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					  Involvement of Non-VCU Institutions in
     VCU Human Subjects Research
Prepared for the 5th Thursday for Human Subjects Protection Program
                                              3/07




                                                                      1
What is a Non-VCU Institution?

An institution (or an employee or agent of the
institution) that is not under the authority of VCU or
VCU Health Systems and is located within the
United States or a United States territory. Examples
include clinics, schools, other universities, consulting
firms, etc.




                                                       2
     VCU Responsibilities

Review each institution’s role in the human
subjects research, adequacy of the facility (in
order to ensure human subject safety in the case
of an unanticipated emergency), responsibilities
of its agents/employees, and oversight that our
PI will provide in order to ensure adequate and
ongoing protection of the human subjects.




                                                   3
        VCU Responsibilities
                   (Continued)

Ensure that all collaborating institutions “engaged” in
non-exempt VCU human subjects research operate
under an appropriate OHRP-approved or other
federally-approved assurance for the protection of
human subjects when the research: (a) is funded by
a direct federal grant, contract, or cooperative
agreement awarded to VCU or (b) involves serving
as the coordinating center for federally-conducted or
–supported research.


                                                      4
When is a Collaborating Institution
           Engaged?
 In general, the collaborating institution becomes
 engaged whenever: (a) the institution’s employees
 or agents intervene or interact with human subjects
 for purposes of non-exempt federally-conducted or -
 supported research; or (b) the institution’s
 employees or agents obtain individually identifiable
 private information about human subjects for
 purposes of non-exempt federally-conducted or -
 supported research.


                                                    5
        Examples of Engagement

  Examples of when an institution is considered
  “engaged” in human subjects research can be
  found at
  http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm

 Institutions whose employees intervene with living
  individuals by performing invasive or noninvasive
  procedures for research purposes (e.g., drawing blood;
  dispensing drugs; administering other treatments.



                                                               6
       Examples of Engagement
                      (Continued)


 Institutions whose employees or agents interact with
  living individuals for research purposes (e.g.,
  conducting research interviews; obtaining informed
  consent).

 Institutions whose employees obtain, receive or
  possess private information that is individually
  identifiable (either directly or indirectly through
  coding systems) for research purposes (e.g.,
  obtaining private information for data analysis
  purposes).
                                                        7
What is a Federalwide Assurance?

A Federalwide Assurance is "documentation of an
institutional commitment to comply with the
Department of Health and Human Services
regulations for the protection of human subjects". The
Terms of the Federalwide Assurance can be found at
http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm.




                                                                8
       Steps to Take if You Plan to
      Involve Non-VCU Institutions

 Plan for their involvement as you are designing your
  study and submitting grant applications.

 Review the VCU IRB Policy on Involvement of Non-
  VCU Institutions in VCU Human Subjects Research
  http://www.research.vcu.edu/irb/wpp/flash/wpp_guide.htm#XVII-6.htm




                                                                   9
       Steps to Take if You Plan to
      Involve Non-VCU Institutions
                            (Continued)
 Determine whether the institutions will be “engaged” in the research
  project.

     If they are not engaged, or the project
      comprises exempt review status, or the
      project does not involve a direct federal award
      or application for such:
      Be prepared to thoroughly describe their
      involvement in your protocol.



                                                                         10
    Steps to Take if You Plan to
   Involve Non-VCU Institutions
                      (Continued)
 If they are engaged and the research project is non-exempt
  and involves a direct federal award or application for such:

  Determine whether the institutions have a Federalwide
  Assurance (FWA).

   • If they have an FWA, you will need to include their Assurance
     number in Section XII: Involvement of Non-VCU Institutions in
     VCU Human Subjects Research of your protocol/research
     synopsis.




                                                               11
Steps to Take if You Plan to Involve
  Non-VCU Institutions (Continued)


   • If they do not have an FWA, discuss with
     them the need to obtain one if they intend
     to be involved in your research project.




                                                  12
       Steps to File a Federalwide
               Assurance

 Review Steps to File a Domestic Federalwide
  Assurance at
  http://www.hhs.gov/ohrp/assurances/assurances_in
  dex.html

 The collaborating institutions will need to identify an
  IRB of record for their institution when they file.



                                                        13
       Steps to File a Federalwide
               Assurance
 If these institutions do not routinely engage in
  human subjects research, they are likely to prefer
  relying on the VCU Institutional Review Board (IRB)
  when engaged in VCU human subjects research.
  VCU would need to agree to the arrangement and
  such an arrangement must be documented in writing
  between the two institutions. If VCU agrees to the
  arrangement, the collaborating institution will list the
  VCU IRB registration number for each designated
  IRB and the name of the IRB(s) on its FWA
  application.
                                                        14

				
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