NIH Seeking Feedback on Consent Language Resource to Foster Participant Specimen and Data Sharing



Lyric Jorgenson
Lyric Jorgenson, NIH Acting Associate Director for Science Policy and Acting Director of the Office of Science Policy

NIH is committed to ensuring that study participants are equal partners in research and have input into how their data and biospecimens are collected and used in the future.  At the heart of any research effort lies the need for transparent and clear conversations between researchers and prospective participants about mutual goals and expectations regarding sharing practices.

To assist in facilitating this dialogue, NIH has been working with stakeholders to identify informed consent language “best practices” capable of effectively describing how data and biospecimens will be stored and shared for future research. From these conversations, NIH has developed a new resource that we are seeking the community’s feedback on. The resource describes points to consider when addressing this issue, and provides sample consent language that researchers can tailor based on their own unique study needs.

Don’t worry – this is intended to be a helpful resource for the community and will be completely voluntary in nature – which is why we need to hear from you about its utility and usability. For example, are there gaps or additional components that would be helpful to include? What about barriers to the voluntary use of the sample language by the community? We look forward to hearing from all of our stakeholders – study participants, researchers, institutional authorities, and more – to help make this a valuable tool for enabling effective sharing to advance research.

Deadline for comments is September 29, 2021 and more information can be found here.

One comment

  1. The partnership between study participants and investigators is critical for the success of biomedical projects. On behalf of the authors, we would like to point your attention to the article “From clinical specimens to human cancer preclinical models—a journey of the NCI‐cell line database—25 years later” (PMID: 31803961) that offers some solutions that ultimately led to the successes in lung cancer diagnosis and treatment. One of the key elements and motivating factors of patient consent process is the assurance of sharing with patients the outcomes and positive consequences of their participation in clinical research. Please read more in section “2.7.1. Honoring Donor Intent” of the article. This manuscript was not only written by investigators involved with the generation and use of the cell lines but also with the involvement of cancer patient advocates and a lung cancer survivor familiar with the program.
    The paper also points out how a relatively minor investment by the NIH resulted in a major global impact that is still growing and changing the landscape of lung cancer survivorship. The analysis of objective impact was performed by an independent group of analysts using efficient state of the art bioinformatics techniques in a process that can be readily replicated to assess long-term impact of future research efforts.
    Wishing you and your team success with your project.

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