PREP Course 24: Defining the Differences between FDA and OHRP regulations. Presented by: Hallie Kassan Dorean Flores Office of the IRB

Transcription

1 PREP Course 24: Defining the Differences between FDA and OHRP regulations Presented by: Hallie Kassan Dorean Flores Office of the IRB

2 CME Disclosure Statement The North Shore LIJ Health System adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the North Shore-LIJ for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director, Kevin Tracey, has disclosed a commercial interest in Setpoint, Inc. as the cofounder, for stock and consulting support. He has resolved his conflicts by identifying a faculty member to conduct content review of this program who has no conflicts. Hallie Kassan and Dorean Flores have nothing to disclose

3 Objectives Define research regulated by FDA vs. that regulated by OHRP Discuss the FDA regulations Discuss OHRP regulations Identify the differences between the two sets of regulations

4 General Considerations Discussion will focus on the main human subjects protection regulations 21 CFR 50 and 56, and 45 CFR 46 Other FDA regulations will not be discussed

5 The Common Rule 45 CFR 46 Regulations overseen by the OHRP within DHHS 21 CFR 50, 56 Regulations overseen by FDA, within DHHS

6 Which Regulations Apply? FDA regulations OHRP regulations clinical investigations human subjects research

7 Clinical Investigation Any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to FDA, or results of which are intended to be submitted to or held for inspection by FDA as part of an application for research or marketing

8 Research Systematic investigation designed to contribute to generalizable knowledge

9 Common Rule Human Subject A human subject is a (living) individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information FDA A human subject is an individual who is or becomes a participant in research, either as a recipient of a test article or as a control

10 Which regulations apply when? OHRP FDA OHRP

11 Administrative Differences OHRP - FWA and IRB registration FDA IRB registration Includes number of FDA protocols Types of products reviewed

12 Exemptions The Common Rule Six Exemptions FDA Two Exemptions

13 Common Rule Exemptions 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices 2. Research involving the use of educational tests survey procedures, interview procedures or observation of public behavior, 3. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

14 Common Rule Exemptions 4. Research involving the collection or study of existing data, documents, records, or specimens, if these sources are publicly available or if the information is recorded in a deidentified manner 5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. 6. Taste and food quality evaluation and consumer acceptance studies,

15 FDA Exemptions Emergency Use of a test article Taste and food quality evaluation and consumer acceptance studies

16 Informed Consent Basic Elements required are the same FDA explicitly requires that consent forms be dated, whereas OHRP does not. FDA (but not OHRP) requires language in the consent form to: 1. Indicate that FDA can inspect records 2. Trial will be listed on clinicaltrials.gov

17 Waivers of Informed Consent Common Rule Allows waivers of informed consent for minimal risk research when proper protections are in place FDA Emergency use of a test article Exception from IC for Emergency Research

18 FDA Exception to Informed Consent Use of specimens in FDA regulated research of IVD

19 Waivers of Documentation of Informed Consent Common Rule Only linking record is ICD and confidentiality breach risk Minimal risk and no procedures requiring consent FDA Minimal risk and no procedures requiring consent

20 Vulnerable Populations Common Rule Special protections for children, pregnant women, fetuses and prisoners Allows for a waiver of parental permission FDA Special protections for children only Does not allow for a waiver of parental permissions

21 Regulatory Actions Common Rule FWA restriction or removal FDA Refusal of Inspection Issuance of Warning Letter Restriction Disqualification of an IRB Any other alternative actions as appropriate

22 What is the same? Definitions of IRB Approval, Minimal Risk, Legally Authorized Representative, IRB Membership Requirements IRB functions and operations IRB review of research Expedited review procedures for minimal risk studies or modifications Criteria for approval of research

23 Questions??

24 Contact the IRB Office of the Institutional Review Board 350 Community Drive Manhasset, NY Phone: Fax: