REB Delegated Review
REB Delegated Review
|Department||Applied Educational Research|
|Creation Date||January 18, 2011|
|Approval Date||January 18, 2011|
|Effective Date||January 18, 2011|
This policy pertains to all staff, faculty, students or external persons intending to participate in or carry out research at and/or in collaboration with the Michener Institute.
The purpose of this policy is to describe the process for determining what types of research submissions meet the criteria for delegated review.
Minimal Risk: “research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research.” TCPS 2, Chapter 2 Section B.
Minor change: change that neither increases the risk nor changes the risk-benefit ratio of the study and does not significantly change the objectives or design of the study.
All research involving human participants must meet certain criteria before REB approval is granted.
The REB adopts a proportionate approach to research ethics review in that “the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review)”. TCPS 2, 6.12. As a result, research submissions will be stratified by the Chair of the REB into those studies requiring full board review and those studies that may be delegated.
Delegated REB approval begins with a complete submission package to the Research Office (see Policy: REB Submission Requirements and Administrative Review). Submissions must meet current scientific, regulatory and ethical standards for the protection of human research participants, and maintain alignment with Michener’s corporate policies, vision, mission and values.
This policy applies to the Chair, members of the Research Office and/or administration, and REB.
The Chair of the REB is responsible for determining if the research in question meets the criteria for delegated review. Once the Chair has made this determination, he/she is responsible for delegating the review to a qualified member of the REB including him/herself. Responsibility for the review remains with the Chair.
The REB Chair or delegated REB member is responsible for conducting the delegated review assuring that the research submission meets current scientific, regulatory and ethical standards for the protection of human research participants.
The REB Chair or designate is responsible for ensuring that all REB members are adequately educated and trained and/or have the expertise to review submissions appropriately. (see Policy: Training and Education of REB members and Research Office Staff)
2.1 Determination of Qualification for Delegated Review
2.1.1 The Research Coordinator or designate will make sure the submission requirements have been met before the Chair considers the proportionate degree of review required;
2.1.2 Where it is determined that the research submission poses minimal risk to participants, the research submission may be classified as a delegated review;
2.1.3 Delegated reviews will meet any of the following criteria:
- research involves minimal risk;
- minor changes to approved research;
- continual review (annual renewal) of approved minimal risk research;
- annual renewals of more than minimal risk research where the research no longer involves new interventions to current participants, renewal does not involve the recruitment of new participants, and the remaining research activities are limited to data analysis;
- Continuing review of approved research. (Note: Continuing Review of this type of research will be submitted as an agenda item for approval at the REB Full Board Meeting)(see Policy REB: Continuing Review).
2.1.4 Categories of research that may quality for expedited review include:
- Research involving surveys, interviews, oral history, focus groups, human factor evaluation;
- Research involving materials originally collected for non-research related purposes (data, documents, medical records, anonymous tissue specimens);
- Research involving group characteristic or behaviour (perceptions, cognition, motivation, identity, language, communications, cultural beliefs, social behaviour);
- Research involving tissue such as hair or nail clippings collected non-invasively and/or may have been collected as part of routine care (placenta, discarded tissue);
- Research utilizing data collected non-invasively (EEG, ECG);
- Research involving blood samples not associated with banking or genetic testing that may have been collected during routine clinical care;
- Research involving other clinical non-invasive data that may be collected as part of routine clinical care.
2.1.5 The Chair may delegate the review of a research submission that has undergone full board review at another institution providing all the REB documentation of that review accompanies the research submission.
2.2 Authority of the Delegated Reviewer(s)
2.2.1 A delegated review may be carried out by the Chair of the REB, or by one or more experienced members of the REB;
2.2.2 The designated reviewer will apply the same approach as listed in 2.1 “Minimal Criteria for Approval of Research” of the Procedure section of Policy-REB Initial Review to determine if the research submission should be approved;
2.2.3 The designated reviewer will defer to the Chair for questionable submissions;
2.2.4 Questionable reviews that cannot be satisfactorily approved by the designated reviewer and/or the Chair will be deferred to the Full REB for review;
2.2.5 The designated reviewer will not be in conflict of interest with the research submission;
2.2.6 The REB Chair will sign all designated review reports and any correspondence(s) associated with the submission.
2.3 Length of Approval:
2.3.1 Studies will be reviewed at least once per year;
2.3.2 The REB will review research submissions as frequently as required based on the degree of risk attributable to study participation. Studies of the following type may be reviewed more frequently:
- Procedures/treatments/agents that have not been previously used in humans;
- Research where the risks are unknown;
- More than minimal risk exists to vulnerable populations with no prospect of direct benefit;
- The presence of SAE’s;
- Previously confirmed instances of non-compliance with the principal investigator;
- The REB believes more frequent review is required.
2.4 Continuing Review
2.4.1 Research that meets the following criteria may be eligible for delegated review:
- Research that was previously reviewed by delegation;
- Research that was previously reviewed by the full board where there are minimal risk changes or no changes. (Continuing Review of this type of research will be submitted as an agenda item for approval at the REB Full Board Meeting)(see Policy REB: Continuing Review);
2.4.2 The REB Chair or designate may review by delegation minimal risk changes that pose no threat to participant safety or welfare.
2.5 Adverse Event Reports
2.5.1 The REB Chair or designate may review by delegation reports of unanticipated problems including adverse events and safety updates (see Policy: Adverse Event Reporting);
2.5.2 The REB Chair may, based on consideration of reports, call a Full Board or sub-committee meeting too address and determine what action needs to be taken.
2.6.1 Delegated review procedures may be used to address amendments, changes
and notifications including the following (see Policy: Amendments/Changes/Notifications):
- Recruitments tools;
- Participant materials;
- Protocol deviations;
- Translations of English documents previously approved by the REB;
- Investigator correspondence;
- REB minutes that have been contingently approved by the REB.
2.7.1 The type of REB review will be documented on the review (See Policy: Documentation), on the approval letter sent to the investigator and in the Research Office (see Policy: Corespondance with Investigators).
- Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Chapters 2 & 6.
- ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996. Section 3.
- World Health Organization (WHO). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011. http://www.who.int/ethics/publications/research_standards_9789241502948/en/index.html
- Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT)