Reality vs Urban Myth: The Truth About Regulations - PowerPoint PPT Presentation

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Reality vs Urban Myth: The Truth About Regulations

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Understand the variety of regulations and other requirements under which the HRPP operates ... The honorarium is under the $10,000 limit. ... – PowerPoint PPT presentation

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Title: Reality vs Urban Myth: The Truth About Regulations


1
Reality vs Urban Myth The Truth About
Regulations
  • Marisue Cody, PhD
  • Deputy Director, PRIDE

2
Objectives
  • Understand the variety of regulations and other
    requirements under which the HRPP operates
  • Analyze complex problems when more than one set
    of requirements apply

3
Authority Responsibilities
  • United States Code (U.S.C.)
  • Code of Federal Regulations (CFR)
  • Directives
  • Handbooks
  • Manuals
  • Memorandums
  • Professional standards

4
U.S. Codes (law)
  • 5 Government organization employees
  • 21 Food and drugs
  • 38 Veterans benefits
  • 41 Public contracts
  • 42 Public health welfare

5
Code of Federal Regulations
  • 5 Administrative personnel
  • 21 Food drugs
  • 38 Pensions, bonuses, Veterans relief
  • 41 Public contracts property management
  • 45 Public welfare
  • 48 Federal acquisition regulations system

6
VA Policy Requirements
  • Brochures - Informational material mass-produced
    for patients and staff
  • Directives - establish mandatory VHA policies
  • Handbooks - prescribe mandatory VHA procedures
    and/ or operational requirements
  • Manuals - also prescribe mandatory VHA procedures
    or operational requirements (older documents not
    yet replaced by Handbooks)
  • Memorandums - establish mandatory VHA policies
    which apply within VHA Central Office
  • Information Letters - release nondirective
    information of one-time interest or short
    duration i.e., applications for training
    opportunities, describing new programs,
    announcing meetings, reminders etc.
  • Notices - provide significant information of
    interest VHA-wide
  • Program Guides - contain non-mandatory and
    non-directive procedures for development of a
    program
  • VHA Record Control Schedule (RCS 10-1) - provides
    disposal authorities for VHA general and
    administrative records and program records.

7
VA-wide policies
  • Information security
  • Directive 6500
  • Handbook 6500

8
VHA Temporary Directives
  • 2008-014 - AUDITING OF VHA HUMAN SUBJECTS
    RESEARCH TO DETERMINE COMPLIANCE WITH APPLICABLE
    LAWS, REGULATIONS, AND POLICIES
  • 2007-044 - USE OF A COOPERATIVE RESEARCH AND
    DEVELOPMENT AGREEMENT (CRADA)
  • 2007-040 - APPOINTMENT OF FACILITY INFORMATION
    SECURITY OFFICER (ISO) AND PRIVACY OFFICER TO THE
    INSTITUTIONAL REVIEW BOARD (IRB) OR THE RESEARCH
    AND DEVELOPMENT (RD) COMMITTEE

9
VHA Directives
  • 1058 - RESPONSIBILITIES OF THE OFFICE OF RESEARCH
    OVERSIGHT
  • 1200 - VETERANS HEALTH ADMINISTRATION RESEARCH
    AND DEVELOPMENT
  • 1201 - OVERVIEW OF VHA RESEARCH PROGRAMS
  • 1605 - VHA PRIVACY PROGRAM

10
VHA Handbooks - ORO
  • 1058.03 - ASSURANCE OF PROTECTION FOR HUMAN
    SUBJECTS IN RESEARCH
  • 1058.04 - DEBARMENTS AND SUSPENSIONS BASED ON
    RESEARCH IMPROPRIETY IN VA RESEARCH
  • 1058.1 - REPORTING ADVERSE EVENTS IN RESEARCH TO
    THE OFFICE OF RESEARCH OVERSIGHT
  • 1058.2 - RESEARCH MISCONDUCT

11
VHA Handbooks - ORD
  • 1200.05 - REQUIREMENTS FOR THE PROTECTION OF
    HUMAN SUBJECTS IN RESEARCH
  • 1200.06 - CONTROL OF HAZARDOUS AGENTS IN VA
    RESEARCH LABORATORIES
  • 1200.1 - THE RESEARCH AND DEVELOPMENT (RD)
    COMMITTEE HANDBOOK
  • 1200.18 - INTELLECTUAL PROPERTY

12
VHA Handbooks - Privacy
  • 1605.1 - PRIVACY AND RELEASE OF INFORMATION
  • 1605.2 - MINIMUM NECESSARY STANDARD FOR PROTECTED
    HEALTH INFORMATION

13
VHA Handbooks others.
  • 1004.1 - VHA INFORMED CONSENT FOR CLINICAL
    TREATMENTS AND PROCEDURES
  • 1050.1 - VHA NATIONAL PATIENT SAFETY IMPROVEMENT
    HANDBOOK
  • 1108.04 - INVESTIGATIONAL DRUGS AND SUPPLIES
  • 1907.01 - HEALTH INFORMATION MANAGEMENT AND
    HEALTH RECORDS

14
Examples
15
Conflict of Interest Case
  • An investigator asks you whether he needs to
    disclose that Lilly has invited him to speak at a
    seminar they are conducting. The honorarium is
    under the 10,000 limit. He will be speaking
    about the outcomes of the clinical trial he has
    been a lead investigator on.
  • What would you do?

16
Conflict of Interest
  • 18 USC 11.208 Bribery, graft, and conflicts of
    interest
  • 5 CFR 2635 Standards of ethical conduct for
    employees of the executive branch
  • 48 CFR 9.500-9.508 Federal acquisition
    regulation (institutional COI)
  • Memorandum Sept 23, 2005 Financial conflicts of
    interest
  • VHA Handbook 1200.13 Financial conflicts of
    interest in research (rescinded). Also mentioned
    in 1200.05 and 1200.1

17
Failure to report SAEs
  • A recent OIG report cited a PI and the facility
    for failure to report SAEs as required by VA
    policy. The study in question was a longitudinal,
    observational study of veterans with prostate
    cancer. There were 105 deaths that were not
    disclosed AND it was unlikely that study
    participation contributed in any way to their
    deaths.
  • Why is this a problem?

18
Unanticipated Problems and Adverse Events
  • 38 CFR 16.103(b)(5)
  • 21 CFR 56.108(b)(1) 21 CFR 312.32 21 CFR
    812.150(a)(1) 21 CFR 812.3(s)
  • VHA Handbook 1200.05
  • VHA Handbook 1058.1
  • VHA Handbook 1050.1
  • OHRP Guidance on reviewing and reporting
    unanticipated problems involving risks to
    subjects or others and adverse events, Jan 15,
    2007
  • Memorandum, Reporting UPRs and AEs to IRBs, Dec
    6, 2006

19
How do you consent a blind person?
  • We have an investigator who wishes to consent a
    legally blind participant for a study and they
    did not present this possibility to the IRB when
    the study was originally approved.  Questions
  • Can they have a witness to the process (not
    associated with the study) who also reads the
    informed consent document orally to the subject
    before it is presented to them by the
    investigator?
  • Do they need statements added to the usual
    statements similar to the following
  • ltName of witnessgt, who is not associated with the
    study, has read the informed consent document to
    me and was present when ltname of investigatorgt
    presented the study to me.  (subject would sign)
  • Witness to Informed Consent Process  I have
    read the informed consent document to ltname of
    subjectgt and was present for the oral
    presentation by the investigator. 
  • If they do this, do they need to have IRB
    approval for this change in the normal process
    before consenting the subject?  If so, can it be
    expedited?

20
Informed Consent
  • 38 CFR 16.116 .117 45 CFR 16.116 .117 21
    CFR 50.20-27
  • 38 CFR 17.32
  • VHA Handbook 1200.05
  • VHA Handbook 1004.1
  • VHA Handbook 1907.01
  • VHA Handbook 1605.1
  • OHRP guidance
  • State laws

21
Administration of drugs legally marketed by a
foreign country
  • A patient suffers from Hansens disease
    (leprosy). He is unable to tolerate any of the
    U.S. legally marketed drugs for the treatment of
    his disease because of life-threatening side
    effects. His disease has progressed to where he
    is suffering from paralysis of fingers and toes.
  • The patient has been taking a drug marketed in
    Europe for 13 months which has slowed the
    progression of his paralysis. The drug is not
    marketed in the United States.
  • The patient has been admitted to the VAMC with
    pneumonia. Both he and his wife beg his
    admitting physician to allow him to continue
    taking the only drug that has been effective for
    the treatment of his illness. The drug has been
    brought to the VAMC by the patient.
  • Question Can this drug be given to the patient?

22
Studies involving drugs
  • 21 CFR 11, 50, 54, 56, 312
  • Good Clinical Practice
  • VHA Handbook 1200.05
  • VHA Handbook 1108.04

23
QUESTIONS
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