Glossary of Terms and Acronyms
- Federalwide Assurance (FWA)
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A written agreement with the federal Department of Health and Human Services (HHS) by which an institution commits to complying with the requirements in the HHS…
- Food and Drug Administration (FDA)
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The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological…
- full board review
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When proposed research does not meet the criteria for exempt status or expedited review, the research is reviewed at a convened meeting of the full Institutional…
- Good Clinical Practice
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An international set of quality standard for clinical care, including clinical trials involving human subjects. The standards are developed by the International Conference on Harmonisation (ICH/GCP)….
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
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Contains provisions to protect the confidentiality and security of individually identifiable health care information about patients (Protected Health Information, or PHI) that arises in the course…
- HIPAA Authorization
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The formal documentation of consent for release of protected health information, given by either the patient or a legally authorized representative. For the authorization to be…
- Human Subjects Assistance Program (HSAP)
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The Human Subjects Assistance Program (HSAP) is a discretionary no-fault program developed to provide medical and other assistance to otherwise healthy subjects who experience a research-related…
- humanitarian device exemption (HDE)
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Is a status granted by the Food and Drug Administration (FDA) to devices intended for treatment or diagnosis of a disease or condition that affects no…
- humanitarian use device (HUD)
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A medical device (1) intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in no more…
- identifiable data
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Data which are either (a) directly connected to name/other identifiers, or (b) indirectly connected via a study number or other coding scheme. Even if neither condition…