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Extramural Update - Clinical Trial Registration Requirements

By Martha Barnes
September 2007

Have you been asked to include your research protocol in ClinicalTrials.gov (http://www.clinicaltrials.gov/) Exit NIEHS Website? Was your first response, "Not me, I'm not doing a clinical trial!" Because of new directions in environmental sciences research, when it comes to ClinicalTrials.gov, the answer may not be what you think.

What is ClinicalTrials.gov?

Established in 2000 by the National Library of Medicine under the Food and Drug Administration Modernization Act, ClinicalTrials.gov was designed originally to serve as a means for critically ill patients to find a trial in which they might participate. The ClinicalTrials.gov registry now includes information on federally and privately supported observational studies (examples: mechanisms of human disease, development of new technologies, epidemiologic and behavioral studies, or outcomes and health services research) and interventional clinical research in human volunteers. A clinical trial is a subset of clinical research. The only conditions required for inclusion are that the study must be approved by an institutional review board or an equivalent and that it must conform to the regulations of the appropriate health authority when applicable.

NIH Mandate

Registries serve the ethical function of ensuring that the public has information about new, ongoing and previously conducted clinical research. They also serve as a scientific resource on all clinical research and published results. NIH has mandated that all research using human subjects be included in ClinicalTrials.gov.

Why me?

If you are interacting with human subjects or you have identifiable information on human tissue, your study qualifies as clinical research and should be included in ClinicalTrials.gov. Some journals require that a clinical trial be included in a registry before enrolling the first patient, in order for papers from that trial to be included in the journal. The International Committee of Medical Journal Editors issued a joint statement in September 2004 promoting registration of all clinical trials [N Eng J Med. 2004, 351:1240-1251]. ClinicalTrials.gov is an approved registry.

How do I include my NIEHS-supported study in ClinicalTrials.gov?

To include your NIEHS-supported study in ClinicalTrials.gov, contact Martha Barnes (barnes@niehs.nih.gov).

NIH Definitions

Clinical Research: (1) Patient-oriented research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research.

Clinical Trial: A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).


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