February 17, 2022
Director's Voice Blog
Contributions of the Behavioral and Social Sciences in Addressing the Pain and Opioid Crises.
One of the central functions of the OBSSR is to facilitate and coordinate NIH's efforts on cross cutting behavioral and social science topics, such as the interrelated crises of pain and opioid addiction. In 2017, the U.S. Department of Health and Human Services declared the opioid crisis a public health emergency and developed the Five-Point Strategy to End the Opioid Crisis. As part of this effort, the OBSSR initiated activities to help coordinate and support behavioral and social science research in conjunction with The Helping to End Addiction Long-TermSM Initiative, or (NIH HEAL InitiativeSM). In this month’s blog, we highlight some of the activities that resulted in the American Journal of Public Health (AJPH) special issue on behavioral and social sciences research—“US Opioid and Pain crises: Gaps and Opportunities in Multidisciplinary Research.”
Behavioral and Social Sciences Research Spotlights
Increased anxiety and worrying may lead to increase heart disease and diabetes risk factors in men at younger ages
The mechanisms that explain the link between anxiety and cardiometabolic risk are not well understood in men. Limitations in study designs that are best to develop more understanding of associations have restricted understanding of the relationships. This NIA, NCATS, and U.S. Department of Veterans Affairs-funded study sought to understand associations between anxiety characteristics, neuroticism and worry, and trends in cardiometabolic risk over four decades in a prospective study of men.
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Cash payments to low-income families impact infant brain activity
Recently published research supported by the NICHD, HHS Administration for Children and Families, and others, examined the impacts of providing unconditional monthly cash transfers to low-income mothers on the brain activity of their babies in the first year of life. Previous research has demonstrated an association between early childhood poverty and lower school achievement, educational attainment, and adult earnings. However, causality between poverty and early childhood development had not been established. In the current study (Baby’s First Years), the research team conducted the first randomized control trial of poverty reduction in early childhood.
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Access to ambulatory healthcare services decreased during the COVID-19 pandemic, especially for poorer Americans
The COVID-19 pandemic has impacted the lives of Americans in many ways, including in their use of healthcare services. In a recent study funded by NIA and others, researchers looked at the use of different ambulatory care services by populations with different insurance types over the course of the pandemic. Based on a prior study, the use outpatient health services decreased sharply early in the COVID-19 pandemic, then rebounded to near-normal levels by the end of 2020. In this study, researchers sought to determine if this recovery in care was the same across all populations.
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News and Events
Apply for the 2022 Summer Institute on Randomized Behavioral Clinical Trials by 2/22
The 22nd Summer Institute on Randomized Behavioral Clinical Trials will be held July 14 – 23, 2022 at the Bolger Hotel and Conference Center in Potomac, Maryland. The Institute is sponsored by OBSSR and the National Heart, Lung, and Blood Institute (NHLBI).
Applications are due by February 22, 2022.
The Summer Institute provides an intermediate/advanced course in planning, designing, and conducting high-impact randomized controlled trials of health-related behavioral interventions. It emphasizes programmatic research and prepares fellows to lead or collaborate on rigorous, high-impact behavioral trials and on systematic efforts to develop and improve health-related behavioral interventions. The Institute’s long-term goal is to build an outstanding scientific workforce that is able to plan and conduct the kinds of clinical trials that can change practice guidelines, health care policies, and third-party coverage for health-related behavioral interventions, and that can help to increase the role of evidence-based behavioral interventions in clinical and preventive services. By the end of this course, participants will be able to:
- Evaluate the evidentiary requirements of health care gatekeepers and the needs of stakeholders in health-related behavioral interventions.
- Formulate long-term goals for high-impact health-related behavioral intervention research programs.
- Use the best-fitting translational research models and intervention optimization frameworks to plan and conduct intervention research programs.
- Incorporate basic behavioral and social science findings and advanced methodologies in this research.
- Understand the role of interdisciplinary team science in high-impact behavioral intervention research.
- Produce a plan to disseminate the knowledge gained in this course.
Please send questions about the Summer Institute to Kenneth Freedland, Ph.D., Program Director, at [email protected].
Applications are due by February 22, 2022.
Applicant Information Webinar: RFA-NR-22-001 Evaluating the Impact of COVID-19 Pandemic-related Food and Housing Policies and Programs on Health Outcomes in Health Disparity Populations (R01 Clinical Trial Optional)
The National Institute of Nursing Research is holding an applicant webinar related to the recently released funding opportunity announcement (FOA) RFA-NR-22-001 Evaluating the Impact of COVID-19 Pandemic-related Food and Housing Policies and Programs on Health Outcomes in Health Disparity Populations (R01 Clinical Trial Optional). The purpose of this FOA is to identify and evaluate ongoing and long-term impacts of the COVID-19 pandemic, focusing specifically on governmental (local, state, tribal, federal) policy and programmatic actions that address two specific social determinants of health: food/nutrition security and housing security. Applications are requested to examine how these food/nutrition and housing policies and programs, aimed at lessening the effects of the pandemic, impact health and health equity in individuals, families, and communities from health disparity populations.
The webinar will provide an overview of the FOA and address questions submitted in advance of the webinar pertinent RFA-NR-22-001. NIH staff will discuss the purpose and scope of this funding opportunity; go over the scientific review process and review criteria; and share the specific research interests of each of the participating NIH Institutes and Office. Participants are also asked to submit their questions in advance of the webinar to [email protected]. Participation in the webinar is recommended but not required in order to submit an application in response to this funding announcement.
The webinar will be hosted via videocast on the following website: https://videocast.nih.gov/watch=44675
Date: Tuesday, February 23, 2022
Time: 1:30 PM to 3:00 PM Eastern Time (EDT)
NIH Scientific Workforce Diversity Seminar Series: Fostering Cohort Recruitment Virtual Forum
The COSWD Office looks forward to hosting you at the FCR Virtual Forum on February 23 and 24, 2022, from 12:00 to 5:00 pm ET (both days).
Marie A. Bernard, M.D., NIH's Chief Officer for Scientific Workforce Diversity COSWD, will moderate a discussion on the outcomes of faculty cohort recruitment programs and other evidence-based strategies for enhancing faculty diversity.
The FCR Virtual Forum is free and open to the public. The forum is intended for implementers and potential implementers of a cohort program, but all are welcome to attend. Registration is required. Once registered, you will receive a link to join the forum via email. A recording of the forum and other meeting materials will be available after the event.
The goal of the FCR Virtual Forum is to galvanize the scientific community around the success of cohort recruitment models geared toward enhancing DEIA for faculty. NIH is committed to excellence in scientific research through enhancement of diversity, equity, inclusion, and accessibility (DEIA) across the biomedical research enterprise. Data shows that inclusion of diverse perspectives leads to greater creativity and innovation in science. This commitment shows in a number of programmatic ways, including through NIH UNITE, the activities of the COSWD Office, and many initiatives that lie within the 27 ICs.
Held over two half days, the FCR Virtual Forum will explore faculty cohort recruitment adoption, implementation, and dissemination, its impact on DEIA, practices that make it successful, barriers that might exist, and finally, the ways to effectively evaluate both implementation and outcomes.
Visit the COSWD website to learn more, and please reach out to Carly Sullivan ([email protected]) with any questions.
Research Challenges and Needs in the Interaction of Sleep and Emotion Regulation to Improve Health and Well-being across Health Conditions RFI
OBSSR, in partnership with NHLBI and NCI, recently released a RFI (NOT-OD-22-053) requesting information to gain feedback, comments, and novel ideas from members of the scientific community to help identify the needs and priorities of research on how the interaction between sleep and emotion regulation influences health and variety of disease processes. This information will be used to plan future activities and initiatives that can enhance the research in this area. Feedback on robust biomedical, behavioral, and neurophysiological mechanistic approaches to improve precise, novel targets for sleep and circadian interventions is requested.
Responses must be received by 11:59pm ET on February 28 , 2022, to be considered.
All comments must be submitted electronically using the online comment form at https://www.surveymonkey.com/r/XS59566. “NOT-OD-22-053”.
Apply Now: Michigan Integrative Well-Being and Inequality (MIWI) Training Program
The MIWI Training Program is a state-of-the-art, interdisciplinary methods training program that prepares participating scholars to investigate the intersection of mental and physical health, with an emphasis on how this intersection relates to health disparities. The training encompasses conceptual frameworks, study designs, data collection needs, and analytic approaches necessary to conduct this innovative research. The program includes an intensive 3-day summer institute in Ann Arbor, MI, followed by ongoing collaboration with a mentorship team. The MIWI Institute will be held from June 12-15, 2022 in Ann Arbor, Michigan.
This program is funded by the National Institutes of Health through OBSSR and the National Center for Complementary and Integrative Health (NCCIH). It is the only NIH-funded program focused on building the methodological expertise needed to address the intersection of mental and physical health. This program will support efforts to increase cross-pollination in interdisciplinary scientific teams, and foster an integrative approach to clinical care and health services programming that can better meet the needs of persons with comorbid mental and physical health conditions.
The application deadline is March 1, 2022.
If you have any questions about the application process, please email [email protected].
Deadline Extended: RFI on Research Challenges and Needs in the Biobehavioral Mechanisms of Aggression
The comment period closes at 11:59pm ET on March 1, 2022.
OBSSR, in partnership with NIAAA, NICHD, NIMH and NCCIH, recently released a RFI (NOT-OD-22-041) requesting information on the challenges and research gaps and opportunities that can best be addressed through a concerted and coordinated effort to enhance research on the biobehavioral contributions to aggressive behavior and its impact across the lifespan.
Specifically, respondents are asked to provide input on the following gaps and opportunities:
(1) in our fundamental understanding of biobehavioral mechanisms of aggression in humans and animals;
(2) in the development and use of methods, tools, technology, or other research resources to enable better characterization of the biological, psychological, and environmental mechanisms underlying aggressive behaviors and the biobehavioral impact of those experiencing aggression;
(3) in the identification of biomedical, behavioral, and psychosocial intervention targets for preventing and treating aggressive behavior and mitigating its impact on health and well-being;
(4) in the characterization of multimodal / multivariate approaches applicable to either primary or secondary data to understanding how other biological, behavioral and/or social/environmental factors such as alcohol and substance use or gender norms interact to influence aggression;
(5) in the considerations of ethical, legal, and social implications for research investigating the biobehavioral mechanisms of aggression, including implications for applied work in human research; and
(6) any other issues that NIH should consider that may advance research on identifying neurobiological mechanistic approaches and potential intervention targets for preventing/treating aggressive behavior and/or mitigating its impacts across the lifespan.
The comment period closes at 11:59pm ET on March 1, 2022.
All comments must be submitted through the following link: https://www.surveymonkey.com/r/TLMC8BP
Social Network Diffusion of Individual Behavior Change Interventions Virtual Workshop
On March 2-3, 2022, the National Institute on Aging’s Division of Behavioral and Social Research will convene a workshop with subject matter experts to discuss gaps, opportunities, and strategies for adapting individual behavior change interventions to leverage social network dynamics. The workshop will focus on how social network interventions can be leveraged to promote healthy aging, slowing of cognitive decline and prevention of Alzheimer’s Disease and Related Dementias (AD/ADRD), and improved care for persons living with AD/ADRD and their care partners. March 4 will be a closed session for workshop speakers and NIH staff.
Large-scale behavior change is often conceptualized as resulting from widespread dissemination and implementation of behavioral interventions that have been developed for individuals or other small social units, such as the dyad or family. Efforts prioritize direct administration of an intervention to all individuals within a target population. An alluring but underexamined alternative model for producing large-scale behavior change involves leveraging social network dynamics. By strategically administering an intervention to key “change agents” within a social network, behavior change can be efficiently diffused to other members of the network whom themselves never directly received the intervention.
CPSTF Recommends Digital Health Interventions to Increase Healthy Eating and Physical Activity
The Community Preventive Services Task Force (CPSTF) recommends digital health and telephone interventions in community settings, worksites, and institutions of higher education to increase healthy eating and physical activity among adults interested in improving these behaviors. The recommendations are based on systematic reviews of evidence that were specific to each setting and showed favorable results.
These interventions aim to increase healthy eating and physical activity by using websites, mobile apps, text messages, emails, or one-on-one telephone calls. Interventions vary by setting and include a combination of coaching or counseling with trained professionals, self-monitoring to record health behaviors, goal setting, computer-generated feedback that provides tailored information, or educational resources. Some also include social support from peers or motivational strategies such as incentives, rewards, and gaming techniques.
The CPSTF was established by the U.S. Department of Health and Human Services in 1996 to develop guidance on which community-based health promotion and disease prevention intervention approaches work and which do not work, based on available scientific evidence.
The Community Guide Resources:
- Community-based Digital Health and Telephone Interventions to Increase Healthy Eating and Physical Activity
- Worksite Digital Health and Telephone Interventions to Increase Healthy Eating and Physical Activity
- Digital Health and Telephone Interventions to Increase Healthy Eating and Physical Activity among Students at Institutions of Higher Education
- CDC, Division of Nutrition, Physical Activity, and Obesity
- Twitter® @CPSTF - official account for The Community Preventive Services Task Force
Recently Published Funding Announcements
Notice of Intent to Publish a Funding Opportunity Announcement for Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)
Notice Number
NOT-CA-22-042
Key Dates
Release Date: January 25, 2022
Earliest Estimated Date: November 30, 2022
Purpose
The National Cancer Institute (NCI) intends to reissue a Funding Opportunity Announcement (FOA) to solicit applications for dissemination and implementation (D&I) research in health. This FOA is intended to be a re-issuance of PAR-19-274, Dissemination and Implementation Research in Health (R01 Clinical Trial Optional), which will expire May 8, 2022, following the May 7, 2022 AIDS Application Due date. The re-issuance FOA will be published on May 8, 2022, and the D&I Program will continue without interruption and R01 Research Project Grant applications will be accepted on Standard Application Due date(s) of June 5, 2022, and thereafter.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
Notice of Intent to Publish a Funding Opportunity Announcement for Dissemination and Implementation Research in Health (R21 Clinical Trial Optional)
Notice Number
NOT-CA-22-043
Key Dates
Release Date: January 25, 2022
Earliest Estimated Date: November 30, 2022
Purpose
The National Cancer Institute (NCI) intends to reissue a Funding Opportunity Announcement (FOA) to solicit applications for dissemination and implementation (D&I) research in health. This FOA is intended to be a re-issuance of PAR-19-275, Dissemination and Implementation Research in Health (R21 Clinical Trial Optional), which will expire May 8, 2022, following the May 7, 2022 AIDS Application Due date. The re-issuance FOA will be published on May 8, 2022, and the D&I Program will continue without interruption and R21 Research Project Grant applications will be accepted on Standard Application Due date(s) of June 16, 2022, and thereafter.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
Notice of Intent to Publish a Funding Opportunity Announcement for Dissemination and Implementation Research in Health (R03 Clinical Trial Not Allowed)
Notice Number
NOT-CA-22-044
Key Dates
Release Date: February 2, 2022
Earliest Estimated Date: November 30, 2022
Purpose
The National Cancer Institute (NCI) intends to reissue a Funding Opportunity Announcement (FOA) to solicit applications for dissemination and implementation (D&I) research in health. This FOA is intended to be a re-issuance of PAR-19-276, Dissemination and Implementation Research in Health (R03 Clinical Trial Not Allowed), which will expire May 8, 2022, following the May 7, 2022 AIDS Application Due date. The re-issuance FOA will be published on May 8, 2022, and the D&I Program will continue without interruption and R03 Research Project Grant applications will be accepted on Standard Application Due date(s) of June 16, 2022, and thereafter.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
Notice of Special Interest (NOSI): Validation of Digital Health and Artificial Intelligence Tools for Improved Assessment in Epidemiological, Clinical, and Intervention Research
Notice Number
NOT-CA-22-037
Key Dates
First Available Due Date: March 7, 2022
Expiration Date: March 9, 2024
Purpose
The purpose of this Notice of Special Interest (NOSI) is to encourage grant applications to support the evaluation of the utility and validity of digital health and artificial intelligence (AI) tools and technologies in epidemiological, clinical, and intervention research. The intent is to support the addition of new measurement modalities to evaluate existing and recently developed but not yet validated digital health and AI tools such as sensor technologies, smartphone applications, software as a medical device (SaMD), and AI algorithms.
Evaluating the Impact of COVID-19 Pandemic-related Food and Housing Policies and Programs on Health Outcomes in Health Disparity Populations (R01 Clinical Trial Optional)
FOA Number
RFA-NR-22-001
Key Dates
Open Date (Earliest Submission Date): March 7, 2022
Expiration Date: April 8, 2022
Purpose
The purpose of this FOA is to identify and evaluate the ongoing and long-term impacts of the COVID-19 pandemic, focusing specifically on governmental (local, state, tribal, federal) policy and programmatic actions that address two specific social determinants of health: food/nutrition security and housing security. Applications are requested to examine how these food/nutrition and housing policies and programs aimed at lessening the effects of the pandemic impacted health and health equity in individuals, families, and communities from health disparity populations.
Health disparity populations include Blacks/African Americans, Hispanics/Latinos, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.
HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
Notice Number
NOT-NS-22-066
Key Dates
First Available Due Date: April 29, 2022
Expiration Date: April 30, 2022
Purpose
This Notice of Special Interest (NOSI) provides an opportunity for clinical trials and studies funded by the Helping to End Addiction Long-Term (HEAL) initiative to address challenges of recruitment, retention and engagement of populations suffering from pain and opioid use disorder.
NIH will support supplements to current HEAL awards that would either 1) enhance their patient, community, and other stakeholder engagement efforts or 2) improve recruitment, retention and inclusion of participants from U.S. racial and ethnic minority populations; or 3) both, as appropriate for a particular study.
This supplement program is not intended to support research on basic processes but rather to implement strategies to enhance stakeholder engagement and diversity and inclusion in HEAL clinical studies. Activities proposed must be within the scope of the approved aims of the parent award.
BRAIN Initiative: Targeted BRAIN Circuits Projects- TargetedBCP (R01 Clinical Trial Not Allowed)
FOA Number
RFA-NS-22-026
Key Dates
Open Date (Earliest Submission Date): June 1, 2022
Expiration Date: October 3, 2024
Purpose
This FOA solicits applications for research projects that seek to understand how circuit activity gives rise to mental experience and behavior using innovative, methodologically-integrated approaches. The goal is to support adventurous projects that can realize a potentially transformative outcome within 5 years. Applications are expected to address circuit function in the context of specific behaviors or neural systems, such as sensation, perception, attention, reasoning, intention, decision-making, emotion, navigation, communication, or homeostasis. Projects should link theory, data analysis, and/or computational approaches to experimental design and should produce predictive models (conceptual or quantitative). Projects should aim to improve the understanding of circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating dynamic patterns of neural activity. Diverse species or experimental systems and a cross-species/comparative approach are welcome and should be chosen based on their power to address the specific question at hand and to reveal generalizable and fundamental neuroscience principles.
BRAIN Initiative: Targeted BRAIN Circuits Planning Projects – TargetedBCPP (R34 Clinical Trials Not Allowed)
FOA Number
RFA-NS-22-027
Key Dates
Open Date (Earliest Submission Date): June 1, 2022
Expiration Date: October 3, 2024
Purpose
This R34 FOA solicits applications that offer a limited scope of aims and an approach that will establish feasibility, validity, or other technically qualifying results that, if successful, would support, enable, and/or lay the groundwork for a potential, subsequent Targeted BRAIN Circuits Projects - TargetedBCP R01, as described in the companion FOA (RFA-NS-22-026). Applications should be adventurous, exploratory research projects that use innovative, methodologically-integrated approaches to understand how circuit activity gives rise to mental experience and behavior.
Emergency Award HEAL Initiative: Optimizing Existing Evidence-Based Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)
FOA Number
RFA-MH-22-175
Key Dates
Open Date (Earliest Submission Date): February 18, 2022
Expiration Date: April 20, 2022
Purpose
NIMH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS. See "Determination that a Public Health Emergency Exists Nationwide as the Result of the Opioid Crisis" as renewed in "Renewal of the Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of the Opioid Crisis".
In April 2018, the National Institutes of Health (NIH) launched the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. More information about the HEAL Initiative is available at: https://heal.nih.gov/.
Emergency Award HEAL Initiative: Developing and Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)
FOA Number
RFA-MH-22-176
Key Dates
Open Date (Earliest Submission Date): February 18, 2022
Expiration Date: April 20, 2022
Purpose
NIMH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS. See "Determination that a Public Health Emergency Exists Nationwide as the Result of the Opioid Crisis" as renewed in "Renewal of the Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of the Opioid Crisis".
In April 2018, the National Institutes of Health (NIH) launched the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. More information about the HEAL Initiative is available at: https://heal.nih.gov/.
For interventions with prior evidence of clinical effectiveness, see RFA-MH-22-175.
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).