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