Chicago Association for Research and Education in Science
RIGHT TO PUBLISH POLICY

Principle: In no case can the sponsor of a study be given absolute control over the right of the investigator to publish. To do so represents an unacceptable infringement on academic freedom and may jeopardize the tax-exempt status of CARES.

As responsible members of the scientific and academic community, we must be wary and resist taking or allowing actions and efforts which will erode the bedrock of American scientific productivity, academic freedom. It is also recognized that private and commercially-driven science are crucial components of the pre-eminent American scientific community and that their interests must also be respected and protected.

One of the tests the IRS uses in determining whether an organization qualifies for tax-exempt 501(c)3 status as a scientific research institution asks if the research “is carried out in the public interest”. The IRS has determined that research will be regarded as carried out in the public interest if, among other things, the research results are made available to the interested public on a non-discriminatory basis. The easiest way to do this is to meet the IRS publication/presentation requirements. These specify that: publication or presentation at research conferences or other symposia must be adequate and timely; some public disclosure beyond that which flows naturally from the issuance of a patent is required; the publication or presentation should disclose substantially all of the information concerning the results of the research which would be useful or beneficial to the interested public. The IRS allows publication to be delayed for a reasonable time to permit a commercial SPONSOR to obtain patent rights. Also, the IRS allows the publication or presentation to be “sanitized” to set forth only the scientific principles developed, without disclosing confidential information of the SPONSOR.

Subsequently, the following examples of clauses to be used in confidentiality agreements, contracts and agreements have been constructed in such a way as to protect the interests of both the investigators and study sponsors.

Sample 1
(A) (1) If the Study has been designed as a single-center Study, INVESTIGATOR shall have the right, consistent with academic standards, to publish or present the results of his/her work performed pursuant to the Study, provided that any proposed publication or presentation (collectively, "Proposed Publication") is first provided to SPONSOR for review in accordance with Section (B) below.
(2) If the Study has been designed as a multicenter Study, INVESTIGATOR acknowledges that, due to the limited patient population in its treatment group, the data generated from its individual participation in the Study and evaluation of its individual results may not be sufficient from which to draw any meaningful scientific conclusions. For these reasons, except as provided below, INVESTIGATOR agrees not to individually publish or present the results it obtains from INVESTIGATOR's participation in the multicenter Study. INVESTIGATOR may, however, upon written notice to SPONSOR participate in a joint, multicenter publication of the Study results with other third party INVESTIGATOR's and/or institutions, provided that the proposed publication is first reviewed by SPONSOR in accordance with Section (B). In the event that the multicenter publication has not been completed within one (1) year from the date of the completion or termination of the Study, then notwithstanding the foregoing, INVESTIGATOR may individually publish a proposed publication regarding individual results from the Study, provided that the proposed publication is first provided to SPONSOR for review in accordance with Section (B).
(B) SPONSOR shall complete its review within thirty (30) days after receipt of any proposed publication (individual or multicenter) from INVESTIGATOR. If SPONSOR believes that any proposed publication contains any information relating to patentable items, the disclosure of such proposed publication to any third party shall be delayed for up to sixty (60) days (beyond the thirty [30] day review period) to permit the filing of a patent application. Should SPONSOR request such a delay, then upon the written request of INVESTIGATOR, SPONSOR shall use its best efforts consistent with reasonable business and scientific practice to do all things which it believes would expedite the filing of such patent application. However, if at the end of such 60 day period, despite the use of diligent efforts on the part of SPONSOR, additional time is necessary or required in order to complete the filing of a patent application. SPONSOR may request, and INVESTIGATOR shall grant, an extension of the period of time within which to file the patent application not to exceed an additional sixty (60) days. If SPONSOR believes that any proposed publication contains any confidential information, SPONSOR shall so notify INVESTIGATOR, and INVESTIGATOR shall remove all references to such confidential information.
(C) Notwithstanding the foregoing, SPONSOR, INSTITUTION and INVESTIGATOR shall not issue a press release that references or that uses the other party's name or trademarks without the express written consent of such other party. INVESTIGATOR and INSTITUTION shall not issue a press release that references a Study or its results without the express written consent of the SPONSOR.
Sample 2 INSTITUTION and INVESTIGATOR reserve the right to publish or otherwise publicly disclose the results of, or information developed pursuant to, the research performed under this protocol, for non-commercial purposes (provided such publication or disclosure does not disclose confidential and/or proprietary information received from, or which is the property of, SPONSOR). INSTITUTION and INVESTIGATOR further agree to permit SPONSOR to review the content of any intended scientific publication or public presentation by submission of all such scientific manuscripts to SPONSOR prior to their public presentation or submission to publisher, for manuscripts at least 45 days prior to submission, and for abstracts, at least 21 days prior to submission. If SPONSOR notifies INSTITUTION or INVESTIGATOR, as the case may be, during this period that SPONSOR proposes to file patent applications relating to matters contained in such disclosure, disclosure will be delayed up to an additional 60 days.

Copyrights: Section 105 of the U.S. Copyright Act of 1976 specifically excludes United States Government works from copyright protection. Subsequently, works created by employees of the U.S. Government as part of their duties are inherently in the public domain, free for use by anyone and therefore not to be copyrighted. Publishers should be informed that your work as a U.S. Government employee is exempt from copyright transfer.