1. Human Research Ethics: Issues and Procedures Dr. Constance Jones Chair, Committee for the Protection of Human Subjects

2. Overview Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining Human Subjects Approval CSUF Paperwork for Obtaining Human Subjects Approval

3. Overview Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining Human Subjects Approval CSUF Paperwork for Obtaining Human Subjects Approval

4. Why? All agencies receiving federal funds (all public universities) are required to have an Institutional Review Board Protection of: Research participants Researcher University

5. Overview Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining Human Subjects Approval CSUF Paperwork for Obtaining Human Subjects Approval

6. Committee for the Protection of Human Subjects Covers research done with human subjects What is research? What are human subjects?

7. Research is Any systematic investigation or collection of data intended for scientific presentation or publication Researchers may be undergraduate students, graduate students (projects or theses), faculty, staff, administrators

8. Research is not Data collected for classroom evaluation, illustrative purposes, or educational purposes

9. Human Subjects Research can involve: Contact with humans via telephone, mail (paper or electronic), or in-person interaction Study of records of human behaviors or attitudes (e.g., case files, police records, hospital records) Study of specimens collected from humans (e.g., blood, urine)

10. Overview Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining Human Subjects Approval CSUF Paperwork for Obtaining Human Subjects Approval

11. Risk Categories No risk research Minimal risk research At risk research

12. No Risk Research Study of existing anonymous data Study of existing documents Study of publicly observable, legal behavior

13. Minimal Risk Research Study of “normal adults’” attitudes opinions, cognitions, personality, etc. Study of “normal adults’” moderate exercise Study of “normal adults’” biological specimens

14. At Risk Research Study involving possibility of physical or psychological harm Study involving collection of reports of illegal / embarrassing behavior Study using deception and debriefing

15. At Risk Research Study of protected populations Those younger than 18 years old Those with psychological, cognitive, and/or physical impairments Incarcerated individuals Pregnant women

16. Overview Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining Human Subjects Approval CSUF Paperwork for Obtaining Human Subjects Approval

17. Levels of Review Departmental Chair Departmental Committee University Committee

18. No Risk Research Unfunded: Memo to Departmental Chair Funded: Departmental Committee, then University Committee (Expedited)

19. Minimal Risk Research Unfunded: Departmental Committee Funded: Departmental Committee, then University Committee (Expedited)

20. At Risk Research Unfunded: Departmental Committee, then University Committee Funded: Departmental Committee, then University Committee (Full)

21. Overview Why? Who and What is Covered? Levels of Risk CSUF Procedures for Obtaining Human Subjects Approval CSUF Paperwork for Obtaining Human Subjects Approval

22. CPHS Webpage Checklists Example memos Example Informed Consent Forms Training modules

23. Paperwork / Timing Problems No departmental review No training certificate Missing instruments Missing informed consent forms Premature submission of grants

24. Proposal Problems Lack of clarity in terms of: Who will be studied How they will be studied When they will be studied Context of study Minimization of risk Incorrect classification Too brief consideration and/or description of risk