Reporting Adverse Events
About Adverse Events
The Office for Human Research Protections (OHRP) defines adverse events as “any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.”
When to Report to VDH IRB Within 10 Business Days
During the course of a study, report within 10 business days of the principal investigator finding:
- That the expected adverse events are occurring with a greater frequency or at a higher level of severity than expected.
- There is an occurrence of an unanticipated adverse event.
When to Report to VDH IRB Immediately
- The death of any study subject.
- The only exception is when the study is conducted among subjects who are expected to have a high rate of mortality from their underlying condition, and the investigator has absolutely ruled out any connection between any study procedure and the subject’s death.
How to Report Adverse Events
- Adverse events should be reported by emailing the completed Adverse Event Form to vdhirb@vdh.virginia.gov.
- Expected adverse events (those noted on the consent form) do not need to be reported to the VDH IRB on an individual basis.
Reporting Modifications to the Approved Protocol
- All modifications to currently approved research must have IRB review and approval prior to implementation.
- Both minor and major modifications should be reported by completing the IRB Modification Request Form and attaching any revised documents such as the research protocol, informed consent, recruitment materials, etc.
Minor Modifications
A minor modification is defined as a change that:
- Would not materially affect an assessment of the risks and benefits of the study OR
- Does not substantially change the specific aims or design of the study
Examples of minor modifications include:
- An increase or decrease in proposed human research subject enrollment
- Changes to improve the clarity of statements or to correct typographical errors, provided that such changes do not alter the content or intent of the statement
- A change in principal investigator or the addition or deletion of qualified investigators
- The addition or the deletion of study sites
Major Modifications
- A major modification is defined as a change that materially affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.
Continuation Review
For research requiring a continuation review, the principal investigators will be sent a reminder by the VDH IRB approximately six weeks prior to the review due date. The Continuation Review Form must be received on/before the due date.
Minimal Risk Research
- For research with minimal risk to the participants and approved prior to January 21, 2019, the VDH IRB must conduct continuing review of protocols at intervals appropriate to the degree of risk, but not less than once per year.
- For research with minimal risk to the participants and approved on or after January 21, 2019, the IRB may schedule continuation review as appropriate to the level of risk.
Greater than Minimal Risk Research
- For all research that has greater than minimal risk to participants, the IRB will conduct continuing review at intervals appropriate to the degree of risk, but not less than once per year.
More Information:
Reporting of Completion or Termination of Study
To close a study in the VDH IRB files the principal investigator must:
- Complete and submit an IRB Project Closure Form
- Submit a brief summary of the research findings.
Materials should be received within 30 days of the conclusion of the research project.