IRB Overview

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IRB Overview

• Susie Hoffman RN BSN CIP
• IRB-HSR Director

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IRB

• What does it stand for?

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YES

• INSTITUTIONAL REVIEW BOARD

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NO

• International Rugby Board
• Internet Radio Broadcasters
• International Research Bureau
• Irish Republican Brotherhood
• Indian River Bulldogs
• International Register on Biosafety
• Investigational Review Board
• Internal Review Board

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Why do IRBs Exist?

• Answer choices
• To drive you and your colleagues crazy
• To create mounds of paperwork and kill all the
  trees in the forest
• To add another thing to your list of 329023494
  things to do
• None of the above!

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Role of the IRB is to

• Protect research participants by reviewing human
  subject research from the standpoint of its
  ethical conduct

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Public trust

• is the bottom line

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Why wouldnt the public trust clinical research?
Nuremburg code
WWII Crimes against humanity
1940s
Post WWII military medical abuse, Willowbrook
study, Witchita study
1950s
Declaration of Helsinki, NEJM Beecher article,
FDA regs requiring informed consent
Thalidomide study, JCDH study of cancer immunity,
Milgram study of obedience to authority
1960s
Congressional hearings, the National Research
Act /Belmont Report/IRB System, amendments to
regulations for vulnerable populations
1970s
Tearoom trade study, San Antonio Contraception
study, Tuskegee study makes the news
1990s thru today
Deaths of normal volunteers in research
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Resources for Protecting Human Subjects

• Ethical Codes
• Nuremberg Code
• Declaration of Helsinki
• Belmont Report
• Federal Regulations
• Regarding Informed Consent
• Regarding IRBs
• IRB-HSR Standard Operating Procedures
• Internal policies governing how UVA IRB-HSR does
  business

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Ethical Principles in Belmont Report

• Respect for Persons
• Informed consent, privacy and confidentiality,
  special protections for vulnerable populations
• Beneficence
• Minimize risks, balance risks and benefits
• Justice
• Select research participants equitably

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Where do the regulations come from?The
Government of the United States
The Constitution
Legislative Branch
Executive Branch
Judicial Branch
The President The Vice President Executive Office
of the President Council of Economic
Advisors National Security Council Office of
Management and Budget Office of Policy
Development Office of Science and Technology
The Congress Senate House Architect of the
Capital US Botanical Garden General Accounting
Office Library of Congress Congressional Budget
Office
US Supreme Court US Court of Appeals US District
Courts US Tax Court US Court of Appeals for
Veterans Claims Administrative Offices of the US
Courts
Department of Education
Department of Commerce
Department of Defense
Department of Agriculture
Dept Homeland Security
Department of Energy
Dept Health and Human Services
Department of State
Department of Justice
Department of Labor
Department of The Interior
Dept of Veterans Affairs
Department of Transportation
Department of The Treasury
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Department of Health Human Services
The Secretary
This is not a complete org chart!
Office of Public Health and Science (OPHS)

• Office of Human
• Research Protections (OHRP)
• 45 CFR 46
• Common Rule

• Office of Research Integrity (ORI)
• Research misconduct issues
• FOIA

• Office of Civil Rights
• HIPAA Oversight
• 21CFR160
• 21CFR164

Centers for Disease Control and Prevention (CDC)

• Food and Drug
• Administration
• (FDA)
• 21CFR50
• 21CFR56

National Institutes of Health (NIH)
Inspector General
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DHHS Regulations OHRP

• 45 CFR 46, Subpart A Adopted in 1981
• Became known as Common Rule in 1991

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DHHS Vulnerable Populations (Subparts of 45 CFR
46)

• Subpart B- Protections pertaining to research,
  development, and related activities involving
  fetuses, pregnant women and human in vitro
  fertilization

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DHHS Vulnerable Populations (Subparts of 45 CFR
46)

• Subpart C- Protections pertaining to biomedical
  and behavioral research involving prisoners as
  subjects
• Subpart D- Protections for children involved as
  subjects in research

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Tip to Remember Subparts

• B - Pregnant
• C - Prisoner
• D - Children

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Food Drug Administration

• Separate regulations
• 21 CFR 56 IRBs
• 21 CFR 50 Informed consent
• Based primarily on use of FDA regulated products
  drugs, devices, or biologics

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FDA DHHS Regulations

• Basic requirements for IRBs and for Informed
  Consent are similar
• Differences in applicability
• DHHS based on federal funding
• FDA regulations based on FDA-regulated products (
  study involves a drug, device or biologic)

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DHHS Definitions

• Research- A systematic investigation designed to
  develop or contribute to generalizable knowledge
• Human Subject- A living individual about whom an
  investigator conducting research obtains data
  through intervention or interaction with the
  individual, or identifiable private information

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Basic Protections for Subjects in Human Research

• Institutional Assurances
• IRB Review
• Informed Consent

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What is an institutional assurance?

• Called an FWA ( Federal Wide Assurance)
• The documentation of an institutional commitment
  to comply with Federal regulations and maintain
  adequate programs and procedures for the
  protection of human subjects
• The principle mechanism for compliance oversight
  by OHRP

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What is an institutional review board?

• Committee established to protect the rights and
  welfare of human research subjects recruited to
  participate in research activities conducted
  under the auspices of the institution with which
  it is affiliated

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IRB Tips

• Must have at least one scientific member, one
  non-scientific member, and one member otherwise
  unaffiliated with the organization
• To vote on a protocol, must have a quorum and at
  least one non-scientific member present

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IRB Review

• The IRB reviews and has authority to approve,
  require modification in , or disapprove all
  research activities, including proposed changes
  in previously approved human research

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IRB Review

• Conducts continuing review of approved research
  at intervals appropriate to the degree of risk,
  but not less than once per year
• Has authority to suspend or terminate previously
  approved research that is not being conducted in
  accordance with IRB requirements, or that has
  been associated with unexpected serious harm to
  subjects.

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Requirements for approving research involving
human subjects

• Risks to subjects are minimized
• Risks to subjects are balanced by anticipated
  benefits to subjects and knowledge to be gained
  by the research
• Equitable selection of subjects
• Informed consent appropriately obtained
• Informed consent appropriately documented
• Adequate procedures in place to monitor subject
  safety
• Adequate procedures in place to protect privacy
  and confidentiality
• Per federal regulations 45 CFR Part 46.111
  (DHHS) and 21 CFR Part 56.111 (FDA)

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IRB Review the Institution

• Institutional officials may not authorize or
  approve the conduct of human subject research
  that has not been approved by IRB
• Research approved by IRB may be subject to
  further review and approval or disapproval by
  institutional officials.

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Informed Consent

• Unless authorized by IRB, no investigator may
  involve a human being as a subject in research
  unless the investigator has obtained the legally
  effective informed consent of the subject or the
  subjects legally authorized representative

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What is informed consent?

• The voluntary choice of an individual to
  participate in research based on understanding of
  purposes, procedures, risks, benefits,
  alternatives, and any other factors that may
  affect a persons decision to participate

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Consent Process Concepts

• Full disclosure of the nature of the research and
  the subjects participation
• Adequate comprehension on the part of the
  potential subjects
• The subjects voluntary choice to participate

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Resources

• Protecting Study Volunteers in Research by Dunn
  and Chadwick
• CITI Online Training http//www.virginia.edu/vpr/
  irb/hsr/citi.html
• Ethical Principles
• http//www.virginia.edu/vpr/irb/hsr/ethical_princi
  ples.html

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Other Common Research Acronyms

• DHHS- Department of Health and Human Services
• OHRP- Office for Human Research Protection
• FDA- Food and Drug Administration
• FWA- Federal Wide Assurance
• ORI- Office of Research Integrity
• NIH- National Institutes of Health
• OCR- Office of Civil Rights
• IOM- Institute of Medicine
• OIG- Office of the Inspector General
• SACHRP-Secretaries Advisory Committee on Human
  Research Protections
• IND- Investigational New Drug Application
• IDE-Investigational Device Exemption
• DSMB- Data and Safety Monitoring Boards
• DSMP- Data and Safety Monitoring Plans

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Final Thoughts

• Jesses Intent
• http//www.circare.org/jintent.pdf