Tag Archives: NIH compliance

Webinar: The “New” NIH Data Management & Sharing Policy: A Conversation

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This webinar is a great opportunity to learn more about the new NIH Data Management & Sharing Policy and its impact on grant applicants. Join us for a conversation that will touch on policy expectations, insights in how to prepare a data management plan, and advice for sharing data responsibly and safely.

A panel of MSK staff from various departments will be sharing their recent experiences with time for attendees to participate in an interactive Q&A discussion.

Date: Thursday, March 23, 2023
Time: 12:00 PM to 1:30 PM, EST
Location – Zoom Webinar – Register Now

Panelist Bios:

Roy Cambria, BS, CCRP, CIP, Director, Human Research Protection Program (HRPP), MSK
Roy has been at Memorial Sloan Kettering since 2005 and has held several positions in clinical research throughout his almost 18 year career with the institution. He began MSK as the Institutional Review Board/Privacy Board (IRB/PB) Coordinator until 2008 when he transitioned to project, and program based positions in the former Office of Clinical Research. He returned to the IRB/PB administration space in 2016 as the Human Research Protections Program Director. The MSK Human Research Protection Program Office is part of the Protocol Activation, Review and HRPP unit in Clinical Research Compliance Administration. As HRPP Director, Roy oversees the daily operations of the HRPP office and MSK’s 3 IRB/PBs. He is responsible for promoting the welfare and rights of human research participants, facilitation of excellence in human subjects research, and ensure timely and high quality review of research. In addition, he and the HRPP office are responsible for ensuring full compliance with Institutional, AAHRPP(Association for the Accreditation of Human Research Protection Programs), State and Federal regulations, requirements and guidance regarding human subjects’ protection. Roy has served on the MSK IRB/PB since 2008 and is a member of the Society of Clinical Research Associates (SOCRA) and a Certified IRB Professional (CIP).

Anthony Dellureficio, MLS, MSc, Associate Librarian, Data Management, MSK
Anthony joined the MSK Library in 2019 to help launch a new Research Data Management program to support researchers by developing, implementing, and integrating resources that focus on data management plan creation, data discovery, and data as a component of the publication process. Prior to joining MSK, Anthony led The New School Library and Archives systems and technology team for about ten years. He has previously worked as the digital archivist at Cold Spring Harbor Laboratory, rare medical text cataloger at the Johns Hopkins Institute of the History of Medicine, and archivist at the Johns Hopkins Medical archives. His academic area of interest is in the history of classical genetics.

Kelly McConnell, PhD, Associate Attending Psychologist & co-Director of the Psycho-oncology of Aging and Cancer research laboratory in the Department of Psychiatry & Behavioral Sciences, MSK
Dr. Kelly McConnell’s research examines the nature and predictors of distress in older adult patients with cancer and their caregivers and care received at the end-of-life. She also examines the efficacy and implementation of interventions to reduce distress and increase rates of advance care planning in patients and caregivers. She has received NIH (K23, R21) and foundation (American Cancer Society, American Federation for Aging Research, RRF Foundation for Aging) grant funding for this research.

Joseph Olechnowicz, MA, Senior Editor, Department of Pediatrics, MSK
Joe Olechnowicz assists investigators with successfully communicating their scientific goals and asking for federal and philanthropic support for achieving them. He joined the Department of Pediatrics in 2008 initially contributing to protocol/project development activities (including protocol review activities of the department as well as the development of the FDA approved drug naxitamab) while also assisting with manuscript submissions and grant application and reporting.

Joe received his B.S. in biology from John Carroll University and his M.A. from Case Western Reserve University (CWRU) in biomedical ethics while also working in the lab of Dr. Sanford Markowitz on the genetics of familial colon cancer syndromes. He went on to work with Dr. Eric Kodish at the Cleveland Clinic analyzing the use of proxy consent and assent in clinical research involving children (Olechnowicz et al. Pediatrics, 2002). He then attempted to study the philosophy underpinning consent and intentional/free action (along with some other stuff) at Florida State University. He currently is employed using the skills he acquired during his academic activities, namely, writing concisely and precisely and making difficult scientific/conceptual explanations understandable.

New Resource: NIH Data Management and Sharing Policy Guide

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The National Institutes of Health (NIH) has issued a new Data Management and Sharing Policy, effective January 25, 2023. This policy includes an expectation that researchers will maximize their data sharing activities, ensure they submit a Data Management Plan (DMP) at the time of grant submission, and deposit their data into a public repository. To support the implementation of this new policy, a resource guide has been developed to provide information and guidance for our researchers. Click the link below to go directly to the guide.   

NIH Data Management and Sharing Policy LibGuide

Whether you are applying for a new grant or have a renewal deadline in your near future, this guide will help you navigate policy changes and requirements, as well as connect you with the right individuals or departments should you have specific questions. This guide has been customized for MSK staff and will be updated accordingly to ensure that researchers are provided with the latest information related to the policy.  

If you have questions about the guide, or would like to request a presentation about the new policy, please contact Anthony Dellureficio, Associate Librarian, Data Management Services. 

What MSK Researchers Can Do to Ensure NIH Compliance

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I often receive on a weekly basis, emails from the MSK Community asking for NIH compliance support. With the steady flow of requests, I wanted to take a moment to remind our MSK authors what they need to do for NIH-funded research papers and where the Library can help.

Once the paper’s applicability has been confirmed (does the published work fall under the NIH Public Access Policy?), the copyright agreement has been addressed (paper/manuscript can be posted to PMC (PubMed Central), and the submission method determined (A, B, C, or D), then there are only three remaining steps left to ensure NIH compliance is achieved, just remember — Acknowledge, Acquire and Associate!

ACKNOWLEDGE and CITE
When an author or his/her delegate is about to submit a research manuscript for acceptance to a journal publication, it is important to acknowledge and cite all relevant grants. This includes the MSK Cancer Center Support Grant (CCSG) which is awarded by the National Cancer Institute (NCI). Acknowledging and citing NIH-funding on the manuscript is critical as it highlights for those publishers who are Method A or D, that action is required by them on behalf of their NIH-authors.

ACQUIRE
To demonstrate NIH compliance, the paper needs to be assigned a PMCID number. Many MSK publications can be found in Submission Method A and Method D, which means that the publisher will handle the manuscript’s deposit. If the author or his/her delegate sees no action taken within three months of the print publication date, contact me so that I can investigate the reason for the delay or work with the publisher to deposit the accepted manuscript.

However, if the journal is a Submission Method C, usually the corresponding author handles the paper’s deposit, but it can be assigned to the corresponding author’s delegate, or one of the other co-authors. Remember, it is the accepted manuscript and not the PDF found on the publisher’s Website that should be submitted to the NIHMS system. Authors or their delegates should not ignore the approval emails sent by the NIHMS system for each submission as they are time sensitive and the links will expire.  Addressing these emails moves the paper forward in the compliance process.

ASSOCIATE
All MSK peer-reviewed research papers need to be associated with the core grant (P30 CA008748). The corresponding author, his/her delegate, or one of the co-authors can complete this task by following these instructions.

If you have any specific questions regarding the NIH Public Access Policy, please don’t hesitate to contact me. I have also included the following links to key materials for guidance and additional information.

Donna Gibson
Director of Library Services