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Athabasca University


Ethical Conduct for Research Involving Humans Procedures


Policy Sponsor:

Office of the Vice President, Academic

Name of Parent Policy:

Ethical Conduct for Research Involving Humans Policy

Policy Contact:

Research Ethics Administrator, Office of Research Services

Procedure Contact:

Research Ethics Administrator, Office of Research Services

Effective Date of Procedures:

June 30, 2009

Review Date:

Annually


Purpose

To outline the procedures for obtaining informed consent from prospective research participants and for conducting Research Ethics Board reviews.

Definitions

Research

An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation. 

Research participant

Those living individuals whose data or responses to questions, stimuli or interventions by the researcher are material to the research question. They are unique among the many parties involved in research, because they bear the primary risks of the research.

AU Research  

The following three categories:

  • research conducted by members of the AU research community
  • research conducted by external researchers in formal collaboration with AU-affiliated researchers;
  • research conducted at or under the auspices of AU by external researchers.

AU Community

All AU faculty, emeritus faculty, visiting or adjunct scholars, staff, research assistants, administrators, paid or unpaid associates, undergraduate and graduate students, postdoctoral fellows, and any other person associated with research at AU.

Minimal Risk Research

If potential research participants can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the research participant 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. (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans)

Competence

The ability of prospective research participants to give informed consent in accord with their own fundamental values. It involves the ability to understand information presented, to appreciate the potential consequences of a decision and to provide free and informed consent. This ability may vary according to the decision being made, the circumstances surrounding the decision or the time in question. Competence to give consent does not require prospective research participants to have the capacity to make every kind of decision. It does require that they be competent to make an informed decision about participation in particular research. Competence is neither a global condition nor a static one; it may be temporary or permanent.

Procedure:

1.0  Obtaining Informed Consent

a)

Throughout the free and informed consent process Researchers or their qualified designated representatives will provide prospective research participants, as a minimum, with the following:

  • information that the individual is being invited to participate in a research project;
  • 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 no action being taken, 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 research participants are free not to participate, have the right to withdraw at any time without prejudice to pre-existing entitlements, and shall be given continuing and meaningful opportunities for deciding whether or not to continue to participate;
  • information on 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, their institutions or sponsors; and
  • the name and contact information for a person not on the research team who may be contacted in the case of concerns, complaints, or consequences.  This will be the AU Research Ethics Officer, or other REB-designated individual within the AU REB office.

2.0   REB Review

a)

The REB shall conduct their review in accordance with the principles established by the TCPS, the AU Ethical Conduct for Research Involving Humans Policy, and the REB Terms of Reference and Responsibilities (see Appendix A). 

b)

While it is not necessary for the REB to review a proposal before it is submitted to a funding agency, REB approval must be obtained before the research begins. Researchers should contact the AU REB Office well in advance of the anticipated research start date for information on procedures and deadlines for submission.

2.1 Conflict of Interest

a)

Upon disclosure of conflicts of interest arising from research, the REB will consider requests from researchers to participate in discussions about their proposals, but researchers will not be present when the REB is making its final decision.

b)

REB members determined to be in conflict may be invited to remain for discussion of the proposal for the purpose of obtaining clarification, but will not be present when the REB is making its final decision.

2.2 Scholarly Review

a)

When conducting the scholarly review as part of the REB review process, normally, any one of the following will be considered a sufficient demonstration of the scholarly merit of a proposal:

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

b)

When evaluating the merit and the scholarly standards of a research proposal, the REB should focus on a global assessment of the degree to which the research might further the understanding of a phenomenon, and will not be driven by factors such as personal biases or preferences. The REB should not reject research proposals because they are controversial, challenge mainstream thought, or offend powerful or vocal interest groups. The primary tests to be used by the REB should be ethical probity and high scientific and scholarly standards.

2.3 Departures from Approved Research

a)

Upon receipt of notification of any adverse events affecting human participants or changes to previously approved research, the REB will respond as quickly as possible to provide review of such events and changes that is proportionate to the risks involved.

b)

Researchers should report to the REB in a timely manner updates for file purpose only on minor procedural changes or minor wording revisions to participant recruitment or informed consent documents.

2.4 Record Keeping

a)

The minutes of all REB meetings, as prepared and maintained by the REB, will be accessible to researchers and authorized AU and funding agency representatives, for the purposes of any internal or external audits, research monitoring, and facilitation of appeals, with due regard to the Alberta Freedom of Information and Protection of Privacy Act and any other relevant privacy legislation.

b)

All REB documentation, including minutes of meetings, submissions, correspondence with researchers, revisions to submissions and board decisions, will be kept on file in a secure manner to maintain confidentiality within the REB Office.

2.5 Decisions of the REB

a)

Research projects may begin immediately upon receipt of approval from the REB. Research projects which receive conditional approval may begin once all the conditions set by the REB have been met to its satisfaction. In the case of proposals conditionally approved by the REB, the Chair of the REB may issue full approval to revised proposals or refer revised proposals back to the REB for further review. When the REB is considering conditional approval or a negative decision, it will provide the researcher with all the reasons for doing so and give the researcher an opportunity to reply before making a final decision. All decisions of the REB will be conveyed to researchers in writing in a timely manner.

2.6 Appeals and Reconsideration

a)

The researcher will send a copy of the appeal letter to the REB Chair. The REAB will meet within one month of receipt of the appeal, and the results of the appeal will be sent to the appellant within seven working days. The responsibilities and composition of the REAB are identified in their Terms of Reference (TOR), see Appendix B.

Applicable Legislation and Regulations

Alberta Freedom of Information and Protection of Privacy Act, R.S.A. 2000, c. F-25

Related References, Policies, Procedures and Forms

Canadian Tri Council Policy Statement: Ethical Conduct for Research Involving Humans

http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

Memorandum of Understanding between AU and the federal funders:
http://www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp

Athabasca University Ethical Conduct for Research Involving Humans Policy

AU REB Research Ethics Application Forms:

 

a)

AU REB Guideline to Research Ethics Application

b)

AU REB Ethical Review Guidelines for Research Involving Students or Other Individuals Related to the Researcher as Research Participants

c)

AU REB Application for Blanket Ethical Approval

c)

AU REB Research Ethics Interim and Final Report Forms

All items listed are available at http://www.athabascau.ca/research/ethics/forms.php

History

 

APPENDIX A

Research Ethics Board (REB) Terms of Reference and Responsibilities

8.0

a)

As an independent decision making board, established by and reporting directly to the highest body within AU, the REB will be responsible for:

  • reviewing approving, rejecting, proposing modifications to, or terminating any proposed or ongoing AU-affiliated research involving human research participants that does not comply with AU ethics policies, the TCPS guidelines, and the  FOIP Act and the FOIP Regulation and other relevant Canadian and international policies, guidelines and regulations;
  • advising on, and, if appropriate, making recommendations on university policies relating to research using human participants;
  • assessing critical skills and ensuring ongoing opportunities for the engagement of REB members, delegated reviewers, and Research Ethics Office staff in individual and group-based educational activities;
  • promoting continuing education for the university community in matters relating to ethics and the use of human participants in research; and
  • preparing an annual report for submission to the highest authorities of the university.

b)

REB members will be expected to attend all meetings and to ensure their adequate preparation for each meeting.

c)

REB members will be expected to review and evaluate proposals within the guidelines of the TCPS and other relevant guidelines, policies and regulations. Each member will determine whether, in his or her judgment, a proposed research study is ethically acceptable. They are also required to maintain a strict level of confidentiality regarding proposal information, reviews and decisions.

d)

REB members will be expected to stay current in their knowledge of ethical guidelines, policies and best practices. It is the responsibility of members to engage in ongoing group-based and self-directed learning to enhance their ability to discharge their responsibilities in ethics review.

e)

Individual researchers will be responsible for informing themselves of and complying with the requirements for the ethical conduct of research as detailed in this Policy, the TCPS, and other policies relevant to their discipline and the countries in which their research is being conducted.

f)

Instructors/advisors/ supervisors of graduate students will be  responsible for ensuring that their students who conduct research involving humans are familiar with and comply with this Policy and other ethical guidelines relevant to their disciplines. Instructors/advisors/supervisors are required to preview and provide their explicit support for student submissions to the REB.

8.1

Composition Requirements of the REB

a)

All REB members will be Canadian citizens or permanent residents under Canadian immigration law.

b)

The REB will ensure balanced gender representation where possible and will strive for a diverse membership, including individuals from various ethnic, cultural, socio-demographic groups, and individuals with disabilities.

c)

The REB will consist of a minimum of six voting members.

  • at least five selected from academic and professional staff
  • at least two have broad experience in the methods and research areas usually reviewed by the REB. Further to this, as a minimum, institutional membership will consist of

    • a member from each academic centre having active graduate programs, and
    • at least one representative from undergraduate programs that regularly offer human research projects in course requirements; and
    • at least one representative experienced in Aboriginal research and/or community participatory research;

  • at least one has broad knowledge in ethics or experience in the evaluation of ethical implications of research involving humans
  • at least one is knowledgeable in the law (but that member should not be the University’s legal counsel or risk manager)
  • at least one has no affiliation with AU, but is recruited from the community served by AU and has relevant experience or training, and
  • at least one, if available, is from local, rural or urban Aboriginal communities (First Nations, Inuit and Metis).

d)

Community representation should be proportionate to the size of the REB; for every five institutional REB members there will be at least one member from the community. (This will be interpreted to mean that if there are more than 5 institutional members, there will be 2 community members, if there are more than 10 institutional members, there will be 3 community members, and so on.)

e)

In order to ensure the ability to conduct timely ethical reviews Academic Centres will appoint an “Alternate” member who will be available to step in as a substitute when the designated Centre REB member is unavailable.

f)

When the REB lacks the experience or expertise to provide ethics review for a particular research proposal, the REB will seek the assistance of one or more expert advisors. Expert advisors will not be voting members or participate in the decision or decisions of the REB. If the REB regularly seeks recourse to expert advisors it will re-examine its composition.

g)

REB members will be are appointed for a two year term with the possibility of renewal. Membership appointments will be staggered to ensure appropriate balance and maintenance of continuity.

8.2

REB Chair

a)

The REB will annually elect one of its members as chair.  The REB Chair will be an experienced and respected REB member, normally with at least one year of experience on an REB, and will have a broad and deep knowledge of ethical literature and debates, national and international guidelines, regulations, policies and their application to the research undertaken by the organization.

b)

The REB Chair will be responsible for ensuring that the operations of the REB comply with the TCPS and AU Policies concerning the review process. The Chair will monitor the REB’s decisions for consistency and will ensure that these decisions are recorded properly and that they are communicated to researchers in writing as soon as possible. The Chair will be provided with adequate administrative support by the university to fulfill his or her role.

8.3

REB Meetings and Attendance

a)

The REB will meet regularly in a synchronous manner to review proposals for research involving human research participants that have been received on or before the monthly cut-off date for the meeting, and to conduct such other business as is necessary to meet its responsibilities. The REB will strive to achieve unanimity in its decisions. In the event that unanimity cannot be achieved, a majority vote will be required for approval of a proposal, and a record of all dissenting and non-voting members will be made.

8.3.1

Quorum

a)

The quorum for each REB meeting will consist of four voting members.

b)

Decisions requiring full review (usually, those involving greater than minimal risk research) should be adopted only if the members attending the meeting possess the range of background and expertise as follows:

  • having experience in the method and research area under review;
  • having broad knowledge in ethics or experience in the evaluation of ethical implications of research involving humans;
  • having general knowledge of applicable law;
  • having no affiliation with AU, having been recruited from the community.

8.4

Support

a)

AU will provide adequate resources and an annual budget to support the administrative processes and educational activities required by the REB so that the University as a whole remains in compliance with the AU Ethical Conduct for Research Involving Humans Policy, the TCPS, the federal funders’ Memorandum of Understanding, and such other regulations and guidelines are may be applicable.

b)

The University will provide timely and adequate research ethics office support to the REB.  It will ensure that appropriate levels of technology, professional and administrative assistance are available to enable:

  • primary ethics guidance and personal consultations for AU academic, professional, and student researchers and research supervisors
  • ethics proposal previewing and feedback to applicants, as a function of education for first time applicants and research supervisors, as applicable
  • guidance and referral for REB members and the REB Chair on issues related to adherence to the TCPS and other applicable ethics-related policies and guidelines, meeting rules, and standards of practice
  • delegated administrative reviews for determinations of exemption from ethics review, and for standard renewals and minor amendments to previously REB-approved research, and such other delegated activities as the REB will determine
  • REB point of contact for the Panel on Research Ethics and its Secretariat
  • support and promotion of the REB’s individual member and ‘institutional community’ educational activities
  • preparation of annual REB reports, and timely creation and maintenance of policy and procedure documents
  • efficient and effective systems for distribution and management of application and reporting forms and materials involved in submissions to the REB, including secure collection and delivery of proposals to REB members and delegated reviewers
  • preparation of REB meeting records to meet standards established within the TCPS and other relevant federal guidelines, including confidential, secure storage of submissions and related materials
  • pre-meeting preparation and post-meeting decision and follow-up correspondence assistance to the REB Chair
  • point of contact for AU research funding committees and award administrators for ethics approval verification and such other forensic and reporting activities as may be required to comply with the federal funders’ Memorandum of Understanding
  • establishment and maintenance of AU research ethics webpages and Internet connections which are current and relevant to the AU research community
  • performance of other duties related to supporting the REB in carrying out their responsibilities, as determined by the REB

APPENDIX B

Research Appeals Ethics Board (REAB) Terms of Reference and Responsibilities

9.0

a)

As a standing a standing committee appointed by the highest authorities of the university, the AU Research Ethics Appeal Board (REAB), upon invocation of the appeal process described in Appeals and Reconsideration (Section 2.8 of the Ethical Conduct for Research Involving Humans Procedures), will be responsible for:

9.1

Composition Requirements of the REAB

a)

The REAB will consist of six members, including both men and women, of whom:

  • five are selected from academic and professional staff;
  • at least two have broad expertise in the methods or in the areas of research that are covered by the REB;
  • at least one has broad knowledge in ethics or experience in the evaluation of ethical implications of research involving humans; and
  • one has no affiliation with the university, but is recruited from the community served by the university.

b)

Members will be appointed for a two-year term, and terms of appointment will be staggered in such as way that no more than half of the membership shall change in any given year.

c)

REAB members may be reappointed.

d)

Serving members of the REB or any of its delegated reviewers will not be eligible for appointment to the REAB.

e)

The REAB will elect one of its members as Chair.

9.2

Mandate

a)

The REAB will meet as required to hear appeals, following the procedure and timeline outlined in Section 8.8 Appeals and Reconsideration of this Policy and Section 2.6 of the Procedures.

9.3

Quorum

a)

The REAB will require a quorum of four of its members at all meetings concerned with appeals of REB decisions.  All meetings concerning appeals will be conducted synchronously.

9.4

REAB Record Keeping and Resources

a)

All REAB documentation, including minutes of meetings, correspondence, and board decisions, will be kept on file in the Research Ethics Office.

b)

AU will provide adequate resources and an annual budget to support the  administrative processes and educational activities required by the REAB to maintain compliance with the AU Ethical Conduct for Research Involving Humans Policy.


Office of the University Secretariat, June 24, 2010

Updated May 30 2014 by Advancement Web Services

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