2. Overview Historical Perspective Human Subjects & Social and Behavioral Research Questions and Answers

3. 20 th Century Research 1972 Tuskegee Study Exposed 1932 Tuskegee Syphilis Study begins Nuremberg Code 1947 Declaration of Helsinki 1964 Belmont Report 1979 Common Rule 1991 Nazi Experiments Milgram Study

4. Nuremberg Code (1947) [Parts relevant to social and behavioral scientists] Say it is research Voluntary consent Anticipate scientific benefits Benefits for participants must outweigh risks Do no harm - Research stops if harm occurs Subjects can withdraw at any time Investigators must be qualified

5. Belmont Report: Principles and Applications

6. Common Rule (45CFR46) No longer trust in investigators No longer general principals Very specific and narrow rules passed by Congress – With enforcement Mandated IRBs – Invented Exempt & Expedited categories

7. Shut Downs- Consequences of Violations Mar 1999 West Los Angeles VA Medical Center May 1999 Duke University Medical Center Aug 1999 University of Illinois Sep 1999 University of Colorado Sep 1999 University of Pennsylvania Jan 2000 Virginia Commonwealth University Jan 2000 University of Alabama at Birmingham Jun 2000 University of Oklahoma – Tulsa Jun 2001 Johns Hopkins Medical University 2010 University of Indiana, Bloomington (“voluntary”)

8. Case Study University of Iowa Stuttering Study

9. Discovery of Second Syphilis Study 2011 Discovery Same PIs as Tuskegee Post WWII studies in Central America

10. ASU 4 Federal Audits in recent years Havasupai Lawsuit

11. Protect researchers/university while facilitating research Follow Regulations Protect Participants

12. Social & Behavioral Research: If No or Minimal Risk No increased risks to participants –Many fit Exempt category (Federal criteria are very narrow) – simpler application form –Expedite category – No more than minimal risk (no more risk than participants experience in normal daily routines) Must fit into one of the Federal categories

13. Social & Behavioral Research: Risks Most common S & B risk – Information Risk –If information collected were exposed AND connected with participant, it could damage: Reputation Employability Family relationships Insurability Health (e.g., domestic abuse research) Legal status/Freedom from imprisonment

14. Protections for Info Risk I Anonymous surveys (one time surveys) –No master list –Information letter, possibly no signed consent forms Reproducible IDs (multiple data points) –No master list required First two letters of mother’s first name __ __ Day of month on which you were born (2 digits) __ __ Year you graduated high school (2 digits) __ __ Last two digits of your SS#

15. Protections for Info Risk II Master list required because of use of addresses or phone numbers for follow up –Master list kept secure –Restricted access to master list –Master list destroyed as soon as possible

16. Protections for Info Risk III: No nos Never put ID#s on consent forms –Makes consent forms into a master list –Consent forms must be kept for 4 (four) years Never use student IDs, Social Security #s, employment numbers, prisoner #s, etc as IDs Research titles on consents and other forms should not identify a vulnerable population

17. Vulnerable Populations as defined by 45CFR46 Pregnant Women, Human Fetuses and Neonates –Rarely an issue for Social & Behavioral research Prisoners!!! –DHHS funded research requires separate approval from Secretary of HHS after IRB approval –Always full board regardless of risk Children (individuals < 18) –Usually requires no increase in risk, parental permission, and child assent (age appropriate) –Review requirements depend on procedures/risk

18. Other Vulnerable Populations Those with a history of abuse by researchers (Indians) Those susceptible to harm from research E. G.: - Decisionally impaired –Undocumented immigrants –Runaway or homeless children –Those with HIV/AIDS –The very poor –Those in third world countries –Participants in any study that asks sensitive questions when a master list is required

19. ASU Human Subjects Review All human subjects research must be reviewed & approved prior to data collection REVIEW TIME DEPENDS UPON THE TYPE OF STUDY! Generally 1-6 weeks from receipt

20. Major determinants of time until decision Quality & completeness of info provided on application PI’s timeliness in responding to questions Risk involved to participants

21. ASU IRB Application Process (Full Board and Expedited Studies) Submit Social Behavioral application form & supplemental materials – Applications accepted everyday –For full board, the deadline is 12 days prior to the monthly meeting Applications must be complete by the deadline

22. Supplemental Materials to Submit –Grant/proposal for funded projects –Consent, parent permission, assent forms –Questionnaires, interview guides, interview themes/categories –Approval/Support letters from institutions if required –HSS training certificates for ALL researchers

23. Ways to make the process smooth Submit materials in English only Submit complete applications Write so that someone unfamiliar with the field will understand (audits may be conducted by biomedical personnel) Respond in a timely fashion to inquiries from IRB staff

24. Principal Investigator ASU faculty or staff member responsible for: Submission of all required forms Conduct of the research Compliance with IRB decisions/federal regs Submitting proposed changes –prior to making changes Reporting unexpected & adverse events quickly PI/Faculty is responsible party for student research

25. Study Approval Non-exempt studies approved for up to 1 year –Annual report and review required Study complete when data collection AND analysis are complete

26. What is Informed Consent? “A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure.”- OHRP IRB Guidebook it is a process, not a form Format can vary: cover letter, consent form, parent permission form, assent form, oral

27. General requirements - Informed Consent Say it is research Purpose & procedures in simple language Health and financial risk, if any* Compensation/costs, if any* Confidentiality promise & process Subjects’ rights (voluntary, can quit, can skip, no penalties) 5 th -8 th grade reading level »* can be left out if not applicable

28. Criteria Used to Evaluate Protocols No risks or risks are minimized Acceptable risk/benefit ratio Equitable selection of subjects Adequate informed consent process Privacy and confidentiality protections Additional safeguards for vulnerable populations

29. Ways to Minimize Risk To Participants Alternatives –Procedures that are less risky Precautions –Procedures to decrease likelihood of harm Safeguards –Procedures to deal w/harms if they occur To Researchers Document Everything Follow approved procedures Submit any changes to IRB –Must be approved before implementing Report unexpected events

30. Full Board Studies More than minimal risk or protected population Or procedures not included in the authorized Exempt or Expedite categories Committee meets once a month –Approve –Approve with modifications (minor vs. substantial) –Disapprove

31. Making changes to a protocol Submit ANY proposed changes for approval before implementing them using a Modification Form Examples of such changes include: Alteration of study design, methodology, or recruitment Changes to instruments Changes to consent/assent documents/process Addition/deletion of investigators Alteration of project title Addition of research sites No review for change to exempt studies unless change makes the study non-exempt.

32. Contact Information Susan MetoskySusan.Metosky@asu.eduSusan.Metosky@asu.edu (480) 727-0871 Tiffany DunningTiffany.Dunning@asu.eduTiffany.Dunning@asu.edu (480) 965-6788 Leticia De Los SantosLeticia.Delossantos@asu.eduLeticia.Delossantos@asu.edu (480) 727-6526 Shana ClarkShana.Clark@asu.eduShana.Clark@asu.edu (480) 727-5617 Debra Murphy, DirectorDebra.Murphy@asu.eduDebra.Murphy@asu.edu (480) 965-2179 Research.integrity@asu.edu

33. Questions?