VA Approved Contract Language

Background: FYI

The checklist gathers information about whether or not the VA is involved in the conduct of the trial, and when the VA is involved DSP should include in the agreement specific VA approved contract language found below or at a minimum secure language that satisfies the principles set forth by the VA approved language. This is one of UF`s roles to help the VA obtain AAHRPP accreditation.

If a sponsor rejects the language in whole or in part, discuss with PI and Study Coordinator to see if the study can be conducted without VA involvement.

If it is determined that study cannot be conducted without VA involvement, bring to the attention of Stephanie Gray or Brian Prindle within the Division of Sponsored Programs for further discussion and direction.


VA Approved Contract Language

Human Subject Protection

The research to be conducted under this Agreement (or equivalent) involves Human Subjects or human tissues within the meaning of 38 C.F.R. Part 16 and all research to be performed under this Agreement (or equivalent) will conform to applicable Federal laws and regulations and local IRB policies and procedures. Additional information is available from the HHS Office for Human Research Protections (http://www.hhs.gov/ohrp/). Sponsor (or equivalent) and UF on behalf of the VA shall immediately notify each other upon identifying any aspect of the protocol, including information discovered during site monitoring visits, or the study results that may adversely affect the safety, well-being, or medical care of participants, or that may affect the willingness of participants to continue participation in the research, influence the conduct of the study, or that may alter the IRB’s approval to continue the study, UF on behalf of the VA shall promptly notify the IRB of any such events. When participant safety or medical care could be directly affected by study results, UF on behalf of the VA will send study participants a written communication about the results

Research Related Injury

Sponsor (or equivalent) shall be responsible for reasonable and customary costs incurred for treatment of physical injury to the subject if Sponsor (or equivalent) reasonably determines, after consulting with UF on behalf of the VA, that the Adverse Event was reasonably related to administration of the Test Article or Protocol; provided, however, that:

  1. the Adverse Event is not attributable to VA Employees’ negligence or willful misconduct;
  2. the Adverse Event is not solely attributable to any underlying illness, whether previously diagnosed or not; and
  3. the Protocol drug or Protocol procedure was administered in accordance with the Protocol.

Presentations and Publications

UF, VA and Sponsor (or equivalent) have the right to make publicly available the results of their research and development activities and are encouraged to do so.

Unless otherwise required by the authorship guidelines or requirements of the meeting or other forum at which the presentation will be made or the journal in which the publication will appear, authorship should reflect a substantial contribution to:

  1. the conception, design and/or conduct of the clinical trial,
  2. the acquisition, evaluation and/or interpretation of the results of the clinical trial and/or
  3. the drafting and revising of the manuscript and its final approval.

Depending upon his or her level of participation in the performance of the clinical trial, the contribution of each participant should be recognized appropriately in all resulting presentations and publications, either as a named author or contributor or in an acknowledgement. The final determination shall be made by mutual agreement of UF, VA and Sponsor (or equivalent).

A manuscript of each proposed presentation or publication of the results of the clinical trial shall be submitted to UF, VA and Sponsor (or equivalent) for review prior to submission to anyone who is not employed by UF, VA or Sponsor (or equivalent) and under an obligation of non-disclosure and non-use at least substantially identical to that imposed on UF and Sponsor (or equivalent) by this Agreement in order to permit UF, VA and Sponsor (or equivalent) to

  1. evaluate the manuscript for accuracy,
  2. ascertain whether Information (other than the results of the clinical trial) is being improperly disclosed,
  3. provide information which may not have yet been made available by UF, VA or Sponsor (or equivalent),
  4. provide input for consideration regarding the content and/or conclusion(s) of the manuscript and
  5. determine whether the manuscript discloses any potentially patentable invention(s).

UF, VA and Sponsor (or equivalent) shall be afforded a review period of fifteen (15) working days for manuscripts not exceeding two (2) double-spaced pages in length (or the equivalent thereof) and thirty (30) working days for all other manuscripts. A working day is any day other than a Saturday, Sunday or Federal holiday. Upon receipt of UF, VA and Sponsor (or equivalent)’s written consent to release the manuscript or, if later, upon the conclusion of the review period with no request, input or notification having been received from UF, Sponsor (or equivalent) and VA, the manuscript may be submitted to anyone.

By mutual agreement of UF, VA and Sponsor (or equivalent), any Confidential Information (other than the results of the clinical trial) contained therein shall be excised from the manuscript and reasonable consideration shall be given to all other input received from Sponsor (or equivalent).

If Sponsor (or equivalent) determines that any manuscript submitted to it for review in accordance with this paragraph contains or describes one or more potentially patentable inventions that should be made the subject of one or more patent applications, Sponsor (or equivalent) shall provide notice to UF on behalf of VA of this determination prior to the expiration of the review period. Sponsor (or equivalent) shall have two (2) months from its receipt of such additional information to file such patent application(s). UF, VA and Sponsor (or equivalent) shall not submit the manuscript to anyone who is not a UF, VA or a Sponsor (or equivalent) employee and who is not under an obligation of non-disclosure and non-use at least substantially identical to that imposed on both UF and Sponsor (or equivalent) by this agreement except by mutual agreement.

If the clinical trial is part of a multicenter clinical trial, the data resulting from the performance of the clinical trial shall be pooled with the data from other centers (final pooled dataset) and analyzed as stipulated in the Protocol. Without the consent of the steering committee of the multicenter clinical trial, no presentation or publication of the results obtained from datasets other than the final pooled dataset (either of data from one center alone or of data from more than one but less than all of the centers) shall be made prior to the presentation or publication of the pooled dataset. Thereafter, should results obtained from datasets other than the final pooled dataset be published for sound scientific reasons, adequate reference shall be made to the primary publication. In no event shall UF or VA be restricted from presenting or publishing independently after the expiration of twelve (12) months from the completion of the Clinical Trial provided that all other provisions of this paragraph have been satisfied and provided that the publication adequately describes the results as obtained from a dataset other than the final pooled dataset, if that is the case.