Upcoming Meeting of the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC)

On June 17, 2024, from 11:30 am – 1:00 pm ET, NIH will be hosting a virtual meeting of the NExTRAC.  At this meeting, the committee will receive an update from the Working Group on Engaging the Public as Partners in Clinical Research and discuss the next steps regarding its current charge.

A draft agenda, webcast information, details on how to submit written comments, and other meeting materials can be found on the meeting page of the OSP Website.

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NIH to Host Webinar on Draft NIH Intramural Research Program Policy: Promoting Equity through Access Planning

NIH will be hosting an informational webinar about its recent request for information (RFI) and draft proposal to incorporate patient access planning in the commercialization process for NIH-owned inventions.

The webinar will take place on Tuesday, June 11, 3:00 pm – 4:00 pm ET. Presenters will provide background on NIH’s Intramural Research Program, discuss patent licensing at NIH, review the concept of access planning, and discuss the RFI and draft policy proposal.

Individuals and organizations interested in learning about the RFI and gaining a better understanding of the NIH Intramural Research Program’s patent licensing process are encouraged to attend. This webinar is free of charge though pre-registration is required. Participants are invited to submit questions for NIH to address during the webinar. Participant questions must be received by Friday, June 7, 2024.

Information on the agenda, how to register, and how to submit questions can be found on the event website.

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Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity in Access Planning

NIH is proposing to develop and implement a new policy within the NIH’s Intramural Research Program, the internal research arm of the agency. The policy would require organizations partnering with NIH through a patent licensing agreement that succeed in bringing certain products to market to submit a plan outlining steps they intend to take to promote patient access to any resulting drug, biologic, vaccine, or device. NIH seeks input on this draft policy and accompanying draft license agreement language that incorporates patient access in the commercialization process for NIH-owned inventions.

NIH will use the responses to this request for information to develop a final policy. Comments on the proposed policy must be submitted at: https://osp.od.nih.gov/comment-form-draft-nih-intramural-research-program-policy-promoting-equity-through-access-planning.  Comments must be received by July 22, 2024.

In addition, NIH will be hosting an informational webinar on the proposed policy on June 11, 2024.  More information on the agenda and how to register will be provided shortly.

For additional context on the benefits of access planning, please see NIH’s 2023 Workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer.

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OSP Celebrates Clinical Trials Day; Releases New Resource Related to Consent Language for Studies Using Digital Health Technologies

Today, May 20th, is Clinical Trials Day; a day to reflect, recognize, and celebrate all that has been achieved through clinical trials and the participants, communities, researchers, clinical staff, and others who make these accomplishments possible.  Clinical trials are at the heart of all medical advances.  On behalf of OSP, thanks to all those who make clinical research possible.

As we look to the future of clinical research, advances in digital health technologies are providing new opportunities to bring trials to participants.  To assist in the responsible deployment of these technologies,  OSP, through an NIH-wide collaboration, has developed and released Informed Consent for Research Using Digital Health Technologies: Points to Consider & Sample LanguageThis resource presents general points to consider, instructions for use, and optional sample language for the research community. This resource will best be used to inform research teams and Institutional Review Board (IRB) members who are planning, reviewing, or conducting research that studies or uses digital health technologies.

Questions about this resource can be sent to SciencePolicy@od.nih.gov

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