Human research protection programs 1a how to navigate human subject protection regulations
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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. Program. 3:00 p.m. Mark E. Sobel (ASIP) [email protected] Why all the fuss?

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

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Human research protection programs 1a how to navigate human subject protection regulations

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.


Program

Program

  • 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

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

Converging Events

Information Technology

Molecular Biology

Human Rights


Era of scientific discovery

Era of Scientific Discovery

  • Fast and easy transfer of information

  • DNA can be retrieved from virtually any specimen

  • Human Genome Project


Personalized molecular medicine

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


Information technology

Information Technology

  • Internet

  • E-mail

  • Lack of firewall protections

  • Fast and easy transfer of information

  • Cross-talk with databases


Genetic research

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

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

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

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 use of human biological materials

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


Types of hbms

Types of HBMs

  • Germline vs. Somatic cell

  • Unidentifiable

    • Anonymous

    • Anonymized

  • Identifiable

    • Coded (Linked)

    • Identified


Identifiable hbms the common rule

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.


Definition of a human subject the common rule

Definition of a Human Subject-The Common Rule

  • Does NOT include:

    • Deceased persons (autopsy specimens)

    • Publicly available information

    • Unidentifiable (Anonymous, Anonymized) Samples


Repositories

Repositories

  • Tissue banks

  • Stored blood samples

  • Freezers containing HBMs under individual control of principal investigators

  • Histologic slide files


Requirements of repositories

Requirements of Repositories

  • Security of samples

  • IRB oversight

  • Record keeping for informed consent

  • Confidentiality

  • Anonymization of samples


Hipaa

HIPAA

  • Health Insurance Portability Authorization Act

  • Privacy of information

  • Affects clinical treatment and research

  • Goes into effect April 14, 2003

  • Application to deceased individuals


Hipaa1

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


Hipaa limited data sets

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


Limited data sets de identification

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


Limited data sets safe harbor method

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


Conclusions

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


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