focused on the future of learning. au research ethics prepared by gail leicht research ethics...
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Focused on the future of learning.
AU RESEARCH ETHICS
Prepared by Gail LeichtResearch Ethics OfficerMay 2014
AU Ethics Review Requirements and Responses
• Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans, 2010 (TCPS-2) (effective Feb/2011)– http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-ept
c2/Default/
– Dictates that all research conducted under the auspices of the university, funded or not, must undergo ethics review (i.e. research conducted by AU faculty, staff or students regardless of where the research is conducted)
• Memorandum of Understanding (MOU) with the Federal Funders– Ties access to funding to ethical review requirements of
TCPS-2• AU Ethics Policy
– http://www2.athabascau.ca/secretariat/policy/research/ethicpolicy.htm
• FOIPP in Alberta, Federal Privacy Legislation– Outlines the conditions for access to AU (or other institutional)
research participants
Elements of ethics review: Key questions
1. Human participants?• Interactions with humans in order to gather
their data, including data which may have been generated previously for a non-research purpose.
2. Minimal risk, or greater?• Greater than minimal risk = full Research
Ethics Board review• Minimal risk = delegated review
Exemptions from review• Analysis or scrutiny of material in the public domain:
– Studies of people’s writings that appear in the public domain (e.g. letters to the editors of newspapers; postings to public websites)
– Studies of public figures (e.g. politicians or celebrities) based on material such as interviews with a journalist or broadcast on television; biographical profiles based on materials in a public archive
– Research for a critical biography not involving living participants (i.e. based exclusively on published or publicly available material)
• Observation of people in public places – where there is no staged intervention by the researcher or direct
interaction with the individuals or groups being observed– Those being observed have no reasonable expectation of privacy (e.g. in
a shopping mall, on a public street)– Dissemination of research results does not allow for the identification of
those observed
• Exclusively secondary use of anonymous information– Statistics Canada demographic data
Other? When in doubt….ASK!
TCPS Elements of ethics review: 3 Key Criteria
Concern for Welfare• Risk in proportion to benefit• No unnecessary risks• Impact on participants &
community
Respect for Persons• Respect for Autonomy• Protect Developing, Impaired or
Diminished Autonomy• Voluntariness• Informed choice• Freedom from influence• Capacity• Impact of decisions & influences
on the participant and community
Justice• Treatment of people fairly &
equitably
• Fairness – treating all people with equal respect & concern
• Equity – distributing benefits and burdens of research; no segment of the population is unduly burdened or denied benefits of knowledge generated from research
• Vulnerable populations
• Justifiable inclusion
• Power – researcher/participant
REB Departmental Ethics Review Committees for expedited delegated reviews
• Provide quicker ethics approval for student research projects:– Since 2003, departmental ethics review committees have been available
to review minimal risk student researcher projects.– Upon submission of an application through the Research Portal, it will be
direct to the departmental review committee of the full REB (whichever will be faster, dependent on availability of reviewers)
• For Minimal Risk research only
• Student projects only– Applied projects or theses (student applicant)– In-course research assignments (blanket approval)
• Instructor applicants only; develops template and ensures ethical procedures are followed, so individual student applications are not required
Departmental Ethics Review Committees• Sub-committee of the AU REB
– Decisions are reported at next regular REB meeting– Greater than minimal-risk applications go automatically to regular REB
review– May refer any application to the regular REB at the committee’s
discretion• Committee Membership
– Centre/Dept Member on the AU REB• Reviews applications• Chairs the review process• Reports on the review decisions to the REB
– Other Centre-nominated members (2 or more)• One regular reviewer• One, or more, alternate reviewers, to provide review when
required to avoid conflict of interest, or when regular reviewer is unavailable
– Regular AU REB Chair• Can be brought in to settle a tie vote, or to provide guidance
Application Process
AU Ethics Webpage:http://research.athabascau.ca/ethics/
Research Ethics Portal (ALL applications)http://research.athabascau.ca/ethics/forms.php
• Review the instructions document (on left hand menu) BEFORE you complete your online application: http://research.athabascau.ca/portal/
• Complete the application thoroughly, and check the ERRORS tab to address all necessary items – SAVE OFTEN!
• Use plain language; provide definitions for specialized terms or acronyms
PROOFREAD!
AU Ethics Webpage:http://research.athabascau.ca/ethics/
Research Ethics Portal (ALL applications)http://research.athabascau.ca/ethics/forms.php
• Review the instructions document (on left hand menu) BEFORE you complete your online application: http://research.athabascau.ca/portal/
• Complete the application thoroughly, and check the ERRORS tab to address all necessary items – SAVE OFTEN!
• Use plain language; provide definitions for specialized terms or acronyms
PROOFREAD!
Submitting your application
Ensure your supervisor reviews and approves your application prior to hitting the SUBMIT button for the application through the portal!
Submit anytime; the sooner the betterThere are no set deadlines for the submission of student applications, HOWEVER…
– Allow 3 – 5 weeks after initial submission for a final decision (i.e. submit your application at least 5 weeks prior to your intended start date). We aim for a turnaround of 2 – 4 weeks, but this timeframe is influenced greatly by availability of reviewers and the quality of the application
– If you intend to use AU participants or systems, Institutional Permission must also be granted. This can add another 2 weeks’ time after final ethics approval. The Research Ethics Office coordinates this process on your behalf.
Include all necessary info in your application…
• Be sure to upload all necessary appendices, such as….– References list
– Informed consent document
– Recruitment/Invitation to Participate documents
– Approvals from other institutions/organizations if needed
– Supervisor’s approval (either noted within the application by the supervisor or appended as a separate document)
• Any other appendices mentioned in the application
Frequent Issues
• Conflict of Interest– Issues around use of students or employees as participants
• Guidance available on the AU website – AU Guide for Research in Dual-Role Situations: “Involving Students or Others Related to the Researcher as Participants”
• Data Storage and Security Details– Who, where, how, for what amount of time; method of destruction
according to data format (notes, tapes, etc.)– Security measures employed (password protections; locked
cabinets; encryptions)– SSHRC Funded? SSHRC Data Archiving policy applies
• Voluntary Consent – Free, Informed & Ongoing– Is participation truly voluntary? Can respondents really withdraw at
any time without negative consequences?
Frequent Issues cont’d…
• Incentives to Participate– Issues around extravagant or excessive incentives which may
influence the free, voluntary consent
• Ensure participants are invited to contact the AU Research Ethics Office if they have concerns or comments– Advise clients that the study they are asked to participate in has
been reviewed by the AU Research Ethics Board and provide them info on how to contact the Ethics Office:
• Phone: 1-800-788-9041, ext. 6718• e-mail: [email protected]
Reviewing your application: Ethics Decisions
Regular Decisions:• APPROVED, with no further requirements, other than the final report
at the conclusion of the research project
• REVISIONS REQUIRED, specific revisions/clarifications or conditions must be dealt with before final approval is issued– Resubmitted/revised application will be reviewed by the Chair on
behalf of the Board or it may be referred back to the Board.– Research CANNOT proceed until final approval is given
• UNABLE TO APPROVE– Reason(s) for decision and guidance for resubmission will be included
in the results memo. Resubmission may be reviewed by the REB or Chair.
Collegial comments
• Friendly suggestions– non-conditional, unofficial in nature– Suggested in order to enhance the research experience or
documentation
• Who gets them?– Faculty and external researchers
• Courtesy– Centre Research Coordinator / Supervisors of Student
Researchers• Design-related or ‘teachable moments’; the supervisor can
consider the essence of the suggestion and continue discussion with the student
– Student Researchers• Sent directly if it is a matter of proofreading, tidying up, or
making more reader-friendly comments
A Separate Process:Gaining Access to Conduct Research• Research involves staff or clients as participants
– FOIPP & PIPEDA legislation impose responsibility on organizations as holders of confidential personal information
• Research involves use of organization’s resources– Electronic & physical bulletin boards, e-mail lists, stored data– Staff assistance with participant recruitment or data collection– On-site recruitment or use of meeting rooms to conduct interviews– Access to private documents, proprietary information
• Just because you work there does NOT mean you have access for ‘research’ purposes– Permission must be sought from executive level
• School Board Superintendent, Principal, Executive Officer– You may be subject to multiple ethics reviews
A Separate Process:Gaining Access to Conduct Research at AU• Recruitment contact – staff or student participants
• Research use of AU systems, physical resources, or proprietary information– Electronic & physical bulletin boards, e-mail lists, stored data, private
documents
• Research involves use of AU staff resources– Assistance with participant recruitment or data collection
• AU Request for Permission to the VP Academic is coordinated by the Ethics Office AFTER Final Ethics Approval
Resources & Training: Online Tutorial and Webinars• Produced by the Interagency Panel on Research Ethics (PRE)
• National body responsible for implementation and changes to TCPS http://www.pre.ethics.gc.ca/
• On-line TCPS-2: CORE Tutorial• Introductory tour of the Tri-Council Policy Statement• Canadian resource for all students, faculty, REB members,
general public• AU-recommended, but not ‘required’ or ‘pre-requisite’*• Certificate of Completion (qualifies across Canada)• Registration keeps track of where you left off• http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/
*When registering, follow instructions for institutions not requiring completion: choose OTHER and fill-in ‘Athabasca University’
• Recorded PRE-led Webinars – various topics, elaborating on TCPS-2• http://www.pre.ethics.gc.ca/eng/education/view_webinar-voir_w
ebinaire/
Other AU Resources
• Sample AU Student Application– http://research.athabascau.ca/documents/sample-app_autoet
hnog.pdf
– Even though not same methodology as yours, may be helpful to see what reviewers expect to see in the application; e.g. depth of responses
– This format is no longer used, but the questions are very similar to the online application form!
• Frequently Asked Questions (FAQs)
– http://research.athabascau.ca/faqs/ethics.php
More Information / Advice:
AU Ethics Webpage:http://www.athabascau.ca/research/ethics/
Researcher and supervisor commentsare always welcome!
Gail LeichtResearch Ethics Officer
1-780-675-6718