Policies and procedures are essential to any clinical research enterprise. In this regard, the Division of AIDS (DAIDS) has standardized and harmonized operational procedures across research. Accordingly, all human subjects research supported and/or sponsored by NIAID must be compliant with these policies and standard operating procedures in addition to the NIAID Clinical Terms of Award; all National Institutes of Health (NIH) clinical research policies; and 45 CFR 46, subparts B-D. These documents also serve as resources for DAIDS collaborators and staff to refer for division requirements on the conduct of DAIDS research.
The applicability of each policy and standard operating procedure to different types of human subject research (i.e., clinical research, observational research, or clinical trials) is outlined in the document’s statement of Scope.
DAIDS expects compliance with all applicable policies and procedures within 30 days of the “effective date” stated on each document. DAIDS may, at its discretion, request the Clinical Site Monitoring Group (CSMG) monitors to spot-check documentation for compliance to these policies and standard operating procedures during monitoring visits.
DAIDS Policy Public Comment Period
The Division of AIDS is soliciting comments for the draft update to the DAIDS Policy Informed Consent Form and Process, and the new DAIDS Informed Consent Form and Process Guidance Document. These policy documents describe the requirements for the development and implementation of informed consent forms, documentation of informed consent, and the ongoing informed consent process for National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS)-supported and/or –sponsored clinical research. Key changes to the policy are included at the beginning of the policy document.
Please submit comments to the DAIDS Policy Branch by Monday, October 22, 2018. Include with your comments: the name of the document, and line number(s) and/or section number that corresponds. A Microsoft Word file or PDF that contains tracked changes or comments will not be accepted.
- Event Reporting and Safety Monitoring
Links to policies and standard procedures relating to the reporting and monitoring of study progress and safety in DAIDS-funded and/or -sponsored clinical trials.
- Laboratory and Specimens Management
Links to policies and standard procedures relating to requirements for laboratories associated with DAIDS-funded and/or -sponsored clinical trials.
- Pharmacy and Study Products Management
Links to policies and standard procedures relating to requirements for pharmacies associated with DAIDS-funded and/or -sponsored clinical trials.
- Protocol and Informed Consent Development
Links to policies and standard procedures relating to the content of protocol and informed consent documents for DAIDS-funded and/or -sponsored clinical research.
- Site Implementation and Operations
Links to policies and standard procedures relating to site operations, monitoring, quality management, and training at clinical research sites conducting DAIDS-funded and/or -sponsored clinical research.
- Glossary of DAIDS Terms
(Currently under revision)
Definitions of clinical research terms used by DAIDS.
- DAIDS Clinical Research Policy Archive
These documents are accessible to the public for reference purposes and should not be regarded as reflecting current U.S. Department of Health and Human Services or DAIDS policy.
- List of DAIDS Acronyms
- List of Frequently Asked Questions
A list of Frequently Asked Questions (FAQs) and DAIDS responses.