Yale University
Human Investigation Committee
Request for Approval of Amendment of a Biomedical Protocol
100 FR 6 (2016-1)
HIC Protocol Number: __________
Date: __________
Title of Research Project: __________
Name of Principal Investigator: : __________
*Faculty Advisor, If applicable __________
Signature of Principal Investigator: __________
*Principal Investigators who are students and trainees must have the guidance of a Faculty Advisor. Faculty
advisor must be full time Yale Faculty member and listed on this form.
Phone:
E-mail:
Correspondent Name:
E-mail:
Phone:
Yale Cancer Center CTO Correspondent (If applicable)
Phone:
Name:
Instructions to Investigators: A research protocol must be carried out in accordance with the protocol as
approved by the HIC. Any changes in the protocol, including but not limited to changes in subject population,
dosage, recruitment activities, advertisement material, funding, study procedures, study instruments, study
sites or research personnel must be approved by the HIC prior to implementation. If applicable, include the
sponsor’s amendment summary, as well as any other supporting information that may prompt this
amendment request (i.e., DSMB report, sponsor letter, unanticipated adverse event, etc.). Formatting:
Documents should contain a version number and date for ease of identification. If you are amending a
protocol, consent form(s), parental permission form and/or study information sheet(s), please update the
version number/date on all affected documents. To facilitate the review process, use Microsoft Word track
changes while you are revising your document; this will track each insertion, deletion, or formatting change
that you make to the document.
1.
☐PI
2.
Amendment requested by:
☐Sponsor (Include a copy of correspondence from Sponsor outlining rationale for changes)
New Sponsor Protocol Version and Date (if applicable): __________
3.
Does this amendment include any changes that were previously approved via a prospective
protocol modification procedure? ☐ Yes ☐ No
If YES, EXPLAIN WHAT WAS PREVIOUSLY APPROVED: __________
4.
Will the change add a billable service? ☐ Yes ☐ No If yes, see the HIC application instructions.
5.
Is the study still open to enrollment? ☐ Yes ☐ No
6.
Number of subjects currently receiving study intervention: __________ ☐ NA
7.
Will changes affect the risk to subjects enrolled in the study? ☐ Yes ☐ No
8.
In the Investigator’s opinion, does this amendment require that subjects be re-consented?
☐ Yes ☐ No
If the Investigator believes reconsent is necessary, answer the following:
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Which group of subjects will be reconsented?
☐ On Treatment/Study ☐ Off treatment
☐ In follow up
☐ All, even those who completed the study
☐ Other: __________
Method of reconsenting (check all that apply):
☐ Revised consent
☐ Revised assent
☐ Verbal/phone call with note to file
☐ Consent addendum
☐ Other: __________
Proposed time of reconsent:
☐ At their next study visit
☐ As soon as possible
☐ Other: __________
Note: If this amendment is a substantive change to a grant that supports this research, it may require
approval from your Project Manager prior to implementation.
Summary of Protocol Changes: Please explain what modifications are being proposed at this time, and why
the modifications are necessary. Compare the modifications to the currently approved protocol and explain their
necessity as well as their effect, if any, on the risks and benefits to subjects. Use the Microsoft Word track
changes feature to indicate the addition and removal of information in the body of the document. Please note in
this box the document name, page and section number or title where the changes have occurred. If the sponsor
provided track changes and a rationale, an explanation in this section is not needed.
Summary of changes to the Consent/Other Research Documents: Describe changes to the consent
form/assent form/recruitment materials. Explain which sections of these materials are being changed, and use
the Microsoft Word track changes feature while you are revising your document. Please note in this box the
document name, page and section number or title where the changes have occurred.
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