REB Communications with Investigators
REB Communications with Investigators
|Department||Applied Educational Research|
|Creation Date||May 6, 2011|
|Approval Date||May 6, 2011|
|Effective Date||May 6, 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 how the Research Ethics Board (REB) and Research Office will communicate with investigators.
The REB is committed to promoting participant protection and ethical conduct for all research endeavours carried out at The Michener Institute. The REB will make every effort to foster and maintain a confidential, collaborative line of communication with investigators. In appreciation of the REB dual role of research review and education (see REB Terms of Reference), the REB will endeavour to assist researchers appreciate the scientific and ethical requirements required for research being carried out at The Michener Institute.
This policy applies to The REB Chair, members of the REB and Research Office and/or administration. The REB Chair will assume responsibility for all official correspondence with investigators related to submissions and projects at The Michener Institute.
2.1 All Communications
2.1.1 The REB Chair or designate will assume responsibility for all official correspondence with investigators (see Policy: REB Signing Authority);
2.1.2 The REB Chair or designate will respond to requests, questions and comments within an acceptable time frame (see AER Service Standards);
2.1.3 The REB Chair or designate will document all communications with investigators and maintain this record on file in the Research Office (see Policy: REB Documentation);
2.1.4 All Official REB correspondence between investigators and the REB will include the following information:
- Unique project identification number;
- Full study title of the research project in question;
iii. Name and contact information of the investigator;
2.2 Notification of REB Decisions
2.2.1 Investigators will be notified of the decisions made by the REB in writing within as practicably expeditious time as possible regarding but not limited to:
- New studies;
- Amendments/changes to currently approved studies;
iii. Continuing reviews;
2.2.1 Notifications for amendments/changes, continuing review and non-compliance will take priority over notifications for new studies;
2.2.2 Notifications will include the following information:
- REB determinations (see Policy: REB Decision Determinations);
iii. Requests for clarification;
- Reasons for suspension/rejection/termination of approval.
2.2.3 For studies that have not received approval, require clarification or pose concerns that must be addressed the REB and/or REB Chair will review responses from investigators, request additional information and/or clarification, consult with additional stakeholders and/or sources before re-issuing any further notifications;
2.2.4 Official notifications for newly approved studies or studies where the conditions have been met will be provided in writing via the REB Approval Letter Template and will include:
- A list of all the documents approved as part of the REB submission (see Policy: REB Submission Requirements and Administrative Review);
- Information regarding continuing review;
iii. A statement prohibiting the alteration of the study or consent documents without prior approval from the REB unless required for the elimination of an immediate hazard to participants or where the changes are merely logistical or administrative in nature;
- A statement charging the investigator with maintaining compliance with all applicable guidance, laws and regulations required for the conduct of research at The Michener Institute.
2.2.5 Investigators may appeal REB decisions to reject approval or any requirement imposed as a condition for approval. (see Policy: REB Appeals);
2.2.6 Only the Full Board REB may approve a previously rejected submission.
- Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Article 6.8, 6.17.
- ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996. Section 3.4, 4.4
- 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)
AER Service Standards
REB Approval Letter Template