Vha handbook 1200 05
1 / 12

VHA Handbook 1200.05 - PowerPoint PPT Presentation

  • Updated On :

VHA Handbook 1200.05. What’s new. General Requirements for Informed Consent. A Legally Authorized Representative may not always qualify as a ‘personal representative’ to sign a HIPAA authorization

I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
Download Presentation

PowerPoint Slideshow about 'VHA Handbook 1200.05' - tavi

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
Vha handbook 1200 05
VHA Handbook 1200.05

  • What’s new

General requirements for informed consent
General Requirements for Informed Consent

  • A Legally Authorized Representative may not always qualify as a ‘personal representative’ to sign a HIPAA authorization

  • If someone other than the investigator conducts the consent process, the investigator must prospectively designate in writing in the protocol or application to the IRB, the individual who will have this responsibility

Additional elements of informed consent
Additional Elements of Informed Consent

  • VA-specific requirements

    • Future use of specimens or data

    • Re-contacting subjects for future studies

    • Disclosure of study results

Documentation informed consent
Documentation Informed Consent

  • Signature blocks are required for the subject and the person obtaining the consent

    • Signature and

    • Date

  • A witness is not required to sign an informed consent form

    • Unless the IRB requires a witness signature

  • Documentation informed consent1
    Documentation Informed Consent

    • CSP Guidelines still apply

      • Human Rights Considerations

      • It specifies whether there must be a witness present throughout the entire consent procedure or simply someone to witness the signature

      • It is the policy of the Cooperative Studies Program that the witness to the signing of the consent document is not to be anyone directly involved in the conduct of the cooperative study

    Engagement in human subjects research
    Engagement in Human Subjects Research

    • Generally, VA facility is “engaged”* when that VA facility’s employee obtains the following for research purposes

      • Data about the subjects through intervention or interaction

      • Identifiable private information about the subjects; or

      • Informed consent from the subjects for the research

    Engaged in research
    Engaged in Research

    • If a VA Facility is “engaged” in research, it

      • Must hold a Federalwide Assurance (FWA)

      • Must have one of its staff members be either the Principal Investigator (PI) or a Local Site Investigator (LSI) for that study

      • Have the study approved by one of its IRBs of record and its Research & Development Committee

    Not engaged in research
    Not Engaged in Research

    • If a VA Facility is not “engaged” in research, it

      • Has no jurisdiction over the study

      • Does not have to have an FWA

      • Does not have to get its IRB or Research & Development Committee approval

      • However, its Facility Director may determine that study cannot be conducted on its premises

    Human subjects protection training
    Human Subjects Protection Training

    • Required training must be updated every two years

    • VA facilities must

      • Have standard operating procedures (SOPs) for training (including whether the facility uses 730 days, or the second calendar or fiscal year to determine when the next training is due)

      • Document compliance

    Human subjects protection training1
    Human Subjects Protection Training

    • Training applies to

      • The entire research team including anyone who has contact with subjects

      • IRB members and VA representatives to external IRBs

      • R&D Committee members and any other committee involved with subjects

    What is the effective date
    What is the effective date?



    OCTOBER 15TH, 2010