Human Subjects Protection - Carn by pengxiang


									Human Subjects Protection in Research

Carnegie Mellon University
Regulatory Compliance Administration
5000 Forbes Avenue, UTDC Bldg., Rooms 108 & 109
Pittsburgh, PA 15213
Facsimile: 412-268-2050

Susan M. Shingle
Compliance Officer
Telephone: 412-268-4727

Mary Lynn Brown
Compliance Assistant
Carnegie Mellon University
Telephone: 412-268-1901
Introduction and Overview
   Basic Principles
   Historical Review
   Oversight
   Process
   Guidance
   Conclusion
Basic Principles
   RESEARCH is defined as “a systematic
    investigation, including research development,
    testing and evaluation, designed to develop or
    contribute to generalizable knowledge”

   HUMAN SUBJECT is defined as “a living
    individual about whom an investigator (whether
    professional or student) conducting research
    obtains: (1) data through intervention or
    interaction with the individual, or (2) identifiable
    private information
Historical Review – Ethical Codes
Nuremberg Code
   Nuremberg Code: developed in October 1946 for
    the Nuremberg Military Tribunal as standards by
    which to judge the human experimentation
    conducted by the Nazis

   The Code captures many of what are now taken
    as the basic principles governing the ethical
    conduct of research involving human subjects
Historical Review – Ethical Codes
Nuremberg Code
   Voluntary consent of the human subject is absolutely essential

   Freely given consent to participation in research the
    cornerstone of ethical freedom from coercion, and comprehension
    of the risks and benefits involved

   Minimization of risk and harm

   Favorable risk/benefit ration

   Qualified researchers using the appropriate research design

   Freedom for the subject to withdraw at any time
Historical Review – Ethical Codes
Belmont Report
   9/30/1978 the National Commission for the Protection of
    Human Subjects of Biomedical and Behavioral Research
    submitted its report entitled “The Belmont Report:
    Ethical Principles and Guidelines for the Protection of
    Human Subjects of Research”

   The Report, named after the Belmont Conference Center
    at the Smithsonian Institution where the discussions
    were held, sets forth the basic ethical principles
    underlying the acceptable conduct of research involving
    human subjects
Historical Review – Ethical Codes
Belmont Report
   Respect for persons – informed consent which
    contains the three elements: information,
    comprehension and voluntariness

   Beneficence – risk/benefits assessment: study is
    carefully designed so that the benefits are maximized
    and any potential harm is minimized (benefit is not

   Justice – requires all subjects be treated fairly:
    selection of research subjects must be the result fair
    selection procedures and fair selection outcomes
   Federal law requires the Department of Health and Human
    Services (DHHS) to issue regulations for the protection of
    human subjects in research projects [codified at Title 45,
    Part 46 of the Code of Federal Regulations, Protection of
    Human Subjects]

   The Office of Human Research Protections (OHRP) is the
    unit within DHHS that implements the regulations for the
    protection of human subjects
   Title 45, Part 46 mandates CMU to register a
    Federalwide Assurance (FWA) with OHRP every three
    (3) years with periodic updates within 36 months of
    a procedural or membership change

   The FWA is a legally binding written document that
    commits CMU to compliance with applicable Federal
    standards for the protection of human subjects

   Federalwide Assurance – FWA00004206
    IRB Registration Number – IRB00000603

   Title 45 CFR Part 46 provides the prospective review and
    approval of human research activities by an Institutional
    Review Board (IRB) whose primary mandate is to protect
    the rights and welfare of humans who are the subjects
    of research

   The IRB at CMU is established under the Provost to
    ensure adequate safeguards to the protection of the
    rights and welfare of human subjects in ALL research

   HIPAA – the Health Insurance Portability and
    Accountability Act of 1996 (effective 4/14/2003)

   Designed to improve the efficiency and effectiveness of
    the healthcare system

   The Privacy Rule – additional regulation that relates
    directly to organizations involved in healthcare
    operations that transmit health information electronically
    (Health plans, Health care clearinghouses and Health
    care providers)
   The Privacy Rule – establishes Federal protections for
    the privacy of protected health information (PHI)

   Directly affects research with human participants where:

    a) the researcher’s data is PHI obtained from a third
    party source such as a physician’s office, hospital, or

    b) the researcher is a physician whose study participants
    are receiving treatment as part of the research

   Six primary “pathways” permitting access to
    PHI for research related purposes:
    1. Review preparatory to research
    2. Patient (participant) authorization
    3. Waiver of authorization by IRB/Privacy Board
    4. De-identification of data (18 categories)
    5. Limited data set and data use agreement
    6. Research on decedent’s information

   HIPAA impacts CMU researchers whose studies involve:

    a) the collection and analysis of existing medical record
    information (PHI) obtained from a third party source
    such as UPMC Health System, Children’s Hospital, West
    Penn (the collaboration with a third party source) OR

    b) the use of medical records for the identification of
    potential research subjects (the use of de-identified

   Collaboration with a third party source:
    CMU researchers submit the “Human
    Subjects Clearance Request Form HIPAA”
    and include a current copy of the third
    party source’s IRB protocol application and

   The use of de-identified data:
    CMU researchers submit the “Human
    Subjects Clearance Request Form –
    Exemption Request” and include
    supporting documentation that states the
    data was de-identified (protocol approval,
    limited data set agreement, etc.)

   CMU Researchers MUST also complete the
    University of Pittsburgh’s online training, Module
    6: Privacy Requirements for Researchers Under
    HIPAA located at

   More information regarding HIPAA can be
    obtained from the Regulatory Compliance
    Administration website located at
   ALL researchers/experimenters working with human
    subjects in research investigations are required to obtain
    clearance from CMU’s IRB PRIOR to running the

   ALL researchers/experimenters are required to complete
    the online training course entitled “Human Participant
    Protections Education for Research Teams” located at

   The IRB WILL NOT release its final decision until all
    training certificates are on file
   Requests for a Human Subjects Clearance Request Packet are obtained

    Regulatory Compliance Administration
    UTDC Building, Room 108 & 109 (Henry Street, off South Craig)
    Telephone No. 412-268-1901 or 412-268-4727
    Email at or

    or Regulatory Compliance Administration web site at
   The Human Subjects Clearance Request Packet (Human
    Subjects Protocol application) includes:

       *ethical principles and guidelines page
       *guideline for submitting the clearance request
       *the protocol request application
       *consent form checklist
       *a sample consent form
       *online training course (
   The human subjects clearance request application (human
    subjects protocol) and supporting documents are forwarded
    to (or as an email attachment):

    Regulatory Compliance Administration
    UTDC Building, Room 108 & 109 (Henry Street, off South Craig)
    Telephone No. 412-268-1901 or 412-268-4727
    Email at or
   Human subjects protocols are preliminary reviewed to ensure that all the
    required documents have been submitted

   Human subjects protocols qualify for either “exempt” “expedited” or “full
    board” review

   Exempt and expedited reviews take between 1-3 weeks and full board
    reviews take between 1-4 weeks

   Letter of Certification and “stamped” consent form (approval and
    expiration date)

   Human subjects protocols are renewed yearly

   Studies CANNOT begin until IRB approval is given
   The Belmont Report

   The Nuremberg Code

   NIH online training
    Human Participant Protections Education for Research Teams

   Office for Human Research Protections (OHRP)
   Institutional Review Board Guidebook

   National Institutes of Health (NIH) Guidelines for the Conduct of
    Research Involving Human Subjects at NIH

   National Science Foundation (NSF) Behavioral and Cognitive

   National Science Foundation (NSF) The Common Rule

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