Human Research Protection Programs 1a: How to Navigate Human Subject Protection Regulations

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Human Research Protection Programs 1aHow to
Navigate Human Subject Protection Regulations
Sponsored by the American Society for
Investigative Pathology Chair, Mark E. Sobel,
M.D., Ph.D.
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Program

• 300 p.m. Mark E. Sobel (ASIP)
• mesobel_at_asip.org
• Why all the fuss?
• Relevance of Human Biological Materials
• HIPAA
• 320 p.m. George Pospisil (OHRP)
• gpospisil_at_osophs.dhhs.gov
• Overview of the Federal Regulations
• 350 p.m. Marjorie Speers (AAHRPP)
• mspeers_at_aahrpp.org
• Approaches to Accreditation
• 410 p.m. Panel Discussion QA

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Why all the fuss?The Era of Molecular Medicine

• Molecular techniques are transforming the
  practice of medicine and the publics
  expectations and fears DNA can be retrieved from
  virtually any specimen.

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Converging Events

• Information Technology
• Molecular Biology
• Human Rights

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Era of Scientific Discovery

• Fast and easy transfer of information
• DNA can be retrieved from virtually any specimen
• Human Genome Project

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Personalized Molecular Medicine

• Publics expectations
• Improved health care
• Personalized medicine
• Publics fears
• Loss of privacy
• Loss of employment
• Loss of insurance
• Social stigmatization

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Information Technology

• Internet
• E-mail
• Lack of firewall protections
• Fast and easy transfer of information
• Cross-talk with databases

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Genetic Research

• Germline
• Inheritability
• Implications for immediate and extended family
• Implications for ethnic group
• Use of normal tissues
• Somatic cell
• Acquired mutations
• Use of diseased tissues
• No implications for family

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Why all the fuss?

• Known abuses of populations and patients
• Naxi experiments
• Radiation experiments (U.S.)
• Tuskegee Syphilis Study
• Taking advantage of prisoners and mentally
  handicapped

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Responses

• Nuremberg Code
• The voluntary consent of the human subject is
  absolutely essential
• Declaration of Helsinki
• Informed consent
• National Commissions
• Belmont Report
• Institutional Review Boards (IRBs)

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Human Subjects Protection

• National Level
• The Common Rule (DHHS)
• HIPAA
• Local Level
• Institutional Level
• Protections are applicable not only to clinical
  trials but to the use of human biological
  materials in research studies, including basic
  science projects

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Human Subjects ProtectionUse of Human
Biological Materials

• HBMs include
• Tissue samples
• Blood, sputum, urine, bone marrow, etc.
• Freshly obtained and archived materials
• HBMs are subject to the same regulations as human
  subjects directly enrolled in studies
• Therefore, informed consent and approval by an
  IRB may be required before using HBMs

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Types of HBMs

• Germline vs. Somatic cell
• Unidentifiable
• Anonymous
• Anonymized
• Identifiable
• Coded (Linked)
• Identified

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Identifiable HBMs- The Common Rule

• Any HBM that can be identified by any one person,
  anywhere, is an identifiable sample
• If a sample is coded, and any investigator keeps
  a key to the code, the sample is identifiable
• Exception If the recipient of the HBMs signs an
  agreement that there is no intent to identify the
  samples, the sample may be considered
  unidentifiable.

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Definition of a Human Subject-The Common Rule

• Does NOT include
• Deceased persons (autopsy specimens)
• Publicly available information
• Unidentifiable (Anonymous, Anonymized) Samples

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Repositories

• Tissue banks
• Stored blood samples
• Freezers containing HBMs under individual control
  of principal investigators
• Histologic slide files

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Requirements of Repositories

• Security of samples
• IRB oversight
• Record keeping for informed consent
• Confidentiality
• Anonymization of samples

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HIPAA

• Health Insurance Portability Authorization Act
• Privacy of information
• Affects clinical treatment and research
• Goes into effect April 14, 2003
• Application to deceased individuals

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HIPAA

• Does not apply to HBMs, but does apply to
  information derived from HBMs
• Affects clinical treatment and research
• Goes into effect April 14, 2003
• Application to deceased individuals
• Exclusion for research
• Must have proof of death

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HIPAA Limited Data Sets

• Create and disseminate a limited data set that
  does not include directly identifiable
  information
• Data use agreement between the covered entity
  and the recipient
• Limited use of the data set
• Ensure security of data
• Do not identify the information or contact any
  individual
• A code may be assigned to allow re-identification

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Limited Data Sets De-identification

• A covered entity may de-identify protected health
  information so that such information may be used
  and disclosed freely, without being subject to
  the Privacy Rules protections.
• A person with appropriate knowledge may render
  the information not individually identifiable and
  certify to a very small risk
• Privacy Rules safe harbor method 18 enumerated
  identifiers must be removed

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Limited Data Sets Safe Harbor Method

• Direct identifiers
• Name, street address, social security number
• Medical chart, surgical pathology, prescription
  numbers
• Other identifiers
• Birth date, admission and discharge dates,
  five-digit zip code (first 3 digits usually OK)
• Permitted demographic information
• Age, gender, ethnicity

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Conclusions

• Use of HBMs in research studies is covered under
  the umbrella of human subject protection programs
• Federal level
• Common Rule
• HIPAA
• Local and Institutional Regulations
• The Future
• Institutional accreditation