Human Subject Protection in Research

1. Human Subject Protection in Research Val Sanchez, MA, CCRP IRB Administrator November 14, 2013

2. UCI Office of Research • Led by: • Vice Chancellor for Research (John Hemminger) • Associate Vice Chancellor for Research (James Hicks) • Two Divisions: • Sponsored Projects • Research Protections • Human Research Protections (HRP) • Animal Care and Use • Human Stem Cell

3. DHHS (OHRP) Definition 45 CFR 46.102(d) Research - a (1) systematic investigation, including research development, testing and evaluation, (2) designed to develop or contribute to generalizable knowledge. A 'systematic investigation' involves a plan which incorporates collection of data, either quantitative or qualitative, or specimens; and analysis to answer a question. Activities ‘designed to develop or contribute to generalizable knowledge’ are those activities designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations beyond the specific study population), inform policy, or generalize findings.

4. DHHS (OHRP) Definition 45 CFR 46.102(f) Human Subject - a living individual about whom an investigator (faculty, staff, or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between researcher and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record information). Private information must be individually identifiable. Individually identifiable includes where the identity of the subject is or may be ascertained by the researcher or associated with the information.

5. Research Ethics Timeline Research Ethics Timeline

6. Belmont Principles (1979) • Respect for Persons (Be Respectful) • Individuals should be treated as autonomous agents • Individuals with limited autonomy are entitled to protection • Beneficence (Be Nice) • Do no harm • Minimize risk/maximize benefits • Justice (Be Fair) • Fair distribution of risks and benefits of research

7. BENEFICENCE JUSTICE RESPECT FOR PERSONS Criteria for Approval 46.111, 56.111 Experimental Design Risk/Benefit AnalysisData Safety Qualifications of Researchers Subject Selection Inclusion/Exclusion Recruitment Fair Distribution Privacy & Confidentiality Vulnerable Populations Informed Consent Surrogate Consent Parent Permission / Assent

8. Institutional Review Board • UCI has four IRB Committees: • IRBs “A” and “B” review biomedical research • IRB “C” reviews social/behavioral/educational • Team “D” – minimal risk biomedical research • IRB “E” reviews non-compliance issues

9. IRB C Led By: • Chair, Elizabeth Cauffman, PhD - Psychology & Social Behavior • Vice Chair, JoAnn Prause, PhD – Psychology & Social Behavior Transaction Types: • New Applications • Modifications / Amendments to approved studies • Continuing Review of approved studies • Adverse Events Meetings: • Full-Committee: Monthly (3rd Friday) • Subcommittee: Weekly (every Friday morning)

10. Level of Risk Generally Determines Level of Review Convened IRB Meeting Full Committee > Minimal Risk Expedited* Subcommittee Minimal Risk Exempt* SubC, Admin, Sr. Analyst Virtually No Risk RISK *defined by lists in regulations

11. Exempt Review See all categories: http://www.research.uci.edu/ora/forms/hrpp/categories_of_exempt_human_subjects_research.pdf Category 1. School Based Research – research in an educational setting (classroom, dojo) (a) instructional strategies or (b) comparing instructional techniques, curricula or classroom management methods. Category 2. Interviews, Surveys, Observation of Public Behavior • Cannot identify subject (anonymous or de-identified), or • Data is identifable, but subject is not at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability or reputation.   Category 3. Public Officials – Interviews or observation of public behavior of elected or appointed public officials or candidates for public office Category 4. Records Review – Collection of existing data, recorded such that subjects cannot be identified

12. Expedited Review See all Expedited Categories: http://www.research.uci.edu/ora/forms/hrpp/categories_of_expedited_human_subjects_research.pdf Category 4. fMRI - Collection of data thru noninvasive means , including studies using cleared medical devices Category 5. Records Review – involving materials collected for non research purposes that have been collected or will be collected (like Exempt #4) Category 6. Recordings – Video, Digital, Audio, Image (ie, Photos) Category 7. Interviews, Surveys, Focus Groups - Individual / Group characteristics or behavior (like Exempt #2)

13. Informed Consent Process Informed consent is not a single event or just a form to be signed -- rather, it is an educational process that takes place between the investigator and the prospective subject. The basic elements of the consent process include: • full disclosure of the nature of the research and the subject's participation, • adequate comprehension on the part of the potential subjects, and • the subject's voluntary choice to participate.

14. Basic Elements of Informed Consent 46.116(b), 50.25(b) • Research • Duration • Procedures • Experimental Products • Risks/Discomforts • Benefits • Alternative procedures/treatment, if any • Confidentiality • Compensation for Injury (Full Committee) • Whom to Contact • Voluntary Participation / Right to Refuse or Withdraw at Any Time

15. Waiver of Documentationof Informed Consent 45 CFR 46.117(c) • IRB may waive written / signed Consent: (1) The only record linking the participant and the research is the consent form • The principal risk is a breach of confidentiality; • Not a clinical investigation (2) No more than minimal risk (Exempt or Expedited) and the research does not involve procedures for which written consent is normally required outside of the research context. • The IRB may require the investigator to provide subjects with a written statement (Study Info Sheet) regarding the research.

16. Waiver / Alteration of Informed Consent • Emergency Situation • Observation of Public Behavior • Public Benefit or Service Programs • Deception Involved • Children / Minors

17. US Export Control Regulations • Export Administration Regulations (EAR) • “Dual use” items are controlled by the Export Administration Regulations (EAR – 19 CFR 730-774) administered by The Department of Commerce, Bureau of Industry and Security (BIS) administers the EAR • International Traffic in Arms Regulations (ITAR) • Munitions and defense services are controlled under the International Traffic in Arms Regulations (ITAR) are administered by the Department of State • Office of Foreign Asset Control (OFAC) • Treasury’s Office of Foreign Assets Control (OFAC) administers economic and trade sanctions • Research in or collaborations with any of the following countries, require review from Export Control: Cuba, Iran, North Korea, Sudan, Syria

18. OFAC Sanctions The most restrictive sanctions programs (Cuba, Iran, North Korea, Sudan and Syria) will require a license for: • A broad range of services and transactions • In Iran, conducting surveys is considered a licensable activity • In most cases you will need a license to attend a conference in Cuba • Any exports/imports Sanctions programs vary by country and change regularly. Applies to U.S. Persons: • Any person within the U.S. • Any U.S. citizen or permanent resident alien, wherever physically located • Any entity or institution organized under U.S. law Licenses can be obtained from OFAC on case-by-case basis, but terms must be strictly complied with.

19. Travel Abroad • Taking certain items outside the US might require a license: Laptops, Cell phones • “Tool of Trade” license exception letter for UCI owned • Recommended - do not bring important data on laptop when traveling internationally • Export Control Website: http://www.research.uci.edu/ora/exportcontrol/

20. New Application • Complete the CITI Tutorial (3 modules) • Level of Review – Exempt or Expedited • Narrative and Consent / Study Info Sheet • Other Forms • Authorization for Publication/Presentation • Appendices, Letter of Permission • List of Interview Questions • Recruitment Material (Flyers, Scripts)

21. Common Errors • Instructional Prompts Unanswered • Inconsistency • Missing Documentation • Protocol Narrative • Written Consent Form or Study Info Sheet • Surveys/Questionnaires, Interview Questions • Recruitment Materials – Scripts and Email Text • Signed Application – Lead Researcher, Faculty Sponsor, Department Chair • CITI Tutorials Incomplete – LR and FS • Privacy vs. Confidentiality – Breach

22. 3-year Extended IRB Approval (A3)http://www.research.uci.edu/ora/hrpp/extendedirbapproval.htm • Involves no more than minimal risk to human subjects (ie, Expedited Review), and • Is not subject to federal oversight (e.g. federally supported; with a Certificate of Confidentiality from NIH; MOU), and • Is not subject to UCI Conflict of Interest Oversight Committee (COIOC) ***Notify IRB if status changes***

23. Documents Depothttps://apps.research.uci.edu/irbdocs/ • All IRB-approved documents accessed • Editable and Stamped Versions • Study Documents: Narrative, Consent/SIS, Recruitment Material, etc. • LR Responsible for retaining records • Audits: Internal/External, For Cause/Routine • Previous transactions deleted

24. Contact Information Karen Allen, MA, CIP Director 949-824-1558 Beverley Williams, BA, CIP Assistant Director 949-824-5746 Marci Copeland, MBA Export Control Administrator m.copeland@uci.edu 949-824-0445 Val Sanchez, MA, CCRP IRB Administrator 949-824-4779 valerie.ms@uci.edu Melissa Camarena, BA IRB Sr. Analyst 949-824-7114 mccamare@uci.edu Open Position IRB Analyst 949-824-6662