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?