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)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

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

• E-mail

• 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