Presentation on theme: " Daylene Meuschke, Ed.D Barry Gribbons, Ph.D RP Conference: April 2, 2013."— Presentation transcript:
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 http://ohrp.cit.nih.gov/efile/http://ohrp.cit.nih.gov/efile/ 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 http://ohrp.cit.nih.gov/efile/FwaStart.aspx http://ohrp.cit.nih.gov/efile/FwaStart.aspx 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
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