January 2018 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.

NB: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal Year 2021 Concepts

Fiscal Year 2019 Concept

Fiscal Year 2019 Small Business Innovation Research (SBIR) Contract Solicitation Topics

HIV Prevention Clinical Trials Leadership and Operations Center (Clinical Trial Required)

For the published request for applications, see the January 24, 2019 Guide announcement HIV Prevention Clinical Trials Network Leadership and Operations Center (UM1, Clinical Trial Required).

HIV Vaccines Clinical Trials Leadership and Operations Center (Clinical Trial Required)

For the published request for applications, see the January 24, 2019 Guide announcement HIV Vaccines Clinical Trials Network Leadership and Operations Center (UM1, Clinical Trial Required).

HIV/AIDS Adult Therapeutics Clinical Trials Leadership and Operations Center (Clinical Trial Required)

For the published request for applications, see the January 24, 2019 Guide announcement HIV/AIDS Adult Therapeutics Clinical Trials Network Leadership and Operations Center (UM1, Clinical Trial Required).

HIV/AIDS Clinical Trials Laboratory Centers (Clinical Trial Required)

For the published request for applications, see the January 24, 2019 Guide announcement HIV/AIDS Clinical Trials Networks Laboratory Centers (UM1, Clinical Trial Required).

HIV/AIDS Clinical Trials Statistical and Data Management Centers (Clinical Trial Required)

For the published request for applications, see the January 24, 2019 Guide announcement HIV/AIDS Clinical Trials Networks Statistical and Data Management Centers (SDMC) (UM1, Clinical Trial Required).

HIV/AIDS Clinical Trials Units (Clinical Trial Required)

Request for Applications—proposed FY 2021 initiative

Contact: Manizhe Payton

Objective: This initiative will provide the clinical research site infrastructure necessary to conduct clinical trials developed and implemented by the HIV/AIDS Clinical Trials Networks.

Description: The focus of this initiative is to support coordinated Clinical Trials Units (CTUs) for domestic and international HIV/AIDS clinical research. Each CTU will include an administrative hub and one or more domestic and/or international Clinical Research Sites (CRS). The CTUs will provide clinical and scientific expertise to conduct clinical research; laboratory, pharmacy, and local data management resources; and robust community engagement activities.

Each CTU will be responsible for overseeing and evaluating clinical trial conduct at the sites, ensuring compliance with policies and procedures, adhering to regulations, and developing standard operating procedures with Network leadership for selecting, implementing, and closing of clinical sites.

Each CTU will be linked to separately-funded network awards for leadership and operations, statistics and data management, and laboratory services.

  • Each CTU will be composed of one to eight experienced CRSs. A CRS is a discrete entity where clinical research protocols are implemented. The CRS must have demonstrated access to an appropriate clinical trial population based on demographics, incidence, and prevalence of HIV/AIDS, and other relevant population characteristics.
  • The CRS must:
    • Be staffed by trained, qualified professionals capable of conducting clinical research in accordance with Good Clinical Practice/International Conference on Harmonization (ICH) standards, local and/or national regulatory requirements, and other applicable NIH requirements.
    • Be directed by a CRS leader with the experience and qualifications to oversee all HIV/AIDS Network clinical activities at the CRS.
    • Have a main clinic location with appropriate infrastructure and equipment to conduct clinical research activities, although the CRS may include more than one location where clinical research activities are conducted.
    • Have a community advisory board and other community engagement strategies to meaningfully engage with the community in which the CRS works.
    • Be staffed by trained, qualified professionals with experience in good data management practices.
    • Perform quality management functions at all levels of the CRS to ensure research activities are conducted at the highest standards of quality and compliance.

All CTU activities will be compliant with current applicable Federal regulations.

CTU activities must adhere to current globally-accepted standards, including the following:

  • International Conference on Harmonization (ICH) E2, Clinical Safety Data Management, ICH E3 Clinical Study Reports, ICH E6 Good Clinical Practice
  • Compliance with coding to M1 MedDRA Terminology and ICH M5, Data Elements and Standards for Drug Dictionaries
  • Compliance with coding to the World Health Organization Drug Dictionary, protocol-specific requirements, and all applicable NIH/NIAID/DAIDS policies and procedures
  • Compliance with current industry standards for clinical data management, current example–Clinical Data Interchange Standards Consortium (CDISC). Provisions to maintain compliance with changing industry standards must be in place at no additional cost to the government.

NIAID is seeking “research ready” CRSs that have demonstrated experience conducting investigational new drug-level clinical research and have demonstrated access to the appropriate clinical trial participant populations for studies. There are no changes to the overall goals of this initiative to provide appropriate scientific and technical expertise as well as clinical research infrastructure to support the NIAID research priorities. Significant effort during the current grant project period is focused on streamlining and harmonizing administrative, regulatory and protocol operations, and funding across all Networks, and it is expected that CTUs will be integrated into this harmonized approach.

HIV/AIDS Maternal, Adolescent, and Pediatric Health Therapeutics Clinical Trials Leadership and Operations Center (Clinical Trial Required)

For the published request for applications, see the January 24, 2019 Guide announcement HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network Leadership and Operations Center (UM1, Clinical Trial Required).

Novel Biomarkers for the Development of HIV Incidence Assays With Improved Specificity

For the published requests for applications, see the April 11, 2018 Guide announcements, Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R01 Clinical Trial Optional) and Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R21 Clinical Trial Not Allowed).

In Vivo Targeted Degradation of HIV Proteins

For the published request for proposals, see the July 18, 2018 Solicitation of NIH and CDC for Small Business Innovation Research (SBIR) Contract Proposals (PHS 2019-1).

Particle-Based Delivery of HIV Env Immunogens

For the published request for proposals, see the July 18, 2018 Solicitation of NIH and CDC for Small Business Innovation Research (SBIR) Contract Proposals (PHS 2019-1).

Co-Delivery and Formulation of Adjuvants for HIV Vaccines

For the published request for proposals, see the July 18, 2018 Solicitation of NIH and CDC for Small Business Innovation Research (SBIR) Contract Proposals (PHS 2019-1).

Content last reviewed on January 25, 2019