Do I need to include a TCPS2 CORE Certificate or CITI-Canada GCP Certificate, with my submission for ethics review?2019-02-01T14:08:37-04:00

Yes. Investigators wishing to conduct research at RVH must submit evidence of ethics training for each new REB submission. Please visit http://www.rvhresearchinstitute.ca/ethics/how-to-apply/ to learn more about which ethics certifications are required based on the type of research being performed.

Can submissions be made using paper copies?2019-02-01T14:16:20-04:00

All applications submitted on or after October 15, 2018 should must be submitted electronically through the REO portal.

Is the submission deadline for full board review flexible?2019-02-01T14:23:42-04:00

Permission from the REB Chair must be obtained to consider the review of submissions after the deadline for the upcoming full board meeting. Please contact the REB Coordinator, Romaine Miller, at 705-728-9090 Ext. 43318 to inquire about submitting after the deadline.

How long does ethics review take?2019-02-01T14:40:22-04:00

Minimal risk studies that qualify for delegated review (formerly known as expedited review) are reviewed within 30 days. Greater than minimal risk studies that require full-board review will be reviewed within 30-90 days, depending upon the complexity of the study, the number of clarifications and/or modifications required by the REB, and the time taken by the Principal Investigator to respond.

I am an external researcher. Who would I contact at RVH to help obtain departmental impact signatures?2019-02-01T15:34:47-04:00

If you require assistance with obtaining departmental impact signatures, please contact RVH Research Manager, Dr. Jesse McLean, at (705) 728-9090 Ext. 41350

I have ethics approval from another REB, do I still need to obtain approval from the RVH REB for my study?2019-02-01T15:43:50-04:00

Yes. The RVH REB  must review and approve research that meets any of the following criteria:

  • The research involves living human participants at RVH;
  • The research involves the collection, storage, or transport of human biological materials at RVH (e.g., blood, urine, human embryos, fetuses, fetal tissue, reproductive materials, and stem cells). This applies to materials derived from living and deceased individuals;
  • The research is conducted fully or partially on RVH property;
  • The research involves testing an experimental drug or medical device at RVH;
  • The research involves reviewing patient medical records; and/or
  • The research utilizes RVH resources, including, but not limited to:
    • Electronic medical records (e.g., Meditech, ARIA);
    • Imaging or diagnostic services;
    • Laboratory services;
    • Pharmacy services;
    • Surgical services;
    • Emergency services; and/or
    • Other departmental services
How do I know if my research requires REB review?2018-05-22T16:56:48-04:00

Research involving the use of human subjects and/or information about them generally requires REB review and approval.  Use of human subject information for quality improvement purposes only may not need REB review and approval.  The final decision lies with the REB who will provide clarification on a case by case basis.  The Research Office is available to review your project/idea/study and facilitate a clarification from the REB.   It is strongly recommended that you obtain clarification and confirmation in advance of beginning your project if you believe it does not need REB approval. 

I’m ready to submit my REB application – what do I do?2018-05-22T16:58:39-04:00

All research with the exception of Oncology and FMTU resident projects (which undergo a similar review) must be referred to the Research Office prior to REB submission.  The Research Office ensures submissions are complete (approvals, paper/electronic versions, training certificates, CV’s, etc.), that necessary agreements or other administrative components are done or in process and privacy review and sign off is facilitated. 

I am an experienced researcher – do I still need to submit my project to the Research Office prior to the REB?2018-05-22T16:59:20-04:00

Yes, unless you are submitting your project through Oncology or as a FMTU resident project.   The Research Office assigns a unique number to all research studies and enters information about all research projects into the RVH study database.  To assist in the process completion of an intake form is recommended. 

Does RVH have policies related to conducting clinical trials research?2018-05-22T18:40:19-04:00

Yes, RVH is a member of the Network of Networks N2 a pan Canadian organization committed to facilitating clinical trials at the highest level and has adopted their standard operating procedures (SOPs).  Importantly, these SOPs have passed Health Canada inspection.  D

isclosure – As there can be a brief time lapse between the introduction of a new or revised SOP from N2 and its adoption at RVH please confirm with the Research Office the most current versions in use at RVH.  The N2 SOPs are currently available in the Research Office as well as the Cancer Program Clinical Trials Office.

Does my quality improvement (QI) project require REB approval?2019-02-01T16:17:06-04:00

In general, projects that are considered quality improvement/assurance (QI/QA) or program evaluation do not require ethics approval. However, when there is doubt as to whether or not the activity does or does not meet the definition of research involving humans, the researcher must confirm with the REB as to whether ethics approval is required. The intent to publish does not necessarily distinguish an activity as research, since findings from QA/QI and program evaluation projects are often published. The REB will not provide ethics approval retroactively; the onus is on the researcher to obtain the necessary approvals. For more information about differences between QA/QI and research, please click HERE.