Human Research Protection Program

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Human Research Protection Program IRB
Responsibilities

• Marisue Cody, PhD
• Director
• Center on Advice Compliance Help

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Objectives

• Describe the shared responsibilities of a
  facility Human Research Protection Program
• Describe the responsibilities for Human Subjects
  Protection
• Explore risks, privacy, confidentiality review
  by the IRB

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HRPPP (Human Research Participant Protection
Programs)

• Institute of Medicine report 2001
• Preserving the Public Trust
• Broader system with multiple functional elements
• Advocated accreditation of the HRPPP

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Human Research Protection Program (HRPP)

• Shared responsibility
• Organization
• Leadership
• Research Office
• RD Committee
• IT, Privacy, Ethics
• IRB
• Investigators and research staff

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New model HRPP
Old model
Director
Chief of Staff
RD
QA/QI
Patient Advocates
ACOS/Education
IRB
ACOS/R
RCO
RD Committee
AO
Medical Records
HPA
Clinical managers
Public Affairs
IRB
Privacy Office
Pharmacy
Investigators
DSMB
Radiation Safety
ISO
Study Coordinators
Subjects
Conflict of Interest Committee
Grants Contracts
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AAHRPP Accreditation Standards Domains

• Organization
• Research Review Unit
• Investigator
• Sponsored Research
• Participant Outreach

Obligations of
Obligations to
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How does accreditation work?
Application
Self Evaluation
Expert site visitors Tailored to setting
Site Visit
Determines Accreditation category
Council on Accreditation
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Categories of Accreditation

• Full AAHRPP accreditation
• Qualified AAHRPP accreditation
• Accreditation-pending
• Accreditation withheld

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AAHRPP Accreditation Update

• 74 applications (94 FWAs)
• 72 site visits (92 FWAs)
• 53 applications reviewed by AAHRPP Council (65
  FWAs)
• 35 HRPPs accredited (40 FWAs)

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Institutional Responsibilities
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Regulatory Guidelines for the Institution

• Dept of Health Human Services FWA
• FDA none
• VA
• VHA Directive 2003-031 (funding of the facility
  HRP)
• VHA Directive 1200 (Facility RD program)
• VHA Handbook 1200.1 (RD Committee)

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Federalwide Assurance (FWA)

• This documents your institutional commitment to
  comply with the Common Rule.
• It is required from each institution engaged in
  covered research
• http//www.hhs.gov/ohrp/policy/index.htmlengageme
  nt

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Assurance of Compliance (38 CFR part 16.103)

• Statement of principles governing the institution
• Designation of one or more IRBs
• List of IRB members
• Written procedures the IRB will follow
• Written procedures for reporting unanticipated
  problems involving risk, and any suspension or
  termination of IRB approval
• Executed by individual authorized to act for the
  institution

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Review by institution (38 CFR part 16.112)

• Research approved by an IRB may be subject to
  further review by official of the institution
• Those officials MAY NOT approve the research if
  it is not approved by the IRB

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IRB Requirements
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Federal Policy for the Protection of Human
Subjects

• Originally issued in 1974 as Part 46 of Title 45
  of the Code of Federal Regulations (Subpart A) by
  DHEW
• Adopted in 1991 by 17 federal agencies
• 38 CFR part 16 refers to the VA
• 45 CFR part 46 refers to DHHS
• 21 CFR parts 56 (IRB) and 50 (informed consent)
  refers to the FDA

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Common Rule and VHA Handbook 1200.5

• Common Rule Regulation
• Establish IRBs and responsibilities
• Ensure Informed Consent of Subjects
• VHA Handbook 1200.5 Policy
• Medical Center Responsibilities
• IRB Composition Responsibilities
• Investigator Responsibilities
• Investigational Drugs Devices in VA
• Handbook and Federal Regulations
• Same regulatory weight (not optional)

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What is covered?

• All research involving human subjects conducted,
  supported or otherwise subject to regulation by
  any federal department or agency which takes
  action to make this policy application. (38 CFR
  part 16.101)
• In the VA, that is all research involving human
  subjects conducted completely or partially in VA
  facilities, approved off-site locations,
  facilities, and/or by VA researchers while on
  official VA duty time (VHA Handbook 1200.5, p. 6).

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Research
a systematic investigation, including research
development, testing and evaluation, designed to
develop or contribute to generalizable
knowledge. (38 CFR part 16.102d)
20
Human subject

• means a living individual about whom an
  investigator (whether professional or student)
  conducting research obtains(1) data through
  intervention or interaction with the
  individual, or(2) identifiable private
  information

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IRB Review of Research (38 CFR part 16.109)

• Authority to Approve, require modifications to
  seek approval, or disapprove
• Require that information given to subjects is in
  compliance with informed consent regulations
• Shall require documentation of informed consent
  or waive documentation
• Notify investigators in writing of its decision
• Conduct continuing review and have authority to
  observe consent process and research

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Additional VHA 1200.5 requirements

• Prior to initiating research
• Research MUST be reviewed and approved by IRB AND
  RD, approval must be in writing
• If approval is contingent on substantive
  modifications, subsequent review must be by the
  convened IRB
• If approval is contingent on specific minor
  conditions, the IRB chair or designee may approve
  it on behalf of the IRB

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Criteria for IRB Approval (VHA Handbook 1200.5)

• Risks to subjects are minimized
• Risks are reasonable in relation to benefits
• Selection of subjects is equitable
• Informed consent will be sought prospectively
• Informed consent is appropriately documented
• Research plan makes adequate provisions for
  safety monitoring
• There are adequate provisions to protect privacy
  and confidentiality
• Protection of vulnerable subjects
• 9. Conflict of interest
• 10. Ensure investigator educational requirements
  and certifications

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Criteria for IRB Approval (VHA Handbook 1200.5)

• Risks to subjects are minimized
• Risks are reasonable in relation to benefits
• Selection of subjects is equitable
• Informed consent will be sought prospectively
• Informed consent is appropriately documented
• Research plan makes adequate provisions for
  safety monitoring
• There are adequate provisions to protect privacy
  and confidentiality
• Protection of vulnerable subjects
• 9. Conflict of interest
• 10. Ensure investigator educational requirements
  and certifications

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Risk What is it?

• The probability of harm or injury occurring as a
  result of participation in a research study
• Prediction of some future occurrence of harm
• Consideration of probabilities what has happened
  before?

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Benefit What is it?

• A valued or desired outcome an advantage
• The probability of hoped for benefits

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Risk/Benefit Analysis

• Risks and benefits are not parallel ideas
• Risks often individual, immediate, measurable
• Benefit often elusive, future, potential
• Need to maintain a favorable balance

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The Role of the IRB

• Review potential risks, discomforts, hazards, or
  inconveniences of protocol
• Probability, magnitude, duration, reversibility
  of risks
• Separate risks of research from standard of care
  risks
• e.g. Risks of surgery already scheduled
• Give special consideration to risks for research
  involving vulnerable populations
• Children, mentally impaired, prisoners, others

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The Role of the IRB (cont.)

• Consider hoped for benefits
• Benefits can take the form of therapy, education,
  information, resources or empowerment
• Benefits can be directed at participants, their
  community, society, medical knowledge, medical
  technology
• Consider if risks reasonable in relation to
  possible benefits
• Balancing potential risks to participant/others
• against possible benefits to participant/society

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VHA DIRECTIVE 2007-040 November 30, 2007

• All human subjects research conducted at the
  facility is reviewed prior to the research being
  initiated by an ISO and a Privacy Officer who
  have been appointed to either the IRB of record
  or the RD Committee of record.

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Privacy the IRB (VHA Handbook 1605.1)

• All VHA Investigators conducting VHA-approved
  research must obtain the authority to use
  individually-identifiable information as follows
  
• VHA individually-identifiable health
  information involving non-employee research
  subjects may be used by a VHA Investigator for
  research purposes provided there is a prior
  written authorization. A prior written
  authorization may be incorporated into an
  informed consent.

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Privacy the IRB (2)

• VHA individually-identifiable health information
  involving non-employee research subjects may be
  used by a VHA Investigator for research purposes
  when there is an IRB or Privacy Board waiver of
  authorization in accordance with 45 CFR
  164.512(i).

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Privacy the IRB

• Authorizations
• Recruitment

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Data Security the IRB (VA Handbook 6500)
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Data Security Research

• The security policies, procedures, and controls
  in this handbook apply to all VA employees,
  contractors, researchers, students, volunteers,
  representatives of Federal, State, local, or
  Tribal agencies, and all others authorized access
  to VA facilities, information systems or
  information in order to perform a VA authorized
  activity.

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Confidentiality

• Collection of data
• Data transfer
• Data storage
• Granting access to data

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Key Points Related to Privacy IT Security

• http//www.research.va.gov/resources/data-security
  /docs/Key_Points.pdf

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Checklists, Certification Forms Other
Responsibilities

• http//www.research.va.gov/resources/data-security
  /checklists.cfm
• Check these links for specific information for
• Principal Investigators (PIs)
• Associate Chief of Staff for Research
  Development (ACOS/RD) or Research Coordinator
• Medical Center Directors
• VISN Directors

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QUESTIONS