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Institutional Review Boards: Why California Community Colleges Need Them and How To Get Started

Institutional Review Boards: Why California Community Colleges Need Them and How To Get Started. Daylene Meuschke, Ed.D Barry Gribbons, Ph.D RP Conference: April 2, 2013. What is an IRB?. Review research proposals to ensure ethical treatment of human subjects

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Institutional Review Boards: Why California Community Colleges Need Them and How To Get Started

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  1. Institutional Review Boards: Why California Community Colleges Need Them and How To Get Started Daylene Meuschke, Ed.D Barry Gribbons, Ph.D RP Conference: April 2, 2013

  2. What is an IRB? • Review research proposals to ensure ethical treatment of human subjects • Recognized by Department of Health & Human Services (HHS)

  3. What is human subjects research? • Contributes to a generalizable body of knowledge • Human subject…a living individual • Involves data collection through intervention or interaction • Can involve identifiable private information • Generally is not used for program planning, institutional planning, or course-related activities (may qualify in some circumstances) • Remember…research is a privilege, not a given right Federal Regulations define research as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45CFR46.102(d)). “Generalizable knowledge” is information where the intended use of the research findings can be applied to populations or situations beyond that studied.

  4. Are IRBs Optional? • Do you use human subjects in your research? • Do you conduct surveys as part of your research? • Do you plan to publish or present the results of your study/project (involving human subjects), now or at any time in the future? • Is this study part of a federal grant (e.g., NSF, Title III, DOE, etc.)?

  5. How do you start one? • Establishing a Federally Recognized IRB: • Identify committee members • Need at least 5 members with varying backgrounds to promote complete and adequate review of proposed research activities • Members must be familiar with the discipline and methodology under consideration • Include at least 1 member with primary background in scientific areas and at least 1 from a non-scientific area • Include a member not affiliated with the institution • Register with OHRP http://ohrp.cit.nih.gov/efile/ • Request a submission number from OHRP • Submit form • Renew every 3 years

  6. Federal-wide Assurances (FWAs) • Registering an IRB and obtaining a Federal-wide Assurance: Related but separate processes • FWA – commitment to comply with requirements in HHS Protection of Human Subjects regulations 45 CFR part 46 • Before obtaining an FWA an institution must… • Register its own IRB, or • Designate an already registered IRB operated by another organization (requires written agreement) • Filing an FWA • Request a submission number http://ohrp.cit.nih.gov/efile/FwaStart.aspx • After receiving your submission number, file the FWA • Effective for 5 years

  7. What does the IRB do? • Reviews proposed research checking for: • Beneficence • Maximize benefits • Minimize risk • Autonomy: Respect for Persons • Justice • Equitable risk and benefits • Approve or Disapprove research • Require modifications to proposed research • Observe/verify changes, including amendments • Conduct continuing reviews • Suspend or terminate approval • Observe consent process and research procedures

  8. Informed Consent • Purpose • Procedures • Risks/Benefits • Compensation • Confidentiality • Assurance of voluntary participation/withdrawal • Contact Information

  9. Types of Review • Exempt • No more than minimal risk • 6 categories, e.g. normal educational practice, surveys of adults, publically available data • Expedited • No more than minimal risk • 9 categories • Full • Vulnerable Population, Deception, mandated legal reporting, more than minimal risk

  10. Important Considerations • Vulnerable populations • Minors: Assent; Parents : Consent • Inmates • Confidential Information • Criminal Behavior

  11. Examples: Potential Ethical Problems • Saugus University wants to conduct a study involving veterans…. • For a class research project, students propose to stage a domestic argument, having it escalate, and measuring how long it takes until someone intervenes • For a class project, students propose administering mild electric shock to see if it enhances learning

  12. Examples: Potential Ethical Problems • Four-year institutions approval of studies involving community college students • Study of drug use and sexual behaviors among college students • Interview • Anonymous survey

  13. How does it work on a day-to-day basis • Proposal submissions • Tools • Training • Online submission/tracking • Committee meetings

  14. Cool resources / Tools • CITI Training Demo • Online Submission Demo

  15. Some Practical Tips • Require faculty / staff sponsor • Make training good for 2-3 years • Use existing forms, with permission of course • Participate in PRIM&R • Utilize resources available from OHRP • Designate someone to be primary contact for IRB related questions

  16. Questions?

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