Delegated Review and Submission Requirements for New Studies

New Studies qualifying for Initial Delegated Review

Research deemed to be minimal risk and falling in the categories listed below may be reviewed via delegated process:

  • Investigations primarily epidemiological in nature and where data is anonymous or anonymized (i.e. not linked to personal identifying information such as name address, initials, date of birth, etc.) involving retrospective or prospective study of existing data, documents or records.  Review TCPS 2 for definitions on anonymous data.
  • Research involving a mail returned survey(s) or questionnaire(s) provided the questions are not unduly alarming, intrusive, sensitive or embarrassing and there is limited collection of potentially identifying information (i.e. names, address, e-mail address or identifiers such as SIN, PHIN are not collected).
  • Secondary analysis of anonymized or de-identified data collected from a previously approved research project by a Bannatyne Campus REB at the discretion of the chair.
  • Retrospective chart or records review study where data is anonymous,  anonymized or de-identified.
  • Research protocols from the National Research Council which qualify as per SOP REB 24 “National Research Council and Bannatyne Campus REB Coordination”.
  • Request to establish an electronic or paper database of individuals who agree to be contacted for consideration in future research studies.  The data collected is limited to information required to contact individuals and to establish eligibility criteria for future studies.  (NOTE: Research databases/registries designed to monitor or evaluate clinical care shall usually undergo full board review.) New investigators/sites for protocols that have already received approval from the BREB/HREB at a full board meeting within the past year.
  • Expanded access/compassionate use protocols (for pharmaceutical studies) may be considered for delegated review with prior consultation of the REB coordinator.
  • Research involving analysis of anonymous, anonymized or de-identified biological samples in the custody of well-established tumor/tissue banks supported by an Advisory Committee (e.g. Manitoba Breast Tumor Bank) for which participants have previously consented to use of their biological samples for research.  In consultation with the Chair, a graduate course based project which has previously undergone a departmental review and approval process per University of Manitoba policies.
  • In consultation with the Chair, graduate course based projects may be considered for delegated review provided they have undergone ethics review as per the departmental review process outline in SOP REB 07 Departmental Review.  Consultation with REB may be required to organize Departmental Review committee.
  • In consultation with the Chair, minimal risk studies not included in the above list may be considered for delegated review that do not involve direct contact with potentially vulnerable populations (e.g. children or adolescents(under 18 years), mentally incompetent, prisoners, etc.).

NOTE:  generally all research projects/studies involving genetic analysis are not eligible for the delegated review processes.

Updated:  July 10, 2015


IS A DELEGATED REVIEW APPROPRIATE? ?
Applicants should indicate the level of review they are requesting based on the criteria of studies listed in these guidelines that qualify for delegated review and not based on the speed with which they would like to receive approval.

The REB Chair will make the final decision as to whether an delegated or full review is required.