REB Amendments, Changes, Notifications

AC-AER-007
REB Amendments, Changes, Notifications
DepartmentApplied Educational Research
Creation DateJanuary 26, 2011
Approval DateJanuary 26, 2011
Effective DateJanuary 26, 2011

Organizational Scope

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.

Purpose

The purpose of this policy is to describe the process for submission and review of amendments, changes and notifications to the Research Ethics Board (REB)

Definitions

Amendment:  a permanent intentional action proposed to revise/amend/modify a previously approved research project or component of that project.

Notification:  any study update(s) that does not involve changes to a previously approved research project.

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: a change that neither increases the risk to participants, nor changes the risk-benefit ratio or the aims/design of the study.

Protocol Deviations:  any change, divergence or departure from the study design or procedures of a REB approved research protocol. (US Department of Health and Human Services)

Protocol Violation:  any change, divergence or departure from the study design or procedures of a REB approved research protocol that may affect the participant’s rights, safety or well-being and/or the completeness, accuracy and/or reliability of the study data. (US Department of Health and Human Services)

Policy

The REB adopts a proportionate approach to research ethics review including the review of amendments, changes, and notifications 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.

The REB will place greater importance on the ethical implications of the amendment(s), change(s) or notification(s), rather than the size of the amendment(s), change(s), or notification(s) in determining the degree of scrutiny required for review.

Responsibility:

This policy applies to the Chair, Investigators, members of the Research Office and/or administration, and REB.

2.0 Procedures

2.1         Process of review and approval for amendments, changes, notifications

The REB will review research amendments, changes and notifications including protocol deviations and violations in the following manner:

2.1.1      Investigators will submit as soon as reasonably possible, utilizing any appropriate form(s), any amendment(s), change(s), or notification(s) associated with their research projects to the REB for review (see Policy: REB Submission Requirements and Administrative Review).  Examples of protocol deviations include;

  1. changes to procedures meant to eliminate an immediate hazard to participants;
  2. enrolment of participants outside of the approved protocols inclusion/exclusion criteria;

iii.   medication/intervention errors;

  1. inadvertent deviation from a specific research intervention;
  2. breach of privacy and confidentiality;
  3. deviation from approved consent process.

2.1.2      The Investigator will not implement any amendments or changes to their research project until approval from the REB has been given unless the amendment/change eliminates an immediate hazard or the change involve only logistical or administrative aspects of the study;

2.1.3      In cases where the investigator has implemented an amendment/change to eliminate an immediate hazard, the REB must be notified immediately;

2.1.4      For protocol deviations investigators should provide the following information to the REB:

  1. A description and explanation of the circumstances surrounding the deviation;
  2. An explanation of how (if at all) the deviation affected the scientific integrity of the project;

iii.   Information pertaining to any increase in risk to participants;

  1. Any steps taken to correct associated problems;
  2. A plan to mitigate future issues associated with this occurrence.

2.1.5      For amendments/changes/notifications investigators should provide the following information to the REB:

  1. What aspects of the previously approved research are affected;
  2. Nature of the proposed change;

iii.   Rationale for the proposed change;

  1. Effect on risk-benefit ratio;
  2. Changes to consent process;
  3. If re-consent is required;

vii.  If participants need to be informed.

2.1.6      The REB Chair will determine the degree of scrutiny required for review of the proposed amendments or changes;

2.1.7      For amendment(s)/change(s) that involve minimal risk and are minor changes, a delegated review may be carried out;

2.1.8      For amendment(s)/change(s) that involve greater than minimal risk and are not minor changes will be deferred to the Full Board for review;

2.1.9      The REB will apply the minimal criteria for approval of research to all amendments, changes and notifications submitted for consideration (see 7.1 Minimal Criteria for Approval of Research” of Policy-REB Initial Review).

2.1.10   The REB or delegated board of record (see Policy: Use of another REB as the board of record) has the authority to suspend or terminate REB approval of any research being carried out at The Michener Institute.  (see Policy: Suspensions Terminations of REB Approval)

2.2         Documentation and Communication

2.2.1      The REB will document all review activities (see Policy: REB Documentation)

2.2.2      The REB will review amendment/change submissions and respond in writing to either approve the amendment/change or request further information. (see Policy: REB Communication with Investigators)

3.0 References

  1. Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Chapter 2, 6.

http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

2. ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996. Section 3, 4.4, 4.5, 4.10, 4.11, 4.12

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php

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

4. Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT)

5. United States Department of Health and Human Services. Protocol Deviations and Violations. NIH IRB Professional Administrators Committee Regulatory Process Work Group 2005.

http://www.genome.gov/Pages/Research/Intramural/IRB/Deviation_Violation_examples8-07.pdf

Associated Documentation

Policy:  REB Submission Requirements and Administrative Review

Policy:  REB Initial Review

Policy:  Use of another REB as the board of record

Policy:  Suspensions Terminations of REB Approval

Policy:  REB Documentation

Policy:  REB Communication with Investigators