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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 D ivisions: Sponsored Projects Research Protections

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Human subject protection in research

Human Subject Protection in Research

Val Sanchez, MA, CCRP

IRB Administrator

November 14, 2013


Uci office of research
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
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 definition1
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

Research Ethics Timeline


Belmont principles 1979
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

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


Institutional review board
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


Irb c
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)


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


Exempt review
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


Expedited review
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)


Informed consent process
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.


Basic elements of informed consent
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
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.


Waiver alteration of informed consent
Waiver / Alteration of Informed Consent

  • Emergency Situation

  • Observation of Public Behavior

  • Public Benefit or Service Programs

  • Deception Involved

  • Children / Minors


Us export control regulations
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


Ofac sanctions
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
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/


New application
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
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 http www research uci edu ora hrpp extendedirbapproval htm
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***


Documents depot https apps research uci edu irbdocs
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


Contact information
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

[email protected]

949-824-0445

Val Sanchez, MA, CCRP

IRB Administrator

949-824-4779

[email protected]

Melissa Camarena, BA

IRB Sr. Analyst

949-824-7114

[email protected]

Open Position

IRB Analyst

949-824-6662


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