Steps After Approval

  • You must contact the IRB if you make any changes or additions to your materials or procedures to determine if a revision to your proposal is required.
  • At the conclusion of your study be sure you follow your approved procedures for data storage and/or deletion.
  • Your consent forms must be kept on file with the Principal Investigator for at least three years.
  • The following applies only to research that is funded by a Department of Health and Human Services agency.

“Adverse events that are anticipated by the researcher must be discussed as part of the IRB proposal, and the possibility of such effects must be made known to study participants as part of the informed consent process. If expected adverse events occur during such research, no special reporting to the Office for Human Research Protections (OHRP) is required.

Adverse events that are unanticipated in their nature, severity, or frequency require immediate attention. Although such events are most likely to occur in medical experiments, they are not unknown in behavioral or psychological studies. If your research is HHS supported, then you should become familiar with regulations regarding such incidents. Please consult the document here and explore the links contained therein.”