The August 27th Research Town Hall focused on helping Duke researchers understand and meet the ever-evolving requirements of funders. As new policies have been introduced, Duke has created tools and resources that aim to make finding funding, submitting proposals, and compliance with funder requirements as easy as possible. You can find the recording and slides for this session along with previous research town halls here.
Lesley Skalla, PhD, MSLS, Research and Education Librarian with Duke Medical Center Library and Archives, started off the Town Hall with information on using SciENcv, the Science Experts Network Curriculum Vitae, to create biographical sketches (e.g., biosketches). As of October 2023, the NSF requires all researchers to submit biosketches created using SciENcv (NSF Policy Announcement). The NIH also has changes coming in 2025 that will adopt Common Forms and require the use of SciENcv to develop the biosketch (policy updates can be found here). Thankfully, SciENcv is a tool that aims to simplify and streamline this process by automatically pulling your information directly from sources (e.g., eRA Commons, PubMed, NSF, and ORCID) and formatting your information into a PDF that is compliant with specific funder requirements. Lesley recommends saving time by connecting your ORCID ID to the various systems you use so that they can automatically update your ORCID profile and using ORCID to populate SciENcv. Instructions on cleaning up your scholarly profiles and linking them to automatically updated your ORCID profile can be found here. There is also a video tutorial on creating your biosketch using SciENcv here. For more information, you can contact Lesley Skalla directly or reach out to the Medical Center Library.
Laurianne Torres, MNM, Associate Dean for Research Administration with the Duke Office of Research Administration (ORA), provided information on sponsor prior approval requirements. Prior approval is “written approval by an authorized sponsor representative to undertake certain activities or incur specific costs.” The approval must be sought in advance. Laurianne emphasizes that this is a request to the sponsor, not a notification. While there are many activities that require prior approval, especially for Federal sponsors (see Uniform Guidance), Laurianne focuses on the five most common examples for researchers. The first is research activities involving international activities or collaborators, which needs prior approval whether or not grant funds are being expended. Next is any change in project scope, which the NIH defines as “a change in direction, aims, objectives, purpose, or type of research training, identified in the approved project.” While this can be subjective, Laurianne encourages researchers to work closely with their grant manager to identify any possible changes to a project that may need to receive prior approval. Researchers must also seek prior approval for any change in status or effort of the PI or any key personnel. When receiving a no cost extension (NCE), Duke has expanded authority to approve the first NCE up to one year past the original project end date, but all subsequent NCEs must have prior approval from the sponsor. And lastly, researchers must seek prior approval for any carryover of unspent funds during a specific budget period, which is intended to cover prospective costs, not costs that have already been incurred. Laurianne ends with giving some tips for best practices, including familiarizing yourself with the terms and conditions of your award and working closely with your grant manager to discuss any potential activities or costs that may need prior approval.
Beth Blackwood, MSLS, Research and Education Librarian with the Duke Medical Center Library and Archives, provided updates on the NIH Public Access Policy. This policy requires that any publications that come directly from grant funded projects be submitted to PubMed Central. These changes are coming in 2025 and include an end to embargo periods and a guarantee that authors will have a free option for publication submission that does not require an article processing charge. The Duke Medical Center library will be sending out bi-monthly email reminders to all Duke authors that are listed on a paper attached to a Duke grant, so be on the look-out for these! Beth highly recommends that all researchers save a copy of their finalized manuscript while they still retain the copywrite and designate someone on your team to submit to PubMed Central to make this process easier. You can reach out to elizabeth.blackwood@duke.edu or nihpublicaccesscompliance@dm.duke.edu with any questions or to get help with long-term planning. You can also sign up for the Medical Library newsletter to receive news and updates!
Adam J. King, Associate Director for International Research Administration Support Resources (iRASR), next gave information on updates to the NIH Policy for Foreign Subrecipients. The policy states that at the time of the Research Performance Progress Report (RPPR), grant recipients at Duke must obtain “copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report” and make these readily available should the NIH request access. While this is not a new requirement, the updated NIH policy statement aims to clarify this policy. Enforcement at Duke is effective as of June 30, 2024. The NIH has also published some FAQs to help address questions, though Adam notes that these rules do not provide much flexibility. There are no exceptions for data that may be protected under another local or national law, though personally identifying information can be redacted to protect the privacy of research participants. It is also no longer acceptable for data to be kept at a partner site for periodic review – Duke grant recipients must be able to provide the data directly to the NIH should it be requested. The FAQs also clarify that all materials, data, and documentation must be translated into English in order to meet the requirement. Duke recommends that researchers utilize LabArchives to securely store their data. Researchers will also need to submit a formal attestation once the data update is complete. More information can be found here. Please reach out to irasr@duke.edu with any questions.
Kelsey R. Smith, PhD., Research Integrity Associate with the Duke Office of Scientific Integrity (DOSI), presented information about LabArchives, an electronic research notebook that all Duke researchers have premium access to at no individual cost. As mentioned above, Duke recommends that researchers with international subrecipients use Lab Archives to meet the NIH subrecipient requirements. Users outside of Duke that are invited to join a notebook by a Duke researcher will have the same premium access as Duke researchers, making it an excellent tool for collaboration. LabArchives has flexible user roles with easy sharing tools, can monitor folders for automatic file upload, and has unlimited storage for files < 15 GB. LabArchives also now allows Protected Health Information (PHI) to be uploaded from consented research participants, an important change for Duke researchers! The LabArchives team at Duke is currently collecting information about those interested in using LabArchives to store PHI, so please consider filling out this survey if you would like to start using LabArchives for PHI. You can also enter to win a $20 gift card by filling out this survey and sharing your thoughts and experiences using LabArchives. For more information, questions, or to request a demo please reach out to asist@duke.edu.
Derek Jones, Associate Director of Research Initiatives and IT engagement for the Duke Office of Research Initiatives (DORI), next spoke about new resources for finding funding for your research. There have been exciting changes to Duke's Research Funding website that aim to make finding funding sources simple and easy. Researchers can now save searches and turn on notifications to receive a weekly email summarizing all of the new funding opportunities meeting their search criteria with links directly to those opportunities. DORI has also updated their newsletter to be easier to read and engage with. The newsletter will include new and noteworthy opportunities, key resources, and new funding opportunities. There is also a new tool on myRESEARCHhome called “myFundingOpportunities” that will automatically recommend new, relevant opportunities based on the eligibility and interests in your profile each time you log in. Please visit the Researching Funding website for more information or request help using the Get Help page or “Contact Us” option. Derek also gives a demo for the website that can be viewed starting at the 1-hour mark of the August Research Town Hall Recording.
Jenny Ariansen, Director of Research Integrity with the Duke Office of Scientific Integrity (DOSI), wrapped up the Town Hall with updates to the NIH Data Management and Sharing Policy. This policy went into effect January 25, 2023. DOSI has been working with Duke researchers to implement this policy along with the Duke University Libraries and the Medical Center Libraries. The NIH requirements for Data Management and Sharing Plans (DMSPs) specify that the “only data that must be shared are those that are of sufficient quality to validate and replicate the research findings.” Researchers must request prior approval for any significant changes to their approved DMSPs, and noncompliance with the approved DMSP may result in the NIH adding terms and conditions to the award or terminating the award altogether. Jenny also notes that all allowable costs, including those for personnel duties, should be specifically broken down in the data management section of the budget. There are also changes coming to the NIH peer review process in January 2025 that aim to simplify the process for reviewers and allow them to more easily identify research with the highest potential impact and to minimize bias. Duke researchers should reach out to researchdata@duke.edu with any questions regarding data management plans, or they can submit a request using this form.