Documentation of Research Undergoing Initial or Continuing Review by the Expedited Procedure- PRO136   

PROCEDURE

OIRB Responsibilities

Reviewing Staff:

• Receives initial review, continuing review, or exemption requests on FOR200 IRB application eForm;
• Verifies research qualifies under one or more of the permissible categories;
• Verifies additional review has been obtained for DoD-sponsored research, if applicable (see GUI339);
• Reviews application to identify any protocol specific findings required by local policy and applicable regulations;
• Creates and issues the approval and applicable consent documents to  the investigator.

Administrative Staff:

• Documents presentation to the convened IRB of research approved via expedited procedure.

IRB Responsibilities

The IRB Chair or Experienced Reviewer:

• Documents proposed research meets permissible category for expedited review;
• Documents review does or does not meet approval criteria;
• Documents actions taken including rationale for determination that activity is greater than minimal risk;
• Documents if study requires annual review and justifies why it would enhance the protection of human subjects;
• Documents under the exemptions (Categories 2, 3, 7, and 8) requiring limited review that there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of the data;
• Completes the IRB Reviewer Sheet eForm (FOR243) to document protocol-specific findings by  local policy and regulations, as applicable, for:
  • Waiver or alteration of informed consent;
  • Waiver of consent documentation;
  • Research including pregnant women, fetuses, or neonates;
  • Research including children as subjects;
  • Research involving decisionally-impaired adults.