Amendment & Revised Consent Form

1 Hospital Court Oshawa, ON L1G 2B9

AMENDMENT / REVISED CONSENT FORM

All revisions, additions or deletions to approved studies are considered amendments, and must be submitted by the PI to the Research Ethics Board for review and approval that the research remains scientifically and ethically sound. Refer to Guidelines for Submitting Amendments/Revised Consent. Full Study Title:

Principal Investigator:

Telephone #: Cell/Pager #: Fax #: Email: ( ) - ( ) - ( ) -

DOCUMENTS ATTACHED:

Amendment (Amended Protocol) Date and Version #:

Revised Consent Date:

Study Participant Material (eg. patient wallet card, poster):

REB Initial Approval Date of Study:

# of patients enrolled since REB approval: Study Status (Open to Accrual or Closed to Accrual): Amendments since REB approval:

Amendments involve changes to (check all that apply): GENERAL INFORMATION BENEFITS/RISKS Study Potential Benefits of the Study Principal Investigator Known/Anticipated Risks of the Study Research Team Members Procedures for Risks in Place Conflict of Interest INFORMATION/CONSENT PROCESS Budget Informed Consent/Absence of Consent Impact Assessment (programs/fees) Process for Parental/Guardian Consent STUDY SUMMARY Process for Withdrawal of Consent Purpose/Rationale/Objectives CONFIDENTIALITY Methodology/Design Procedures to Ensure Confidentiality Dosage/Procedures OTHER (specify) Sample Size Inclusion/Exclusion Criteria Recruitment Process Amendment/Revised Consent May 2013; May 2014; Feb 2015;Oct2015 Page 1 of 3 LAKERIDGE HEALTH – RESEARCH ETHICS BOARD

1. For each amendment and/or revised consent and/or study participant material:

(a) briefly explain the rationale:

(b) how the amendment and/or revised consent and/or study participant material will affect the study:

(c) attach the revised consent form document with tracked changes

(d) attach a clean copy of the revised consent on LH letterhead

2. If study subjects need to be informed of changes related to the amendment and/or revised consent and/or study participant material, describe how and when study subjects will be informed:

3. Does this study involve investigational drugs or devices: No Yes. Complete questions below.

(a) Does this study involve any of the following (check all that apply): Investigational new drugs Investigational biologics Investigational natural health products Investigational medical devices Approved drug for a new indication (e.g., new age group, disease entity)

(b) If the amendment involves any of the above, is a “No Objection Letter” or authorization letter from Health Canada attached?

YES: Health Canada “No Objection Letter” is attached.

(c) Provide FDA IND number (drug studies): or PMA number (device studies):

Amendment/Revised Consent May 2013; May 2014;July 2014;Feb/15;Oct/15 Page 2 of 3 LAKERIDGE HEALTH – RESEARCH ETHICS BOARD

Principal Investigator Declaration:

I accept the amendments as submitted. I have assessed the safety implications of the amendments and the impact on study procedures, and am prepared to take all necessary steps to implement the changes.

Signature of Principal Investigator or Designate Date

*************** FOR RESEARCH ETHICS BOARD USE **************

This Research Ethics Board is organized and operates in compliance with the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans Version 2 (TCPS), ICH/GCP Guidelines and Pact C, Division 5 of the Food and Drug Regulations of Health Canada.

The above-noted amendment and/or revised consent were reviewed and approved by the Research Ethics Board at/by:

A Full Board Meeting The Chair with Notification to All Board Members

Date:______

Signed: ______John Montgomery, BA, LLB OR Andy Benson, BSc, AEMC, ACP Chair, LH-REB Vice-Chair, LH-REB

LHREB approval released on:______

Amendment/Revised Consent May 2013; May 2014;July 2014;Feb/15;Oct/15 Page 3 of 3