FAQ: Ethics Application Process

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For queries related to completing a research ethics board application, contact Dina Shafey, Research Ethics Coordinator

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Application forms and Guidance notes for Initial Ethical Review are available on the web.

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The FH Research Ethics Board (FHREB) meets monthly to review submissions that require Full Board review. See deadlines for submissions.

For Delegated Review, the FHREB co-chairs conduct reviews once per week. The dates for Delegated Review vary weekly.   Please consult Dina Shafey, Research Ethics Coordinator for dates of review.

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Delegated Review is reserved for those studies that are defined as minimal risk.  A study is considered to be of minimal risk "... if potential subjects 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 subject 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" [TCPS Ch 2, Ch 6 – A 6.12].

In general, in order to be considered for Delegated Review, the study must: 1) not have any corporate sponsorship (i.e. commercial); not involve subjects who are incapable of giving full consent, and; not deviate from standard clinical practices or procurement of tissue/blood outside of normal sampling events.  For further details refer to the Fraser Health Research Ethics Policy and the Guidance Notes for Initial Review. You may also consult with Dina Shafey, Research Ethics Coordinator for more information.

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Delegated Review: one (1) signed copy is required (electronic or paper copy).
Full Board Review: one (1) electronic copy, one (1) originally signed copy

Mail submissions to:  Department of Evaluation and Research Services, Fraser Health Corporate Office, #400, Central City Tower, 13450 102 Avenue, Surrey, BC V3T 0H1

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Visit our Research Ethics page for a copy of the current membership list. Visit our Meeting Schedule page to view our deadlines for submission and meeting schedule.

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Visit our Process and Timelines page for details.

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If you are FH staff or privileged physicians:
Designate a "FH" Principal Investigator (PI) who is responsible for the overall study and for submitting ethics applications to the FHREB for that study.  If submitting an ethics application to the FHREB, the PI must be FH staff or a privileged physician and the application must be approved by the PI’s administrative supervisor.

The principle is that the PI must have a sufficiently clear connection to FH such that the PI will be bound by requirements placed on her or his performance of the research by FH.

If you are a non-FH Researcher:
Non-FH researchers conducting research on humans, material or on information derived from humans, to be carried out at a FH facility, must: 1)  become an affiliated FH researcher, 2) ensure that there is at least one FH co-investigator on the study and, 3) obtain ethics approval from the FHREB.

Read more details on becoming an affiliated researcher. Please consult the Guidance Notes for Initial Ethical Review for more information regarding FH-affiliation.

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Medical residents and fellows can only act as co-investigators on a study being conducted within the Fraser Health Authority.

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Make the required changes or respond to questions as indicated and submit the response on the Fraser Health REB form for submission of revisions.  The response may be submitted by email to Dina Shafey. The response will be reviewed during the weekly Delegated Review by one of the REB co-Chairs.  For the appropriate form, go to Forms and Guidance Notes.

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Deferred status means that the REB had significant concerns regarding protocol research design, validity, recruitment methods or major revisions to the consent form.

Make the required changes or respond to questions as indicated and submit the response on the Fraser Health REB form for submission of revisions. One (1) electronic copy, one (1) original and six (6) paper copies are required as the material will be reviewed by all REB members.  The protocol or the IB does not need to be copied as these are retained by staff for distribution with the new material.

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

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Anonymous: Data collected does not contain any information that would permit identification of the individual(s) about whom the data were collected [TCPS Ch 5].
De-identified: When collected, data contained identifiers or information that would permit identification of the individual(s) about whom the data were collected, but the identifiers or other links to identity have been removed [TCPS Ch 5].

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Information that identifies a specific individual through direct identifiers is considered identifiable information. The list below outlines the major types of identifying information:

• Name (first, middle, last and title) 
• Location references smaller then province (including postal code)
• Birth date i.e. month year day 
• Dates of treatment in cases where treatment is especially unique or rare 
• Telephone number 
• E-mail address 
• Social Insurance Number (SIN) 
• Medical Record Number (MRN) 
• Health plan beneficiary number (OHIP number) 
• Any or all account numbers 
• Certificate or license numbers 
• Vehicle identifiers (including license plate) 
• Device identifiers (including serial number) 
• URL (uniform resource locator or worldwide Web address)
• IP address (internet protocol address)
• Photograph (full face), and any comparable images 
• Any other unique identifying characteristic or code

Note that business contact information is excluded from this definition. 

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Generally, a normal participant refers to a randomly chosen member of the general population.   Any individuals chosen for enrolment in a study based on specific baseline characteristics are, by definition, not "normal" individuals for this purpose.

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Fraser Health requires that all studies involving Fraser Health personnel must be reviewed and approved by the Fraser Health REB.  The approval of non FHREB's is not considered to be sufficient as it does not represent a local review.

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All research that involves human subjects must be submitted to the FHREB for review prior to commencement of study procedures, including recruitment of subjects. This policy applies to clinical, health services and population health research, whether or not investigational agents are being used.

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Yes. Any activity conducted by an individual that involves research on human subjects must be prospectively reviewed by the FHREB, including those studies involving only a few subjects.

In addition, the FHREB may require additional safeguards for vulnerable populations involved in this type of research.

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All protocols involving research with human subjects that are conducted at Fraser Health must be submitted to the FHREB for review and approval. This requirement applies regardless of the risk level of procedures.

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The research activities must be reported to the FHREB as soon as possible. The FHREB does not approve research retroactively.  If approval was not obtained prospectively, a researcher should cease study procedures and contact the FHREB.  The researcher will be asked to submit an application to the FHREB for review and include an explanation for why s/he thought that FHREB approval was not required.  Based on the information provided, the FHREB will conduct an inquiry.  The FHREB will review the research activity and determine the extent of noncompliance, whether the research was conducted ethically, and whether the data may be utilized. Following which, the researcher will receive a letter from the FHREB advising them of the appropriate action.

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Pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects.  Pilot studies should be identified as such in applications to the FHREB.

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No. Federal regulations require that a REB conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year [IHC-GCP 3.1.4].

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Investigators and/or administrative supervisors are responsible for reporting promptly to the FHREB any serious or continuing noncompliance with the Tri-Council Policy:  Ethical Conduct for Research Involving Humans, Health Canada, or the United States Food and Drug Administration 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 subjects be reported to the FHREB [IHC-GCP 3.3.8].

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You should notify at least one of the co-Chairs of the FHREB.  You may also talk to any member of the board.  If you are uncertain what constitutes a violation, please contact Dina Shafey, Research Ethics Coordinator.