Human Subject Protection
in Research
Val Sanchez, MA, CCRP
IRB Administrator
November 14, 2013
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
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.
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.
Research Ethics Timeline
Research Ethics Timeline
Kefauver-Harris Amendments
Thalidomide Tragedy Declaration of Helsinki
National Research Act
Human Radiation Experiments
November 72
DHHS/FDA Consolidate
Nazi Experiments
Syphilis Study
Syphilis Study
Nuremberg Code
September 72
Syphilis Exposé
in NY Times
Belmont Report
Common Rule
Belmont Principles (1979)
• Respect for Persons (Be Respectful)
– Individuals should be treated as autonomous agents
– Individuals with limited autonomy are entitled to
• Beneficence (Be Nice)
– Do no harm
– Minimize risk/maximize benefits
• Justice (Be Fair)
– Fair distribution of risks and benefits of research
Criteria for Approval
46.111, 56.111
Experimental Design
Risk/Benefit Analysis
Data Safety
Qualifications of Researchers
Subject Selection
Fair Distribution
Privacy & Confidentiality
Vulnerable Populations
Informed Consent
Surrogate Consent
Parent Permission / Assent
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
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
• Full-Committee: Monthly (3rd Friday)
• Subcommittee: Weekly (every Friday morning)
Level of Risk Generally
Determines Level of Review
> Minimal Risk
Convened IRB Meeting
Full Committee
Minimal Risk
Virtually No Risk
SubC, Admin, Sr. Analyst
*defined by lists in regulations
Exempt Review
See all categories:
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
(a) Cannot identify subject (anonymous or de-identified), or
(b) 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:
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)
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
• 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
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
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
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
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.
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:
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)
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
3-year Extended IRB Approval (A3)
• 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***
Documents Depot
• 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
Contact Information
Karen Allen, MA, CIP
Val Sanchez, MA, CCRP
IRB Administrator
[email protected]
Beverley Williams, BA, CIP
Assistant Director
Melissa Camarena, BA
IRB Sr. Analyst
[email protected]
Marci Copeland, MBA
Export Control Administrator
[email protected]
Open Position
IRB Analyst

Human Subject Protection in Research