Tarleton State University Human Subjects Institutional Review Board Sally Lewis-Human Subjects IRB Chair Tarleton State University

All Human subjects research must have IRB approval prior to beginning the research project.

Human Subjects Research Review and Approval The Institutional Review Board (IRB) reviews research involving human subjects. The IRB may deem projects as Exempt, may approve projects as Expedited or require Full Board review before approval.

Human Subjects Research Scope Any activity that involves research with human subjects that is conducted by System member personnel in the course of their employment by the System member, or uses System member facilities or resources.

Human Subjects Research Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45CFR46.102).

Human Subjects Research Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains Data through intervention or interaction with the individual, or Identifiable private information. (45CFR46.102)

Human Subjects Research Examples of activities that may be human subject research: Surveys and Interviews Taking blood from living individuals for research The use of specimens or data from a repository or database Program evaluation, program assessment or demonstration project conducted for research Pilot studies, preliminary studies, or other preliminary research with human subjects Classroom research Observing or recording private behavior Obtaining private identifiable information that has been collected about or provided by individuals

Human Subjects Regulations US Department of Health & Human Services Office of Human Subjects Research Protections (OHRP) 45 CFR part 46 TAMUS Regulations Tarleton State University Compliance

IRB Sponsored Projects Office of Sponsored Projects Office of Research Compliance IRB IACUC IBC Office of Faculty Research Proposal development and submission Office of Student Research and Creative Activities Student research support

Office of Sponsored Projects Office of Research Compliance Office of Faculty Research Office of Student Research and Creative Activities Mekka Steinruck Compliance Coordinator (until 3/30/2016) Dr. Roger Wittie Executive Director

INSTITUTIONAL REVIEW BOARD MEMBERS  COMMITTEE FOR HUMAN SUBJECTS Dr. Sally Lewis  - Chair Dr. Barry Lambert, Institutional Official and Chief Research Officer [ex officio] Dr. Jordon Barkley, COE Representative Dr. Gerald Burch, COBA Representative Dr. Elaine Evans, COST Representative Dr. Chris Gearhart, COLFA Representative Dr. Mike Haynes, IE Representative Dr. Charlie Howard, Prisoner Advocate Dr. Curtis Langley, COA Representative Ms. JoAnne Phillips, Community Representative Dr. Roger Wittie, Ex-Officio

Institutional Review Board for the Use of Human Subjects

IRB 2014: TAMUS Internal Audit Tarleton State University does not have adequate processes and controls in place to ensure compliance with laws and policies governing human subject research. A review of existing human subject protection processes identified multiple conditions and instances of noncompliance with A&M System requirements. Although TSU's IRB was established in 2001 to oversee human subject research, the university does not have a functioning Human Subject Protection Program (HSPP) in place and established procedures are not adequately documented and do not meet federal and A&M System requirements. Without a fully functioning HSPP, the university is not in compliance with federal regulations related to federally funded research involving human subjects which could lead to penalties, loss of research funding, and reputational damage to the university. The university has recently put forth significant effort to create and implement procedures to improve their HSPP and IRB processes and bring them in compliance with A&M System regulations and federal laws.

IRB Process PI Determines if research is HS research? Determines if research is eligible for exempt or expedited review. Completes proposal form and submits to IRB (Mekka Steinruck) IRB Completes Clerical Review (CITI;COI; completeness; Cooperating Facilities) Assigns review to IRB Member(s) Provides weekly update to Reviewers Completes Administrative Documentation of Review Provides PI with recommendations

IRB Process PI Completes recommendations and resubmits entire proposal to Mekka Steinruck IRB Reviewer documents recommendations were included in re-submission Reviewer makes recommendation to IRB Chair for approval Chair approves proposal Completes research Maintains required documents and statistics Files Continuing Review or Amendment form if required

IRB Process PI Completion/termination document Stores documents relating to research for compliance audit IRB Monitors compliance

Human Subjects Decision Charts Is your research human subjects research? In what category of research does your project belong? Exempt Expedited Full Board Review

Training for PI’s and Researchers CITI

Proposal Form