See the Glossary for more terms.
Concepts represent early planning stages for program announcements, request 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 the Opportunities and Announcements portal.
NB: Council approval does not guarantee that a concept will become an initiative.
Request for Proposals
Contact: Anita HughesPhone: 301-451-3694Internet: AnHughes@niaid.nih.gov
Objective: The objective of this contract is to provide on-site monitoring of DAIDS-sponsored clinical trial studies and clinical trial sites.
Description: This contract initiative will provide monitoring for international and domestic clinical trials sponsored by DAIDS. The Clinical Site Monitoring Contractor(s) will be responsible for the following activities:
Periodic on-site monitoring visits will be conducted at sites to examine source documents and other related clinical trials documents to assess the accuracy and completeness of the trial data, to identify problems with protocol implementation, Good Clinical Practices/ICH adherence, and all applicable regulatory requirements. Monitors will review IRB documentation, informed consents, and site registration of protocols. Additionally, monitors will verify the proper storage, dispensation, and accountability of investigational study products. They may be asked to complete special assignments should a site display performance problems.
For the published initiative, see the December 11, 2008, solicitation, NIAID/DAIDS Clinical Research Auditing.
Contact: Jason BellPhone: 301-496-0612Internet: firstname.lastname@example.org
Objective: The objective of this contract will be to provide DAIDS with independent and specialized quality assurance auditing of the monitoring of DAIDS clinical research and third party “for cause” auditing of clinical research sites.
Description: This initiative will provide independent auditing in support of international and domestic clinical research sponsored by DAIDS. The Clinical Research Auditing contractor will be responsible for the following activities:
Periodic auditing visits will be conducted at clinical research sites to measure the consistency, thoroughness, and quality of on-site monitoring by DAIDS monitors and non-DAIDS monitors. It is anticipated that the contractor will audit a minimum of 10 percent of scheduled monitoring visits during the first year of the contract. Based upon audit findings, this number may be adjusted. Auditors may be asked to complete special assignments (primarily third party “for cause” on-site audits) to address serious performance problems at clinical research sites.
For the published initiative, see the May 11, 2009, solicitation.
Contact: Joshua LaVinePhone: 301-496-0612Internet: email@example.com
Objective: To provide: (1) the required regulatory expertise and support necessary to perform DAIDS-funded and/or -sponsored domestic and international clinical trial research, (2) training in key functions of clinical trial research investigators, and (3) computer and database expertise required for entering and maintaining all contract-associated data and records in the DAIDS Enterprise System.
Expanded scope and/or budget areas include:
Contact: Cassandra EllisPhone: 301-451-3691Internet: firstname.lastname@example.org
Objective: This contract will provide wide ranging clinical trial research management services on a standard basis as well as in response to periodic, auxiliary, or special needs that arise in maintaining current operations or responding quickly to situations requiring resources above those planned for and established.
Description: To date no changes have been made in the scope, mechanism, or budget for this initiative. This contract will continue to provide clinical trial management and support resources to DAIDS-funded studies as needed, and that include activities in four broad areas:
For the published initiative, see the May 19, 2009, Guide announcement, Basic HIV Vaccine Discovery Research.
Request for Applications
Contact: Stuart ShapiroPhone: 301-402-0122Internet: email@example.com
Objective: The goal of this initiative is to accelerate HIV vaccine discovery efforts by supporting the generation of new knowledge that will inform new conceptual approaches to HIV vaccine design and/or yield new HIV vaccine designs.
Description: This program is designed to support a broad range of research that can lead to highly significant HIV vaccine-applicable discoveries. Knowledge gained from these projects should lead to new approaches for vaccine design. Research that outlines new approaches to overcoming difficult scientific obstacles and that may come from diverse fields, including but not limited to virology, immunology, genetics, cellular biology, and structural biology, is highly encouraged. Examples of fundable research ideas may originate from feedback obtained from the Request for Information (RFI) NOT-AI-08-048, as well as the recently held NIAID HIV vaccine summit. This program is expected to support studies that may include:
Last Updated July 08, 2011
Last Reviewed August 03, 2009