Yale University Institutional Review Boards
HUMAN SUBJECTS COMMITTEE
REQUEST FOR APPROVAL OF CHANGE TO PREVIOUSLY APPROVED
PROTOCOL
100 FR 3 (2015-1)
Principal Investigator:
Study Correspondent:
________________________________________________
Phone/e-mail address:
Protocol Title & Number:
INSTRUCTIONS TO INVESTIGATOR
A research protocol must be carried out in accordance with the protocol approved by the
Committee. Any changes in the project including subject population, recruitment plans,
research procedures, study instruments, study sites, or research personnel must be
approved by the Committee prior to implementation.
For exempt protocols – Only certain modifications (see Exemption Guidance, 100GD9)
in exempt protocols must be submitted to the IRB for review and determination that the
modification doesn’t change the status of the exemption. Use this form for those changes
ONLY. For minor modifications a formal review and determination are not necessary
before implementation of the modification. However, revised (via track changes)
documents must be submitted to the HSC via email notification with an explanation of
the changes.
1. Document Change Description (check all as appropriate):
______ Change to currently approved protocol
______ Change to currently approved consent form
______ Other (ads, questionnaires, surveys, etc)
2. Check one:
______ This change does not increase risks to participants enrolled in the study.
______ This change does increase risks to participants enrolled in the study.
3. Please explain what modifications are being proposed at this time, and why the
modifications are necessary. Explain 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
Revised 7/15