Human Research Protections: A Regulatory Perspective

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Human Research Protections A Regulatory
Perspective

• Yvonne K. Higgins, CIP
• Acting Director, Division of Assurances and
  Quality Improvement
• Office for Human Research Protections

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• Office of the Director
• - International Activities
• - Division of Education and Development
• Division of Policy Planning and Special
  Projects
• - Division of Compliance Oversight
• - Division of Assurances and Quality Improvement

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General Requirements

• HHS regulatory requirements for human research.
• Assurance
• Board Review
• Consent

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Title 45 Code of Federal Regulations Part
46 Protection of Human Subjects
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Research

• A systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable knowledge.
  45 CFR 46.102(d)

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Human Subject

• A living individual about whom an investigator
  conducting research obtains
• (1) Data through intervention or interaction
  with the individual or
• (2) Identifiable private information.
• 45 CFR 46.102(f)

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Who needs a Federalwide Assurance?
Not funded or supported by DHHS
Exempt Research
Institutions engaged in human research funded or
supported by DHHS
Institutions not engaged
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Engaged in Research

• An institution becomes "engaged" in human
  research when its employees or agents
• (i) intervene or interact with living individuals
  for research purposes or
• (ii) obtain individually identifiable private
  information for research purposes

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Engaged in Research

• An institution is automatically considered
  "engaged" in human subjects research whenever it
  receives a direct HHS award to support such
  research.

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Is the Institution Engaged?

• Conducting research interview?
• Obtaining informed consent?
• Informing prospective subjects about the
  availability of research?
• Providing prospective subjects with information
  about contacting investigators for information or
  enrollment?

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Is the Institution Engaged?

• Obtaining private information from medical
  records in an individually identifiable form?
• Releasing patient names to investigators for
  solicitation as research subjects?

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Old System Negotiated Assurances
Multiple Project Assurance (MPA) Cooperative
Project Assurance (CPA) Single Project Assurance
(SPA) International Project Assurance IIAs AIIs NI
As
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New System Federalwide Assurance

• 1 Institution 1 Assurance
• Institution may rely on own institutional IRB,
• another institutions IRB, and/or
• commercial review board

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Terms of Assurance

• Research is guided by ethical principles
• Research complies with Common Rule
• Written procedures
• Institutional support for IRB

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Terms of Assurance

• Informed consent
• Collaborating institutions file FWA
• Non-affiliated investigators sign agreement
• Education and training

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Contact OHRP
http//ohrp.osophs.dhhs.gov OHRP_at_osophs.dhhs.gov 3
01-496-7005