Research Protection Program Process and Review Guidelines
Learn about the HUA Human Research Protection Program and its pre-review, incoming items processing, post-review procedures, definitions like ancillary review, and the post-review process with important timelines and actions. Understand how the program handles disapproval and the detailed process of finalizing documents and communication with researchers.
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Presentation Transcript
HUA HUMAN RESEARCH PROTECTION PROGRAM
HRP-020 INCOMING ITEMS ENDS WHEN AN IRB STAFF MEMBER DETERMINES THE APPROPRIATE ACTION FOR THE RECEIVED INFORMATION BEGINS WHEN ANY COMMUNICATION IS RECEIVED BY THE IRB
RECEIVE Harvard Policies? MTRSA? HRP-021 PRE-REVIEW Admin Manual? NIH? New PI? CONSIDER AND COMMUNICATE Ancillary Review? GDS? Restricted? NEXT STEP COMPLETE
DEFINITIONS: ANCILLARY REVIEW Allow individuals, departments, offices, and other additional reviewers to give feedback, approval, and/or provide documentation IRB Staff select the reviewer or reviewing organization/department each time a review is needed or required May be initiated on new study, modification, or continuing review
HRP-052 POST-REVIEW ENDS ALL CORRESPONDENCE SENT TO RESEARCHER AND OTHER PARTIES AS NECESSARY BEGINS NON-COMMITTEE REVIEW COMPLETE IRB MEETING MINUTES APPROVED MRTSA REVISIONS REVIEWED
PROCESS: Finalize documents Prepare letter Send letter HRP-052 POST-REVIEW DISAPPROVAL: IRB provides rationale from Belmont Report; PI may respond BY THE NUMBERS: 5 business days: Review outcomes sent to PI 30 business days: For RNIs requiring further reporting, outcomes sent to outside agencies
