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
(Manage UCI’s program for research compliance) 2

3. DHHS (OHRP) Definition
45 CFR (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: Dept of Human and Health Services
OHRP: Office of Human Research Protections
Title 45 code of federal regulations part 46 subpart 102

4. DHHS (OHRP) Definition
45 CFR (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
The Nazi atrocities of World War II re: research on jews in concentration camps which led to the creation of Nuremberg Code of 1949: The voluntary consent of the human subject is absolutely essential. Significant because it was the first international document that advocated voluntary participation and informed consent
As part of a research project conducted by the U.S. Public Health Service, 600 low-income African-American males, 400 of whom were infected with syphilis, were monitored for 40 years. Free medical examinations were given; however, participants were not told about their disease. Even though a proven cure (penicillin) became available in the 1950s, the study continued until 1972 with participants being denied treatment. In some cases, when participants were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. Many participants died of syphilis during the study. The study was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its existence was publicized and it became a political embarrassment.
Belmont Report (1979) -

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
Respect for persons:
Autonomy - Choice, Obtaining informed consent. Ensure that potential participants understand the elements of informed consent
Minimize the possibility of coercion and undue influence;
The protection of vulnerable populations; obtain assent; honor dissent of cognitively impaired
Privacy and Confidentiality – Identify participants without violating privacy and ensure confidentiality of the information/data obtained.
Beneficence:
Minimize risk/maximize benefits; ensure that the potential benefits outweigh the risks.
Ensure that the rights/welfare of the subject prevail over the need for science
Justice:
Distribute burdens and benefits of research equally
Recruit participants fairly without discrimination or bias

7. Criteria for Approval BENEFICENCE JUSTICE RESPECT FOR PERSONS
46.111,
BENEFICENCE
JUSTICE
RESPECT FOR PERSONS
Experimental Design Risk/Benefit Analysis Data 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 – misnomer: Exempt from federal regulations, not exempt from IRB Review
Exempt – Administrator, Sr. Analyst – Category 2, some Category 4 (records review, not review of medical records)
Exempt SubC – Category 1, children / minors
Exempt*
SubC, Admin, Sr. Analyst
Virtually No Risk
RISK
*defined by lists in regulations

11. 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
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  
Category 2: underage drinking, illicit drug use, tax evation; employability and reputation (HIV status, STDs) social standing, LGBT
Category 3: interviewed in their official capacity, interviewed as a civilian (Cat 2)

12. 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)
Categories 2 and 7
Categories 4 and 5

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.
Adequate Informed Consent. Only the subjects can evaluate the degree of risk in a given situation. The IRB must ensure that subjects are given sufficient information regarding the study to determine for themselves what the risks are and whether they want to assume those risks.
Must be understandable to subjects: Risks described in terms that the subjects can understand. Comparisons to everyday risks.
Avoid Bias and Creation of Negative Mindsets: Consent process should not increase the likelihood of harm.

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
Compensation – for Injury or time (gift card given)
Compensation is not Benefit (some studies the amount is in $1K, may be considered coercive), compensation for time and effort

15. Waiver of Documentation of Informed Consent
45 CFR (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.
Justification Required – cant be because you don’t have time

16. Waiver / Alteration of Informed Consent
Emergency Situation
Observation of Public Behavior
Public Benefit or Service Programs
Deception Involved
Children / Minors
Public benefit or service programs - Research subject to approval of state or local government officials
Deception
Children / Minors – 1-5 year olds, for the 1-2 year olds: observing playtime (act of playing is implied consent) + parents consent
Recent study, observing dispatchers in 911 calls, callers were considered research subjects, but consent waived bc documents available publicly and it would interrupt the emergency situation.

17. US Export Control Regulations
Export Administration Regulations (EAR)
“Dual use” items are controlled by the Export Administration Regulations (EAR – 19 CFR ) 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
How many of you plan to do international research?
Any of you go to Cuba, Iran, North Korea, Sudan, or Syria?
These are embargoed countries for which special requirements such as obtaining a license must be met prior to departure
There three governmental agencies for which oversee any activity (research or otherwise) between US and these 5 countries

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.
Office of Foreign Asset Control

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:

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)
Modules – Privacy and Confidentiality, Informed Consent, Historical and Ethical Principles (1/2 hour), good for 5 years (FS needs to take it)
One of the first questions asked is the level of review – important, determines what paperwork to fill out.
Templates used

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 Text
Signed Application – Lead Researcher, Faculty Sponsor, Department Chair
CITI Tutorials Incomplete – LR and FS
Privacy vs. Confidentiality – Breach
CITI - Faculty Sponsor
Documentation – need signed application
FS is DC, then the person s/he reports to will have to sign (cant have dual role)
The person whom s/he reports to is Hemminger, notify us and we will obtain signature after IRB Approval

22. ***Notify IRB if status changes***
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***

23. Documents Depot https://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
, LR: Cauffman
Uci.edu, research, office of research, research administration,
- human research, student researchers, FAQs

24. Contact Information
Karen Allen, MA, CIP Director Beverley Williams, BA, CIP Assistant Director Marci Copeland, MBA Export Control Administrator
Val Sanchez, MA, CCRP IRB Administrator Melissa Camarena, BA IRB Sr. Analyst Open Position IRB Analyst
Analyst position – Le’Quan (promoted), lucky we still have him assisting part-time
Office Hours (phone) – Fridays are hectic
Uci.edu
Research – office of research
Research administration
Applications & Forms
Human Research
Student Researchers