Quality Assurance Worksheet

IRB Quality Assurance Program Meeting Worksheet

When a researcher’s protocol is selected for the Quality Assurance Program, he or she will be given notice two weeks in advance of their meeting with the Office for Research Protections staff. Researchers should be ready to discuss the following questions, but do not need to prepare written answers.

  • How has the recruitment process been working so far? What methods of advertising and recruitment are you using?
  • Where does the consent process take place? Who obtains consent from the subjects?
  • Are you using the dated/stamped IRB-approved version of the consent form?
  • How many subjects are currently enrolled?
  • Have any subjects dropped out? How many? Why?
  • Where do you store signed consent forms? If you collect consent electronically or orally, how are you storing this information?
  • Where and how do you store your data? How is it de-identified? Is this consistent with your description of the process in the protocol?
  • If you keep any video or audio recordings, when do you delete them? Have you deleted them according to the timeline you proposed in your protocol?
  • Have any of your sources of funding for the project ended, and do you have any new funding sources?
  • Do you compensate your subjects? If so, how? Have there been any issues with compensation?
  • Have you received any complaints or questions about the consent form or research? (For example, if your study takes place in a school, have school administrators or parents contacted you?)
  • Is your research staff list up to date? Is their required human subjects training up to date?
  • Have there been any adverse events or unanticipated events?
  • If so, have you reported them to the IRB and your sponsor (if applicable)?
  • Where do you store the physical data? Do you have a timeline or plan for destroying or archiving the data?
  • What process are you using to de-identify data (if applicable)?
  • Have any data been lost (inadvertently) or deleted (on purpose)?
  • Have you learned or developed any data handling or consent techniques that work well, and if so, would you be willing to share these techniques with other researchers?
  • What feedback do you have on this process? Do you find this to be more or less burdensome than an annual continuing review?
  • Do you have any suggestions to improve any IRB policies or procedures?