Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) or subsequent re-issues

PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional) or subsequent re-issues

Issued by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

The NOSI invites administrative supplements and competitive revisions to existing grants and cooperative agreements that advance understanding of critical interactions between alcohol, SARS-CoV-2, and COVID-19. A principal area of focus is research that can improve public health in the near term by informing responses to the current COVID-19 pandemic and its consequences.

Background

Alcohol consumption and COVID-19 have potential multifaceted interactions that arise from complicated biological, behavioral, and psychosocial causes and consequences of alcohol misuse. Alcohol consumption is a common coping mechanism for psychological distress. The well recognized and prolonged stress due to the COVID-19 pandemic may cause individuals to increase the use of alcohol as a means of stress reduction, which in turn may lead to alcohol misuse and alcohol use disorder (AUD). Furthermore, physical distancing requirements have impacted the design and delivery of treatment and prevention services, thus complicating the ability to mitigate pandemic-associated increases in alcohol misuse. Provision of services across the continuum of care, including both telehealth and in-person treatment, is also disrupted by the pandemic, impacting individuals with AUD. Increased stress and reduced access to social supports may also raise the risk for relapse among those in recovery from AUD.

Separately, alcohol misuse interferes with normal immune system function, and thus may elevate susceptibility to viral infections or the severity of COVID-19-associated symptoms. Alcohol misuse also disrupts neuroimmune interactions and is associated with neuroinflammation. The impacts of excessive alcohol consumption on the body and brain complicate physical and mental health outcomes in individuals with COVID-19. Acute alcohol intoxication can increase impulsivity and risk-taking behavior, which in turn may have consequences for the spread of coronavirus infection. Public settings in which alcohol is consumed may pose particular hazards for virus transmission, and public policies have sought to limit such risks in bars, restaurants, and other gatherings. These and other potential biological and behavioral interactions between alcohol and the COVID-19 pandemic present a range of urgent research needs and opportunities.

The long-lasting impact of SARS-CoV2 infection on physical, cognitive, and mental health has emerged as a new challenge of the pandemic. The post-acute sequelae appear to arise from the extended effects of SARS-CoV2 infection and its consequences on both peripheral and central systems, beyond the initial infection by SARS-CoV-2. It remains to be determined whether and how alcohol misuse may interact with or contribute to post-acute sequelae following acute SARS-CoV-2 infection.

Research is needed to understand the potentially complex, bi-directional relationships between alcohol consumption and COVID-19, as well as the impact of social and policy measures on alcohol consumption and related outcomes. Such studies also will help to lay the groundwork for responding to future public health emergencies. This Notice of Special Interest (NOSI) encourages supplement applications to assess the impact of alcohol as a biological contributor to COVID-19 outcomes and sequelae, and to assess behavioral, social, and economic consequences of the pandemic and the restrictions that the pandemic has imposed, as they relate to alcohol consumption and related outcomes.

Research Priorities

Research is needed that can inform and enhance the nation’s response to the COVID-19 pandemic by advancing understanding of the relationships between alcohol consumption and misuse, and COVID-19- related outcomes. NIAAA will support research on risks and outcomes associated with alcohol consumption, SARS-CoV-2 infection, and the COVID-19 pandemic in the general population and among underserved populations, such as racial, ethnic and sexual/gender minorities, rural populations, individuals with low socioeconomic status, and those who are incarcerated or homeless.

Examples of research objectives include but are not limited to those that:

• Determine the influence of alcohol drinking history, patterns, amount, and duration on susceptibility to SARS-CoV-2 infection and COVID-19 prevalence, severity, progression, and outcomes, including post-acute sequelae. If evidence of an adverse impact of alcohol is affirmed, pathophysiological research into the mechanisms of alcohol as a physiological effector, the results of which will inform therapeutic approaches during the current pandemic, is sought.

• Determine how alcohol misuse and AUD may contribute to neurological and psychiatric manifestations of COVID-19, such as cognitive impairment, sleep disruption, pain, anxiety, etc.

• Characterize changes in alcohol consumption levels and patterns during the pandemic and identify pandemic-related causal influences and mediating and moderating factors.

• Identify best practices in service delivery and barriers to service delivery during the pandemic, including telehealth and in-person options, across the continuum of care for individuals with AUD and in recovery.

Priority consideration will be given to applications that propose urgent, time-sensitive research with a strong conceptual or theoretical foundation and the potential to inform responses to the current pandemic. Proposals must address the relationship between alcohol- and COVID-19-related outcomes or behaviors. Secondary analyses of COVID-19- and alcohol-related datasets are also encouraged.

Across topic areas, applicants are strongly encouraged to use measures drawn from one or both of the NIH Public Health Emergency and Disaster Research Response (DR2) [ https://dr2.nlm.nih.gov/ ] and the PhenX Toolkit [ https://www.phenxtoolkit.org/index.php ]. Additionally, applications focusing on vulnerable populations, including but not limited to racial/ethnic minorities, health disparity populations, and individuals with existing medical vulnerabilities conferring increased risk for severe COVID-19 infection, e.g., advanced age, obesity, HIV/AIDS, etc., are especially encouraged.

Research supported under this NOSI is expected to be relevant to the U.S. Projects relying on data or cohorts outside of the U.S. must provide a strong justification for the relevance of the research to the U.S. context.

Applications for this initiative must be submitted using the following opportunities or their subsequent reissued equivalents.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
• PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional) is intended to provide funds for NIH grantees applying to expand the scope of their active grant.
  • Within Scope: An applicant that is proposing work that is within scope (e.g., expansion of existing specific aims) of the parent grant should apply to the Administrative Supplement announcement, PA-20-272.
• • Change in Scope: Work that is considered a revision of the parent grant, i.e., expanding the scope with a new specific aim, should apply to the Competitive Revision announcement, PA-18-935, or the re-issue of PA-18-935.

The following changes in scope are not allowed due to the nature and duration of this initiative.

• • introduction of a new vertebrate species (e.g., mice in parent grant and propose to study nonhuman primates in the supplement, with the exception that supplement is a collaboration with outside researcher who is providing the samples from the alternate species and the role of parent grant PI is to provide analytic capacity using tools established from the parent grant).
  • introduction of non-exempt human subjects research in the supplement when the parent grant does not already involve human subject research.
  • introduction of a new study arm in a clinical trial that can’t be easily implemented into the current study or would cause significant delays to the current study,
  • introduction of a clinical trial in the proposed supplement when the parent grant does not already include a clinical trial, or
  • introduction of new additional risks to human subjects (e.g., change from minimal risk human subjects research to more than minimal risk research) such that a new IRB approval and Data and Safety Monitoring Plan and/or a Data and Safety Monitoring Board is now required.

The funding instrument, or activity code, will be the same as the parent award. All active grant mechanisms and cooperative agreements are eligible, except the F’s, T’s, R13’s and L’s.

• • Special consideration:
    • R24 (Resource Grant) Mechanism - Supplement aim(s) must align with the parent grant, and specimens or data obtained through the supplement must be readily available to the research community. Hypothesis or mechanistic driven studies will not be considered, since the R24 mechanism is to provide resources to the extramural community.

• • • K’s – COVID-19 Supplement requests must describe the training in this area of research, with a mentor whose expertise is COVID-19 related. Career development awards (K awards), while eligible, will not be high priority.

• • • SBIR/STTR Grants - Supplements to small business grants may be considered, but COVID-19 SBIR supplements aims must be well integrated into the product or end point being developed in the parent grant. SBIR exploratory studies may not be considered.

All instructions in the SF424 (R&R) Application Guide , PA-20-272, and PA-18-935 must be followed, with the following additions:

• The Research Strategy section of the application is limited to 6 pages.
• As part of the application, investigators must submit an abstract of the proposed research that shows the relevance to Coronavirus Disease (COVID-19) and Alcohol Use Disorders. Place the abstract in the Project Summary/Abstract section of the SF424 (R&R) form.
• Application budgets are generally limited to no more than $100,000 direct costs per year.
• Applications requiring more than $100,000 direct costs in any project year must obtain approval from NIAAA, using the following procedure. Prior to preparing the application, the applicant must send the following documents to the program officer of the parent grant. 1) Formal letter from the applicant requesting approval of the budget countersigned by the institution signing official, 2) abstract/project description, 3) specific aims page, 4) detailed budget and 5) budget justification. Following review by NIAAA Senior Staff, the applicant will be notified by the Director of the Office of Extramural Activities if approval to submit has been granted.
• NIAAA may support supplements for a minimum of 1 year, up to two years, provided the parent grants are in compliance as described below:
  • For a one-year award request, at the time of submission, the parent grant must remain active for not less than 16 months.
  • For a two-year award request, at the time of submission, the parent grant must remain active for not less than 28 months.
  • NIAAA will not accept competitive revision and administrative supplements linked to the parent grants going into a no cost extension period, or in no cost extension at the time of submission.
• Applications will be accepted for consideration on a rolling basis. Accepted applications received on or before the 15th day of each odd-numbered month will be reviewed together by program staff.
• Supplements and competitive revisions involving human subjects research are subject to data sharing with NIAAA_DA if the parent grant is subject to data sharing with NIAAA_DA. Applicants may consult the Notice of Award from the parent grant to determine whether the parent grant is subject to data sharing with NIAAA_DA.
• All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package:
  • Administrative supplement applications to PA-20-272 must use the application form package specified in PA-20-272. In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
  • Competitive revision applications to PA-18-935 must use the application form package as specified in PA-18-935.
• IMPORTANT: For funding consideration, all applicants must designate “NOT-AA-22-002” (without quotation marks) in the Agency Routing Identifier field (Box 4b) of the SF424 (R&R) Form. Applications without this information in Box 4b will not be considered for this initiative.
• Investigators planning to submit an application in response to the NOSI are strongly encouraged to contact the program officer of the parent grant early in the application process to discuss the proposed project.

EMERGENCY ADMINISTRATIVE SUPPLEMENTS DUE TO UNPLANNED COSTS IMPOSED BY THE PANDEMIC AND ITS RESTRICTIONS ARE NOT APPROPRIATE FOR NOT-AA-22-002.

Applicants are advised to follow the procedures as described in the NIAAA website https://www.niaaa.nih.gov/grant-funding/application-process/administrative-supplements.

Inquiries

Please direct all inquiries to:

M. Kathy Jung. Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
301-443-8744
Email: jungma@mail.nih.gov