This section of the Investigator Manual details general change requirements, editorial changes, exempt changes, analysis center changes, and changes in Principal Investigator.
General Change Requirements
You must report planned changes in a study and receive approval from the IRB prior to implementing these changes, except where necessary to eliminate apparent immediate hazards to the subjects. In the case of changes implemented to eliminate immediate hazards to the subjects, the emergency protocol changes must be reported to the IRB using a reportable event submission. See Reportable Event Requirements.
When revising previously approved documents, such as protocols, consent forms, recruitment materials, etc., use a tracked changes feature to denote all revisions. Maintain electronic copies of all documents submitted to the IRB in case revisions are required. Please note that research must continue to be conducted without inclusion of proposed changes until IRB approval of the modification is received unless the changes are necessary to eliminate apparent immediate hazards to subjects.
If revisions to a consent document are needed, the revised consent incorporating the new information must be submitted. Depending on the type of new information, a consent form addendum may be appropriate for informing currently enrolled subjects of significant new findings that may have a bearing on their willingness to continue participation in the study. The addendum to consent focuses on the new information subjects need to consider when making a decision about their continued participation in the study but avoids them having to reassess the entire consent when much of it may not be relevant to the change(s). Depending on the nature of the changes, study teams should consider whether subjects should be informed of the change orally prior to consent.
The IRB assesses each change to determine whether convened IRB review is required or if the change can be reviewed under expedited procedures (meaning the change can be reviewed by one IRB member apart from an IRB meeting). Typically, changes that can be considered minimal risk (even if the overarching study is more than minimal risk) may be reviewed under expedited procedures. For more information, see HRP 402-CHECKLIST-Non-Committee Review and HRP 313-WORKSHEET-Expedited Review.
For studies funded by NIH, certain modifications will require prior approval by NIH as outlined in NIH’s “Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval: Updated Notice.” Investigators should review this guidance located at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-128.html for information on modifications that require prior approval and the process for submitting prior approval requests.
Editorial Changes to Subject-Facing Materials
The following limited editorial changes can be made to approved study materials without prior IRB approval:
- Changes to contact point person, as long as all listed contacts are current study team members.
- Changes to contact phone number, as long as the new/updated phone number is an internal UW number.
- Changes to contact email address as long as the use of email was previously approved AND the new email is a university-approved email account [NOTE: Only secure, university-issued or approved email accounts should be used, such as @wisc.edu, @medicine.wisc.edu or @uwhealth.org accounts. Personal email accounts, such as @gmail.com, may not be used. Use encrypted email if possible.].
- Correction of typographical or spacing errors (e.g. correction of misspelled words, removal of blank spaces, reorienting the layout).
- Changes in graphics, unrelated to subject remuneration
Changes to approved study materials that do require submission of a change of protocol prior to use include:
- Changes to study materials’ text or images about subject remuneration
- Changes to the description or presentation of study activities.
- Changes to the estimated length of visits or study participation.
- Changes to content, such as adding or removing questions from a survey.
- Any change to consent documents or to the protocol.
Changes to Research Determined to be Exempt
Since some changes to research previously determined to be exempt may alter either the category(ies) under which the exemption was granted or require that the project be reviewed under a different review process, certain modifications to these applications need to be submitted as changes. For information on what types of changes need to be submitted for exempt studies, see Exemption Change FAQ Table.
Changes to Analysis Center Protocols
Analysis center studies apply to situations where the UW’s role is limited to analysis of data, samples, or images on behalf of a multi-site study. Only changes that affect procedures at UW-Madison require review and approval by the IRB. Examples of changes that affect local procedures include:
- Revisions to data transmission procedures
- Change in information associated with data, images, or samples provided to the UW-Madison or the type or source of data, images, or samples the UW-Madison will review
- Local personnel changes.
- Changes that do not directly affect the analysis center activities can be described at the time of continuing review.
- Research teams do not need to provide the revised documents (e.g., updated study-wide protocols or IDBs).
Changes in Principal Investigator
If a PI is leaving UW-Madison, changes in the PI should be reported to the IRB prior to the former PI leaving the research study, if possible. In all cases, a PI change should be submitted within 14 business days after the departure of the former PI. A change in PI cannot be addressed via the Update Personnel function, but rather requires a Change of Protocol application.
If the former PI is leaving the institution but will remain a study team member, please contact the Reliance and Navigation Team (firstname.lastname@example.org) to discuss what additional steps may need to be taken to ensure appropriate IRB oversight is in place.
If the PI (or another study team member) is leaving the UW and plans to take research data or specimens with them, there are contractual agreements that may be needed in order to share individual level human subjects research data/specimens. Please see this guidance.
Temporary changes in PI may be needed if the PI cannot provide oversight of a research study for a planned period of time (e.g., parental leave, sabbatical) or unplanned leave for a substantial period of time. For federally funded research, it is the responsibility of the PI to ensure that funding agencies are notified of any temporary changes.
In cases where the leave will be less than 6 weeks, but is assumed to be temporary, the PI is responsible either for ceasing study activities or ensuring oversight of these activities is delegated to a qualified member of the study team. The study team does not need to inform the IRB in these cases.
In cases where the leave will be 6 weeks or longer, but is assumed to be temporary, the study team should submit a New Information Report to the IRB confirming one of the following:
- Specifies the anticipated length of absence,
- No study activities will occur during the PI’s leave,
- Only activities involving data analysis will occur, or
- Identify who will assume PI responsibilities and/or how oversight of study teams will be ensured during the leave
The New Information Report should be provided to the IRB as soon as possible, preferably before the PI takes leave. If the PI cannot return from leave as planned or changes their role after the leave ends (e.g., becomes a sub-investigator), a change of protocol to formally update the PI for the study would be required.
If a change of PI is necessary, carefully review the approved file and ALL supporting documents (recruitment, consent, etc.) to ensure that updates are made to reflect the change in PI.