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 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