Procedure
Amendments are categorized into minor changes and significant changes.
- Minor Change | A proposed change in research-related activities that does not significantly affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study.
- Examples of minor changes to a research study include, but are not limited to, the following.
- Addition or deletion of study team members;
- Addition of procedures that do not significantly increase risk to subjects, considering the original purpose and study design of the approved study;
- Removal of research procedures that would thereby reduce the risk to subjects;
- Addition of non-sensitive questions to survey or interview procedures;
- Addition of or revisions to recruitment materials or strategies;
- Administrative changes to the approved documents (e.g., correction of spelling, grammatical, or typographical errors).
- Significant Change | A proposed change in research-related activities that significantly affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.
- Examples of significant changes to a study may include, but are not limited to, the following.
- Addition of a new and/or separate subject population (e.g., control group, additional cohort, vulnerable population, etc.);
- Addition of research procedures that involve greater than minimal risk to subjects;
- Addition of surveys/questionnaires/interview procedures that could have adverse psychological consequences for subjects or damage their financial standing, employability, insurability, or reputation;
- Removal of follow-up visits that appear necessary for monitoring subject safety and welfare.
Level of Review for Amendments
Significant modifications/changes will generally be reviewed at the same level of review in which the study was first reviewed, either by the screening committee or by the full IRB. However, if an amendment by the screening committee is determined to increase the level of risk beyond minimal risk, the screening committee will refer the amendment to the full IRB.
Minor modifications/changes may be reviewed and approved using an “administrative approval” process. The IRB Chair may give administrative approval. Such approvals are then put on the agenda of the next IRB or screening committee, as appropriate, for concurrence.
Sponsor Agency Modifications
Modifications can be made only to IRB-approved studies. A sponsor agency may modify the research protocol before the study has received final approval from the IRB. If this occurs, it is recommended that investigators await receipt of the IRB approval letter before making changes to the research protocol.
Sponsor agency-generated modifications (or addenda) require review and approval by the IRB or Screening Committee, as appropriate. The investigator should provide all sponsor documentation and summarize how the changes affect the approved protocol, recruitment, enrollment, treatment, and follow-up of participants.