Human Subjects Protections:A Public-Private Model

Friends Research Institute, Inc., Baltimore MD

Investigators

Abstract

This grant application is for an additional, final year of short-term interim support that began in OD-02-003, and has allowed Friends Research Institute (FR[) to enhance human protections in five ways: (1) Additional IRB software purchased; (2) training of FRI IRB staff on software and its use in tracking protocols and SAEs, and a more "papedess" operation;(3) increased linkages between East and West Coast human protections departments, with consolidated reporting mechanisms and trending software (Prism); (4) greatlly increased human protections educational activities e.g. classes, seminars and online training; and (5) the production of a video on informed consent that wilt help prospective research participants understand the basis of, and need for, truly informed consent. We are requesting additonal funding to: [A] continue educational activities for FRI staff and investigators, and IRB members and staff, on advanced content in human research protections, such as vulnerable populations, conflicts of interest, research integrity, quality improvement, HIPAA,, and special topics; [B] allow wider distribution of our video, after government approval, and fund a new video production for research staff, on protecting human participant confidentiality, with special emphasis on HIPAA in research, and interactions of HIPAA with 42 C.F.R. part 2; [(3] help fund our outreach to an entity not receiving previous OD-02-03 funding-- the State of Florida's Review Council fort Human Subjects (RCHS). A biomedical and psychosociai IRB within the Florida Department of Health, in Tallahassee, the RCHS, (staffed and administered by FRI under contract to the State of Florida) is responsible for reviewing and approving most biomedical and psychosocial protocols using Florida DOH patients as subjects. The State has agreed to partner with us to provide RCHS the following enhancements to the exisiting protections program: (1) Quality Assurance visits to problematic and non-problematic sites; (2) outreach educational presentations--beginning and advanced--to Florida DOH personnel and other State entities identified as most likely to benefit from human research protections knowledge, viz. State university IRBs, and other State IRBs; (3) preparation for, and completion of, an OHRP Quality Improvement visit, and accreditation preparation and site visit by a national IRB-accrediting agency; and (4) More local / national educational opportunities for RCHS members and staff.