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Clinical trials in the United States and throughout much of the world are creatures of regulation. Regulations define how trials are conducted, and how vaccines are licensed. A regulation may protect trial participants, or it may determine how vaccines are determined to be effective. Regulations, in short, can affect the legitimacy of vaccine trials, and may determine whether an HIV vaccine reaches the public.
The purpose of AVAC's advocacy is to ensure that HIV vaccine trials are conducted safely, equitably and ethically and that there are no unnecessary regulatory roadblocks to rapid licensure and distribution. We have commented on proposed or final regulations in the US and elsewhere, for example, to influence the development of protocols for clinical trials; to advocate for regulations permitting adolescent trials; to open access to government funded research; and to urge more rapid review of potential HIV prevention technologies.
Comments by AVAC or AVAC Board Members
To U.S. FDA, NIH or DHHS-OHRP:
Comments on Proposed Rule - Issuance of a Visa and Authorization for Temporary Admission Into
the United States for Certain Nonimmigrant Aliens Infected With HIV
submitted December 6, 2007
Comments on Fogarty International Center Strategic Plan
submitted November 12, 2006
Guidance for Industry - Development of Preventive HIV Vaccines for Use in Pediatric Populations
submitted October 27, 2006
National Institutes of Health Public Access Policy - Ensure public access to the results of research funded by taxpayers
submitted May 22, 2006
Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others
submitted January 13, 2006
Critical Path Initiative; Developing Prevention Therapies
submitted October 31, 2005
Draft Guidance for Industry on Using a Centralized Institutional Review Boards Process in Multicenter Clinical Trials
submitted May 26, 2005
DHHS/Office of Human Research Protections - Proposed Criteria for Determinations of Equivalent Protection
submitted May 20, 2005
International Conference on Harmonisation: Draft Guidance on E2E Pharmacovigilance Planning
submitted May 14, 2004
Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
submitted April 29, 2005
Reporting of Adverse Events to Institutional Review Boards (IRB)
submitted April 20, 2005
Reporting of Adverse Events to Institutional Review Boards
submitted April 17, 2005
Enhanced Public Access to National Institutes of Health (NIH) Research Information
submitted November 1, 2004
Human Subject Protection - Foreign Clinical Studies Not Conducted Under an Investigational New Drug (IND) Application - Proposed Rule
submitted September 7, 2004
NIH Policy: Improving Access to Biomedical Research
submitted August 25, 2004
Open Access: Publication of Scientific Research
submitted August 6, 2004
Critical Path Initiative
submitted July 29, 2004
Innovation or Stagnation? - Challenge and Opportunity on the Critical Path to New Medical Products
submitted April 13, 2004
Proposed Rule - Safety Reporting Requirements for Human Drug and Biological Products
submitted October 10, 2003
DHHS Proposed Standards for Privacy of Individually Identifiable Health Information
submitted April 14, 2002
To CIOMS or WHO:
AVAC comments on the Report of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property
submitted November 13, 2006
Draft International Guidelines for Ethical Review of Epidemiological Studies
submitted October 31, 2005
Draft Manuscript for "Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation"
submitted September 22, 2005
To Others:
Department for International Development's Consultation Document on Advanced Market Commitments
submitted January 13, 2006
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