Athabasca University Policy

Ethical Conduct for Research Involving Humans Policy

Policy Sponsor:	Office of the Vice President, Academic
Policy Contact:	Research Ethics Administrator, Office of Research Services
Effective Date:	June 30, 2009
Approval Group:	AUGC Executive Committee, Motion 260-8
Approval Date:	June 16, 2010
Review Date:	Annually

Purpose
Since research is an essential component of the mission of Athabasca University (AU), this policy is intended to: address the ethical conduct of research involving humans because this confers special ethical responsibilities on both the university and individual researchers; and recognize the value of research while ensuring that research participants are respected, valued and protected.
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.

Policy Statements
1.0 Background
a)	AU’s policy for ethical research involving humans will conform to the Tri-Council Policy Statement (TCPS), Ethical Conduct for Research Involving Humans (official version). The TCPS is issued jointly by the Canadian Institutes of Health Research (CIHR) the Natural Sciences and Engineering Research Council (NSERC), and the Social Sciences and Humanities Research Council (SSHRC), and is available at the following website: http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf
b)	In addition to the guidelines provided by the TCPS, AU’s policy will adhere to the Freedom of Information and Protection of Privacy (FOIP) Act which controls the collection, use and disclosure of personal information from individuals by AU. Further details of the FOIP Act are available from the AU FOIP/Policy Coordinatoror can be found at: http://www.athabascau.ca/foipp
c)	The ethics review process will offer a level of assurance to research participants, the investigators and AU that research participants will be involved in ethically sound research and will be engaged in a prior consent process that is fully informed and voluntary. The ethics review process also is intended to ensure adequate protection of individuals’ privacy as well as the confidentiality of the information they provide. In addition, the ethics review process increases the probability that known and anticipated risks associated with the research are identified and adequately communicated to research participants prior to participation. Moreover, it ensures that the known and potential benefits are judged to outweigh potential risks from conducting the research. Procedures used to recruit research participants are examined to ensure they are free of explicit or implicit coercion and enable research participants to withdraw their consent at any time without fear of reprisal.
2.0 Guiding Principles for Ethical Research Involving Humans
a)	AU endorses the seven ethical principles set out in the current official version of the TCPS. 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 achieving an appropriate balance between potential harms and benefits minimizing harm and maximizing benefit
b)	Each of these ethical principles is discussed in detail in the Tri-Council Policy Statement. Researchers are referred to the policy statement for further discussion of these principles.
3.0 AU’s Research Ethics Board
a)	The seven ethical principles listed above will serve as the touchstone for the AU Research Ethics Board (AU REB). AU will have one REB, which will be an independent board appointed by and reporting directly to the highest authorities of AU. It will be empowered to ensure that all AU-affiliated research involving humans meets approved standards of ethical acceptability. It will operate under applicable laws and regulations of the Province of Alberta and of Canada, and will give due consideration to relevant laws and regulations of other countries.
b)	The REB will have the authority to approve, reject, propose modifications to, or terminate any proposed or ongoing AU-affiliated research involving human research participants that does not comply with AU ethics policies, the TCPS guidelines, the FOIP Act and the FOIP Regulation or other relevant Canadian and international research ethics policies, guidelines and regulations. The REB will seek appropriate expert advice should issues of determining compliance arise.
c)	AU’s REB will be tasked with reviewing research proposals involving human research participants for all areas of AU, including student proposals. Varying levels of delegated review will be employed by the AU REB in providing proportionality of review which appropriately addresses the level of risk in each research proposal and ensures timely reviews for AU researchers.
4.0 Research Requiring Prior REB Approval
a)	Prior written approval from the REB must be received for all research involving:
	i)	living human research participants, or
	ii)	human remains, cadavers, tissues, biological fluids, embryos or fetuses; in any of the following circumstances: where research is conducted by members of the AU community or in collaboration with those members where research is conducted using AU resources (e.g.: research space, material, equipment, human resources, research funds). where research is conducted at or under the auspices of AU by external researchers.
4.1	Exceptions to REB Review
a)	While exceptions not included in the list below may arise, the onus for demonstrating a reasonable exception to a principle will fall on those claiming the exception.
b)	REB review will not be required in the circumstances listed below. However, these exceptions are subject to the FOIP Act. Research that relies exclusively on publicly available information will not require REB review. This includes research on living individuals and research on organizations such as governments or corporations, so long as the research is based entirely on material to which the public has access. REB review will usually not be required for research involving public policy issues, the writing of modern history, or literary or artistic criticism. Quality assurance and quality improvement studies, program evaluation, and performance reviews or testing within normal educational requirements will not be subject to research ethics board review. Research involving observation of people in public places that does not allow for the identification of the individuals in research material and that is not staged by the researchers will not require research ethics board review. Creative practice activities in and of themselves will not require research ethics board review. Research that employs creative practice to obtain responses from human participants that will be analyzed to generate or to address a research question will, however, be subject to REB review.
c)	REB review will normally be required for research involving naturalistic observation. However, research involving observation of research participants in, for example, political rallies, demonstrations or public meetings should not require REB review since it can be expected that the research participants are seeking public visibility.
d)	Members of the AU community, who wish to undertake research under their own auspices or under the auspices of another institution, and not under the auspices of AU, must apply in writing to the REB to obtain a determination of exemption from review.
5.0 Proportionate Approach to Reviews
a)	The REB will use a proportionate approach based on the general principle that the more invasive or sensitive the research, the greater should be the care in assessing the research. By tailoring their level of scrutiny to the level of risk, the REB will aim to reduce unnecessary impediments and facilitate the progress of ethical research.
6.0 Free and Informed Consent
a)	Research involving human participants that is governed by AU policies and for which free and informed consent is required may only include research participants if they, or their authorized third parties, have provided their free and informed consent and that consent has been maintained throughout their participation in the research.
b)	Research participants must have freely agreed to take part in the research study on the basis of well-understood information about the objectives of the research and the nature of their participation. Research participants must be fully informed of any and all known or reasonably foreseeable risks of harm associated with the research, as well as possible benefits of their participation. They must have the opportunity to evaluate the relative weight of any risks and benefits.
c)	Free and informed consent must be voluntarily given, without manipulation, undue influence, or coercion. There will not be incentives offered that are so large as to become an undue influence and undermine the voluntary nature of participation. Researchers must take care to avoid problems of informed consent based on a special relationship between researcher and research participant, so that such relationship will not unduly influence the research participant’s free and informed consent.
6.1 Withdrawal of Consent and Concern or Complaint
a)	Research participants may withdraw their consent at any time during the research program, and such withdrawal will not result in penalty or harm or loss of promised benefits that are not inherently dependent on completion of their participation.
b)	Where any research participants express significant concern about the nature of the informed consent or the use of the research, the researcher should report the concerns to the REB.
6.2 Form of Consent
a)	Free and informed consent should normally be provided in writing. If written consent is not culturally acceptable, or where there are good reasons for not recording consent in writing, the procedures used to seek free and informed consent must be documented for review by the REB.
6.3 Altered or Waived Elements of Consent
a)	The REB may approve a consent procedure that does not include, or alters some or all of the elements of informed consent as noted above, or waives the normal requirements for informed consent, provided that the REB decides and documents that: the research will involve no more than minimal risk to the research participants; the waiver or alteration is unlikely to adversely affect the rights and welfare of the research participants; the research could not practicably be carried out without the waiver or alteration; whenever possible and appropriate, the research participants will be provided with additional pertinent information after participation; and the waiver or altered consent will not involve a therapeutic intervention.
6.4 Informed Consent
Researchers will provide to prospective research participants, or to 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 research participants are given adequate opportunities to discuss and contemplate their participation.
6.5 Competence
a)	Researchers will comply with all applicable legislative requirements of the jurisdiction in which participation takes place.
b)	Subject to applicable legal requirements, individuals who are not legally competent will only be asked to become research participants when; the research question can only be addressed using the identified group(s); and free and informed consent shall 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.
c)	For research involving incompetent individuals, the REB will ensure that, as a minimum, the following conditions are met: The researcher will show how the free and informed consent will be sought from the authorized third party, and how the research participant’s best interests shall be protected. The authorized third party will 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 research participant in research, so long as the research participant remains incompetent. When a research participant who was entered into a research project through third-party authorization becomes competent during the project, his or her informed consent will 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 will seek to ascertain the wishes of the individual concerning participation. The potential research participant’s dissent will preclude his or her participation. If a legally incompetent research participant expresses a desire to cease participation after the research procedure has commenced, such indication will be deemed dissent, and the procedure will be terminated.
6.6 Emergency Health Situations
a)	Subject to all applicable legislative and regulatory requirements, research involving emergency health situations will be conducted only if it addresses the emergency needs of individuals involved, and then only in accordance with criteria established in advance of such research by the REB. The REB may allow research that involves health emergencies to be carried out without the free and informed consent of the research participant or of his or her authorized third party if ALL of the following apply: a serious threat to the prospective research participant requires immediate intervention; and either no standard efficacious care exists or the research offers a real possibility of direct benefit to the research participant 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 research participant; and the prospective research participant 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 research participant is known to exist. Dissent will preclude his or her participation.
7.0 Privacy and Confidentiality
a)	Assurance of privacy and confidentiality for research participants will be a fundamental requirement of ethical research, except in cases in which the research participant explicitly waives the right to privacy and confidentiality. In proposals in which the potential for harm is significant, researchers will provide detailed protocols on how privacy and confidentiality will be maintained including protocols for storage and disposition of data. In its deliberations about the adequacy of provisions for maintaining privacy and confidentiality in proposals submitted to it, the REB will employ the principle of proportionate review. Researchers are advised to consult section 42 of the FOIP Act.
8.0 REB Terms of Reference and Responsibilities
a)	The REB will be an independent board which is appointed by and reports directly to the highest authorities of the university. The responsibilities and composition of the REB are identified in their Terms of Reference (TOR), see Appendix A of the Ethical Conduct for Research Involving Humans Procedures.
b)	All AU research involving humans must receive prior written approval of the REB, with the exception of those activities listed in 4.1 Exceptions to REB Review of the Ethical Conduct for Research Involving Humans Policy.
c)	Research ethics review proportionate to the level of risk in the research under review will be followed by the REB. Two levels of review may be undertaken: Full REB review, which is the default; or Delegated REB review of Minimal Risk Research. The REB may delegate ethics review to an individual or individuals, selected from among the REB membership and, in the case of student research, the department or faculty in which the student’s program is affiliated. Delegated reviewers may refer reviews back for full REB review.
8.1 Conflict of Interest
a)	Researchers must disclose conflicts of interest arising from their research in their submissions to the REB.
b)	In situations where REB members or delegated reviewers may have a personal interest in the research under review, they will declare any actual or perceived conflicts of interest before the beginning of review of the research proposal in conflict.
8.2 Scholarly Review as Part of the REB Review
a)	The REB will ensure that research posing more than a minimal risk has undergone scholarly review to ensure that it is capable of addressing the question (s) being asked in the research.
8.3 Continuing Ethics Review
a)	Further to the initial review of research that falls within the scope of this policy, the REB will annually review ongoing research throughout the life of the project. This includes review of departures from approved research that result in a change in the level of risk of research, or other ethical implications that have an impact on the welfare, autonomy and equal moral status of all humans. As with initial review, continuing ethics review will be based on a proportionate approach.
b)	Continuing ethics review of research exceeding the threshold of minimal risk may require additional reviews beyond the annual review.
8.4 Multi-Centred Review
a)	For reasons of institutional responsibility, all multi-centred research (research involving multiple investigators associated with other institutions, or multiple research sites located in Canada or other countries) involving AU researchers will be evaluated by the AU REB. The REB will also require the submission of ethical approvals issued by the home institution of the Principal Investigator if he or she is not an AU researcher.
8.5 Departures from Approved Research
a)	Researchers must immediately report to the REB all adverse events affecting human participants’ physical or psychological safety or the security of personally identifiable data, and any significant changes to approved recruitment, informed consent, data collection and data security protocols, instruments, participant documents and methods. The researcher will suspend further research activity until the REB has reviewed the changes and issued a decision to allow resumption of research.
8.6 Record Keeping
a)	Minutes of all REB meetings will be prepared and maintained by the REB. The minutes will clearly document the REB’s decisions and any dissents and the reasons for them.
8.7 Decisions of the REB
a)	The REB may issue approvals or conditional approvals, or may deny approval. Researchers have the right to request, and the REB has an obligation to provide, reconsideration of decisions affecting a research project.
8.8 Appeals and Reconsiderations
a)	Researchers may appeal a negative REB decision to the Research Ethics Appeal Board (REAB) within two months of the date of the decision. The decision of the REAB shall be final. AU may not override negative REB or REAB decisions.
9.0 Research Ethics Appeal Board (REAB) Terms of Reference and Responsibilities
a)	The AU Research Ethics Appeal Board (REAB) will be a standing committee appointed by the highest authorities of the university. The responsibilities and composition of the REAB are identified in their Terms of Reference (TOR), see Appendix B of the Ethical Conduct for Research Involving Humans Procedures.
Applicable Legislation and Regulation
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/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf
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 Procedures
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
	d)	AU REB Research Ethics Interim and Final Report Forms
	All items listed are available at http://www.athabascau.ca/research/ethics/forms.php
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Office of the University Secretariat, June 24, 2010