RESEARCH COMPLIANCE Due Diligence and Institutional Review Boards - How Much Oversight is Enough?
Institutional Review Boards: Why California Community Colleges Need Them and How To Get Started
-
Upload
brent-vinson -
Category
Documents
-
view
28 -
download
0
description
Transcript of 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.DBarry Gribbons, Ph.D
RP Conference: April 2, 2013
What is an IRB? Review research proposals to ensure ethical
treatment of human subjects Recognized by Department of Health & Human
Services (HHS)
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.
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.)?
How do you start one? Establishing a Federally Recognized IRB:
o 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/ o Request a submission number from OHRPo Submit formo Renew every 3 years
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…o Register its own IRB, oro Designate an already registered IRB operated by another
organization (requires written agreement) Filing an FWA
o Request a submission number http://ohrp.cit.nih.gov/efile/FwaStart.aspx
o After receiving your submission number, file the FWAo Effective for 5 years
What does the IRB do? Reviews proposed research checking for:
o Beneficence• Maximize benefits• Minimize risk
o Autonomy: Respect for Personso 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
Informed Consent1. Purpose2. Procedures3. Risks/Benefits4. Compensation5. Confidentiality6. Assurance of voluntary participation/withdrawal7. Contact Information
Types of Review Exempt
o No more than minimal risko 6 categories, e.g. normal educational practice, surveys
of adults, publically available data Expedited
o No more than minimal risko 9 categories
Fullo Vulnerable Population, Deception, mandated legal
reporting, more than minimal risk
Important Considerations
Vulnerable populationso Minors: Assent; Parents : Consento Inmates
Confidential Information Criminal Behavior
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
Examples: Potential Ethical Problems
Four-year institutions approval of studies involving community college students
Study of drug use and sexual behaviors among college studentso Interviewo Anonymous survey
How does it work on a day-to-day basis
Proposal submissions Tools
o Trainingo Online submission/tracking
Committee meetings
Cool resources / Tools CITI Training Demo Online Submission Demo
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
Questions?