FDA-Regulated Research

Transcription

1 Research Compliance Office FDA-Regulated Research Jennifer S. Brown, RN IRB Education February 2008

2 Today s Topics FDA & OHRP integrated in HRPP What does FDA regulate? Scope of FDA regulations and comparison with OHRP Practical information for IRB members Resources January 2008 Research Compliance Office 2

3 Integrated within AAHRPP Element I.3.C. The Organization has and follows written policies and procedures for determining when studies meet the regulatory definitions of human research. Element I.3.F. The Organization includes in its Human Research Protection Program policies and procedures regarding the areas in which federal and state law differ, and provides guidance about regulatory compliance. Research Compliance Office 3

4 What does FDA regulate? FDA regulates Drugs, biologics & devices used in diagnosis, cure, mitigation, treatment or prevention of disease Clinical research that evaluates safety and effectiveness of FDA-regulated products (IND/IDE regulations) FDA approves (releases to market) products with labeling that summarizes safety and effectiveness, intended use & indications for use FDA exempts further clinical studies, that are conducted according to approved labeling, from IND/IDE regulations* All HS research with FDA-regulated products must undergo IRB review, even if exempt from IND/IDE regulations *Drug (IND) and device (IDE) regulations define and determine exemptions differently Research Compliance Office 4

5 Different Scope FDA (21 CFR ) IRBs that review clinical investigations regulated by the FDA under sections 505(i), 507(d), and 520(g) of the act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. OHRP/HHS (45 CFR ) All research involving human subjects conducted or supported by HHS or conducted in an institution that agrees to assume responsibility for the research in accordance with 45 CFR 46 regardless of the source of funding. Research Compliance Office 5

6 Major Similarities IRB membership requirements Event or UP reporting requirements IRB functions and operations IRB review of research, including expedited review procedures Criteria for IRB approval of research IRB records requirements General requirements for informed consent Research Compliance Office 6

7 Some Areas of Difference Definitions of human subjects, research, clinical investigation, sponsor, sponsorinvestigator, IRB Children s finding paragraph numbers Specific requirements for informed consent Emergency use, waivers, etc. Exemptions from IRB review Multi-institutional (FDA) and cooperative project (OHRP) projects Research Compliance Office 7

8 Some Definitions from FDA Human subject = An individual who is or becomes a subject in research as a recipient of a test article or as a control Clinical Investigation (research) = Any experiment that involves a test article and one or more human subjects that either... Meets requirements for prior submission to the FDA. IND IDE OR Need not meet requirements for prior submission to the FDA, but the results of which are intended NSR to be later submitted to, or held for inspection by, FDA as part of device off-label for marketing new use an application for a research or marketing permit. 510(k) application Research Compliance Office 8

9 Practical IRB Implications FDA Not allowed Waiver of documentation of consent (minimal risk) Not applicable Waiver of consent for military personnel OHRP Waiver or alteration of consent, waiver of assent or parental permission Waiver of documentation of consent (minimal risk) Waiver of documentation of consent (breach of confidentiality) Not applicable Consent document must state FDA may inspect records Emergency use of a test article Planned emergency research Not applicable Not applicable (Planned emergency research) Children s findings and paragraph numbers (light blue laminate) Children s findings and paragraph numbers (orange laminate) Research Compliance Office 9

10 References and Resources Comparison of FDA and HHS Human Subject Protection Regulations (FDA) Comparison of Regulations (OHRP) Investigational New Drug Application (21 CFR 312) cfm?cfrpart=312 Investigational Device Exemptions (21 CFR 812) cfm?cfrpart=812 STANFORD HRPP, Chapter 5 Light blue and orange laminates Research Compliance Office 10