Resources for Researchers and Clinicians

Regulatory Webinar Series: Presented by Mike Fusakio, PhD; Nathan Hawk, BSPS; Samantha Sonoda, MS, CCRA; and Lisa M. Tully, MA, CCRP, all affiliated with Cincinnati Children's Hospital Medical Center.

Regulatory Webinar Series: Features Nichelle Cobb, PhD, Smart IRB Director at University of Wisconsin-Madison. Panelists include James Cnota MD (Cincinnati Children's), Jeremy Corsmo, MPH (Cincinnati Children's), Pooja Khatri, MD, MSC (University of Cincinnati) and Mike Linke, PhD (University of Cincinnati). 

Regulatory Webinar Series: Presented by Mike Fusakio, PhD, Cincinnati Children's Hospital Medical Center.

A centralized information page that includes links to a variety of guidance, information, resources, FAQs and NIH funding opportunities relating to COVID-19, from the NIH Central Resource for Grants and Funding Information.

An array of Frequently Asked Questions (and answers) in response to inquiries on policies and programs affecting the grants process, updated 7/2/2020.

Offers an overview of research activities that the NIH's National Center for Advancing Translational Sciences is supporting, spanning the translational science spectrum to address the novel coronavirus 2019 (SARS-CoV-2) and the disease it causes (COVID-19).

This presentation will address the unique concerns of diversity, equity, inclusion, and accessibility in the rare disease space. Dr. Washington will share a number of rare disease DEIA projects that she has spearheaded, highlighting grassroots collaborative engagement approaches.

Terminology, usage, word choice, and representativeness are critically important in medical publication, especially when describing people and research participants and when discussing race and ethnicity and other demographic characteristics or variables. This session will provide recommendations and suggestions from the AMA Manual of Style that encourage fairness, equity, consistency, and clarity in use and reporting of race and ethnicity in medical publication, with specific examples.

Rare diseases overall are still unrecognized, especially in Hispanic communities where access to sub-specialist care and diagnostic tools is limited or unavailable. This webinar features Wilfredo De Jesús Rojas, MD, FAAP, MSc, fellow of the American Academy of Pediatrics and a board certified pediatric pulmonologist/physician-scientist. Dr. Wilfredo De Jesús Rojas was inspired to become a pediatric pulmonologist and a physician-scientist to be an advocate and study rare lung diseases in Puerto Rican children.

How have housing, education and economic policies influenced social determinants of health? This webinar features Tonya Winders, MBA, of the Allergy & Asthma Network and explores explores how we can move forward to reduce systemic barriers to ensure better health outcomes.

This report shares NIH's ongoing efforts to safeguard scientific integrity in genomics and promote the responsible design of research studies so that all populations benefit from scientific advances.

This paper outlines pitfalls in the conceptualization, contextualization, and operationalization of race in quantitative population health research and provides recommendations on how to appropriately engage in scientific inquiry aimed at understanding racial health inequities.

In this paper, we first present arguments for inappropriate use of race in health research and then discuss alternative explanations for health disparity findings that use race as a predictor.

In this review, the inclusion and exclusion criteria of the 182 studies included in the Cochrane Review on Interventions for Enhancing Medication Adherence were evaluated for their inclusion of people with disabilities.

The goal of this guidance is to provide recommendations and suggestions that encourage fairness, equity, consistency, and clarity in use and reporting of race and ethnicity in medical and science journals.

In the United States, race, ancestry, genetics, and medicine are inextricably linked in a complex and fraught history. Medicine is replete with examples of racial injustice inflicted by the use of race and ethnicity as biologic constructs to engender hierarchical discrimination.

This publication discusses the history and evolution of disability language, explores current trends, and recommends language for academic articles.

Reviews the limitations of classifying research participants by race and recommends a series of steps for authors, researchers and policymakers to consider.

US Food and Drug Administration guidance which recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.

New NIH Policy for Data Management and Sharing that goes into effect January 25, 2023 and replaces the existing 2003 NIH Data Sharing Policy. Updated to keep pace with scientific and technological advancements and emphasizes the NIH’s commitment to data management and sharing.

On May 16 and 17, 2022, the FDA’s Center for Drug Evaluation and Research (CDER) and NIH’s National Center for Advancing Translational Sciences (NCATS) hosted a jointly sponsored virtual workshop on regulatory fitness in rare disease clinical trials.