Review of the 1995 Food and Drug Administration/National Institutes of Health Public Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances

1995 ◽  
Vol 160 (12) ◽  
pp. 599-603
Author(s):  
James M. Lamiell ◽  
John D. Grabenstein ◽  
Dale G. Vander Hamm
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Public Forum

Investigational Drug Information

1974 ◽  
Vol 8 (4) ◽  
pp. 182-183
Author(s):  
Larry M. Kleinman ◽  
Joseph A. Tangrea ◽  
Joseph F. Gallelli
Keyword(s):  
Clinical Research ◽  
Drug Administration ◽  
Drug Information ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Investigational Drug ◽  
Fact Sheet ◽  
Research Protocols ◽  
Clinical Center ◽  
Investigational Drugs

The drug information appearing in this column is for investigational drugs studied in clinical research protocols being pursued in the Clinical Center at the National Institutes of Health. This same information, in the form of an “Investigational Drug Fact Sheet,” is distributed, prior to its use, to the dispensing pharmacist and the appropriate nursing units involved in the administration of the drug As with all investigational drugs, the drugs reported in this column have a Notice of Claimed Investigational Exemption for o New Drug (IND) assigned to them by the Food and Drug Administration (F.D.A.).

Investigational Drug Information

1974 ◽  
Vol 8 (1) ◽  
pp. 25-26
Author(s):  
Larry M. Kleinman ◽  
Joseph A Tangrea ◽  
Joseph F. Gallelli
Keyword(s):  
Clinical Research ◽  
Drug Administration ◽  
Drug Information ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Investigational Drug ◽  
New Drug ◽  
Research Protocols ◽  
Clinical Center ◽  
Investigational Drugs

The drug information appearing in this column is for investigational drugs studied in clinical research protocols being pursued in the Clinical Center at the National Institutes of Health. As with all investigational drugs, the drugs reported in this column have a Notice of Claimed Investigational Exemption for a New Drug (IND) assigned to them by the Food and Drug Administration (F.D.A.).

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

The FDA's Proposal for Public Disclosure of Adverse Events in Gene Therapy Trials

2000 ◽  
Vol 19 (2) ◽  
pp. 261-268
Author(s):  
Deborah R. Barnbaum
Keyword(s):  
Gene Therapy ◽  
Clinical Trials ◽  
Informed Consent ◽  
Adverse Events ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Public Disclosure

In January 2001, the Food and Drug Administration (FDA) proposed annual public disclosure of adverse events during gene therapy and xenotransplantation trials. The proposed policy raises the following questions: (1) Is the reformed policy in accord with the FDA's long-standing informed consent policies? (2) Why pair gene therapy trials and xenotransplantation trials in the revised guidelines? (3) Why single out these trials for public disclosure of adverse events? Each question is examined, and three conclusions are drawn. First, the FDA's own policies on informed consent require prompter public disclosure of adverse events. Second, the coupling of gene therapy and xenotransplantation trials entails a conceptual mistake in the types of communities that are harmed by each therapy's related adverse events. Third, all clinical trials merit such public disclosure of adverse events, not only gene therapy and xenotransplantation trials.

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