Modifications to an Approved Protocol

Requesting a Modification or an Addendum to an Approved Protocol

After receiving the written approval from the NU IRB to begin a research project, investigators must follow the protocol procedures and use only the versions of the recruitment materials, consent and assent forms and study instruments as approved and on file at the Office of Human Subject Research Protection. However, if you need to make changes to the study, you may do so by requesting a modification in writing to the Office of Human Subject Research Protection (45 CFR 46.110(b)(1)(ii)). The modification must be approved by the NU IRB before you institute the change.

Modifications that require approval include, but are not limited to, changes in Principal Investigator (PI), inclusion/exclusion criteria for subjects, sites of study, recruitment strategy, consent and authorization process, informed consent document, questions on survey/interview/focus groups, testing procedures, confidentiality measures, or safeguards for participants. Conducting a study with unapproved procedures invalidates the approval status.

To request approval for a change, address a memo to the Office of Human Subject Research Protection that states:

  1. Subject line: Request for Modification
  2. PI name and contact person
  3. Date
  4. Project title and IRB #
  5. Describe the requested modification and the reason for the change
  6. State whether this change affects the level of risk to the participant
  7. If the level of risk is increased, explain the extent of the risk and what procedures will be instituted to minimize it. Explain whether the risk affects current or only future subjects. Make appropriate changes to the consent document. The new consent must be approved as well.

Note: Minimal changes are approved by expedited means and involve little time. Most changes fall in this category. However, if modifications are significant, they will be reviewed by the full IRB.