Protocol Modification Procedures

All modifications to currently approved research are required to have CPHS/IRB review and approval prior to implementation. All modification requests must be submitted on the most current version of the modification application.

1. TO BEGIN: Download the modification application and open it with your word processor. To fill out the application, type your responses directly into the document. Be sure to mark ALL applicable changes. Keep in mind that some changes (e.g. new funding) may also necessitate changes to the recruitment and consent documents. Please do not reformat the application or delete items.


2. ATTACHMENTS: These will be filled out only by those researchers for whom they are relevant. For example, Attachment A must be filled out by any researcher who is adding new funding to current research; researchers who are not adding funding are not required to fill out Attachment A.
   
   • Attachment A—Funding Information
   • Attachment B—Human Subjects Research Conducted Online
   • Attachment C—Use of Existing Data in Research
   • Attachment D—Use of Audio and/or Video Recording in Research
   • Attachment E—Use of Drugs, Substances, Compounds, and Biologics
   • Attachment H—Recruiting Subjects through the Psychology/Linguistics Pool
   • Attachment I—Research Personnel Qualifications and Training


3. SUBMIT YOUR APPLICATION: Submit ONE copy of your application to OPHS. You can mail your application, fax it, or drop it off in person. You may also email it as an attachment provided that either the signature page has been physically signed and scanned into a PDF file or you have 'signed' the document using a digital image of your physical signature.

Review and approval of a modification generally takes 7-10 business days. Keep these points in mind:

• Minor changes that do not increase the risk to research subjects may receive an expedited review.
• 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.
• 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 a modification is approved during this time, the approval still lasts only until December 31, 2007.
• All modifications and addendums must be incorporated into the protocol and, when applicable, the informed consent forms for CPHS/IRB consideration during the continuing review.
• When the modification involves a change of investigator, include the modification application outlining the change in responsibility for the project and signed by the outgoing Principal Investigator (PI); in addition, include an Investigator Agreement signed by the new PI.