Archived Content
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July 14, 2021
Director's Voice
Considering Others When Considering Getting Vaccinated for COVID-19. Together we came close (67%) but failed to achieve the President’s goal of 70 percent of Americans receiving their first COVID vaccination by Independence Day. Together we must continue to help as many people get vaccinated as can be vaccinated, not only for our own sake but for the sake of others as well. To illustrate how getting vaccinated helps others, I want to share a personal story.
Two and half years ago, after a serious bout of pneumonia, my wife was diagnosed with leukemia. After inpatient and outpatient chemotherapy, she received a bone marrow transplant. We are among the fortunate—her bone marrow transplant was successful, and she is now in remission—but during the many months of treatment, her body was unable to fight infections. Interestingly, the process of replacing her bone marrow also resulted in her immune system starting anew with no built-up immunity from prior infections or from prior vaccinations.

Research Spotlights
Findings from Recently Published Research

Response to chronic stress passed down from fathers’ sperm in mice
Stress in future fathers has been shown to induce long-lasting changes in sperm cells that can change genetic factors and behavior in later generations. However, it is unknown whether transmission patterns differed depending on fathers’ responses to chronic stress. In a study in mice funded by the NIMH, researchers tested whether fathers’ resiliency or susceptibility to chronic stress impacted behavioral responses in offspring. Read More

Barriers to opioid treatment for reproductive-age women decrease access to life-saving medications
How easy is it to get treatment for opioid addiction/opioid use disorder (OUD) if you are female and pregnant? To add to the question, how difficult is it to get treatment if you are pregnant and on public insurance? A study funded by NIDA sought to answer these questions. Learn More

Computational modeling – a potential tool to guide individually tailored language rehabilitation plans for bilingual stroke patients with aphasia
In recently published results from a study supported by the NIDCD, scientists demonstrate the utility of using computer simulations to predict language recovery in bilingual patients with aphasia. Following stroke or other similar brain injuries, aphasia is the most common speech and language disorder that affects bilingual adults. Go There Now

In the Know
Events and Announcements
Dr. Elizabeth Howell on July 20 at 2 p.m. ET: Quality of Care, Disparities, and the Healthcare Crisis for Moms and Babies of Color
Please join OBSSR for a virtual presentation by Elizabeth A. Howell, M.D., MPP, University of Pennsylvania Health System, on Tuesday, July 20, from 2:00 to 3:00 p.m. ET.
During this talk, Dr. Howell will describe the intertwined racial and ethnic disparities in maternal and infant mortality. She will introduce a framework that describes the complex web of factors that contribute to these disparities. The model also describes pathways linking hospital organization and quality to maternal and infant health disparities. Dr. Howell will also share her team's research findings on quality of care, disparities in severe maternal morbidity and very preterm morbidity and mortality in New York City hospitals. The presentation will discuss levers to reduce disparities.
Individuals who need reasonable accommodation to participate should contact Erica Moore, [email protected], or the Federal Relay at 1-800-877-8339.
NIH WORKSHOP: Management of Pain for People with Sickle Cell Disease (July 21–22, 2021)
The NIH invites you to attend a research workshop on sickle cell disease (SCD) pain and opportunities for optimizing the management of acute and chronic SCD pain. This virtual NIH workshop—Approaches to Effective Therapeutic Management of Pain for People with Sickle Cell Disease—takes place on July 21–22, 2021. Free registration is required. The workshop will be livestreamed and archived for future viewing.
The workshop is designed to—
- Discuss the current state of science in sickle cell disease acute and chronic pain as well as identify critical knowledge gaps and research challenges (Day 1), and
- Brainstorm challenges and opportunities for optimizing management of this understudied pain condition in an underserved population (Day 2).
The agenda includes expert presentations; panel and roundtable discussions; and patient perspectives. Effective, safe multicomponent and whole person treatments within a biopsychosocial context are topics to be explored.
Individuals who need reasonable accommodation to participate should contact [email protected] or the Federal Relay, 1-800-877-8339, by July 14.
2021 NIH Behavioral and Social Sciences Research Festival
SAVE THE DATE: Friday, November 19, 2021
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. View Past Festival Recordings

Funding Announcements
Recently Published FOAs
Notice of Special Interest (NOSI): Navigating Pediatric to Adult Health Care: Lost in Transition
Notice Number
NOT-HD-21-027
Key Dates
First Available Due Date: June 5, 2021
Expiration Date: January 8, 2024
Purpose
The purpose of this Notice of Special Interest (NOSI) is to encourage applications in high-priority research areas related to pediatric health care transition for youth with chronic physical/medical conditions or intellectual/developmental disabilities. Research applications that will advance our understanding of promising practices designed to facilitate successful health care transitions (HCT) from pediatric to adult care settings, as well as barriers and facilitators to such transition are encouraged. The ultimate goal is to improve care quality and patient and family outcomes during and after HCT.
Prevention of Perinatal Depression: Improving Intervention Delivery for At-Risk Individuals (R01 Clinical Trial Required)
FOA Number
RFA-MH-21-240
Key Dates
Open Date (Earliest Submission Date): October 8, 2021
Expiration Date: November 10, 2021
Purpose
The purpose of this FOA is to encourage research addressing major gaps identified in the United States Preventive Services Task Force (USPSTF) recommendation statement concerning interventions to prevent perinatal depression, with an emphasis on populations experiencing mental health disparities. The research scope for this FOA includes: (1) strategies for identifying women at risk for perinatal depression; (2) developing and testing tools for selecting those most likely to benefit from preventive interventions; (3) testing service-ready efficacious preventive interventions that are of appropriate intensity/dose, and are scalable, such that they can be delivered with fidelity by setting providers; and (4) testing strategies that can be used to train providers and to support delivery of evidence-based approaches with fidelity across diverse health care and community settings.
This FOA is intended to support effectiveness research trials that are statistically powered to provide a definitive answer regarding the effectiveness of the intervention. Support for pilot effectiveness is provided via a companion R34 FOA (RFA-MH-21-241) that supports pilot effectiveness studies in preparation for the larger-scale, fully powered studies described in this FOA.
Prevention of Perinatal Depression: Improving Intervention Delivery for At-Risk Individuals (R34 Clinical Trial Required)
FOA Number
RFA-MH-21-241
Key Dates
Open Date (Earliest Submission Date): October 9, 2021
Expiration Date: November 10, 2021
Purpose
The purpose of this FOA is to encourage research addressing major gaps identified in the United States Preventive Services Task Force (USPSTF) recommendation statement concerning interventions to prevent perinatal depression, with an emphasis on populations experiencing mental health disparities. The research scope for this FOA includes: 1) refining and pilot testing strategies for identifying women at risk for perinatal depression; 2) developing and testing tools for selecting those most likely to benefit from preventive interventions; 3) refining and testing service-ready efficacious preventive interventions that are of appropriate intensity/dose, and are scalable, such that they can be delivered with fidelity by setting providers; and, 4) optimizing and testing strategies that can be used to train providers and to support delivery of evidence-based approaches with fidelity across diverse health care and community settings.
This FOA is intended to support pilot effectiveness research trials. Support for larger-scale effectiveness research trials that are statistically powered to provide a definitive answer regarding the effectiveness of the intervention is provided via a companion R01 FOA (RFA-MH-21-240).
Dyadic Interpersonal Processes and Biopsychosocial Outcomes (R01 Basic Experimental Studies with Humans)
FOA Number
PAR-21-280
Key Dates
Open Date (Earliest Submission Date): February 5, 2022
Expiration Date: May 8, 2022
Purpose
This FOA invites basic and/or methodological research projects that illuminate and/or measure independent and interdependent health-related effects within dyads across relationships and settings. For the purpose of this FOA, a dyad is a unit of two individuals whose interactions and influences on one another are nested within larger social contexts and networks. Dyads are social relationships that extend beyond the individual and have strong bidirectional influences on physical and mental health. For the purpose of this FOA, independent effects are those effects that affect each member of the dyad individually (i.e., by nature of being part of the dyad), whereas interdependent effects are those that affect one member of the dyad contingent upon the other member of the dyad (i.e., not only because the individual is part of a dyad but also because being part of the dyad has an effect on the other individual within the dyad as well).
Dyadic Interpersonal Processes and Biopsychosocial Outcomes (R01 Clinical Trials Not Allowed)
FOA Number
PAR-21-281
Key Dates
Open Date (Earliest Submission Date): February 5, 2022
Expiration Date: May 8, 2023
Purpose
This FOA invites basic and/or methodological research projects that seek to illuminate or measure independent and interdependent health-related effects within dyads. For the purpose of this FOA, a dyad is a unit of two individuals whose interactions and influences on one another are nested within larger social contexts and networks. Both animal and human subjects research projects are welcome. Types of projects submitted under this FOA include but are not limited to, observational studies involving humans, or existing/synthesized datasets studies. Researchers proposing basic science experimental studies involving human participants (i.e., experimentally manipulate independent variables) should consider the companion FOA PAR-21-280 “Dyadic Interpersonal Processes and Biopsychosocial Outcomes (R01 Basic Experimental Studies with Humans).”
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).