Human research protection programs 1a how to navigate human subject protection regulations
This presentation is the property of its rightful owner.
Sponsored Links
1 / 23

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


  • 191 Views
  • Uploaded on
  • Presentation posted in: General

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?

Download Presentation

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

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


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?

    • 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

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 Discovery

  • Fast and easy transfer of information

  • DNA can be retrieved from virtually any specimen

  • Human Genome Project


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

  • 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: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

  • Germline vs. Somatic cell

  • Unidentifiable

    • Anonymous

    • Anonymized

  • Identifiable

    • Coded (Linked)

    • Identified


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

  • 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


HIPAA

  • Health Insurance Portability Authorization Act

  • Privacy of information

  • Affects clinical treatment and research

  • Goes into effect April 14, 2003

  • Application to deceased individuals


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

  • 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

  • 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

  • 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

  • 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


  • Login