Adverse Event Reporting
Adverse Event Reporting
|Department||Applied Educational Research|
|Creation Date||February 18, 2011|
|Approval Date||February 18, 2011|
|Effective Date||February 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 define the limitations of a reportable event and describe the process for reporting adverse events to the Research Ethics Board (REB).
Adverse Event: Any event associated with an intervention that is:
- Usually unanticipated
- May or may not be considered related to the intervention
Reportable Event: An adverse event that is unanticipated. An event or issue that increases the risk to participants or has ethical implications. (CAREB, AE Guidance 2010).
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.
As per TCPS 2, Article 6.15, “Researchers shall report to the REB any unanticipated issue or event that may increase the level of risk to participants, or has other ethical implications that may affect participants’ welfare.”
Minor deviations from the research that do not increase risk to participants or have ethical implications need not be immediately reported and may be summarized in annual status reports.
This Policy applies to the Chair, members of the Research Office and/or administration, the REB and investigators.
2.1 Process of review of reportable adverse events
The REB will review all reportable adverse events in the following manner:
2.1.1 Investigators will submit (see Policy: REB Submission Requirements and Administrative Review) within 15 calendar days any reportable adverse events associated with their research projects to the REB for review via the Adverse Event Reporting Form (FORM 4);
2.1.2 The Investigator will not implement any amendments or changes to their research project associated with the adverse event until the REB has reviewed the adverse event report and approved any associated amendments/change request(s) unless the amendment/change eliminates an immediate hazard or the change involve only logistical or administrative aspects of the study (see Policy: Amendments/Changes/Notifications);
2.1.3 In cases where the investigator has implemented an amendment/change associated with an adverse event meant to eliminate an immediate hazard, the REB must be notified immediately;
2.1.4 The REB Chair will determine the degree of scrutiny required for review of the adverse event;
2.1.5 For adverse events that involve minimal risk and are minor, a delegated review may be carried out;
2.1.6 For adverse events that involve greater than minimal risk and are not minor deferral to the Full Board for review may occur and actions may be taken such as:
- suspension of enrolment;
- suspension of research procedures on currently enrolled research participants;
- modifications to study protocol, informed consent documents;
- implementation of additional procedures for monitoring;
- requiring additional training for investigators and/or research staff;
- providing additional information about newly recognized risks to previously enrolled and current participants;
- requiring current participants re-consent for ongoing participation;
- altering the schedule for continuing review;
- observing research and informed consent processes;
- termination of the research.
2.1.7 The REB will apply the minimal criteria for approval of research to all amendments, changes and notifications submitted for consideration (see 2.1 Minimal Criteria for Approval of Research” Procedure section of Policy-REB Initial Review);
2.1.8 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 adverse event reports and associated amendment/change submissions and respond in writing to the investigator (see Policy: REB Communication with Investigators).
- Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Chapter 2, 6.
- ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996. Section 3, 4.4, 4.5, 4.10, 4.11, 4.12
- Canadian Association of Research Ethics Boards (CAREB). Guidance on Reporting of Unanticipated Problems including Adverse Events to Research Boards in Canada 2010.
- World Health Organization (WHO). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011.
- Canadian General Standards Board. Research ethics oversight of biomedical trials 2010. (DRAFT) 4.4.5, 4.4.6.