Categories and Procedures for Review of New Research Protocols
Full Board Review
Delegated Review (previously referred to expedited)
HREB Policy Statement on Retrospective Chart or Records Reviews
Request for Preliminary Access to Grant Funding (RPA)
Case Report Studies
Uncertain whether Ethics Review is Required
In accordance with The Tri-Council Policy Statement 2, ICH Good Clinical Practice Guidelines, Health Canada regulations and University of Manitoba policies, submissions to the Bannatyne Campus REBs will receive proportionate review, based on the degree of risk. That is, the depth and extent of the ethics review will be proportional to the anticipated degree of risk to study participants.
Studies determined to be of negligible or low risk may undergo delegated (previously referred to expedited)/or departmental review, while protocols that involve greater than minimal risk must undergo full REB review.
"Categories and Procedures for Review of New Research Protocols" guidelines will assist the researcher/Principal Investigator (PI) determine
All research submitted for initial review will require full board review unless it is specifically outlined as a study qualifying for delegated review in the "Categories and Procedures for Review of New Research Protocols" guidelines.
Some studies may qualify for delegated ethical review. Please review Initial Delegated Review criteria to determine if a study qualifies for expedited review prior to preparing your package for submission to a Bannatyne Research Ethics Board.
This policy statement specifically describes the procedures and submission criteria required to obtain Health Research Ethics Board approval to conduct a retrospective chart or record review. These procedures are not applicable to any other studies or including chart/record review studies that are prospective in nature. There is a to be used for
New Federal regulations require that researchers cannot access funding for research projects with activities that require ethics approval at any point of the the award term prior to receiving preliminary approval from the appropriate ethics committee. Researchers must provide the ethics committee with sufficient information by completing the RPA Form in order to permit interim access to funding until the research activities requiring ethics approval are to begin. Full review of the protocol will still be required and the documentation for this should be submitted well in advance of the RPA end date to ensure access to funding is not discontinued.
Our general approach to case reports is to request that authors obtain the patient's consent whenever possible, write up the case study, and then submit it to the Health Research Ethics Board (HREB) before sending it off for publication We review the case report largely to assess the risk that patient/individual identity may be inadvertently revealed by the author(s) in the write-up. This is our primary concern in this situation. If the probability of inadvertent identification of an individual based on the write-up is judged to be low we generally approve it. If we think that the probability of individuals identification is unacceptably high (e.g. very rare condition, a lot of demographic data is provided in the write-up, etc.) we will request changes (that hopefully don't result in the loss of critical information) designed to lower the risk of inadvertent individual identification from the publication of the case report. In cases in which patient/individual or family consent is either impossible or extremely difficult (and thus quite impractical to obtain) as well as cases in which attempting to obtain consent from a living or from the family of deceased patient/individual would be too traumatic for those involved we may waive the requirement for consent on a case-by-case basis.
Case Report Submission Requirements:
Sample Case Report Consent Template - This is designed to assist in preparing a simple case report consent form to present to individuals, as applicable. Other consent templates may be acceptable for use.
Please contact Shelly Rempel-Rossum at 204-789-3389 if you have any questions regarding ethics review and approval of case report studies.
The ethical review of research that is to be carried out by undergraduate students in a course based (i.e. not independent study) may be delegated to a departmental level process as outlined in "Categories and Procedures for Review of New Research Protocols". Research conducted by graduate students in a course based project may qualify for delegated review following a departmental review process which is outlined in the delegated review guidelines.
If a PI is uncertain whether REB review is required, he/she must outline the main intent of the project in a one page summary addressed to the appropriate Chair and specifically request whether REB approval is required. This must be submitted to the REB coordinator in a letter or via e-mail at least 4 weeks prior to the submission deadline for full board review to provide sufficient time to advise whether ethics review is required.
MANDATORY CLINICAL TRIAL REGISTRATION
TCPS 2 requires registration of certain clinical trials. The International Committee of Medical Journal Editors requires certain clinical trials be registered as a condition of publication.
You must also contact the institution(s) or organization(s) (e.g. Health Sciences Centre, St. Boniface Hospital, WRHA, CADHAM Lab, Manitoba Centre for Health Policy, Manitoba Health, etc.) where research activities will be conducted and/or services accessed to determine the submission requirements/deadlines specific for conducting research at that facility.
Provides a quick reference to the various documents required for ethics review of new studies.
ADDITIONAL REVIEW REQUIREMENTS FOR: RESEARCHERS AFFILIATED WITH NRC-IBD
Radioactive substances and healthy volunteers