Ethics Application Process

 Do I need to submit an ethics application?

Do Quality Assurance, Quality Improvement, or Program Evaluation studies/activities require Research Ethics Review?

What is the overall process for obtaining approval?

Once your application is submitted, it will be reviewed in date order of receipt. A preliminary review will be conducted to make sure that you have all the documents required to support your study and those documents are in compliance with TCPS 2 and Policy R20.01. Once the application is deemed to be complete, your supervisor (if you are a student, post-doctoral, or staff) will be given the link to access your on-line application. If the supervisor approves, s/he will send an email to dore@sfu.ca approving the application. The application will then be forwarded to the Associate Director, Office of Research Ethics for review. If this application is deemed to be minimal risk, the application will be approved on behalf of the REB and you can begin immediately. If this application is deemed to be greater-than-minimal, the application will go to the next meeting of the appropriate subcommittee of the Research Ethics Board for full evaluation and review. Please see Review Process page for more details.

I was told my submission needs some changes/clarifications; what do I do now?

Make the required changes and/or respond to questions as indicated and submit the response and revised documents in PDF to dore@sfu.ca with your study number in square brackets as the first item in the subject line. The ORE staff will upload these for you and your application will proceed to formal review. Be sure that you include the current version date in the footer of all documents you re-submit. Also, please highlight over the changed portions of the documents.

 I have an urgent request for review, as I will be leaving the country to start my research in the next two weeks.

While the ORE and SFU REB try to accommodate reasonable requests, ethics review is not a quick process. The SFU REB is responsible for conducting proportionate review (in relation to level of risk) and full board reviews are conducted at scheduled meetings. It is the responsibility of the researcher to ensure sufficient time for review, prior to the commencement of the research activity.

What is the difference between identifying and directly identifying information?

Anonymous information – the information never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low.[TCPS 2 Ch 5].

Anonymized information – the information is irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low [TCPS 2 Ch 5].

Coded information – direct identifiers are removed from the information and replaced with a code. Depending on access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a list that links the participants’ code names with their actual name so data can be re-linked if necessary)[TCPS 2 Ch 5].

Indirectly identifying information – the information can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal characteristic)[TCPS 2 Ch 5].

Directly identifying information – the information identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number).

I am just administering surveys/questionnaires; do I need ethics approval, even if I am only interviewing a few people?

Yes. The ORE/SFU REB, including those studies involving only a few participants, must review any activity conducted by an individual that involves research on human participants. In addition, the ORE/SFU REB may require additional safeguards for vulnerable populations involved in this type of research.

My study does not involve any risk of any kind. Do I still need to submit an application?

All studies involving research with human participants that are conducted under the auspices or jurisdiction of SFU must be submitted to the ORE for review and approval. This requirement applies regardless of the risk level of procedures.

I intend to run a pilot study before my large research project begins. Do I need SFU REB approval before starting the pilot study?

Pilot studies and feasibility studies require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the ORE.

Who is responsible for reporting any problems that may occur during the conduct of approved research?

Researchers and/or Faculty Supervisors are responsible for reporting promptly to the ORE any serious or continuing noncompliance with the Tri-Council Policy: Ethical Conduct for Research Involving Humans, and other regulations, as applicable. In addition, every approval of a research project is granted with the stipulation that any unanticipated problems and risks, changes in the research plan, and any injury to participants be reported promptly to the ORE. An Unanticipated Problem Report must be completed immediately and forwarded to the Office of Research Ethics at dore@sfu.ca. Please see Unanticipated Problem Policy for more details

What should I do if I know of research that has violated ethics?

You should notify the Director, ORE. You may also talk to any member of the board.

Who can I contact for guidance when completing any application for research ethics board review (i.e. initial applications, amendments and renewals)?

Refer to the study detail guidelines and consent form guidelines in the http://www.sfu.ca/ore/ethics-forms---templates.html page and guidelines in Policies and Guidelines. If you are still having trouble with your application, please send an email to dore@sfu.ca or contact the appropriate person listed on the Contact Us page.

What is Conditional Approval?

Conditional Approval means that your ability to go forward with this study is contingent on our office receiving the documentation outlined in your Conditional Approval Letter. You must therefore submit this documentation to our office as soon as possible after it is received so it can be added to your file. Our office will then remove the conditions and issue you a new Approval Letter.

What is a harmonized study at SFU?

A harmonized study is a multi-institutional research project where ethics review is required at more than one institution. For the process refer to our Multi-Jurisdictional Research page.