 Daylene Meuschke, Ed.D Barry Gribbons, Ph.D RP Conference: April 2, 2013

 Review research proposals to ensure ethical treatment of human subjects  Recognized by Department of Health & Human Services (HHS)

 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.

 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.)?

 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 o Request a submission number from OHRP o Submit form o Renew every 3 years

 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, or o Designate an already registered IRB operated by another organization (requires written agreement)  Filing an FWA o Request a submission number o After receiving your submission number, file the FWA o Effective for 5 years

 Reviews proposed research checking for: o Beneficence Maximize benefits Minimize risk o Autonomy: Respect for Persons o 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

1. Purpose 2. Procedures 3. Risks/Benefits 4. Compensation 5. Confidentiality 6. Assurance of voluntary participation/withdrawal 7. Contact Information

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

 Vulnerable populations o Minors: Assent; Parents : Consent o Inmates  Confidential Information  Criminal Behavior

 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

 Four-year institutions approval of studies involving community college students  Study of drug use and sexual behaviors among college students o Interview o Anonymous survey

 Proposal submissions  Tools o Training o Online submission/tracking  Committee meetings

 CITI Training Demo  Online Submission Demo

 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