Approval of Human Subjects Research: Who needs it and why

1.  Approval of Human Subjects Research: Who needs it and why?  Dr. Paula Garcia McAllister, IRB Director Northern Arizona University Paula.Garcia@nau.edu 928-523-4236 http://www.research.nau.edu/vpr/IRB/index.htm 1

2. The Institutional Review Board is a panel of researchers, non-researchers, and community members concerned with protecting the rights of individuals participating in research in terms of: Risk of physical, mental, emotional or financial harm Full disclosure of research procedures and outcomes Confidentiality of personal information, views and opinions 2 What is the IRB?

3. Does it involve human subjects? Will you be obtaining personal identifiable information? Does it involve a systematic investigation in which you interact with people? Will it be published, presented, or disseminated beyond the classroom environment? Is it a thesis or dissertation? 3 Does my project need to be reviewed by the IRB?

4. Research is �a systematic investigation that is designed to develop or contribute to generalizable knowledge.� Human subject means �a living individual about whom an investigator conducting research obtains: data through intervention or interaction with the individual, or identifiable private information.� Source: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 4 What is human subjects research?

5. Nazi Human Experimentation, search Steven Spielberg Video Archive of Nuremberg Trials Monster Study, 1939, settled in 2007 Tuskegee Syphilis Study, 1932-1972 Stanford Prison Experiment, 1971 ASU � Havasupai Tribe settlement of $700,000 plus scholarships and facilities 5 Past events shaped today�s regulations:

6. Have a research plan that warrants the use of human participants Be knowledgeable about the federal guidelines for human subjects research (CITI tutorial) Provide the IRB with a fully-detailed plan for complying with the guidelines Carry out your plan in good faith 6 What do I need to do as a researcher?

7. To guide the student researcher through the research design process To take the CITI tutorial To review the student researcher�s IRB application and provide feedback To accept the student�s online IRB application and respond to the conflict of interest question To make sure students file continuations and amendments 7 What are the responsibilities of the faculty sponsor?

8. How many? Different groups Age range Social or occupational situations Special categories: children, pregnant women and their fetuses, and prisoners are considered vulnerable, economically or educationally disadvantaged persons, and cognitively impaired persons may also require additional safeguards 8 What will the IRB ask for?1. Participants

9. What is your plan for recruiting participants? Include all flyers, email messages, memos, etc. that will be used Should include topic, what is expected from participants, time/place, benefits and risks, compensation, contact info 9 2. Recruitment

10. PLAN for disseminating informed consent info to participants How will it be delivered? (in person, email, telephone) Must include specific elements Templates available on website Signature can be waived in rare circumstances 10 3. Informed Consent

11. What instruments will be used: surveys, focus groups, observations, etc. Special requirements for photographs, audio and video recordings Off-campus sites, collaborators, partners, etc. 11 4. Methodology and Data Collection

12. Will identifiers be revealed? How will confidentiality be maintained? Data must be kept secure for 3 years after completion of study Photos and audio/video recordings require a disposition plan and checkbox on informed consent form 12 5. Confidentiality

13. What are the potential benefits to the participants? What are the benefits to society or the field? There may not be any direct benefits to individuals Compensation is described separately and should not be coercive, should be a small token of thanks that is culturally appropriate 13 6. Benefits

14. What are all the possible risks participants may face, including psychological, social, or physical If minimal, say �no more than the risk encountered in everyday life� What will you do to minimize risks? (e.g., provide contact information for counseling service) 14 7. Risks

15. Descriptions of the research free of jargon, acronyms, and overly technical language Support documents from collaborating partners, target agencies, or off-campus locales Designation of other researchers involved All instruments (surveys, questionnaires, checklists, assessments, etc) even if in draft form Informed consent documents 15 What else will the IRB ask for?

16. Greater than minimal risk Vulnerable populations or novel methodologies Board meets monthly PI�s and Faculty Sponsors are invited to attend question/answer session during meeting Usually results in revisions or re-submittal 16 Types of Review: Full Board

17. Reviewed by IRB Director as designated by IRB Chair Low-risk Intervention or treatment Recordings, photos Surveys and interviews Non-invasive procedures Focus groups 17 Types of Review: Expedited

18. Doesn�t mean exempt from IRB review Low-risk Normal educational practices Surveys and interviews that are not audiorecorded De-identified data Records review 18 Types of Review: Exempt

19. Extend IRB approval beyond the usual 12 month period Form available at IRB website under �Forms� Submit informed consent form if applicable Report any problems or adverse events 19 Continuing Review

20. Report changes in instruments, participants and sample, additional partners, sites, or researchers Form available at IRB website under �Forms� Submit by email along with any affected documents 20 Amendments

21. Any unforeseen complications, problems, incidents, adverse events, or other research-related negative consequences should be reported to the IRB as soon as possible to be documented by the IRB. Contact Paula.Garcia@nau.edu if you experience any such occurrences 21 Adverse Events

22. All researchers are required to follow the guidelines in 45 CFR 46 Anybody can report non-compliance Disciplinary actions can include suspension or termination of research, seizure of all data, prevention of publication or presentation, written reprimand, and sanction from conducting future research 22 Consequences of Non-Compliance

23. Flagstaff Medical Center: Cynthia.Beckett@nahealth.com, Director, Pediatrics/Perinatal Services & Evidence-Based Practice OR Gretchen.McMasters@nahealth.com Evidence-Based Practice Project Manager/Coordinator, 928-773-2346 Navajo Nation Human Research Review Board meets the 3rd Tuesday of each month at 9 AM in Window Rock, AZ, open to the public: http://www.nnhrrb.navajo.org/ Hopi Cultural Preservation Office: http://www.nau.edu/~hcpo-p/ 23 Other Local IRBs

24. Federal Government: http://www.hhs.gov/ohrp/ IRB Profession: http://www.irbforum.org/, http://www.primr.org/ Educational Research Ethics (AERA): http://www.aera.net/AboutAERA/Default.aspx?menu_id=90&id=717 Psychological Research Ethics (APA): http://www.apa.org/ethics/ Political Science Research Ethics (APSA): http://www.apsanet.org/content_9350.cfm?navID=12 24 Resources