Hot Topics In Clinical Research:Knowing the Risks, Applying the Law
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Molly HugginsSmith Moore Leatherwood LLP
2800 Two Hannover SquareRaleigh, NC 27601T: (919) 755-8792
Publication Rights:Building the Contract Provision
Step 1: Do you need the right to publish the study results?
If so, affirm the right to publish.
“Upon completion of the Study, Institution and Investigator shall have the right to publish the results of the Study in accordance with the terms of this Agreement.”
Publication Rights: Building the Contract Provisions
• Step 2: Permit Sponsor an opportunity to review and comment, but Institution/Investigator should retain editorial control.
“Institution or Investigator shall provide Sponsor with a copy of any proposed publication or presentation at least thirty (30) days in advance of submission to a journal, editor, or other third party. Sponsor shall have thirty (30) days to respond with any comments or requested revisions. Institution and Investigator shall consider the requested revisions in good faith.”
Publication Rights: Building the Contract Provisions
Caution! Do you see the problem with these provisions?
Section A: Confidentiality. “Confidential Information” shall mean information disclosed by Sponsor to Institution under this Agreement and any and all information arising from performance of the Study.
Section B: Publication. Sponsor shall have the right to require the removal of any Confidential Information from the proposed publication.
Publication Rights: Building the Contract Provision
• Be careful to ensure that the contract does not contradict itself.
• Suggested work arounds:
(1) “Sponsor shall have the right to require the removal of any Confidential Information from the proposed publication, other than Study results and background information required for publication.
Publication Rights: Building the Contract Provision
or
(2) “Confidential Information” shall mean information disclosed by Sponsor to Institution under this Agreement and any and all information arising from performance of the Study, other than Study results published in accordance with the terms of this Agreement.
Publication Rights: Building the Contract Provision
• Step 3: Provide Sponsor with an opportunity to take steps to protect proprietary information.
“If Sponsor determines that the proposed publication or presentation contained patentable or otherwise proprietary information that requires protection, Institution and Investigator shall delay the publication or presentation for up to an additional sixty (60) days to permit Sponsor an opportunity to seek such protection.”
Publication Rights: Building the Contract Provisions
• Step 4: If applicable, account for multi-center studies.
“Because this is a multi-center Study, Institution and Investigator shall not publish their site’s Study results until the publication or presentation of the multi-center results. Notwithstanding the foregoing, if a multi-center publication is not submitted for publication within twelve (12) months after the conclusion, abandonment, or termination of the Study at all sites, or upon Sponsor notice that there will be no multi-center publication, Institution or Principal Investigator may publish the Study results as set forth herein.”
• Suspension of research funding• Risk to human subjects• Anti-Kickback violations• Litigation• Professional reputation• False Claims Act liability, as amended• Physician Payments Sunshine Act of 2009
– Infrastructure• Create the internal policies … and follow through• Know who, when and how• Communicate enforcement protocols• Require disclosure on an ongoing basis• Internal, random audits• Acknowledge and report noncompliance
Budget Negotiations: “A Common Hurdle”Investigational Items and Services• For those items and services
that the institution determines are “investigational” in its Medicare coverage analysis, should the institution take a “bill first” approach before billing the sponsor?
