June 23, 2022
Director's Voice Blog
A Reflection on Public Service, Gratitude, and the Behavioral and Social Sciences
This month’s blog will be a little more personal than I have been so far. I want to reflect on public service and gratitude. I am writing this at the conclusion of the Memorial Day weekend where we honor members of the military who have died in service to the country. While Memorial Day weekend is also often filled with fun to kick-off the summer, it is an important time to reflect and be thankful. As a military veteran myself, I am deeply thankful to those who served in the military and lost their lives during that service. This past Memorial Day weekend, I found myself thinking more broadly about gratitude and service. As I reflected, I had to acknowledge that it has been a rough few years.
Behavioral and Social Sciences Research Spotlights
A novel weight-loss intervention that targets appetite cues may help with weight loss among adults with overweight and obesity
Overweight and obesity are concerns for many adults in the U.S. Recently published research supported by the NIDDK, NCATS and others, examined the efficacy of a novel, regulation of cues-based weight loss intervention based on behavioral susceptibility theory and designed to target appetitive traits. Although there are many weight loss interventions that show promise, not all interventions work for everyone, and sustaining weight loss after the intervention period continues to be a significant challenge. This heterogenous response to these interventions are likely due different underlying factors that impact an individual’s ability to lose weight and maintain weight loss. The behavioral susceptibility theory posits that genetically determined appetitive traits, such as eating onset driven by food responsiveness and eating offset driven by satiety responsiveness, interact with the current food environment and result in overeating and weight gain.
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Exposure to new objects primes people to learn
During development, we learn to identify commonplace items, such as a table, chair, or a dog, and what category items belong to, such as cats verses dogs, prior to receiving explicit information or teaching. Recently published research supported by the NICHD sought to answer the question of how incidental exposure contributes to category learning. More specifically, they wanted to determine if incidental exposure to categories contributes to category learning by making people “ready-to-learn” categories after briefly receiving explicit teaching.
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Adult health and well-being is negatively influenced by income disparities experienced in childhood
The United States has been experiencing declining life expectancy and growing income inequality across the nation. Morbidity and mortality rates of Baby Boomers (1946-1955) have been increasing faster than expected; additionally younger cohorts are experiencing a rise in shortened life expectancies, creating a population health crisis. Research supported by the NICHD, NIA and the CDC sought to understand the relationship between the increases in morbidity and mortality rates of American birth cohorts from 1925-1999 and income inequality exposure in childhood.
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News and Events
Register: NIH OBSSR Director's Webinar on July 19 with Dr. Irene Dankwa-Mullan
Please join OBSSR for a virtual presentation on Tuesday, July 19, at 2:00 p.m. ET by Irene Dankwa-Mullan, M.D., M.P.H., Chief Health Equity Officer, Deputy Chief Health Officer, IBM Watson Health.
Presentation
Leveraging Data-Driven Advanced Analytics and Artificial Intelligence Technologies to Address Social and Behavioral Determinants for Health Equity
Overview
This presentation will describe the role of data-driven advanced analytics leveraging artificial intelligence (AI) technologies in providing insights for health equity. The talk will include current use of these AI-driven technologies, including tools that were implemented to address the COVID-19 pandemic. These technologies are being used in pre-clinical research, drug discovery, developing clinical pathways, risk-predictive algorithms, population-level surveillance, and analytics, among others. The drivers of these efforts include comprehensive and massive amounts of data from heterogenous sources. The technologies have tremendous potential to enhance current precision medicine and health equity efforts, but it also has potential to exacerbate existing health disparities without thoughtful, transparent, and inclusive approach, that includes addressing bias in the technology design, development, and implementation. Discussion will address applications for social and behavioral determinants of health. Finally, the presentation will include potential opportunities for collaborative research partnerships to advance efforts in the behavioral and social sciences community.
If you require reasonable accommodations to participate in this event, please contact Rachel Pisarski at [email protected] and/or the Federal Relay (1-800-877-8339).
Register for the NIH Digital Health Interventions Workshop on July 12-13
The workshop is sponsored by: National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Mental Health (NIMH), Office of Behavioral and Social Sciences Research (OBSSR), and the NIH Digital Therapeutics Interest Group.
The goal of this workshop is to explore the issues around the design, development, and dissemination of digital health interventions. Digital interventions, accessed via mobile devices or personal computers, have been a growing part of the healthcare landscape over the last decade. The Covid pandemic has served to underscore the value of remotely delivered interventions. While there are thousands of interventions currently available to the public, many of them have never been tested for efficacy. However, the number of validated interventions is growing, with some now authorized by the FDA and others being utilized by health organizations following rigorous testing. These technologies cover a broad range of therapeutic areas, including mental health, metabolic disease, substance use, and more. Their potential to promote public health and wellbeing is only beginning to be tapped. As digital health interventions become more ubiquitous and the industry continues to see tremendous growth, academic investigators have a significant opportunity available to them to create engaging, effective, and ultimately the wide adoption of new digital health interventions. This workshop seeks to elucidate the pathways, requirements, and capabilities needed to develop and sustain effective digital health interventions.
For more information, contact Drs. Will M. Aklin, [email protected] or Kevin Walton, [email protected].
NIH Issues New Resources for Implementing the NIH Policy for Data Management and Sharing
NIH continues working with stakeholders to get ready for the implementation of the NIH Data Management and Sharing Policy on January 25, 2023. NIH recently released two new resources for the research community that aim to protect privacy and respect the autonomy of research participants when sharing data.
The first resource is the Informed Consent for Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing. This document is intended to provide sample language to investigators and IRBs when developing consent for secondary use of data/biospecimens.
We are also releasing a request for comment on protecting the privacy of research participants when data is shared. NIH is seeking comments on this draft guidance through June 27, 2022. Full information, including how to comment can be found here.
To learn more please see the latest “Under the Poliscope” blog post by Dr. Lyric Jorgenson: Gearing Up for 2023 Part II: Implementing the NIH Data Management and Sharing Policy
For questions, contact the NIH Office of Science Policy at [email protected].
NIH Request for Information (RFI) on Interdisciplinary Research Opportunities that Bridge Neuroscience and Environmental Health Science
This RFI seeks input on challenges and opportunities for interdisciplinary research that brings together neuroscientists, environmental health scientists, and scientists from other related disciplines to form new teams to advance understanding of the contribution of environmental toxicants to impaired function of the nervous system across the life span.
For the purpose of this RFI, environmental toxicants of primary interest include industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, plastics, fungal exposures, and bacterial or biologically derived toxins. Expression of toxicity can take many forms across different ages and developmental stages, ranging from neurodevelopmental to neurodegenerative disorders, and encompassing alterations in cognition and behavior that range from subtle to severe. The full range of nervous system outcomes is relevant to this RFI.
Responses will be accepted through July 11, 2022. All comments must be submitted electronically on the Web Portal at: https://www.ninds.nih.gov/EnviroNeuro-RFI. Responders are free to address any or all the questions listed above. All submitted information will be reviewed by NIH staff.
Please direct all inquiries to:
David A. Jett PhD
Environmental Neuroscience Working Group
National Institutes of Health
Email: [email protected]
Prevention Science, Supplemental Issue Call for Papers: Design and Analytic Methods to Evaluate Multilevel Interventions to Reduce Health Disparities
The ODP is sponsoring this supplemental issue to the journal of Prevention Science, the official publication of the Society for Prevention Research, to bring together current thinking and new ideas about design and analytic methods that would be appropriate for studies aimed at reducing health disparities, including strategies for balancing methodological rigor with design feasibility, acceptability, and ethical considerations. Of particular interest are design and analytic methods for parallel group- or cluster-randomized trials (GRTs), stepped-wedge GRTs, group-level regression discontinuity trials, and other methods that are appropriate for evaluation of multilevel interventions.
Investigators should submit a two-page manuscript precis to [email protected] by Sept. 1, 2022, outlining the design, analytic, and sample size methods they propose, together with any new research they propose to evaluate those methods.
By Oct. 1, 2022, the Guest Editors will invite selected authors to submit a full manuscript. The Guest Editors will make recommendations to the Editor for publication and the Editor will make the final decision regarding the disposition of each manuscript.
Initial manuscript drafts are due Feb. 1, 2023, and the anticipated publication of the supplemental issue is in March 2024.
Send questions and submission materials to [email protected].
Ontologies in the Behavioral Sciences: Accelerating Research and the Spread of Knowledge
New research in psychology, neuroscience, cognitive science, and other fields is published every day, but the gap between what is known and the capacity to act on that knowledge has never been larger. Scholars and nonscholars alike face the problem of how to organize knowledge and to integrate new observations with what is already known. Ontologies - formal, explicit specifications of the meaning of the concepts and entities that scientists study - provide a way to address these and other challenges, and thus to accelerate progress in behavioral research and its application.
View the recent OBSSR Director's Blog co-authored with Dr. Janine Simmons, NIA: Advancing Ontology Development and Use in the Behavioral and Social Sciences.
New PATH Study Data Files Available
The NIH’s National Institute on Drug Abuse (NIDA) and the FDA’s Center for Tobacco Products (CTP) announce the release of special collection restricted use data files (SCRUFs) from Wave 5.5 and from the Population Assessment of Tobacco and Health (PATH) Study Adult Telephone Survey (ATS). The Wave 5.5 Special Collection data were collected from youth participants ages 13 to 19 between July and December 2020. Data in the PATH-ATS were collected between September and December 2020 from a subsample of adult participants ages 20 and older, complementing the Wave 5.5 Special Collection. Researchers may apply for access to the SCRUF at https://doi.org/10.3886/ICPSR37519. In addition, the PATH Study Restricted-Use Files (RUF) and the Restricted-Use and Public-Use Master Linkage Files have been updated. All files can be accessed at https://doi.org/10.3886/Series606. The PATH Study is a household-based, nationally representative, longitudinal cohort study of youth (12-17 years old) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act. Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to [email protected] (not to be used for questions about statistical analysis or analytic guidance).
Save the Date: 2022 NIH Behavioral and Social Sciences Research Festival
Friday, December 2, 2022
The Annual NIH Behavioral and Social Sciences Research Festival will be hosted by OBSSR and the NIH Behavioral and Social Sciences Research Coordinating Committee. The purpose of the festival is to highlight recently funded behavioral and social sciences research that the NIH supports; bring together behavioral and social scientists within the NIH extramural and intramural communities to network with each other and share scientific ideas; and explore ways to advance behavioral and social sciences research.
Recently Published Funding Announcements
NOSI: Administrative Supplements to NIH-funded T32 and TL1 Training Grants to Better Integrate Behavioral and Social Sciences (BSS) with other Health-Related Sciences
Notice Number
NOT-OD-22-141
Key Dates
First Available Due Date: July 11, 2022
Expiration Date: July 12, 2022
Purpose
OBSSR is interested in supporting the integration of health-related behavioral and social sciences (BSS) with other biomedical methodological and scientific disciplines (e.g., genetics, immunology, metabolomics, molecular biology, microbiome, biochemistry, or physiological sciences). The goal is to train a research workforce that has the integrated content expertise and skills to meaningful address gaps in scientific advancement that are not well served by a more siloed approach to research. To support this goal, the OBSSR is soliciting applications for a one-time administrative supplement to existing NIH T32 and TL1 training grants for the enhancement of activities that support the acquisition of expertise and skills that are foundational to conducting multidisciplinary science that integrates BSS with biomedical approaches, methods, paradigms, and outcomes.
NOSI: Administrative Supplement for Research Efforts that Illuminate Fundamental Processes Underlying Behavior Change, Maintenance, and Adherence (Admin Supp Clinical Trial Optional)
Notice Number
NOT-OD-22-140
Key Dates
First Available Due Date: June 27, 2022
Expiration Date: July 16, 2022
Purpose
OBSSR announces the availability of administrative supplements to support research to examine causal, process, or contextual variables that:
- Assess mechanisms of action (MOA) consistent with the application’s hypothesis, those that might elucidate alternative MOA than the primary hypothesis, as well as those variables or processes that might explain a lack of intervention effect.
- Assess underlying causes/MOA explaining behavior change, maintenance of behavior and/or adherence beyond the active intervention period.
- Are hypothesized to be associated with or contributing to (mediators or moderators) an intervention study’s main effect (efficacy) over the course of behavior initiation and maintenance, including measures of adherence.
- Barriers and facilitators of behavior adoption and sustainment over time.
- Contextual information about the intervention delivery system and environmental, social, or community factors that might explain the intervention effectiveness or lack of effect; including assessing differences between those who respond or don’t respond to the behavioral intervention.
NOSI: Administrative Supplements to Advance Precision Medicine Using the All of Us Research Program’s Data
Notice Number
NOT-PM-22-002
Key Dates
First Available Due Date: July 5, 2022
Expiration Date: July 6, 2022
Purpose
The All of Us Research Program (All of Us) within the Office of the Director (OD) encourages eligible grantees of the participating Institutes, Centers, and Offices (ICOs) to apply for administrative supplements to support analysis of currently available data within the All of Us Research Program’s Researcher Workbench or to develop analysis tools for the available data within the general scope of the parent award.
Background
The All of Us Research Program is building a database to help transform the future of health research by equipping researchers nationwide with expansive health data from diverse populations, especially those underrepresented in biomedical research. It is built in partnership with participants spanning different ages, races and ethnicities, and regions of the country. New data are added twice a year. Available to registered researchers includes:
- data from 329,000+ participants [about 50% racial and ethnic minorities, 80% from communities underrepresented in biomedical research overall (including racial and ethnic minorities, sexual and gender minorities, people living in rural areas, and other groups)].
- whole genome sequence data from nearly 100,000 participants (nearly 50% of whom self-identify as a member of a racial or ethnic minority group)
- 593,000,000+ unique variants, which Include 100M+ variants with = 3 occurrences not seen in gnomAD 3.0 (n = 71,702)
- electronic health record data from 214,200+ participants (including demographics, visits, diagnoses, COVID diagnoses and medications)
- survey data from 329,000+ participants from seven different questionnaires capturing participant data on lifestyle, health care utilization and access, and COVID-19 participant experience.
- Fitbit data from more than 11,600+ participants who linked their personal data to their All of Us account
- physical measurements from 267,000 participants (including blood pressure, heart rate, BMI, and more)
Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)
FOA Number
PAR-22-105
Key Dates
Open Date (Earliest Submission Date): May 15, 2022
Expiration Date: May 8, 2025
Purpose
The purpose of this FOA is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Studies that promote equitable dissemination and implementation of evidence-based interventions among underrepresented 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 (e.g. cancer screening) that may have dropped off amidst the ongoing COVID pandemic are encouraged.
Dissemination and Implementation Research in Health (R21 Clinical Trial Optional)
FOA Number
PAR-22-109
Key Dates
Open Date (Earliest Submission Date): May 16, 2022
Expiration Date: May 8, 2025
Purpose
The purpose of this FOA is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Studies that promote equitable dissemination and implementation of evidence-based interventions among underrepresented 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 (e.g. cancer screening) that may have dropped off amidst the ongoing COVID pandemic are encouraged.
Dissemination and Implementation Research in Health (R03 Clinical Trial Not Allowed)
FOA Number
PAR-22-106
Key Dates
Open Date (Earliest Submission Date): May 16, 2022
Expiration Date: September 8, 2025
Purpose
The purpose of this FOA is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Studies that promote equitable dissemination and implementation of evidence-based interventions among underrepresented 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 (e.g. cancer screening) that may have dropped off amidst the ongoing COVID pandemic are encouraged.
Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional)
FOA Number
PAR-22-167
Key Dates
Open Date (Earliest Submission Date): June 15, 2022
Expiration Date: October 18, 2024
Purpose
The Clinical and Translational Science Award (CTSA) Program Collaborative and Innovative Acceleration Award (CCIA) supports synergistic activities that accelerate the translational research process through collaboration and innovation. This funding opportunity announcement (FOA) invites applications to develop, demonstrate and disseminate innovative solutions to transform the field of translational science by addressing the inefficiencies that are common across diseases and bringing more interventions to all people more quickly through collaborative science among the CTSA Program hubs, NIH Institutes, Centers, Offices (ICOs), and/or external stakeholders.
BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19 Basic Experimental Studies with Humans Required)
FOA Number
RFA-NS-22-039
Key Dates
Open Date (Earliest Submission Date): August 16, 2022
Expiration Date: September 14, 2024
Purpose
This FOA will support integrated, interdisciplinary research teams that focus on examining dynamic circuit functions related to behavior, using advanced and innovative technologies. The FOA will support programs with a necessarily-synergistic, team science approach. Awards will be made for 5 years, with a possibility of one competing renewal. Applications should focus on overarching principles of circuit function in the context of specific neural systems underlying sensation, perception, emotion, motivation, cognition, decision-making, motor control, communication, or homeostasis. Applications should aim to understand these circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating relevant dynamic patterns of neural activity and by measuring the resulting behaviors and/or perceptions.
BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19 Clinical Trial Not Allowed)
FOA Number
RFA-NS-22-040
Key Dates
Open Date (Earliest Submission Date): August 16, 2022
Expiration Date: September 14, 2024
Purpose
This FOA will support integrated, interdisciplinary research teams that focus on examining dynamic circuit functions related to behavior, using advanced and innovative technologies. The FOA will support programs with a necessarily-synergistic, team science approach. Awards will be made for 5 years, with a possibility of one competing renewal. Applications should focus on overarching principles of circuit function in the context of specific neural systems underlying sensation, perception, emotion, motivation, cognition, decision-making, motor control, communication, or homeostasis. Applications should aim to understand these circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating relevant dynamic patterns of neural activity and by measuring the resulting behaviors and/or perceptions.
BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Basic Experimental Studies with Humans Required)
FOA Number
RFA-NS-22-041
Key Dates
Open Date (Earliest Submission Date): August 23, 2022
Expiration Date: September 22, 2024
Purpose
Invasive surgical procedures offer the opportunity for unique intracranial interventions such as the ability to record and stimulate intracranially within precisely localized brain structures in humans. Human studies using invasive technology are often constrained by a limited number of patients and resources available to implement complex experimental protocols and need to be aggregated in a manner that addresses research questions with appropriate statistical power. Therefore, this RFA seeks applications to assemble diverse, integrated, multi-disciplinary teams that cross boundaries of interdisciplinary collaboration to overcome these fundamental barriers and to investigate high-impact questions in human neuroscience. Projects should maximize opportunities to conduct innovative in vivo neuroscience research made available by direct access to the brain from invasive surgical procedures. Projects should employ approaches guided by specified theoretical constructs and by quantitative, mechanistic models where appropriate.
BSSR Accomplishments
The NIH has been an instrumental leader in shaping and supporting behavioral and social sciences research (BSSR) to improve the nation’s health. Integrated with advances in other scientific disciplines, BSSR has made substantial contributions to the prevention or treatment of numerous physical health and mental health conditions.
In collaboration with subject matter experts from Institutes, Centers, and Offices across NIH, OBSSR has summarized some of the important scientific advances that demonstrate the valuable contribution of BSSR across various health conditions and behaviors. These summaries are provided as fact sheets (PowerPoint slides forthcoming) that highlight a significant public health problem and the corresponding BSSR-informed approaches used to address the problem. Various audiences such as academic researchers, public health organizations, and other health federal agencies, may find these materials useful to demonstrate to their stakeholders the importance of BSSR to the health of the United States population.
These new BSSR accomplishment resources are available on the OBSSR website:
Improving Sleep
Managing Chronic Pain
Preventing and Treating Diabetes
Preventing Intimate Partner Violence
Reducing Teen Pregnancy
Reducing Tobacco Use
Treating Depression
Treating Obsessive-Compulsive Disorder
Treating Phobias
Treating Post-Traumatic Stress Disorder
Additional BSSR accomplishments will be added to the website in 2023.
BSSR Clinical Trials Resources
The Clinical Trials Protocol Template for the Behavioral and Social Sciences is a resource for communicating the science, methods, and operations of a clinical trial. This template is a suggested format for clinical trials that are testing a behavioral or social intervention or experimental manipulation. Use of the protocol template is encouraged but not required.
The Behavioral and Social Clinical Trials Template was derived from the successful NIH-FDA Phase 2/3 IND-IDE Clinical Trial Template but was adapted to include terminology and approaches used by behavioral and social scientists. While the template is a suggested format for clinical trials that are testing a behavioral or social intervention or manipulation for which a stand-alone clinical protocol is required, the template can also be a useful tool for those trials funded by NIH Institutes or Centers that do not require stand-alone clinical protocols. Using the template to anticipate decision points and potential challenges before a study launches can help avoid subsequent delays and problems.
The DECISION SUPPORT TOOL: Features to Consider in Determining if a Clinical Trial is Phase II or Phase III is the result of a working group led by OBSSR, with participants from other NIH Institutes, Centers, and Offices. It is a designed to be a resource to help investigators, program officers, and reviewers determine if a behavioral or social science study is better characterized as a Phase II or a Phase III clinical trial. Distinguishing earlier phases of clinical trials (Phase 0 or I) is not usually difficult but distinguishing between a Phase II and III study can be more challenging, particularly for non-drug trials. Being thoughtful about this distinction is important for a variety of reasons, not least of which is that a Phase III designation for an NIH funded clinical trial generally requires following additional policies and practices beyond those that already apply to Phase II clinical trials, such as the requirement for valid analysis and for a Data and Safety Monitoring Board (DSMB). Data and safety monitoring are required for all clinical trials but for a Phase III trial, the constitution of a board is required.
NIH’s definition of a Phase III Clinical Trial is quite broad, including drug studies, device studies, behavioral interventions, epidemiological studies, community trials, and more. Phase III trials are usually large, prospective trials that compare two or more interventions against other standard or experimental interventions. In this next episode of our NIH All About Grants podcast (MP3 / Transcript) we explain what a Phase III trial is, how it compares to other types of clinical trials, considerations for your application and its review, how these studies influence standards of care, helpful tools and other resources, and much more. The guests include Ms. Dawn Corbett, NIH’s Inclusion Policy Officer, and Dr. Christine Hunter, OBSSR Acting Director.
Social and Behavioral Good Clinical Practice eCourse
In September 2016, the NIH issued a Policy on Good Clinical Practice (GCP) Training for NIH Awardees Involved in NIH-funded Clinical Trials. GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. The principles of GCP help assure the safety, integrity, and quality of clinical trials. Investigators and clinical trial staff who are competent in GCP principles will be better able to assure that the rights, safety, and well-being of human subjects are protected; that clinical trials are conducted in accordance with approved plans and with rigor and integrity; and that data derived from clinical trials are reliable.
Extramural Researchers can go here to take the course.
NIH Employees can go here to take the course. (NIH login required)
Educational Facilities can Download the Good Clinical Practices for Social and Behavioral Sciences Course for your educational facility's Learning Management System (LMS).