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

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

3. 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.

4. 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.

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

6. 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)

7. 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

8. 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

9. 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

10. 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

11. 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

12. Institutional Review Board for the Use of Human Subjects

13. 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.

14. 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

15. 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

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

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

18. Training for PI’s and Researchers
CITI

30. Proposal Form