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

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

2. Program • 3:00 p.m. Mark E. Sobel (ASIP) • mesobel@asip.org • Why all the fuss? • Relevance of Human Biological Materials • HIPAA • 3:20 p.m. George Pospisil (OHRP) • gpospisil@osophs.dhhs.gov • Overview of the Federal Regulations • 3:50 p.m. Marjorie Speers (AAHRPP) • mspeers@aahrpp.org • Approaches to Accreditation • 4:10 p.m. Panel Discussion: Q&A

3. 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.

4. Converging Events Information Technology Molecular Biology Human Rights

5. Era of Scientific Discovery • Fast and easy transfer of information • DNA can be retrieved from virtually any specimen • Human Genome Project

6. Personalized Molecular Medicine • Public’s expectations • Improved health care • Personalized medicine • Public’s fears • Loss of privacy • Loss of employment • Loss of insurance • Social stigmatization

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

8. 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

9. 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

10. 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)

11. 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

12. Human Subjects Protection:Use 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

13. Types of HBMs • Germline vs. Somatic cell • Unidentifiable • Anonymous • Anonymized • Identifiable • Coded (Linked) • Identified

14. 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.

15. Definition of a Human Subject-The Common Rule • Does NOT include: • Deceased persons (autopsy specimens) • Publicly available information • Unidentifiable (Anonymous, Anonymized) Samples

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

17. Requirements of Repositories • Security of samples • IRB oversight • Record keeping for informed consent • Confidentiality • Anonymization of samples

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

19. 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

20. 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

21. 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 Rule’s safe harbor method: 18 enumerated identifiers must be removed

22. 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

23. 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