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 Web: research.nau.edu/compliance/irb

2. What is the IRB? 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

3. Does my project need to be reviewed by the IRB? • 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?

4. What is human subjects research? • 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

5. Past events shaped today’s regulations: • Nazi Human Experimentation, search Steven Spielberg Video Archive of Nuremberg Trials • Monster Study, 1939, settled in 2007 • Tuskegee Syphilis Study, 1932-1972 • Guatemalan STD Study, 1946-1948 • Stanford Prison Experiment, 1971 • ASU – Havasupai Tribe settlement of $700,000 plus scholarships and facilities

6. What do I need to do as a researcher? • 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

7. What are the responsibilities of the faculty sponsor? • 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

8. What will the IRB ask for?1. Participants • 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

9. 2. Recruitment • 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

10. 3. Informed Consent 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

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

12. 5. Confidentiality • 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

13. 6. Benefits • 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

14. 7. Risks • 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)

15. 8. Attachments • Instruments: surveys, interview questions, observation checklists, tests, etc. • Informed consent, parental consent, and child assent documents • Letters of support/permission to collect data • Recruitment flyers, emails, scripts

16. What else will the IRB ask for? • 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

17. Types of Review • Full Board: greater than minimal risk, vulnerable populations • Expedited: low risk, recordings, focus groups, non-invasive procedures • Exempt: minimal risk, surveys, records review, de-identified data

18. Other Functions • Continuing review: extend IRB approval beyond the usual 12 month period • Amendments: report changes in instruments, participants, sample, additional partners, sites, or researchers • Adverse events: unforeseen complications, problems, or other research-related negative consequences should be reported to the IRB as soon as possible

19. Consequences of Non-Compliance • 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

20. Other Local IRBs • 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/

21. Resources • 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