What if my research plans change after I receive approval from the IRB?
The IRB requires prompt reporting of changes in research activities, and will ensure that investigators do not implement proposed protocol changes without prior IRB review and approval, except when necessary to eliminate apparent immediate hazards to subjects. It’s useful to distinguish two types of changes in research plans: (1) Those that change the level of risk to the research participants – substantive changes -- and (2) those that do not affect level of risk – minor changes.
a) Substantive changes in protocol which may change the level of risk to human subjects involved in the project must be reported immediately to the IRB. Such changes may include but are not limited to:
- categories of participants to be recruited (e.g., minors or vulnerable populations not included in the original, approved application);
- in the case of vulnerable (“protected”) categories, any and all changes are defined as substantive; for example, adding “state prison inmates” to a protocol in which the approval was for a study of “county inmates” is a substantive change.
- recruitment methods that were not enumerated in the approved application;
- adding or dropping incentives for participating;
- methods of collecting data (e.g., adding interviews, electronic recordings, etc.) that were not part of the approved application;
- methods that supplant the investigator’s original responses to application items concerning deception, offensive materials and interactions, psychological/social/physical/legal risks to participants, or collection of personal/sensitive information;
- consent documents;
- plans for securing and maintaining confidentiality of data.
Any such changes must be re-reviewed and approved by the IRB before being implemented. To communicate such changes, investigators will send a request to the IRB chair or designee via the Mentor Amendment system, in which they
1. list each planned protocol change,
2. state the exact wording of the original plan that the change will replace, and
3. give reasons for the change.
Within two weeks after the proposed change is approved, investigators must forward an amended application to the IRB chair for the file.
b) Changes to eliminate apparent and immediate hazards to research subjects. In this exceptional case, changes in protocol are to be reported to the IRB immediately.
1. The investigator(s) will suspend administering the protocol to other research subjects so the precipitating episode may be documented and discussed.
2. The investigator will notify the IRB chair or a designee as soon as is feasible but in any event within 24 hours of the episode that prompted the protocol change.
3. Protocol administration will remain suspended until the investigator(s) receive written approval from the IRB that it may be resumed.
c) Minor changes to protocol that do not affect the level of risk to human subjects involved in the project must be reported to the IRB. Such changes, which in the opinion of the investigator, do not involve increased risk to human subjects, might include these:
- rewordings of scripts, consent forms, or questions to improve clarity, and spelling corrections in consent forms;
- new questionnaire/interview items that do not supplant the investigator’s original responses to application items concerning deception, offensive materials, psychological/social/physical/legal risks to participants, or collection of personal/sensitive information;
- using different media for administering research materials (e.g., switching from paper-and-pencil to online questionnaires) than were approved in the original application
- recruiting individuals who are in the same non-protected risk category as those in the original recruitment plan, but who were not enumerated in that plan (e.g., new courses or organizations).
To report such changes to the IRB, investigators should attach a list of all amendments and copies of the amended documents to the chair via the Mentor Amendment system. The report is due within two weeks after data collection for the approved project is complete or by the project expiration date, whichever comes first.
Any change that investigators acting in good faith cannot clearly define as minor should be reported to the IRB for follow up review and approval, as described in a) Substantive changes (above). The IRB strongly encourages investigators to contact the chair or designee with questions about these judgments.