ONLY ONE COPY OF THIS CHECKLIST IS NEEDED!!
Directions for Amendment Submission
Any proposed modification to an HIC-approved research protocol or informed consent and authorization
document must be approved by the HIC prior to implementation of the proposed change unless there is an
urgent need to implement the change prior to HIC approval.
To determine if a protocol amendment meets the criteria for expedited review, see HIC policy #202
“Amendment to the Protocol.”
Expedited Review Submission Requirements:
1 Copy of Amendment Form with original signature(s) and when applicable:
 1 copy of the amended, revised protocol with highlighted changes
 1 copy of sponsor summary of changes (if available)
 1 copy of the revised consent/assent/information sheet with tracked/highlighted changes; and 1 clean
copy of the amended version
 1 copy of revised advertisement/flyer/educational brochure(s), etc. with highlighted changes; and 1 clean
copy of the amended version
 1 copy of any new documents (consent forms, questionnaire, etc.)
 1 copy of the revised/updated Investigator’s Drug Brochure(s)/Package Insert(s)
 1 copy of Conflict of Interest Disclosure Form for each Key Personnel, and updated CV (if applicable)
Full Board Review Submission Requirements:
4 collated packets containing the Amendment Form (one with original signature(s)), and when applicable:
 1 copy of the amended, revised protocol version with highlighted changes
 1 copy of sponsor summary of changes (if available)
 1 copy of the revised consent/assent/information sheet with tracked/highlighted changes
 1 copy of revised advertisement/flyer/educational brochure(s), etc. with highlighted changes
 1 copy of any new documents (consent forms, questionnaires, etc.)
21 collated packets containing the Amendment Form and when applicable:
 1 copy of sponsor summary of changes (if available)
 1 copy of the revised consent/assent/information sheet with tracked/highlighted changes
 1 copy of revised advertisement/flyer/educational brochure(s), etc with highlighted changes
 1 copy of any new documents (consent forms, questionnaires, etc.)
2 copies of Investigator Brochure/Package Insert (if applicable)
1 copy of Conflict of Interest Disclosure Form for each new Key Personnel, and updated CV (if applicable)
Advertisement/Notice/Flyer:
Advertisement(s) (Total per packet:
Notice(s)/Flyer(s) (Total per packet:
)
)
Consent/Assent/Information Sheet:
Consent(s) (Total per packet:
)
Parental Permission (Total per packet:
)
Assent(s) (Total per packet:
)
Information Sheet(s) (Total per packet:
)
Grant Application/Research Protocol
Investigator Brochure for a drug/device (Total per packet:
Page 1 of 6
)
Version 6/22/12
Amendment Request Form
William Beaumont Hospital
Human Investigation Committee
Phone: (248) 551-0662 Fax: (248) 551-2884 Mail Code: 104 RBS
All HIC Submission Forms must be the current form date and typed/computer generated
Section A: Principal Investigator (PI)
1.
2.
3.
4.
HIC #:
Title of Project:
Protocol #:
Principal Investigator:
Department:
Phone / Pager:
Fax:
Email address:
Mail Code or
Off-Site Address:
Form Completed By:
Title:
Phone / Pager:
Fax:
Email address:
Mail Code or
Off-Site Address:
Send additional HIC
response to: If offsite, provide email
address
N/A
None
Section B: Protocol Information
5.
HIC Approval Expiration Date:
6.
7.
Is this protocol closed to
recruitment?
Amendment originates from:
No
Yes
Sponsor
8.
Type of review requested:
Expedited (Minor changes that involve no more than minimal risk and
minor changes in approved research)
Full Board
Principal Investigator
Section C: Key Personnel
9.
Key Personnel Deletions:
(Provide names)
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Version 6/22/12
10.
Key Personnel Addition(s):
Complete table below. Provide Conflict of Interest Disclosure Form(s). CV’s (signed and dated) required
for new Investigators.
*
Division 01 = RO Hospital Employee, Division 02 = Troy Hospital Employee, Division 03= Grosse Pointe Hospital
Employee, Division 08 = Research Employee
** Research role responsibility delegation by the PI - use the following numbering system:
1 = Principal Investigator, 2 = Co-investigator, 3 = Research Nurse Manager, 4 = Research Nurse Clinician,
5 = Clinical Research Coordinator II, 6 = Clinical Research Coordinator I, 7 = Clinical Research Assistant II,
8 = Clinical Research Assistant I, 9 = Data Analysis, 10 = Data Collection, 11 = Specialist (include description),
12 = Other (include description)
*** For Non-Division 08 Employees, percentage of time during a year spent on project
Name
(Alphabetize by
Last Name)
11.
Job Title
Department
Division*
Percent of
time***
Research
Role**
Obtain
Consent
Yes/No
No
Will there be a new Principal
Investigator for the study?
Yes (New PI must sign below)
I verify that other than customary compensation for my clinical services, or the clinical services of other
investigators or staff involved with this study, no other financial arrangements have been made to provide
additional compensation. I also verify that no investigator or staff inducements, including a finder’s fee, will
be used in the conduct of this study.
I agree to take on the role of Principal Investigator for this study.
Signature of New Principal Investigator
Printed name
Title
Date
Section D: Proposed Changes
#
Category:
Description/Justification:
12.
Advertising Materials:
Please include information such as location of posting and/or name of
radio station or newspaper, the intended audience and the means by
which the information/brochure will be distributed. Any advertisements
must be submitted to Marketing/Advertising for review.
Advertisement
Notice/Flyer
Participant information/
brochure or pamphlet
Press Release
Website
N/A
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Version 6/22/12
13.
Protocol Revisions:
Administrative/editorial
Study design
Enrollment criteria
(increase/decrease in
accrual, change in sites,
etc.)
Addition of vulnerable
participants
Change in treatment
Data collection
methods
Are there any new
Risks and/or Benefits
If Yes, is this risk
minimal risk?
Please address the reason for the revision, how it will change the
study, if it will change the risk/benefit ratio and what safeguards will be
implemented to protect the study participants from additional risks, if
applicable.
If the changes, increase risk/benefit ratio, study requires full board review
No
Yes (for more than minimal risk studies requires a full board review)
If Yes, submit appropriate Appendix A, B, C
No
Yes
Yes
No (for more than minimal risk studies a full board review is
required). Submit Full board! Please call if you need clarification.
If there are any changes in
risks please list them
14.
15.
Other
N/A
Consent/Assent
Forms(s)/Information
Sheet(s):
Consent Form(s)
Parental Permission(s)
Assent Form(s)
Information Sheet(s)
Addendum to
consent(s)
N/A
Drug Brochures/Package
Insert:
Version Date:
New IB with no risk to
participants identified.
New IB with new risks
identified and consent
revised.
Additional side effects have the potential to change the risk/benefit
ratio and require full board review.
Describe proposed changes and justification.
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Version 6/22/12
16.
17.
18.
19.
20.
New IB with new risks
identified and no
consent form changes
required.
N/A
Miscellaneous:
Data Safety Monitoring
minutes / memos
Sponsor annual reports
Study on-hold
Study off-hold
Other
N/A
Does this amendment
affect currently or
previously enrolled study
participants?
How will study participants
be notified of the changes?
Will any of the changes
affect the budget?
Does this amendment
change the way the device
is being utilized or
modification to the device?
Describe proposed changes and justification.
Yes, please describe how this will affect participants
No, skip to question 18
Does not affect study participants
No participants enrolled
Will be re-consented within
(define time frame)
Number of currently enrolled participants
Number of participants in active treatment
All participants have completed research activities and there are no
possible long term effects
Patient discussion documented in research record/source documents
No
Yes (Please submit a copy of this amendment to Research Accounting)
No
Yes (Please submit the IDE letter and the amendment to Clinical
Engineering)
N/A
If available, attach the approval
notification from Clinical
Engineering & Technology
Management.
21.
Was this study initially
reviewed by Biosafety?
All studies initially reviewed by
Biosafety require the PI to send
Amendments to the Institutional
Biosafety Committee.
No
Yes (If Yes, please submit a copy of this amendment to the Biosafety
Committee)
Research Nurse Manager Signature (If you do not have a research nurse manager for your department,
please contact the Research Institute for sign off).
In signing the description of this research project, I have reviewed the project and am aware of the budget
considerations of this project.
Signature of Research Nurse Manager
Printed name
Page 5 of 6
Title
Date
Version 6/22/12
Principal Investigator
In signing this request to modify this research project, I have reviewed the changes, the delegation of
responsibility to key personnel and any associated budgetary ramifications.
Signature of Principal Investigator
Printed name
Page 6 of 6
Date
Version 6/22/12