When conducting research projects there are times that changes may be required for the research study to proceed. As a general rule, if there are any changes or updates in any information previously provided to the IRB, this information would need approved by the IRB before any changes can be implanted. The Medical/Behavioral Protocol Amendment Form was designed to allow the principal investigator (PI) to provide the specific detail(s). Examples of items that would be included as an amendment:

1. Changes/additions of the PI, Co-Investigator and key personnel,
2. Changes/additions to advertisements/notice/flyer
3. Changes/additions to the consent/assent form/information sheet
4. Changes/additions to the Investigator’s Brochure/package insert
5. Changes/additions to the protocol including administrative changes, study design, enrollment criteria, data collection methods, and risk/benefit ratio
6. Submission of Data safety monitoring reports/minutes
7. Submission of interim reports and/or analysis

When requesting changes to PI, Co-Investigators, and key personnel, it is a requirement that all persons have completed the WSU HIC training program or equivalent. All faculty who will have access to the research participants or their data should be listed as co-investigators. Anyone else who will be responsible for the design and conduct of the study and will be interacting with human participants or have access to personally identifiable data should be listed as key personnel. When changes occur within a department, please update the protocol to reflect all persons who may have access to the study. To make changes in PI, the original PI should submit the amendment with the request for a change in PI. All contact information for the new PI should be submitted with amendment form.

Any changes to the informed consent must take into account both prospective research participants and if applicable, research participants already enrolled in the study. When the modifications in a protocol may influence whether or not a participants wishes to remain in the study, provisions should be made to communicate this information to them as soon as possible. All consent/assent form changes must be submitted with the changes highlighted. If there is an additional consent added to the protocol, justification for the additional should be clearly stated in the amendment form. Consent forms must have a submission/revision date in the footer.

When changes are made to the design or concept of the protocol it could be to the administrative design, study design, enrollment criteria, treatment, data collection methods and risk/benefits. These changes should be reflected under the protocol section on the amendment form. For changes to an industry-sponsored protocol, please highlight all changes in the revised protocol and provide a brief summary describing the amendments to the protocol. For investigator-initiated protocol, please describe the proposed changes and provide justification for the change.

Amendments that constitute minimum risk, one that changes would not affect the assessment of the risk/benefit ratio or does not substantially change the specific aim or design of the study, can be reviewed under expedited process. Examples of changes that may qualify for expedited review include additions of activities that qualify for exempt or expedited review per the federal guidance, an increase/decrease in participant enrollment that is justified, narrowing of inclusion criteria, broadening exclusion criteria, increase in study visits for safety reasons, addition/deletion of qualified co-investigators or key personnel, or minor changes that were specifically requested by the IRB. Review of expedited amendments is normally completed in approximately 10 working days. If the HIC Chair, IRB, or his/her designee determines that the proposed change in more than minimal risk, the amendment will be sent for a full board review. The PI will be notified and the required number of copies needed for a full board review must be submitted to the HIC for proper review.

Any change that affects the assessment of the risk/benefit ratio or substantially changes the specific aims or design of the study is considered more than minimal risk. Examples of major changes that would require full board review include broadening inclusion criteria, narrowing exclusion criteria, deletion of visits that may effect safety evaluations, addition of risk to informed consent, alterations in dosage or route of test administration. Full board review is required for amendments that constitute more than minimal risk and must be reviewed at the next convened meeting of the IRB originally assigned to review the protocol. All submissions for full board review must meet submission deadlines, see the HIC website: http://www.hic.wayne.edu/hicsub.html.

Without approval of an amendment by the IRB, it is not acceptable to change an IRB approved research protocol or consent form to permit enrollment of a specific individual who does not meet the current eligibility criteria or to gain access to a research protocol.

The only exception to this rule is when a change is necessary to prevent immediate hazard to given research participants. When this occurs, the PI must submit a request for an amendment subsequent to the occurrence to make the protocol consistent with the changes. The PI must provide justification as to why it was necessary to make these changes prior to receiving IRB approval.

If you have further questions you can contact the HIC Education Coordinator, Patti Webber, RN at (313) 577-9534 or email her at pwebber@wayne.edu.

–Patti Webber, HIC