Human Subject Protection in Research

1. Human Subject Protection in Research Valerie M. Sanchez, MA, CCRP IRB Administrator September 24, 2012

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 • Conflict of Interest

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 research • 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, Michael Montoya, PhD - Chicano/Latino Studies and Anthropology Transaction Types: • New Applications • Modifications / Amendments to approved studies • Continuing Review of approved studies 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* Chair or Administrator 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. DHHS Federal Policy for the Protection of Human Subjects 45 CFR Part 46 (enforced by the Office of Human Research Protections) • Subpart B: Pregnant Women, Fetuses and Neonates • Subpart C: Prisoners • Subpart D: Children / Minors

14. Special Subject Populations • Cognitive impairment (comprehension; decision making capacity) • UCI Students, Employees (undue influence; compromised objectivity) • Non-English Speakers and Persons who Cannot Read (misunderstanding regarding concepts involved with research participation)

15. 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.

16. 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

17. Add’l Elements of Informed Consent 46.116(b), 50.25(b) • Currently Unforeseeable Risks • Termination of Participation • Additional Costs to Subjects • Consequence of Withdrawal • Informing of New Findings • Number of Subjects

18. 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.

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

20. Contact Information Karen Allen, MA, CIP Director 949-824-1558 Beverley Williams, BA, CIP Assistant Director 949-824-5746 Valerie Sanchez, MA, CCRP Administrator 949-824-4779 “Open Position” Sr. Analyst Le’Quan Jackson, BA Analyst 949-824-6662

21. Thank You!