RePORT International Resources

The Small Business Innovation Research (SBIR) Program is an important funding mechanism that the National Institutes of Health (NIH) uses to develop innovative solutions that address public health challenges. A major objective of the program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of biomedical products is often impeded by a significant funding gap between the end of the SBIR Phase II award and the commercialization stage. This Notice of Funding Opportunity (NOFO) invites SBIR grant applications from SBCs to support later-stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR Phase II awards and which will require eventual Federal regulatory approval/clearance. The purpose of this NOFO and the resulting Phase IIB awards is to assist applicants in pursuing the milestone(s) necessary to advance a product to regulatory approval and commercialization by promoting partnerships between SBIR Phase II awardees and third-party investors and/or strategic partners. Projects proposed under this NOFO MUST be relevant to the NHLBI mission (see B. Scientific/Technical Scope). This NOFO is specifically intended to benefit clinical practice by accelerating the commercialization of novel products that require ultimate approval/clearance by a Federal regulatory agency. This NOFO will give competitive preference and funding priority to applications deemed likely to result in a clinically-relevant commercial product as indicated by the applicant’s ability to secure independent third-party investor funds that equal or exceed the requested NHLBI funds, and competitive preference and funding priority to applications that show a strong potential for clinically relevant commercial products, as evidenced by the applicant’s ability to secure independent third-party investor funds equal to or exceeding the total requested costs. Please refer to the website for detail announcement and key dates.

The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1 used in … clinical trials for safety data reporting to maintain accuracy and consistency in the evaluations of SAEs.

This document provides a detailed list of essential documents” (regulatory documents). “The purpose and/or description of these documents is/are given with a recommended location where they should be filed during the conduct of a clinical trial.

NIH NIAID - Grants and Fundings - Searchable Database

Advancing TB research through open-access, multi-domain, global TB data and tools.

Background: Conversational chatbots are increasingly integrated into daily life, including in health-related information-seeking, decision support, social interaction, and informal caregiving contexts. These systems are now used by individuals to interpret symptoms, manage chronic conditions, make financial and health decisions, and mitigate social isolation, often without professional oversight. Use of chatbot technologies is expanding rapidly, and patterns of adoption, benefit, and risk are likely to differ across populations, contexts, and system designs. At present, there is insufficient evidence regarding the benefits and harms of chatbot use for health and well-being or to characterize unintended consequences such as misinformation, over-reliance, altered decision-making, or delayed engagement with professional care. Rigorous research is needed to understand how chatbot design (including potential built-in safeguards), chatbot use (including but not limited to context and frequency of use), and user characteristics interact to shape health-relevant outcomes. Efforts should inform safeguards, standards, and evidence-based guidance. Purpose: This topic encourages multidisciplinary research that identifies, measures, and explains the benefits and harms associated with chatbot use (both chatbot-based interventions or treatments and routine chatbot use) across a variety of populations, use cases, and settings. Of interest are studies that move beyond proof-of-concept to characterize mechanisms, safety, and impacts on behavior, decision-making, and health outcomes. Of particular interest are studies that: - Identify risk mechanisms: including automation bias, persuasive effects, misinformation exposure, behavioral dependency, and substitution for professional care, and document adverse outcomes across different chatbot designs, and health or wellbeing-related purposes. - Compare safety and performance across chatbot models, including adaptive versus static designs and varying degrees of personalization, information retrieval, or relational engagement. - Examine impacts on decision-making and autonomy: including how chatbot use influences judgment, independence, help-seeking behavior, and relationships with family, caregivers, and clinicians. - Characterize health and functional outcomes associated with patterns of use: including frequency, duration, and longitudinal engagement, with attention to cognitive, emotional, social, and behavioral consequences. - Develop and test safeguards: including monitoring strategies and design features that promote safe, ethical, secure, and beneficial use, particularly for populations at elevated risk of harm. - Ideally, studies will focus on advancing understanding of causal mechanisms driving observed or hypothesized effects and emphasize methodological rigor, appropriate comparators, and real-world relevance.

The NIH Extramural Nexus is the NIH's official platform for updates on grants policies, application processes, and funding news. Hosted within the NIH Grants & Funding website, it serves as a centralized resource for researchers, administrators, and institutions navigating the NIH extramural research landscape. The platform offers timely information on policy changes, application tips, and new resources, ensuring the research community stays informed and compliant with NIH requirements.

Learn the basics with NIH Grants Process: A Walk-Through for Beginners Tune in for answers to your questions in the NIH Expert Q&A Panel: Part 1 Test your knowledge with Submission Policies: You Make the Call More questions and answers in the NIH Expert Q&A Panel: Part 2 Take our panelists’ advice: Grant Application Tips from NIH Experts

The NIH Research Project Grant supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s). This Parent Notice of Funding Opportunity Announcement requires that at lease 1 clinical trial be proposed. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.

Fogarty's new webpage 'NIH Support of International Research: Navigating NIH Public Resources' website page contains useful information for researchers. Alongside links to NIH Guide Notices and NIH extramural news resources, the page offers guidance on the newly published application and award structure for applications that request funding for international organizations (the PA-26-002 NIH Collaborative International Research Project--Parent PF5 Clinical Trial Optional).

Funding Opportunity Purpose: The purpose of this notice of funding opportunity (NOFO) is to support innovative basic, clinical, translational, and implementation science research relevant to HIV and substance use. This initiative encourages high risk high impact transformative studies that advance knowledge and strategies for HIV prevention, diagnosis, treatment and virus suppression in people who use substances and/or have a substance use disorder. Funding Opportunity Goal(s): To support basic, clinical, translational, and implementation research in the field of substance use. To develop new knowledge and approaches for the prevention, diagnosis, and treatment of drug use, misuse, and addiction, drug overdose, and related health outcome, including HIV/AIDS. Application due date: Multiple dates, see announcement.

Most important training for any investigator would be HSP/GCP where they need to learn and understand how Ethical conduct of research is done and why it is important. I have pasted various links below that cover all the topics extensively. DAIDS learning portal, HANC network , DAIDS score manual have good training modules .

This document provides a detailed list of source documentation requirements during the conduct of a clinical trial. Source documentation refers to the record of the participant before, during and after a trial.

Application due date: Multiple dates, see announcement

Application due date: Multiple dates, see announcement

The purpose of this Notice of Funding Opportunity (NOFO) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, sustainability, scale-up, and spread of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies (herein referred to collectively as evidence-based interventions). Studies that promote the dissemination and implementation of evidence-based interventions among relevant communities are encouraged. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (de-implement) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. Applications that focus on re-implementation of evidence-based health services that may be disrupted amidst disasters remain relevant. All applications must be within the scope of the mission of one of the Institutes/Centers listed in the notice. Application DEADLINE: Multiple dates, see announcement.

Application due date: Multiple dates, see announcement

Funding Opportunity Purpose: The goal of this notice of funding opportunity (NOFO) is to address the opioid crisis and/or overdose events by supporting action-oriented research, accelerating the translation of addiction epidemiology, prevention, treatment services, and recovery research to practice. Proposed studies may target the individual, provider, organizational, community, or system level. This initiative prioritizes replicable and scalable approaches for accelerating the routine use of effective, evidence-based prevention, treatment and recovery interventions and services. The translation of research to practice and research relevant to chronic pain comorbid with substance use is also a priority. Research may deploy a variety of methods and approaches, including but not limited to identifying and characterizing malleable factors, developing and testing interventions and implementation strategies, deploying and testing collaborative data science approaches, and/or developing and testing approaches that integrate the collaboration of researchers and decision-makers at any levels (e.g., clinical-, health system-, public health- or policy-level). Funding Opportunity Goal(s): To support basic, clinical, translational, and implementation research in the field of substance use. To develop new knowledge and approaches for the prevention, diagnosis, and treatment of drug use, misuse, and addiction, drug overdose, and related health outcome, including HIV/AIDS. Application due date: Multiple dates, see announcement.

The NIH Center for Scientific Review has produced a series of webinars and videos to give you an inside look at how scientists from across the country review NIH grant applications for scientific and technical merit.

This online course is presented by Dr. David M. Murray, the NIH Associate Director for Prevention and Director of Office of Disease Prevention. This course, updated in September 2024, is meant to help researchers design trials involving groups or clusters.