What's New   (vol. 2)

1. Changes to Health Records Impact Forms
   
   Health Records Impact Form NO longer required when:
   1. Source records for clinical trials/studies are found in vOacis
   2. Health Records is not involved in paper chart retrieval; data extraction; compilation of data; or report writing
   
   Health Records Impact Form IS required when:
   1. You require chart retrieval
   2. Health Records needs to determine a cohort or create a script for your chart review project
   
   Data Warehouse, Decision Support and Performance Measurement
   
   If you require these services you will need to obtain a separate signature from Decision Support. The appropriate form and contact information can be found on our website.
   
   
2. Health Canada Research Ethics Board Attestation (REBA) Form will no longer be signed by the OHSN-REB
   
   In the past the REB signed the REBA form for Health Canada regulated clinical trials to confirm our compliance with the following three statements.
   
   1. The membership of this Research Ethics Board complies with the membership requirements for Research Ethics Boards defined in Part C Division 5 of the Food and Drug Regulations;
    
   2. This Research Ethics Board carries out its functions in a manner consistent with Good Clinical Practices; and
   
   3. This Research Ethics Board has reviewed and approved the clinical trial protocol and informed consent form for the trial which is to be conducted by the qualified investigator named above at the specified clinical trial site. This approval and the views of this Research Board have been documented in writing.
   
   In order to avoid additional paperwork for both the investigators and the OHSN-REB, our letters will now include the following statement thus removing the need for completion of the REBA form:
   
   OHSN-REB complies with the membership requirements and operates in compliance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans; the International Conference on Harmonization - Good Clinical Practice: Consolidated Guideline; the provisions of the Personal Health Information Protection Act 2004; and the Food and Drug Act of Health Canada and its applicable Regulations.
   
   The OHSN-REB has reviewed and approved the clinical trial protocol and informed consent form for the trial which is to be conducted by the qualified investigator named above at the specified clinical trial site. This approval and the views of this Research Ethics Board have been documented in writing.
   
   
3. TCPS 2 is being revised
   
   The Panel on Research Ethics has proposed revisions to the TCPS 2 document. They are currently in the consultation phase and are looking for comments from its users. The deadline to comment is January 15, 2014.
   
   Types of Changes:
   1. Clarification
   2. New Guidance
   3. Harmonization – Clinical Trials
   4. Integration – Stem Cell Guidance
   
   The proposed revisions can be found at www.rcr.ethics.gc.ca and your written comments can be sent to secretariat@rcr.ethics.gc.ca.

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