Modifications are required for exempt studies when changes are being made that could alter the original review determination.
In addition to changes that fall outside of the exempt determination that was given [see Exempt Review guidance], below is a list of possible changes, and whether they require a modification or not.
Changes that DO require a modification
- Change of PI
- Addition of new federal funding or other external support
- Addition of active recruitment of participants such as children, prisoners, International, Non-English speakers, Pitt Medical Students, or nursing home residents
- New request for a Waiver or Alteration of HIPAA
- Change/addition of Honest Broker and/or changes to a Data Use Agreement for Limited Data Sets
- Obtaining or recording identifiable datasets or specimens from new sources
- Obtaining fetal tissue from any source
- Decreased data security measures or use of new technologies
- When collecting identifiable data, the response to the following question on the Electronic Data Management page changes from No to Yes: “During this study, will sensitive data be collected where disclosure of identifying information could have adverse consequences for subjects or damage their financial standing, employability, insurability, educational advancement, reputation or place them at risk for criminal or civil liability”
- Disclosure of a new conflict of interest (COI), either personal or institutional
- Modifications requested by the IRB at the time of determination
- New intent to submit the research data to the FDA (Requires new initial submission in PittPRO)
Changes that DO NOT require a modification
- Wording changes that do not affect the meaning of the text
- Updates to contact information for the study team
- Adding similar survey questions, interview questions, or interventions that do not increase risk.
- Increasing data security protections or adding privacy/confidentiality measures
- Number of subjects
- Changes to the study timelines in Study Design item 4
- Changes to the data analysis plan
- Changes in advertisements. Note that investigators are responsible for following IRB recruitment and advertisement policies, including those for special populations.
- A change in compensation unless a Vincent Exception was originally granted and the new amount will exceed $100.
- Updating the study team to include Pitt or UPMC affiliates, unless the changes are needed to grant access to the PittPRO application or to disclose a COI. (In Modification Information add a statement: “Needs access to the application" or "Disclosing COI”).
Note that this is not a complete list of possible modifications. This guidance may be updated over time. It is the PI’s responsibility to ensure that all applicable policies are followed and that study team members have completed all necessary education modules and that they are up to date. It is the PI’s responsibility to ensure that any necessary site permissions are obtained for any research conducted outside of Pitt and UPMC. The PI is responsible for ensuring that subjects are informed of any changes that may impact their participation.
If your proposed change is not addressed above, or you are unsure about whether or not a modification or a new protocol is needed, contact the IRB coordinator listed on the main page of the protocol. Note that submitted modifications that are determined to not affect the original exempt determination may be discarded by the IRB.
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