Update on VHA Handbook 1200.05 by 7354u38


									VHA Handbook 1200.05

K. Lynn Cates, M.D.
Assistant Chief Research & Development Officer
Director, PRIDE

HRPP 201
March 24, 2011
VHA Handbook 1200.05
VHA Office of Research & Development (ORD)
• ORD is responsible for
   • 1200.05 content
   • Interpreting 1200.05
   • Answering questions about 1200.05
      • Email address for unencrypted questions

 VHA Handbook 1200.05
• Clarify new requirements
• Point out issues that have created confusion in the

• Ensure 1200.05 is interpreted consistently

Does the IRB Need to Re-Review
Existing Research?
• Not unless required by local standard operating
  procedures (SOPs)

• Subsequent requirements are published by ORD

 VA Facility Director Responsibilities
• The facility Director is responsible for ensuring that
  recruiting documents, flyers, and advertisements for non-
  VA research are not posted within or on the premises of a
  VA facility (VHA Handbook 1200.05, Paragraph 5n)

• General guidance may be posted
   • Veterans may speak with their health care providers
   • Information on clinical trials is at : http://clinicaltrials.gov

 VA Facility Director Responsibilities
• A clinician
   •   May tell a patient about a non-VA study
   •   May give a patient contact information for a non-VA study
   •   May not recruit patients for a non-VA study
   •   May not obtain informed consent for a non-VA study
   •   May not put recruitment flyers out for a non-VA study
   •   ? Get the patient’s consent to give the patient’s name and
       contact information to the non-VA investigator
        • Must abide by all VA privacy, confidentiality, and information
          security requirements
        • Document getting the patient’s permission in writing

Investigator Responsibilities
Paragraph 9
• Overseeing the research team
• Obtaining all relevant approvals in writing before
  starting the study (see VHA Handbook 1200.01)

• Implementing the protocol as approved by the IRB
• Documenting how the protocol is being implemented

Investigator Responsibilities
Paragraph 9
• Informed Consent
   • Must use the most recent IRB-approved version of
       Informed Consent Form (10-1086)
   •   Must use VA-specific provisions (e.g., research-
       related injury)

• Ensure consistency among
   • Informed Consent Form
   • Protocol
   • HIPAA authorization

 Research Protocol
 Paragraph 10
• Differentiate usual care from research activity
• Provide privacy and confidentiality section
• Provide information security plan
• Provide for reuse of data

IRB Composition
Paragraph 12
• Individuals who cannot serve as IRB members
  (voting or nonvoting)
   • Facility Director & Director’s administrative staff
   • Chief of Staff
   • Other local leadership (e.g., Quadrad members, Chief
       Nurse Executive)
   •   Research Compliance Officers
   •   Nonprofit directors or staff

IRB Composition
Paragraph 12 – Ex Officio, Nonvoting Members
• Individuals who may serve as ex officio,
   nonvoting* IRB members
    • VA facility research office staff
         • ACOS for R&D
         • AO for R&D
         • IRB administrative staff
             • Affiliate (not VA) IRB administrative staff may be
               voting members of the affiliate IRB
    •   Privacy Officer
    •   Information Security Officer

*In 1200.05, “ex officio” = “nonvoting”
IRB Composition
Paragraph 12 – Alternate IRB Members
• What are the criteria for selecting alternate IRB
   • Expertise of the member
   • Member’s contributions relative to the IRB’s portfolio
      • Broad portfolio – one MD could fill in for another
      • Cardiology – a cardiologist must fill in for a cardiologist

• If the IRB membership does not have expertise for a
  given study, it has an obligation to seek expert

Review and Approval of Research
Paragraph 15
• IRB considerations for each project*
    1. Is the project research?
    2. If yes, does the research involve human subjects?
    3. If yes, the IRB must determine if the human research
        project is exempt from IRB review

*The considerations should be addressed in this order

Continuing Review
Paragraph 22
• Continuing review must occur not less than once per

• The IRB may review within 30 days prior to
  expiration and still retain anniversary date

Continuing Review
Expiration of IRB Approval, Paragraph 22g
• No grace period to extend conduct of research
   beyond the expiration date

• If approval expires
  • Stop all research activities
  • Immediately submit to IRB Chair a list of subjects who
      could be harmed by stopping study procedures

IRB Approval Date
Paragraph 24
• The date of IRB approval of a study is used to
  determine when continuing review must be performed
   • Convened IRB review and approval
   • Convened IRB review and approval with minor
   •   Convened IRB review with substantive conditions
   •   Expedited review

  *The approval date of the informed consent form may be
  later than that of the protocol if it was approved contingent
  on minor modifications to the informed consent form

 General Requirements for
 Informed Consent, Paragraph 30

• 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
 Subparagraph 32b
• VA-specific requirements include (if relevant)
   • Future use of specimens or data
   • Re-contacting subjects for future studies
   • Disclosure of study results

 Documentation Informed Consent
 Paragraph 33
• VA Form 10-1086 must be used for all VA approved
   • Except DoD studies with active duty military personnel
       when no VA-specific language is necessary (Paragraph

• Must use the most recent IRB-approved version of
   informed consent form (i.e., the date the informed
   consent form was sent to the IRB for approval)*

*The date on the IRB-approval stamp can never be earlier
   than the “version” date or the protocol IRB approval date

 Documentation Informed Consent
 Paragraph 33 - Signatures
• 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
   • A short form is employed*

* A witness is always required for a short form           20
 Documentation Informed Consent
 Paragraph 33 – Witness Signature
• How can the investigator remove the block for a witness
  signature from the informed consent form of an ongoing
   • The local facility’s SOPs must allow for informed consent
       forms that do not have witness signatures
   •   The investigator must submit an amendment to the IRB
   •   The IRB must approve the amendment (but the IRB has
       the prerogative to disapprove)

 Documentation Informed Consent
 Paragraph 33 – Witness Signature
• The investigator cannot
   • Leave the witness signature block blank
   • Strike-out the witness signature block
   • Put N/A (not applicable) in the witness signature block

Informed Consent
Alternative Procedures
• What is required for documentation of the basic
  element of informed consent “A disclosure of
  appropriate alternative procedures or courses of
  treatment, if any, that might be advantageous to the
  subject” (38 CFR 116.(a)(4)) if there are no alternative
  procedures or courses of treatment?

   • None, unless required by the IRB. The IRB does not
     need to find or document, & the informed consent
     form/process does not need to include language saying
     there are no alternatives

Informed Consent
IRB Documentation
• What is required for IRB documentation of its approval
  of an informed consent procedure that does not
  include, or alters, some or all elements of informed

   • The IRB can say “all criteria have been met”
   • However, it is much better for the IRB to document
     protocol-specific reasons why each of the criteria has
     been met (if this information is not in the IRB minutes,
     information supporting the IRB determination must be
     in the IRB protocol file)

HIPAA Authorization
Paragraph 37
• HIPAA Authorization must be a standalone document
• For ongoing studies with the informed consent form &
  HIPAA authorization combined, do they need to be split
  into two documents (e.g., at the time of continuing
   • Not unless your IRB determines they should be

 Investigational Drugs & Devices
 Paragraphs 39 & 40
• Investigators and IRBs must follow both FDA
  regulations and VA requirements

 Engaged in Human Subjects Research
 Paragraph 50
• Generally, VA facility is “engaged”* when that VA
  facility’s employee obtains the following for research
   • Data about the subjects through intervention or
   •   Identifiable private information about the subjects;
   •   Informed consent from the subjects for the research

*See OHRP Guidance October 16, 2008                           27
Not Engaged in Human Subjects Research
Paragraph 51
• 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 there

Multi-Site Studies
• Who decides whether or not a local site is engaged?
   • The PI’s IRB of record
• Does the PI need to obtain approval from sites that are
  not engaged?
   • No, but
      • The PI must notify the Director of the site that is not
      • The Director has the authority to disapprove

Dual Appointment Investigators
• How can you determine if the VA is “engaged”?
   • Is engaged if she uses VA resources (e.g., works on her
     VA time, uses VA space or equipment)

   • Is not engaged if she does not use VA resources (e.g.,
     works on her university time, in her university office &
     lab, using her university computer & university research

Voice, Video, or Photographs for
Research Purposes, Paragraph 55
• Informed Consent (VA Form 10-1086)
• Consent for Use of Picture and/or Voice (VA Form 10-
  3203) only needed when subject is a patient

Paragraph 64
• VA facilities with Federalwide Assurances (FWAs) must
  achieve and maintain Full Accreditation of their
  Human Research Protection Programs (HRPPs)
   • New IRB arrangements
   • Affiliate responsibilities
        • Obtain Full or Qualified Accreditation, or
        • Cooperate with the VA’s accreditation application process
   • VA facility responsibilities when affiliate is not on target to
       obtain accreditation
   •   Maintaining HRPP accreditation

 Questions About
 New VHA Handbook 1200.05

• Preferred - Send unencrypted questions via e-mail
  to VHACO120005Q@va.gov

• If urgent and/or encrypted, please contact:
   • Kevin Nellis   Kevin.Nellis@va.gov
   • Lynn Cates     Lynn.Cates@va.gov


To top