OFFICE FOR PROTECTION OF HUMAN SUBJECTS
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Protocol Modification Procedures
All modifications to currently approved research are required to have CPHS/IRB review and approval prior to implementation. Minor changes that do not increase the risk to research subjects may receive an expedited review. A “minor change” is a change in a CPHS-approved human subject research protocol that does not increase the risk or decrease the potential benefit to the participants or result in substantial changes to the protocol. The OPHS will determine if the change is “minor” or “substantial” and may do so in consultation with the appropriate panel chair. Significant or substantial changes to approved protocols that may affect the risk to subjects may be forwarded to the full CPHS/IRB for review. Changes in the risks or benefits to subjects may require modifications to the consent form and re-consenting of subjects. Please submit the Protocol Amendment/Modification Form explaining the requested modifications, and any modified items such as consent forms, protocols, investigator brochures, study instruments, recruitment tools, etc.
The CPHS/IRB may only approve modifications submitted during a current approval year to the end of that period. For example, if the new, renewal, or continuing approval is issued on January 1, 2007 it will have an expiration date of December 31, 2007. If an addendum is approved during this time, the approval still lasts only until December 31, 2007. NOTE: All modifications and addendums must be incorporated into the continuation application, protocol, and when applicable the informed consent forms for CPHS/IRB consideration during the annual review.
Application Form:
To complete the application, download it to your computer by clicking the above link. Using your word processesor, enter your responses directly into the document. Submit two signed copies to the OPHS. Students must obtain their faculty advisor's signature in addition to their own.
Changing Investigators:
When changing investigators, please include a Protocol Amendment/Modification Form and a letter from the principal investigator (PI) indicating the change in responsibility and a letter from the new investigator accepting the responsibility for the research. Changes in investigators usually qualify for expedited review.
Checklist for Modification Submissions:
This check-off list is to assist you in submitting a complete addendum application to the CPHS/IRB. Please note that an incomplete submission may delay the process of your application. Please submit two complete sets (original and one copy) of the following required and applicable materials:
REQUIREMENTS:
_____ Complete Protocol Amendment/Modification Form
_____ Principal investigator's signature
IF APPLICABLE:
____ Copy of the new grant proposal clearance form or proposal clearance number, if the addendum is for additional funding only
____ Amended/modified informed consent forms
____ Modified protocol (or summary detailing modifications)
____ New instruments/contact documents