NIH News

New and Updated Resources Available to Help Design Rigorous Clinical Trials We have embarked on a series of initiatives at NIH in recent years to enhance the quality, efficiency, accountability, and transparency of our supported clinical research. While we are all making great progress, our concerns about clinical trials that are overly complex, have small sample sizes, or rely on surrogate end points that lack clinical relevance remain. One resource to help address these concerns is the NIH Research Methods Resources website that NIH’s Office of Disease Prevention (ODP) launched in 2017. Since the site was recently revamped, we wanted to spotlight the new available tools and resources that can help you better plan the design, conduct, and analysis of rigorous NIH-defined clinical trials. Submission and Processing of Federal Financial Reports If you need to submit a Federal Financial Report (FFR) through the HHS Payment Management System (PMS), then you’ll want to be aware of two recent notices in the NIH Guide for Grants and Contracts. All About Grants Podcast – Financial Conflicts of Interest In this NIH All About Grants podcast episode, we virtually sit down with Diane Dean, a senior advisor within the NIH’s Office of Extramural Research, and dive into what you should know about financial conflicts of interest (FCOIs). All About Grants Podcast: NIH Loan Repayment Programs (Part 2) –The Application The NIH Loan Repayment Program (LRP) conversation is back! And, building on Part 1, this time, we are getting into the nitty gritty of the application itself. Dr. Ericka Boone, Director of the Division of Loan Repayment is joined by Dr. Roya Kalantari, a program officer focused on LRPs at the National Heart, Lung, and Blood Institute to discuss what you should do when preparing to apply, the various sections of the application, some tips to consider and mistakes to avoid, as well as thoughts on when seeking a renewal. New FDA Tools for Investigators and Clinicians The FDA recently released two new tools that were developed for investigators and clinicians: 1) Research IND Pilot Portal and 2) Expanded Access eRequest. Common Data Elements: Increasing FAIR Data Sharing Common Data Elements (CDEs) are a type of health data standard that is commonly used and reused in both clinical and research settings. CDEs provide a way to standardize data collection—ensuring that data are collected consistently- and otherwise-avoidable variability is minimized. An Updated Look at Applications Submitted During the Pandemic In a previous post, we looked at the gender distribution of designated principal investigators (PI’s) of R01 and RPG applications submitted before and after the onset of the COVID-19 pandemic. Here we look at NIH R01 and RPG application patterns for January 1 through April 8 over the past 6 years; these applications' patterns may well reflect longer-term pandemic effects. Creating People and System-Friendly PDF Attachments Grant applications, Just-in-Time information, and progress reports all require PDF attachments as part of their submissions. Since both people and systems are consumers of the information conveyed through these attachments, we depend on applicants and recipients to follow a set of formatting ground rules that facilitate readability as well as timely and successful system processing. NIH Seeking Feedback on Consent Language Resource to Foster Participant Specimen and Data Sharing 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.

George and Angelina Kostas Research Center for Cardiovascular Nanomedicine is seeking applications

Key Dates Submission Deadline: Wednesday, July 21, 2021, at noon Committee Review: July-September 2021 Award Announcement: October 2021 Estimated Funding Start Date: January 1, 2022

W. M. Keck Foundation Research Program Grant Call for Concept Papers

Key Date Dear Investigators: The W.M. Keck Foundation Research Program supports projects in (1) medical research and (2) science and engineering. Projects must be distinctive and novel in their approach, question a prevailing paradigm, or have the potential to open new territory in their field. The Foundation encourages projects that are high-risk with the potential for transformative impact. "High-risk" comprises a number of factors, including questions that push the edge of the field, present unconventional approaches to intractable problems, or challenge the prevailing paradigm. Funding Information Historically, grants range from $500,000 to $5 million (typically, $2 million or less) with an average duration of one (1) to five (5) years. We encourage anyone interested in applying to review the Grant Abstracts for those previously funded by the Keck Foundation. Award Details Funding is awarded to universities and institutions nationwide for projects in research that:

• Focus on important and emerging areas of research
• Have the potential to develop breakthrough technologies, instrumentation or methodologies
• Are innovative, distinctive and interdisciplinary
• Demonstrate a high level of risk due to unconventional approaches, or by challenging the prevailing paradigm
• Have the potential for transformative impact, such as the founding of a new field of research, the enabling of observations not previously possible, or the altered perception of a previously intractable problem
• Do not focus on clinical or translational research, treatment trials or research for the sole purpose of drug development
• Fall outside the mission of public funding agencies
• Demonstrate that private philanthropy generally, and the W. M. Keck Foundation in particular, is essential to the project’s success

Concept Papers (1-page maximum; 12-point font with 1-inch margins) should include:

• Organization Name
• Project Title
• Full name of Principal Investigator
• An overview of the proposed project emphasizing any unique aspects and pilot studies (indicate medical research or science and engineering research)
• A description of the methodologies and key personnel
• A brief justification of the need for Keck support;
• An estimated budget broken down, if possible, by major areas, e.g., personnel, equipment, consumable supplies, etc.;
• Other details, if space allows (e.g., background to put the research into perspective, description of the institution’s prominence in the field, etc.)

Note: When developing the single page concept paper, avoid illustrations and if a reference is necessary, abbreviate is as (Science, 323, 45, ‘11). DO NOT USE (Jones et al., 2011). Additional details for page concept paper can be found here. The W. M. Keck Foundation Research Program guidelines are available here. Please note that our institution may submit only one (1) full application in Science and Engineering and only one (1) full application in Medical Research. Catherine S. Del Paggio at the Houston Methodist Hospital Foundation will assist with the application submission to the Keck Foundation. For any questions or concerns regarding this award opportunity, please feel free to reach out to Academic Affairs.

Cures Within Reach

Key Date Proposals due July 30 and August 6 The deadline for the Cures Within Reach Request for Proposals (RFP) for US-based underrepresented racial / ethnic minority PIs is July 30, 2021. This funding opportunity is part of CWR's new Diversity, Equity & Inclusion (DEI) community. More info about our open DEI RFPs is available at https://bit.ly/cwrrfps. At least three grants will be awarded for clinical repurposing trials:

• In any disease led by US-based racial / ethnic minority PIs underrepresented in biomedical research (as defined by the NIH); budgets of up to $70,000 accepted; proposals due July 30
• Led by Chicagoland-based PIs addressing racial / ethnic health disparities (as defined by the NIH); budgets of up to $80,000 accepted; must include community-based collaborators; proposals due July 30
• In any disease led by underserved PIs based in low and lower-middle income countries (as defined by the World Bank); budgets of up to $50,000 accepted; proposals due August 6

NINDS Diversity Supplement program

Key Dates November 16 to February 15 (Application Due Date); March (Funding Decision) February 16 to May 15 (Application Due Date); June (Funding Decision) August 1 to November 15 (Application Due Date); December (Funding Decision) The National Institute of Neurological Disorders and Stroke (NINDS) has an opportunity to apply for additional funding to support a diverse trainee in your laboratory. NINDS uses the Diversity Supplement program to provide “bridge funds” while the supplementee gains the research experience, preliminary data, and other requirements to develop an application for more traditional NIH funding such as a National Research Service Award (NRSA) or Career Development Award. Specific NINDS procedures and supplementary information can be found at https://www.ninds.nih.gov/Funding/Training-Career-Development/Award/SUP-Research-Supplements-Promote-Diversity-Health-Related#DiversitySupplements. Funding decisions for NINDS supplement applications will only be made three times a year, namely by the end of March, June, and December. If you have any questions about our diversity programs, please feel free to contact NINDSDiversityTraining@mail.nih.gov.

Translational Research Initiative Request for Applications

Key Dates Applications Due: August 2, 2021, at noon Applications Reviewed: August 2021 - October 2021 Awards Announced: November 2021 Estimated Funding Start Date: January 1, 2022

Houston Methodist Academic Institute Orthopedics Pilot Project Initiative Request for Applications

Key Dates Applications Due: August 11, 2021; noon Applications Reviewed: August-September 2021 Awards Announced: September-October 2021 Estimated Funding Start Date: January 1, 2022