METHODS OF PROTOCOL REVIEW: DMR, FCR, AND CONTINUING REVIEW
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METHODS OF PROTOCOL REVIEW: DMR, FCR, AND CONTINUING REVIEW JOE CROSSNO, LARISSA DOBBELEARE, NICOLE DUFFEE, CYD GILLETT, TRACY THOMPSON
GOALS At the end of this session, you will be able to understand use of Designated Member Review (DMR) and Full Committee Review (FCR) for protocols and You will be able to understand Continuing Review of protocols
OBJECTIVES – USE OF FCR AND DMR Differentiate between FCR and DMR. Justify the use of FCR and DMR. Evaluate how the use of FCR and DMR may affect regulatory burden, animal welfare and occupational safety. Formulate guidance on when to use FCR and DMR.
OBJECTIVES – CONTINUING REVIEW Contrast the PHS Policy and AWA when using continuing review. Evaluate how continuing review may affect regulatory burden, animal welfare and occupational safety. Formulate guidance on conducting continuing review.
OPTIONS FOR ASSESSMENTS – FCR / DMR Differentiate between FCR and DMR.
OPTIONS FOR ASSESSMENTS – FCR / DMR Justify use of FCR and DMR.
OPTIONS FOR ASSESSMENTS – FCR / DMR Formulate guidance on when to use FCR and DMR.
OPTIONS FOR ASSESSMENTS – FCR / DMR Evaluate how use of FCR and/or DMR may affect regulatory burden, animal welfare and occupational health and safety.
OPTIONS FOR ASSESSMENTS – CONTINUING REVIEW Contrast the PHS Policy and AWA when using continuing review.
OPTIONS FOR ASSESSMENTS – CONTINUING REVIEW Evaluate how continuing review may affect regulatory burden, animal welfare and occupational health and safety.
OPTIONS FOR ASSESSMENTS – CONTINUING REVIEW Formulate guidance on conducting continuing review.
OPTIONS FOR ASSESSMENTS – FCR/DMR Differentiate between FCR and DMR.
Concept map or decision tree to differentiate between FCR and DMR One member calls for FCR Animal research protocol submitted to IACUC office Majority of members vote to approve FCR IACUC decision to PI IACUC Chair may designate members for reviewing protocol All members agree to DMR All membe rs have chance to see protocol DMR members not unanimous to approve Majority votes to disapprove DMR
CONTRAST THE PHS POLICY AND AWA WHEN USING CONTINUING REVIEW Great Eastern University conducts continuing review of protocols by review of PAM report summaries of all active research studies at semiannual program review. Q: Does this method satisfy: A) Animal Welfare Act B) PHS Policy C) Both
CONTRAST THE PHS POLICY AND AWA WHEN USING CONTINUING REVIEW Look up and use the AWA and PHS Policies to re-evaluate and discuss again in your groups the question of continuing review using PAM reports. Do you need to change some of your answers?
IN REVIEW Overall Assessment of Training
IN REVIEW Using what you have learned, you should be able to Differentiate between FCR and DMR. Justify the use of FCR vs DMR. Evaluate how the use of FCR vs DMR may affect regulatory burden, animal welfare and occupation safety. Formulate guidance on when to use FCR vs DMR. Contrast the PHS Policy and AWA when using continuing review. Evaluate how continuing review may affect regulatory burden, animal welfare and occupational safety. Formulate guidance on conducting continuing review.
