Changes in Research Activities: Submission and Review
This document describes the policies and procedures UW-Madison IRBs use to ensure prompt reporting of changes to the IRB and for the review of changes in research activities for non-exempt human subjects research. Changes in research activities are frequently referred to as changes of study or amendments.
- The only changes in research activities that may be implemented prior to IRB approval are those necessary to eliminate apparent immediate hazards to the human participants.
- Changes in approved research initiated without prior IRB approval to eliminate apparent immediate hazards to a participant are considered unanticipated problems and must be reported to the IRB within fourteen (14) business days of implementation.
- Changes are required to be submitted to the IRB for review, regardless of whether or not the study has been approved with no continuing review.
- When a change is planned it should be submitted to the IRB for review promptly.
- Each UW-Madison IRB may have specific required time frames for reporting changes in research activities.
- If changes are the result of new information, such as identification of unanticipated risks or findings that may affect a participant’s willingness to take part in the study, the research team must report this new information to the IRB independent of the change of study as a possible unanticipated problem.
- The research team should report potential unanticipated problems following the UW-Madison Unanticipated Problems policy.
- The criteria for approval of a change in research activity and the determinations that the convened IRB or expedited reviewers make are the same as those made at the time of initial review with the addition of the assessment of whether a re-consenting process is required for participants (or their legally authorized representatives).
- For studies approved by the convened IRB or under expedited procedures, UW-Madison IRBs must determine whether the modified research continues to fulfill the criteria for approval of human participants research and if any additional federal, state, or institutional requirements apply (e.g. federally funded research involving pregnant women, fetuses or neonates; prisoners; or children).
- The federal regulations allow for expedited review by the IRB chair or an experienced IRB member(s) designated by the IRB chair for minor changes in research activities. All other changes require review by the convened IRB. Expedited reviewers may obtain consultation from other IRB members and experts as needed to assess the change.
- The definition of an experienced IRB member is the same as for initial review.
- Changes can be reviewed under expedited procedures in the following cases:
- The study was reviewed under expedited procedures at the time of initial review and the change does not affect the risk level of the study such that it would require review by the convened IRB.
- For studies that were reviewed and approved by the convened IRB, changes are considered to be minor if they present minimal risk to participants or are administrative in nature and meet all of the following criteria:
- Represent minor clarifications of study procedures previously approved by the convened IRB.
- Do not significantly change the study design.
- Do not alter the risk/benefit ratio of the study.
- Generally, with the exception of changes in Principal Investigator for studies that require convened IRB review, changes in personnel are considered minor changes.
- Changes to research involving prisoners may be expedited if the change fits the definition of minor changes as described above.
- In the case of federally funded prisoner research, the IRB Prisoner Representative must be one of the designated reviewers for the change if it affects the determinations required to be made under 45 CFR Part 46, Subpart C.
- For research that is not federally funded, the IRB may obtain consultation on a change of protocol from the IRB Prisoner Representative if that expertise is required to assess the impact of the change on any prisoners participating in the research.
- A change that appears to meet the criteria for a minor change can still be referred for review by the convened IRB in any one of the following circumstances:
- Review of the change requires or would benefit from the assessment by one or more IRB members with relevant expertise.
- The change is for a study that enrolls a vulnerable population and the change could affect that study population.
- A vulnerable population is being proposed to be added to the study as part of the change.
- The change requires input from other committees on campus (e.g., conflict of interest, Radioactive Drug Research Committee) or consultants (e.g., legal services).
- The change involves multiple revisions to research activities that may individually qualify for expedited review but collectively represent a substantial change to the study.
- Numerous changes have been made to a study such that reassessment of the full scope and purpose of the study may be warranted.
- For any changes in research activities approved under expedited review procedures, all IRB members are advised of such approvals.
- IRB members shall be provided access to the IRB files for any research study in which they may have a concern.
Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised: April 12, 2007
Revised: January 22, 2009
Revised: November 5 and December 3, 2009
Revised: March 1, 2012
Revised By: Cross-Campus HRPP Committee
Revision Date: July 7, 2015
Revision Date: April 26, 2018
Copyright © 2015 University of Wisconsin System Board of Regents