18.1 Publication of Research Results

Section revised: 01/12/2016

Before initiating research, the Organization has a written agreement with the Sponsor about plans for disseminating findings from the research and the roles that Researchers and Sponsors will play in the publication or disclosure of results. (AAHRPP Element I.8.D)

Stanford University, Stanford Hospitals and Clinics (SHC) and

Lucile Packard ChildrenŐs Hospital (LPCH)

For sponsored research, Stanford University establishes the importance of disseminating research findings as one of its most important policies through its policy Openness in Research. See Research Policy Handbook RPH 1.4 Openness in Research, which provides, in part: ŇThat the principle of openness in research – the principle of freedom of access by all interested persons to the underlying data, to the processes, and to the final results of research – is one of overriding importance.Ó The Principal Investigator Responsibilities
at Stanford University tutorial (ŇPIshipÓ) also address the principle of openness in research.

Stanford University requires that provisions for fair and reasonable ownership of data and research results be included in its sponsored research agreements and has a process that allows investigators to place their inventions in the public domain if that would be in the best interest of technology transfer and if doing so is not in violation of the terms of any agreements that supported or governed the work. See Research Policy Handbook RPH 9.1 Inventions, Patents and Licensing.

In all sponsored research, Stanford University requires the dissemination of research results in a manner consistent with the above-referenced policy Openness in Research. A Project Checklist is used to implement this policy when reviewing research proposals, solicitations, award notices, non-disclosure agreements, and any other document related to sponsored research. This checklist is referred to from RPH 1.4 Openness in Research and from the PIship tutorial.

Stanford University implements this policy in agreements concerning sponsored research by:

á Including in its standard contract templates a provision that provides the investigator with a right to publish the research results. See Stanford University Clinical Trials/Study Agreement template (Publication Section) and Stanford University Sponsored Research Agreement template (Section 11).

á Revising any provision in any proposed contract that limits an investigatorŐs right to publish research results in a manner that is inconsistent with the Policy on Openness in Research

á In grants: Including in the cover letter accepting and acknowledging the grant a statement of the applicability of the Policy on Openness in Research.

Veterans Affairs Palo Alto Health Care System (VAPAHCS) and

Palo Alto Veterans Institute for Research (PAVIR)

For VA research and PAVIR sponsored research, VAPAHCS has policies that formally state that presentation of research results to the scientific community is an essential part of its research programs and that investigators are encouraged to publish and present the results from sponsored research at scientific and medical conferences.

See:

á VHA Handbook 1200.19, Presentation Of Research Results Handbook

Additionally, the VA retains ownership of all research data and results obtained from the use of resources provided by the VA as a result of conducting the research pursuant to federal law (35 USC 102 & 200-212, 37 CFR 501, and 38 CFR 1.650-1.663).

PAVIR abides by the above-described policies of the VA for its sponsored research at VAPAHCS, and also addresses the dissemination of research results by:

á Including in its standard contract template a provision that states that (a) PAVIR or any investigator may freely publish and disseminate the results of a clinical trial and (b) that the authorship and contents (including scientific conclusions and professional judgments) of any paper submitted shall be determined by PAVIR. See VA Cooperative Research And Development Agreement (CRADA) template (section 7.3 Presentations and Publications) template.

á Revising any provision in any proposed contract that limits an investigatorŐs right to publish research results in a manner that is inconsistent with its standard provision.

18.2 Communicating Study Results to Participants

Section revised: 01/12/2016

When participant safety could be directly affected by study results after the study has ended, STANFORD has a written agreement with the Sponsor that the Researcher or STANFORD will be notified of the results in order to consider informing participants. (AAHRPP Element I.8.E)

When the IRB learns of events that could affect participant welfare after a study has closed (e.g., a drug studied at Stanford is withdrawn by the FDA), the IRB seeks information, deliberates, and considers whether (and how) to contact participants who might be affected. Even when the study is not yet closed, but participants have completed participation, the IRB informs former participants when information is learned that could affect their welfare.

For sponsored research, Stanford University and PAVIR address communication with sponsors regarding the impact of research results on participant health and safety by:

á Including in their standard contract templates a provision that the sponsor will develop a plan of communication with the Protocol Director that is acceptable to the IRB when new findings or results of the protocol might impact the willingness of subjects to continue to participate in the protocol or directly affect their current or future safety or medical care, or by asking for the inclusion of such a provision in any proposed contract that does not use their standard template..

See:

á Stanford University Clinical Trials/Study Agreement template (Human Research Protection Program section))

á Stanford University Sponsored Research Agreement template (Section 17)

á VA Cooperative Research And Development Agreement (CRADA) template (section 7.3 Presentations and Publications