Responsibilities After Approval

Reporting Adverse Events

Expected adverse events (those noted on the consent form) need not be reported to the VDH IRB on an individual basis. At the time of continuation review the principal investigator should report the incidence of these adverse events. If, in the course of conducting the study, the principal investigator finds that the expected adverse events are occurring with a greater frequency or at a higher level of severity than expected, or if there is an occurrence of an unanticipated adverse event, he/she should report this to the VDH IRB within 10 business days of when this finding is noted. Also, the death of any study subject should be reported immediately to the VDH IRB. 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. Adverse events should be reported emailing the completed Adverse Event Form to vdhirb@vdh.virginia.gov

Reporting Modifications to the Approved Protocol

All modifications to currently approved research must have IRB review and approval prior to implementation. Minor modifications should be described to the Chair of the VDH IRB either via email or snail mail. Please reference both the Study # and Title of Protocol and where applicable, attach revised consent form, recruitment materials, etc. with changes or additions either highlighted or in bold font. A minor modification is defined as a change that (1) would not materially affect an assessment of the risks and benefits of the study or (2) 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

Reporting Modifications to the Approved Protocol

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. Major modifications should be submitted to the Chair of the VDH IRB for review as if it were a new study.

Continuation Review

The VDH IRB must conduct continuing review of protocols at intervals appropriate to the degree of risk, but not less than once per year. It is the investigator’s responsibility to ensure that the research is reviewed on or before expiration of the current approval period, even if the research activity did not begin until some time after the IRB gave its initial approval. As a courtesy, 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.

Principal Investigator Responsiblities

 

Reporting of Completion or Termination of Study

To close a study in the VDH IRB files, researchers must complete and submit Section I of the Continuation Review form and attach a brief (1–2 paragraph) study summary report. Materials should be received within 90 days of the conclusion of the research project.