UBC Research Ethics Boards
Guidance Note on UBC Family Practice Resident Research and
UBC Summer Medical Students ResearchProjects
Article 1: Background and Purpose
This Guidance is intended for use by UBC Family Practice Residents (FPR) and UBC Summer Medical Students (SMS). It is meant to clarify the requirements for obtaining ethical review and approval of research projects involving humans that are conducted by those students at certain of the provincial health authorities. (See Definitions). Different processes apply depending upon which health authority is involved in the study.
In the past, students conducting research as part of their course requirements under the FPR program and under the SMS research program have needed to obtain both a HA and a UBC ethical approval. UBC has entered into agreements with Fraser Health Authority (FHA), Interior Health Authority (IHA) and Vancouver Island Health Authority (VIHA) wherein UBC will accept the health authority REBs review and approval as the onlyethical review and approval required for those studies.
This means that UBC Family Practice Residents and Summer Medical Students completing their program required research projects exclusively within the Health Authorities named, will only be required to submit to the applicable Health Authority REBs for ethics review of these projects.
While a single ethical review is all that is required, students and their supervisors should note that there is a mandatory notice requirement that applies to all such research, and that without such a notice being provided to UBC, UBC will be unable to accept the other HA approval.
As outlined below (Articles 3.2 and 4) this arrangement does not apply to research conducted at Northern Health Authority or a UBC-Affiliated Health Authority (see definitions) and in those instances an application for research ethics review must be made to the appropriate UBC-Affiliated REB.
Article 2: Definitions
Family Practice Resident (FPR): Residents with the UBC Department of Family Practice completing a research project as part of their graduation requirements.
Summer Medical Student (SMS): MD and non-MD undergraduate students registered at UBC participating in the Faculty of Medicine Summer Student Research Program (FoM SSRP students). Refer to
Research: For the purposes of this Guidance, the term research means:
i)Human research as per TCPS2 and applicable Institutional Policies; and
ii)Either FPR research as being conducted as part of the FPR course requirements or SMS Research under the auspices of the specific program; and
iii)Conducted exclusively at the health authority whose Institutional REB reviews and approves the study.
Exclusively at the Health Authority means: Research that is conducted only on the sites of, and/or with the patients and staff and/or with the records and resources of the Health Authority whose institutional REB approves the research. Exclusively at the Health Authority specifically does not mean research that is conducted elsewhere or that is conducted at a UBC-affiliated health authority or conducted at botha UBC-affiliated Health Authority and the other Health Authority.
UBC-affiliated Health Authority: Means any of Provincial Health Services Authority (i.e. BC Cancer Agency or its sites; Children & Women’s Hospital or its affiliated sites); Providence Health Care; or Vancouver Coastal Health Authority.
Note: This Guidance and the review process applies only to Family Practice Resident Research Projects and Summer Student Medical Research Projects involving institutions with which UBC has Ethics Review Agreements, i.e. Fraser Health, Vancouver Island Health and Interior Health. There is a separate process for students whose projects are being conducted at Northern Health (See Article 3.2).
Note: Summer medical students may submit their ethics review application, whether funded or not. The mandatory notice requirement to UBC is required. Summer Medical Students should indicate in an email notice to UBC Office of Research Ethics(see Contacts) that FoM SSRP has been applied for, but have not had funding confirmed. If funded, notify UBC ORE contact to advise when funded. If NOT funded, but proceeding, this Guidance stands. Confirm with the Health Authority that except for funding status, the project remains aFoM SSRP project as described in this Guidance.
Note: Research projects conducted within a BC Health Authority may also be required to have organizational approval(s) to conduct research there. This process is individual to each Health Authority and is not part of this streamlined ethics review process. Contact the research office directly for more information.
Article 3: Process for UBC FPR and SMS research projects
3.1: Initial Application review process at FHA, IHA and VIHA
(i) The FPR or SMSidentifies the Health Authority REB they will be required to submit to for research ethics review.
(ii) The resident or medical student completes the appropriate application form (including attachments) and submits to the relevant Health Authority REB office, in accordance with that REB’s standard procedure (e.g. number of copies to be submitted).
(iii)Include “Family Practice Resident Research Project” or “Summer Student MedicalResearch Project” in the study title.
(iv) Informed consent letters/forms should include the UBC and Health Authority logos on them. The complaint contact information should be that as required by the Health Authority.
(v) The Health Authority REB will review, request revisions and grant a Certificate of Approval in accordance with their usual practice.
(vi) Once the approval has been granted, the resident or medical student notifies the UBC Office of Research Ethicsby email that the research project has received approval and includes the following information in the email body: Principal Investigator’s name, resident’s or medical student’s names and contact information (email), the full title of the study and the Health Authority’s research study number (e.g. at FHA, the study number (assigned by the REB) would be ‘FHREB 20XX-XXX’), and the expected study completion date.
(vii) Post-approval activities (PAAs) such as project closure/termination, amendments, renewals, etc. should be submitted to the Health Authority REB.
(viii) Once the project is concluded a Notice of Completion should be emailed to the UBC OREcontact. (see Contacts)
3.2: Initial Application review process at Northern Health (NH)
(i) The FPRor SMS should complete and ‘submit’ the UBC REB application formin RISe for REB review. Ensure that the words “Family Practice Resident Project”or “Summer Student Medical Research Project” in the study title.
(ii) Informed consent letters/forms should include the UBC logo and complaint contact information.
(iii) The FPR or SMS submits the complete UBC application and the “Northern Health supplement”to the Northern Health Research Review Committee (RRC) for review. Note this can occur atthe same time as the submission to the UBC REB.
(iv) Once the UBC REB approval is granted, the FPR or SMS will forward a copy of the approvalcertificate to the Northern Health RRC.
(v) The Northern Health RRC reviews and grants approval for the project in accordance with their usual practice.
(vi) Post‐approval activities (PAAs) such as project closure/termination, amendments, renewals
etc. are to be submitted to the UBC REB. They will notify the Northern Health RRC.
Article 4: Initial Application Review Process at a UBC Affiliated Health Authority
Vancouver Coastal Health, Providence Health Care, Children’s and Women’s Health Centres and the BC Cancer Agency, have UBC-affiliated REBs and therefore, this process does not apply. The FPR and SMS would submit directly to the relevant UBC-affiliated REB for the location and type of the project.
Article 5: Mandatory Notice Requirement if Research is conducted at FHA, VIHA or IHA
As per Article 1, Background and Purpose, a mandatory notice requirement for students and their supervisors applies to all such research, and that without such a notice being provided to UBC, UBC will be unable to accept the other HA approval.
Submit to the UBC OREby email() as soon as the research project has received approval and include the following information: Principal Investigator’s name, resident’s or medical student’s names and contact information (email), the full title of the study and the Health Authority’s research study number (e.g. at FHA, the study number (assigned by the REB) would be ‘FHREB 20XX-XXX’), and the expected study completion date.
Contacts
A list of the contact information follows:
Interior Health Authority
Fraser Health Authority
Northern Health
UBC Office of Research Ethics
Vancouver Island Health Authority
For questions about this process and to submit all mandatory notice requirement emails, please contact Sarah Bennett, UBC at 604.875.4111, extension 68918,.
July 11, 2013