HAMILTON INTEGRATED RESEARCH ETHICS BOARD (HIREB)
AMENDMENT REQUEST
INSTRUCTIONS
N.B. ALL changes to research protocols or information/consent documents, advertisements, study
instruments, etc. must have HIREB 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:
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The old wording is clearly identified (for example, bolded strikethrough text).
The new wording is clearly identified (for example, italicized grey-shaded text).
It is clear why each amendment has been made.
The amendment can be evaluated in context. Supply a copy of the protocol showing tracked
changes or provide a Summary of Changes.
It is clear whether each amendment increases risk or discomfort for the participant in any way.
Please submit:
 One copy of a typed completed Amendment Request Form (attached) with original signature of the
Locally Responsible Investigator.
 A cover letter (synopsis) from the Investigator is mandatory unless the amendment is very minor.

For changes to existing documents:
o One copy of any amended document containing the proposed changes (e.g. protocol, information
sheet/consent form, drug or device brochure, advertisement, study instrument, questionnaire, etc.).
Ensure that all revised documents have a new version # and version date.
o A detailed explanation/justification for each change.
o If the information/consent forms or recruitment advertisements have been changed, provide one “clean”
copy of amended document(s).
o Health Canada Therapeutic Products Directorate (TPD/HCNOL) approval:
 If TPD/HCNOL approved the original protocol, then TPD/HCNOL approval is also
required for this amendment. We CANNOT accept the amendment without the
TPD/HCNOL approval.
o For new documents:
o One copy of any new document (e.g. protocol, information sheet/consent form, drug or device
brochure, advertisement, study instrument, questionnaire, etc.).
o An explanation / rationale for the newly added document(s) must be provided.
Submit the Amendment Request form, together with supporting documentation to the address noted
below. (DO NOT FAX OR EMAIL):
Hamilton Integrated Research Ethics Board
293 Wellington Street N., Suite 102
Hamilton, ON L8L 8E7
Attn: Anna Hoover
905-521-2100 ext. 44406
HIREB Amendment Form
Version October 2015
HAMILTON INTEGRATED RESEARCH ETHICS BOARD (HIREB)
AMENDMENT REQUEST
1. Locally Responsible Investigator and contact information:
2. Research Project Title:
3. REB Project #:
4. Please list the NEW version number and version date of ALL documents being submitted for approval:
NOTE: THIS SECTION MUST BE COMPLETED.
 IF YES
5.
PROPOSED CHANGES AFFECT:
(a)
PROTOCOL (If you are submitting a protocol amendment we ask that you attach either a
Summary of Changes or a detailed outline of each revision and the rationale)
 Study objectives, statistical analysis, design or methods
 Study instruments, questionnaires, etc.
 Number of participants
 Participant recruitment methods
 Eligibility criteria (inclusion/exclusion criteria)
 Study end date
 Principal and/or co-investigators:
If PI is changing, include a letter signed by the outgoing PI and the incoming PI indicating they
both agree to the change. Attach a revised consent form which reflects the change of PI/Co-I.
 Health Canada Therapeutic Products Directorate (TPD/HCNOL) approval:
If TPD/HCNOL approved the original protocol, then TPD/HCNOL approval is also required for
this amendment. We CANNOT accept without the TPD/HCNOL.
Copy of HCNOL Attached [ ].
 Other
CONSENT FORM
INFORMATION SHEET
ADVERTISEMENT AND RECRUITMENT MATERIALS
ADMINISTRATIVE
 Change in name of Sponsor
 Change in contact information
 Other (specify)
OTHER (specify)
(b)
(c)
(d)
(e)
(f)
6. Will there be any increase in risk, discomfort or inconvenience to the participants?
If YES, provide detailed explanation/justification.
[
] YES
7. What follow-up action do you propose for participants who are already enrolled in the study?
Check [  ]:
[ ]
Inform study participants ASAP
[ ]
Re-consent participants with the revised the consent/assent forms (append)
[ ]
Other (please describe)
[ ]
No action required
_____________________________________________
Signature of Locally Responsible Investigator
HIREB Amendment Form
Version October 2015
______________________
Date
[
] NO