Human Subject Protection in Research

Valerie M. Sanchez, MA, CCRPIRB Administrator

September 24, 2012

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

DHHS (OHRP) Definition45 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.

DHHS (OHRP) Definition45 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.

Research Ethics Timeline

Research Ethics Timeline

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

Criteria for Approval

BENEFICENCE JUSTICE

RESPECT FOR PERSONS

Experimental Design Risk/Benefit Analysis

Data SafetyQualifications of Researchers

46.111, 56.111

Privacy & Confidentiality Vulnerable Populations

Informed ConsentSurrogate Consent

Parent Permission / Assent

Subject SelectionInclusion/Exclusion

RecruitmentFair Distribution

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

IRB CLed 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)

Level of Risk Generally

Determines Level of Review

Exempt*Chair or Administrator

Expedited*Subcommittee

Convened IRB MeetingFull Committee

Minimal Risk

RISK

*defined by lists in regulations

Virtually No Risk

> Minimal Risk

Exempt ReviewSee 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

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)

DHHS Federal Policy for the Protection of Human Subjects

• Subpart B: Pregnant Women, Fetuses and Neonates

• Subpart C: Prisoners

• Subpart D: Children / Minors

45 CFR Part 46 (enforced by the Office of Human Research Protections)

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)

Informed Consent Process

Informed consent is not a single event or just a form to besigned -- rather, it is an educational process that takesplace 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.

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

Add’l Elements of Informed Consent46.116(b), 50.25(b)

• Currently Unforeseeable Risks• Termination of Participation• Additional Costs to Subjects• Consequence of Withdrawal• Informing of New Findings• Number of Subjects

Waiver of Documentation of 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.

Waiver / Alteration of Informed Consent

• Emergency Situation• Observation of Public Behavior• Public Benefit or Service Programs• Deception Involved • Children / Minors

Contact Information

Karen Allen, MA, CIPDirector

949-824-1558

Beverley Williams, BA, CIPAssistant Director

949-824-5746

Valerie Sanchez, MA, CCRPAdministrator949-824-4779

“Open Position”Sr. Analyst

Le’Quan Jackson, BAAnalyst

949-824-6662

Thank You!