Guidelines for submitting AMENDMENTS to the Research Ethics Board (REB)
DO NOT SUBMIT THIS PAGE
ALL new information and changes to research protocols or information/consent documents, advertisements, study instruments etc. must undergo REB review and approval prior to implementation, except where necessary to eliminate immediate hazards to study participants. Amendments must be submitted in such a way that changes to the risks and benefits for the participant and rationale for the changes are clearly described (i.e. in a summary table of changes).
SUBMISSION PROCEDURES
Delegated
Amendments submitted requesting delegated review may be submitted to the Research Ethics Office (REO) at any time. The REB Chair/delegate may at any time direct a delegated review request to the full board for review.
Full Board
Amendment submissions requiring full board review must be received by the REO no later than 4:00 pm on the 15th of the month for consideration at the REB meeting held the following month.
Health Canada Regulated research
If Health Canada approved the original protocol, either an amendment or notification must be filed with Health Canada as per the following requirements:
Amendment: when the proposed changes:
· affect the selection, the criteria for selection, monitoring, or dismissal of a clinical trial subject
· affect the evaluation of the clinical efficacy of the drug
· alter the risk to health of a clinical trial subject
· affect the safety evaluation of the drug
· extend the duration of the clinical trial
Notification: when the proposed changes include:
· changes to the protocol that do not affect the safety of trial participants (as outlined above);
· information on site closure of completion of the Clinical Trial;
· discontinuation of the Clinical Trial in its entirety or at any clinical trial site for reasons not related to the safety of participants (i.e. administrative, lack of recruitment etc.); and
· changes to Quality (Chemistry and Manufacturing) information that do not affect quality or safety of the drug
Externally sponsored clinical trial amendments will not be reviewed by the REB until the “no objection letter” or “investigational testing authorization” has been received.
Sunnybrook Investigator- initiated clinical trial amendments should be submitted to the REB prior to submission to Health Canada. Final REB approval of the amendment will not be granted until the “no objection letter” ,“investigational testing authorization” or “notice of authorization” has been received and acknowledged by the REB.
Research Ethics Board (REB)
AMENDMENT SUBMISSION FORM
Refer to the appended submission guidelines on page 1 before completing this form.
A separate form must be completed for each study.
Principal Investigator (PI):
REB Project Identification Number (PIN):
Full Study Title:
Provide 1 copy of each document (as applicable).
Attached / Pending / N/A / DocumentNote: If the Study Title is changed, a revised copy of each document containing the study title must be submitted as part of the amendment. / Version Date
dd/mmm/yyyy
Completed, signed and dated Amendment Request Form
Summary of proposed changes with rationale
Amended Protocol
Both tracked change and clean copy of revised Consent Form – main study
Both tracked change and clean copy of revised Consent Form – other (i.e. tissue)
Updated Investigator Brochure (IB) / Product Monograph
Drug name(s):
Revised Questionnaire(s)
Revised Participant Diary(ies)
Revised Participant Materials
List:
Health Canada No Objection Letter (NOL) / Investigational Testing Authorization (ITA) / Notice of Authorization (NOA)
Letter indicating change in PI signed by both outgoing and incoming PI. Attach a revised consent form reflecting the change.
Other (e.g. wallet card, advertisement, telephone script)
List:
1. Type of REB review requested. (Final decision rests with the REB Chair.)
Delegated Review Full Board Review
2. Does this amendment require a re-submission to Health Canada?
No
Yes (Refer to appended guidelines)
3. Will there be any increase in risk, discomfort or inconvenience to the participants?
No
Yes If YES, provide details:
4. Indicate how the proposed changes will affect the conduct and the participants of the study, in the table below (check ALL that apply):
PROTOCOL
§ Study objectives, statistical analysis, design or methods
§ Study instruments, questionnaires etc.
§ Number of participants
§ Participant recruitment methods
§ Eligibility criteria (inclusion/exclusion)
§ Risks / benefits
§ Alternatives
§ Study end date
§ Principal and/or Co-Investigators
§ Other (i.e. study title), specify:
CONSENT FORM: Indicate the follow-up action for participants already enrolled in the study (check all that apply)
§ Inform study participants verbally ASAP
§ Re-consent participants with the revised consent/assent forms once approved
§ Other, specify:
§ No action required
INFORMATION SHEET
ADVERTISEMENT AND RECRUITMENT MATERIALS
Specify:
ADMINISTRATIVE
§ Change in Sponsor name
§ Change in contact information
§ Change in Principal Investigator
§ Change to contract
§ Other (i.e. questionnaires, participant diaries, wallet card, participant materials), specify:
5. Is this an Industry-Sponsored/Supported study?
No If NO, proceed to question 6.
Yes If YES, complete the table below.
A fee of $500 Cdn is invoiced for all Industry-Sponsored/Supported Studies applying for review of an amendment.
Invoice to the Following Company:
Contact Name:
Telephone: / E-mail:
Street Address: / Suite:
City: / Province/State:
Country: / Postal/Zip Code:
6. Person completing this form.
Title: / First Name: / Last Name:Dept/Div: / Institution:
Full Address: / Room Number:
Telephone: / Extension: / E-mail:
7. Statement of Principal Investigator (PI).
I have assessed the safety implications of this amendment and its impact on the study procedures. I understand that this amendment must undergo REB review and approval prior to implementation, except where necessary to eliminate immediate hazards to study participants. I assume full responsibility for the scientific and ethical conduct of this study and agree to conduct this study in compliance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Human Subjects (TCPS), Personal Health Information Protection Act (PHIPA) and any other relevant regulations or guidelines. I certify that all researchers and personnel involved in this study at this institution are appropriately qualified and trained to fulfill their role in this study.______
Signature of Principal Investigator Date (dd.mmm.yyyy)
Version Date: 02 October 2009 Page 1 of 3
Sunnybrook Health Sciences Centre REB – 2075 Bayview Avenue, Room C819, Toronto ON M4N 3M5
Tel: 416-480-6100 ext. 4276 or 88144 Fax: 416-480-5385 Homepage: http://sunnybrook.ca/research/?page=reohome