to face in order to review submitted research proposals. In case of controversial research proposals, the REB may meet face to face with researchers in order to consider the ethical solutions proposed by researchers for problems arising in their studies.

9.4.2 The REB shall accommodate reasonable requests from researchers to participate in discussions about their proposals, but not be present when the REB is making its decision.

9.4.3 Minutes will be kept for these meetings and inserted into the appropriate case files. Meeting minutes will document the decisions and dissents of the REB and the reasons for them.

9.4.4 The REB shall keep an “open file” in a secure location determined by the Chair of the REB, for researchers applying for ethical approval. The file shall be opened by the Chair when sufficient information has been submitted by the researcher to start the review process. The original application, descriptions of research and methodology, correspondence, relevant documents, ethical certificates, revised materials, and any comments from the public or other information relevant to the research project shall be kept in the file.

9.4.5 It is the responsibility of the researcher to address all the recommendations made by the REB and keep the file complete and up-to-date at all times. When the research project is finished, and the researcher(s) notifies the REB, these files shall be “closed” and kept for a period of at least five years by the REB as records demonstrating compliance with the TCPS. The files remain the property of RRC Polytech and cannot be removed from their secure location by the researchers. These files shall be subject to audit by authorized representatives of RRC Polytech (research administrators), members of Appeal Boards, and funding agencies. The REB file on applications for ethical review should contain the following documents:

• Application form
• Trial protocol and amendments
• Written informed consent forms and any updates
• Subject recruitment procedures (e.g. advertisements)
• Investigator’s brochure (if one exists)
• Available safety information
• Information about payments and compensation available to subjects
• Investigator’s current curriculum vitae and/or other document on qualifications
• Any other documents that the REB may need to fulfill its responsibilities

All research receiving ethical approval, whether through the normal or expedited process, as well as that receiving departmental level review shall require a proper file showing compliance with the TCPS. Insufficient information in the file is grounds for refusing or delaying ethical approval.

9.5 Expedited Review

Expedited review does not require face-to-face meetings of the REB members. The researcher must choose to apply for expedited or full review and the REB Chair may reject any application for expedited review and refer it to the REB for full review. The Chair must report requests for expedited review and results of such reviews to other members of the REB at an appropriate time. Expedited review is review by two members the Chair may be one of these) rather than the full REB. It is available only in cases, which fulfill one of the following criteria:

9.5.1 Research which obviously involves no more than minimal risk (as defined in the TCPS: “if potential subjects 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 subject in those aspects of his or her everyday life that relate to the research, then the research can be regarded as within the range of minimal risk”). Given the heterogeneous nature of subjects, a “reasonable person’s” definition of “minimal risk” as is often employed in the courts concerning subjective harms will also be acceptable to the REB. The researcher is responsible for an acknowledgement of minimal risk to the REB.

9.5.2 Research projects which have already received approval by the RRC Polytech REB, have complied fully with any requirements, have an up to date file, and the applicant is simply renewing the ethical approval without significant changes to the ongoing research process.

9.6 Division/Departmental Level Review

This policy requires that all research involving human subjects must be submitted to the REB. If however a study is a teaching exercise (i.e., part of a diploma or undergraduate degree level course), and entailing no more than minimal risk, it must be reviewed by a divisional/departmental level committee on behalf of the REB and in compliance with the TCPS. The Departmental ethics committee must report results of such reviews to the REB at the end of the academic year.

Student research deemed to be beyond minimal risk must be reviewed by the REB.

Department level review should not be used to review research undertaken by a student as part of a Faculty member’s research program.

9.7 Review of Multi-Centered Research

It is the responsibility of the researcher to ensure that Multi-Centered research is reviewed by all institutions where the research is undertaken. To facilitate the review of multi-centered research protocols, the REB may share documents and findings with REBs at other institutions. The REB may also review the documents and findings of REBs of other institutions as part of its ethics review process.

The RRC Polytech REB Chair may approve a submission where 1) the research proposal has already received approval from another university or college working under the Tri-Council Policy Statement, 2) the application form from the other institution is substantially similar to RRC Polytech’s application, and 3) the submission is viewed as a minimal risk research proposal.

For multi-centered research involving an institution working under the Tri-Council Policy Statement, the researcher may submit two copies of the complete protocol with cover letter and application, proposal, research measures, and REB approval from the other institution.

In the case where an application does not meet these requirements, the applicant will be invited to submit a RRC Polytech REB application, which would then be reviewed by the Board in the usual manner.

9.8 Review of Research in Other Jurisdictions or Countries

Research performed in another jurisdiction or country shall undergo ethics review by the REB and, where such exists, the equivalent REB in the country or jurisdiction where the research is to be conducted.

9.9 Continuing Ethics Review

The REB’S approval of a research project covers only the procedures outlined by the applicant in his/her original application. Any changes in the procedures affecting interaction with human subjects should be reported to the REB. Significant changes will require the submission of a revised application for Ethics approval.

9.9.1 Ongoing research shall be subject to continuing ethics review. The Chair of the REB must be promptly notified of any substantial change to the research plan or research protocol. Researchers will be asked to include monitoring mechanisms by which the public participating in the research may contact the Chair of the REB. Problems or complaints will be taken seriously by the REB and researchers may be asked to modify their studies in view of such complaints.

9.9.2 All protocol approvals are for a maximum of one year, and may be renewed by submission of an annual report prior to the anniversary date of the original protocol approval. Such reports should clearly indicate the status of data collection and, if there will be changes to the protocol that was approved, specify in detail the nature of any changes that are required. If no substantial change has been made to the research plan or research protocol, the Chair of the REB may issue a one-year extension. If in the opinion of the REB Chair, the research plan or research protocol has been substantially changed, re-submission and review by the REB is required. Protocol submissions for data collection for a period less than one year lapse at the end of the time specified.

9.9.3 The researcher shall promptly notify the REB when the project concludes.

9.19 Conflict of Interest

If the REB is reviewing research in which a member of the REB 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 declare their interest and remain neutral or not be present while the REB is discussing or making its decision. In cases of disagreement over conflicts of interest, both the REB member in potential 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 the conflict and how to proceed.

10. Decisions of the REB

After review by a REB, the protocol submission may be:

• approved as submitted;
• approved with suggestions for minor changes;
• approved with conditions (that must be met before final approval is granted);
• deferred, pending receipt of additional information or major revisions;
• not approved.

10.1

The REB shall notify each researcher in writing of its decision regarding his/her proposed research activity. Normally the researcher will accept the proposed modification or offer a counter-proposal to the Chair of the REB. This exchange is concluded normally when an ethically acceptable form for the research is agreed upon. To facilitate the continuing processing of such research ethics protocols between meetings, the REB should specify conditions that should be met to enable the Chair to review and grant approval on behalf of the REB.

10.2

Researchers have the right to request, and REBs have an obligation to provide, reconsideration of decisions affecting a research project.

10.3

If the REB does not approve a research activity for ethical reasons, the notification shall include a statement of the reasons for its decision and the researcher shall be given an opportunity to respond in writing or in person. The Chair will make himself or herself available to the applicant on a reasonable basis to endeavor to develop a proposal that will meet the ethical standards required by the REB. The REB may, at its discretion, review and reconsider its decision to not approve the research activity.

10.4

In the case of ongoing research, the REB has the authority to terminate research that deviates from an approved research protocol and as a result no longer complies with the criteria set forth in these policies or the TCPS.

11. Appeal

Researchers must apply in writing to the President to appeal a negative REB decision. Appeals must be in writing and a copy of the appeal letter should also be sent to the REB Chair. RRC Polytech shall use a duly constituted Appeal Committee to review decisions of the REB. The appeal committee will be appointed by the President and consist of at least five members, none of whom is a member of the REB. Appeal committees shall have the same constitution as the REB. The appeal committee shall consist of both men and women, of whom:

• at least two members have expertise in the area of research covered by the appeal committee;
• at least one member is knowledgeable in the area of ethics;
• in the case of biomedical research at least one member must be knowledgeable in the area of biomedical research law;
• at least one community member with no affiliation to the institution;
• at least one member whose primary area of interest is in a nonscientific area.

Non-compliance with the substance of the TCPS is a reason for refusing to grant an appeal. Appeals may be granted only on procedural grounds or when there is a significant disagreement over an interpretation of the TCPS. The decision of the Appeal Committee shall be binding.

12. Reports of REB Committee Decisions

An annual activity report from the REB will be submitted to the President of RRC Polytech, President’s Council and the Senior Academic Committee.

13. Adverse Events Reports

Normally it is anticipated that research will proceed with little or no special costs or harm to subjects, beyond those noted in the protocol. However, unanticipated negative reactions by subjects or other unexpected events may occur. Researchers are obliged to immediately report, in writing, any known serious adverse event to the REB.

14. Administration

14.1 Administrative Support

The work involved in the ethical review process should be distributed appropriately among faculty members, staff, researchers, and administrators. RRC Polytech will provide administrative support to the REB including:

• Distribution of forms and materials necessary for submission of research proposals to the REB
• Collection of submissions and distribution of submissions to REB members
• Keeping minutes of REB meetings
• Storing submissions and related materials in a secure location
• Supporting the REB in its educational activities
• Acting as the point of contact for the Tri-Council Advisory Group
• Other duties related to the support of the REB in carrying out its mandate.

Deans will provide significant support to the REB, with respect to:

• educational activities
• management of the system for reporting research
• ensuring that research projects requiring ethical review are submitted to the REB.
• advising their faculty members about the need to comply with the TCPS.

Individual departments are expected to support and train students so that their research projects are ethical and those that exceed minimal risk may be efficiently reviewed by the REB. Departments should screen student applications for ethical review prior to submission to the REB where such review is required. The REB may return applications to the department if they do not conform to the requirements of the TCPS.

14.2 College Support

RRC Polytech supports the administrative processes and educational activities required by the REB so that the College as a whole remains in compliance with TCPS.

14.3 Reporting of Non-Compliance

The REB role is limited to reporting cases of failure to comply with the provisions of the TCPS and RRC Polytech research policies to the President.

14.4 Interpretation

Questions of interpretation or application of this policy or its procedures shall be referred to the President, or designate, whose decision shall be final.

15. Forms

Ethical Guidelines and the required forms for submission to the REB will be made available from the secretary to the REB.

Related Policies

A9 – Intellectual Property and Copyright
F9 – Conflict of Interest
H2 – Integrity in Research and Scholarship

Under Development:

Student Rights in the Conduct of Research
Animal Care and Research
Conflict of Commitment
Conflict of Interest in Research

Appendix A

Research Ethics Board Application Procedure

Purpose

This document outlines the review process for research requests to use Red River College Polytechnic staff, students and/or facilities for study and research purposes.

All such projects must follow ethical guidelines governing research involving human subjects as articulated in the Tri- Council Policy Statement: Ethical Conduct for Research Involving Humans² as well as RRC Polytech policy.

The College endorses the ethical principles set out in the Tri-Council Policy Statement. These ethical principles include:

• respect for human dignity
• respect for free and informed consent
• respect for vulnerable persons
• respect for privacy and confidentiality
• respect for justice and inclusiveness
• achievement of an appropriate balance between potential harms and benefits, and
• minimization of harm and maximization of benefit.

To facilitate the review process, applicants are advised to include all requested information in their applications. The Board may request additional information. If all information is provided, the Board should be able to make a decision promptly.

Application Guidelines

1. The Research Protocol Submission Form is to be competed in detail, attaching additional pages as required, by all applicants
2. All applications are to include six (6) copies of all materials.
3. It is the applicant’s responsibility to ensure that all application materials are complete in order to facilitate the review of a submission. In no circumstance will an application be reviewed if the file is incomplete or not in the required format.
4. Prior to submitting an application, the researcher should complete the checklist at the end of the Protocol Submission Form.
5. All submissions should be submitted at least five (5) working days prior to a scheduled meeting of the Research Ethics Board (REB). The Board in September of each academic year prepares and distributes an annual meeting schedule.

Review Process

1. The Research Ethics Board will review all applications in accordance with ethical guidelines governing research involving human subjects as articulated in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans as well as RRC Polytech policy. Reviews will be prompt and are intended to facilitate the conduct of research.
2. After review by the REB, the application may be:
   • Approved as submitted
   • Approved with suggestions for minor changes
   • Approved with conditions for changes
   • Deferred, pending receipt of additional information or major revisions
   • Not approved.
3. The REB shall notify each applicant in writing of its decision.
4. Negotiated revisions: Where the ethics review process requires changes, these will be negotiated by the researcher(s) and the Chair of the REB. Once agreement has been reached, the Chair shall issue a letter indicating ethics approval for the research.
5. Reconsideration: If there is no agreement between the REB and researcher on the changes recommended by the REB, a study does not pass ethics review. The researcher may request reconsideration by the REB of this decision. This request should be accompanied by a detailed explanation of the reasons why the suggested procedure is unacceptable, and preferably a suggestion of an alternative procedure. If requested, the REB will allow the researcher to make his/her case before the REB; however after presenting the case the researcher must leave to allow the REB to deliberate its decision in camera. The REB decision following reconsideration is final.
6. Appeals: Appeals may be made on procedural or substantive grounds. The researcher(s) may appeal a decision by submitting their appeal in writing to the President.

Application Procedure

The completed application should be submitted to:

Research Ethics Board
Research and Planning Department
C509-2055 Notre Dame Ave.
Winnipeg, MB R3H 0J9
(Fax) 204.633.7470

Protocol # ____________
(Assigned by REB Admin.)

Appendix B

Research Protocol Submission Form

Footnotes

¹ Most administrative information gathering procedures and practices are not conducted in the context of research or embedded in a research framework. Rather they are conducted for purpose of assessing choices, ascertaining satisfaction of clients, identifying service enhancements or for similar quality objectives. All such projects must also be done in accordance with the highest research ethical practices. However, in those cases where information gathering through such vehicles as surveys or interviews conducted by administration have a clear research direction, are on sensitive topics, are collected from vulnerable populations or where there may be an issue with the confidentiality of individual responses, REB review would be required.

² This document was produced and is maintained and updated by NSERC, CIHR and SSHRC, the three major research granting agencies in Canada.