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Introduction

Facilitating the Regulatory Process in the Community Setting June 23, 2009 Second Annual CTSA Clinical Research Management Workshop Presented by: Kathleen T. Uscinski, MBA, CIP Deputy Director, Human Investigation Committees. Introduction.

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Introduction

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  1. Facilitating the Regulatory Process in the Community SettingJune 23, 2009Second Annual CTSA Clinical Research Management WorkshopPresented by: Kathleen T. Uscinski, MBA, CIPDeputy Director, Human Investigation Committees

  2. Introduction • Challenges to academic research center, investigators and the IRB • Investigators want to initiate or collaborate with various community agencies in human research. • NIH network; Bring research into areas under represented. (Yale’s CIRA awards to multiple agencies in 18 months.) • Desire to get the research started, thereby desire to avoid duplication of review, ensure consistency in requirements and oversight.

  3. Regulatory Concerns and Issues • Challenges to community investigators, clinics, agencies and settings • Engagement in research means an FWA. • The community entity must designate an IRB. • Other laws and guidance related to research; e.g., HIPAA, COI • The community agency along with the PI bears responsibility for upholding the terms of the FWA and for the protection of research volunteers. • Community agencies may lack the infrastructure, support and expertise to meet regulatory responsibilities in the conduct of human research.

  4. Infrastructure and Research Support • Agency must fulfill obligations required by the FWA (Comply with the Federal Policy for the Protection of Human Subjects and Other Applicable Federal, State, Local, or Institutional Laws, Regulations, Name an IO and HPA, have written procedures for reporting unanticipated problems, serious or continuing noncompliance, suspension or termination, assurances related to informed consent, research team is trained and skilled in human research.

  5. Moving the Processes Forward • Using the institution’s PI and/or the agency’s researcher to tend to the regulatory requirements - Doesn’t work. (telegram, telephone, “teleYale”). • Agency (agency heads) have obligations to share responsibilities in the oversight – not just the researcher • Understand the purpose and authority of the IRB • Know the roles and responsibilities of persons involved in the conduct and review of research • Must be sufficiently capable of challenging the research or the researcher

  6. Research Affiliate Program • HSREP Grant from NCRR in 2003 • Support institutional IRB-related activities. • Target institutions that do not qualify for their own awards • Developed a tool kit • Created template policies and procedures • Required additional policies or procedures that are appropriate to the research being performed. • Policy on Research Involving HIV Testing and Participants Who Are HIV+ • Conflict of Interest (Investigator and Institutional • Developed internal approval for research.

  7. Created an application that explains the nature of the agency, who is listed as IO, HPA, whether or not they’ve completed the training required by OHRP. • Summary of the reasons for engaging in research and the type of research to be conducted at the agency • Designation of the Yale IRB limited to a single study for which a Yale researcher serves as PI, extend to all research at the agency. • Conduct F2F meetings between Yale HPA or designee, IRB Director, the agency PI, Yale PI and others to ensure that responsibilities are understood.

  8. Once the agency is approved as a RA, they are permitted to submit its proposed research protocols to a Yale IRB for review. • The review of the agency’s HRPP policies are conducted annually. • Conduct annual update for RA’s IOs and HPAs. • Invite to HRPP sessions offered at Yale. • Re-evaluate the relationship at time of FWA renewal and then determine if IAA can continue.

  9. Research Affiliates • Over 20 institutions that rely on the Yale IRBs • youth-serving agencies that work to enhance the lives of New Haven's children, youth and their families • comprehensive primary care center—prenatal, pediatric, adolescent, adult and geriatric--to medically indigent Spanish-speaking populations in greater New Haven, • oldest AIDS service organization in Connecticut, providing an array of direct services to greater New Haven: HIV testing and counseling, case management, substance abuse and mental health counseling, support groups, meal delivery, nutritional counseling, • methadone treatment clinic • primary care, behavioral health, and dental services clinic for medically indigent populations adjacent to YSM • behavioral health service for economically disadvantaged residents of neighboring county: substance abuse treatment and supported living services.

  10. Summary • Program in existence since late 2004. • Active and committed community agency leaders. • Publish results, invite community to view their outcome • NAACP Health Fair • Poster and discussion regarding youth and violence at NH Town Hall and Library • Appreciative of research opportunities for their respective populations.

  11. FOR MORE: http://info.med.yale.edu/hic/irb/ra.html

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