1. CSBS Faculty Workshop: The IRB – Institutional Review Board for the Protection of Human Subjects PRESENTED BY: FRANCES SOLANO WITH SPECIAL GUEST: DR. DANIEL RASTEIN MARCH 1, 2016 1

2. Agenda  Introductions  What is the IRB?  History and Purpose  Organization  Protocol review process  IRB Assistance  Possible Consequences  Discussion  Upcoming Workshops 2

3. What is the IRB?  Brief History  Response to ethical concerns surrounding such events as  Nazi experiments on humans in WWII  Nuremburg Code  Tuskegee syphilis study of 1940s  Treatment purposely withheld from persons suffering from disease  The Belmont Report  Addresses not only protection of physical well-being, but also mental/emotional and social well-being of individual 3

4. What is the IRB?  The Belmont Report  Respect for Persons  Informed Consent, for each individual  To assure fully informed and understood  To protect the rights and welfare, especially of vulnerable populations (children, pregnant women, prisoners, mentally disabled, economically or educationally disadvantaged)  Beneficence  Assure sound research procedures, with no unnecessary exposure  Risk is reasonable to anticipated benefit  Data collection is monitored for safety  Justice  Selection of subjects is equitable for the purpose of the research and setting. 4

5. What is the IRB?  Mandated by federal legislation (Code of Federal Regulations), and registered with the federal government (DHHS/OHRP)  An ethics committee – not meant to evaluate the research itself, except as design affects human subjects.  Organization  Composition of Board includes  CSUN faculty  Community members  Managed by CSUN Compliance Officer, Dr. Daniel Rastein 5

6. What is the IRB?  Current IRB Members  David Boyns, Chair (Sociology)  Linda Chassiakos, Vice Chair (Student Health Center)  Edwin Aimufua, Community Member  Kenya Covington, Urban Studies and Planning  Nathan Durdella, Educational Leadership & Policy Studies  Salvador Esparza, Health Sciences  Jonathan Kelber, Biology  Neil Smith, Community Member  Shane Stecyk, Kinesiology  Kat Sohn (alternate), Prisoner Advocate  Abraham Rutchick (alternate), Psychology 6

7. The Process  Obtain your IRB Training Certification:  CSUN > Academics > Research & Graduate Studies  Research & Sponsored Projects > Regulatory Compliance  Responsible Conduct of Research (RCR) Training  http://www.csun.edu/research-graduate-studies/responsible-conduct-research http://www.csun.edu/research-graduate-studies/responsible-conduct-research 7

8. The Process  Types of activities to be reviewed – Systematic investigations :  Designed to develop or contribute to generalizable knowledge—to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations.)  Examples include:  surveys and questionnaires  interviews and focus groups  analyses of existing data or biological specimens  epidemiological studies  evaluations of social or educational programs  cognitive and perceptual experiments  medical chart review studies 8

9. The Process  Prepare and Submit your Protocol  Usually done after grant proposal is submitted, but must be approved before activities with human subjects commence.  http://www.csun.edu/research-graduate-studies/protocol-submission-process http://www.csun.edu/research-graduate-studies/protocol-submission-process  Protocol Approval Form (either for Faculty or Student) AND  Project Information Form  Additional Forms, depending on study needs.  Electronic submission through Cayuse, expected March 2016. 9

10. The Process 10 Protocol DeadlineMeeting Date April 5, 2016April 26, 2016 May 3, 2016May 24, 2016

11. IRB Assistance  Consult with IRB Manager for assistance.  Determination of exempt status for minimal risk studies.  Advice on study design to minimize risk, reduce exposure. 11

12. Possible Consequences  If research has not received IRB approval, may not publish.  Possible cancellation of current or future funding.  Exposure to legal action (both individual and university).  Possible adverse effects on human subjects. 12

13. Discussion…  QUESTIONS?  COMMENTS?  SUGGESTIONS? 13

14. Future CSBS Workshops – Spring 2016  Tuesday, April 5, 3:30 – 4:30 pm  Wednesday, May 4, 3:30 – 4:30 pm Location: Sierra Hall, 4 th Floor Whitsett Room 14