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Understanding Clinical Trials
ClinicalTrials.gov is a database of information on federally and privately supported clinical trials (research studies in people) for a wide range of diseases and conditions. It is sponsored by the National Institutes of Health and the Food and Drug Administration. For more information on clinical trials, please visit their Web site at clinicaltrials.gov.
The Food and Drug Administration (FDA) assures the safety of foods and cosmetics, and the safety and efficacy of pharmaceuticals, biological products, and medical devices. For more information, please visit their Web site at fda.gov.
National Institutes of Health's (NIH) mission is to uncover new knowledge that will lead to better health for everyone. Comprising 27 separate components, mainly institutes and centers, NIH works toward that mission by conducting and supporting research, training researchers, and fostering communication of medical information. Descriptions of each of the institutes and centers, along with their research priorities and links to their Web sites, can be accessed by visiting nih.gov or by calling 301.496.4000.
The Health Insurance Portability and Accountability Act (HIPAA) is a US law designed to provide privacy standards to protect patients' medical records and other health information provided to health plans, physicians, hospitals and other health care providers. Developed by the Department of Health and Human Services (HHS), these standards provide patients with access to their medical records and more control over how their personal health information is used and disclosed. They represent a uniform, federal floor of privacy protections for consumers across the country. State laws providing additional protections to consumers are not affected by this new rule. HIPAA took effect on April 14, 2003. To learn more, please visit hhs.gov/ocr/hipaa/.
The Office for Human Research Protections (OHRP) protects the rights, welfare, and well-being of subjects involved in research conducted or supported by the Department of Health and Human Services and helps ensure that such research is carried out in accordance with the regulations described at 45 CFR part 46. To learn more, please visit hhs.gov/ohrp/.
The Department of Health and Human Services (HHS) is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Department includes more than 300 programs covering a wide spectrum of activities. To learn more, please visit hhs.gov.
For parents thinking about enrolling a child in research, we suggest that you review the information available on bostonchild.vitalconsent.com. It is an excellent website devoted to research with children and the concerns parents have about allowing their children to be in a research study.
You may also access the Institutional Review Board Guidebook, published by the Department of Health and Human Services.