Human Research Protection Programs 1a:Human Research Protection Programs 1a:How to Navigate Human Subject Protection How to Navigate Human Subject Protection
Regulations Regulations
Sponsored by theAmerican Society for Investigative Pathology
Chair, Mark E. Sobel, M.D., Ph.D.
ProgramProgram
3:00 p.m. Mark E. Sobel (ASIP)[email protected]
• Why all the fuss?• Relevance of Human Biological Materials• HIPAA
•3:20 p.m. George Pospisil (OHRP)[email protected]
• Overview of the Federal Regulations
•3:50 p.m. Marjorie Speers (AAHRPP)[email protected]
• Approaches to Accreditation
4:10 p.m. Panel Discussion: Q&A
Why all the fuss?The Era of Molecular Medicine
Molecular techniques are transforming the practice of medicine and the public’s expectations and fears: DNA can be retrieved from virtually any specimen.
Converging Events
•Information Technology
•Molecular Biology
•Human Rights
Era of Scientific DiscoveryEra of Scientific Discovery
• Fast and easy transfer of information
• DNA can be retrieved from virtually any specimen
• Human Genome Project
Personalized Molecular MedicinePersonalized Molecular Medicine
• Public’s expectations– Improved health care–Personalized medicine
• Public’s fears–Loss of privacy–Loss of employment –Loss of insurance–Social stigmatization
Information TechnologyInformation Technology
• Internet
• Lack of firewall protections
• Fast and easy transfer of information
• Cross-talk with databases
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
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
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)
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
Human Subjects Protection:Human Subjects Protection:Use of Human Biological MaterialsUse 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
Types of HBMsTypes of HBMs
• Germline vs. Somatic cell
• Unidentifiable• Anonymous
• Anonymized
• Identifiable• Coded (Linked)
• Identified
Identifiable HBMs- The Common RuleIdentifiable 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.
Definition of a Human Subject-The Common Definition of a Human Subject-The Common RuleRule
• Does NOT include:– Deceased persons (autopsy specimens)– Publicly available information– Unidentifiable (Anonymous, Anonymized)
Samples
Repositories
• Tissue banks
• Stored blood samples
• Freezers containing HBMs under individual control of principal investigators
• Histologic slide files
Requirements of Repositories
• Security of samples
• IRB oversight
• Record keeping for informed consent
• Confidentiality
• Anonymization of samples
HIPAAHIPAA
• Health Insurance Portability Authorization Act
• Privacy of information
• Affects clinical treatment and research
• Goes into effect April 14, 2003
• Application to deceased individuals
HIPAAHIPAA
• 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
HIPAA: Limited Data SetsHIPAA: 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
Limited Data Sets: De-identificationLimited 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 Rule’s safe harbor method: 18
enumerated identifiers must be removed
Limited Data Sets: Safe Harbor MethodLimited 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
ConclusionsConclusions
• 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
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