Research Ethics Presentation 2014 - Research Centre

Prepared by Gail Leicht
Research Ethics Officer
May 2014
Focused on the future of
AU Ethics Review Requirements and
Tri-Council Policy Statement on Ethical Conduct for Research Involving
Humans, 2010 (TCPS-2) (effective Feb/2011)
– 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
Memorandum of Understanding (MOU) with the Federal Funders
– Ties access to funding to ethical review requirements of TCPS-2
AU Ethics Policy
FOIPP in Alberta, Federal Privacy Legislation
– Outlines the conditions for access to AU (or other institutional) research
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
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
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
Treatment of people fairly &
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
Risk in proportion to benefit
No unnecessary risks
Impact on participants & community
Respect for Persons
Respect for Autonomy
Protect Developing, Impaired or
Diminished Autonomy
Informed choice
Freedom from influence
Impact of decisions & influences on
the participant and community
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
– 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:
Research Ethics Portal (ALL applications)
Review the instructions document (on left hand menu) BEFORE you
complete your online application:
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
AU Ethics Webpage:
Research Ethics Portal (ALL applications)
Review the instructions document (on left hand menu) BEFORE you
complete your online application:
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
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 better
There are no set deadlines for the submission of student applications,
– 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
– 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;
– 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
– 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
Who gets them?
– Faculty and external researchers
• Courtesy
– Centre Research Coordinator / Supervisors of Student
• 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
– Electronic & physical bulletin boards, e-mail lists, stored data, private
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
Produced by the Interagency Panel on Research Ethics (PRE)
• National body responsible for implementation and changes to TCPS
On-line TCPS-2: CORE Tutorial
• Introductory tour of the Tri-Council Policy Statement
• Canadian resource for all students, faculty, REB members, general
• AU-recommended, but not ‘required’ or ‘pre-requisite’*
• Certificate of Completion (qualifies across Canada)
• Registration keeps track of where you left off
*When registering, follow instructions for institutions not
requiring completion: choose OTHER and fill-in ‘Athabasca
Recorded PRE-led Webinars – various topics, elaborating on TCPS-2
Other AU Resources
• Sample AU Student Application
– Even though not same methodology as yours, may be helpful to
see what reviewers expect to see in the application; e.g. depth of
– This format is no longer used, but the questions are very similar to
the online application form!
• Frequently Asked Questions (FAQs)
More Information / Advice:
AU Ethics Webpage:
Researcher and supervisor comments
are always welcome!
[email protected]
Gail Leicht
Research Ethics Officer