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An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical.
A Site Management Organization (SMO) is an organization that provides clinical trial-related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company, or a clinical site.
An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose the subjects to unnecessary risks. Other commitments are commitments to obtain informed consent from the research subjects, to obtain a review of the study by an institutional review board (IRB), and to adhere to the investigational new drug ...
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
Institutional Animal Care and Use Committees (IACUCs) are centrally important in applying laws about animal research in the United States.Similar systems operate in other countries, but generally under different titles; for example, in Canada a typical title would be the University Animal Care Committee (UACC), while in the United Kingdom it would be the Animal Welfare and Ethical Review Body ...
An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: Dose (of the study drug) Frequency of dosing interval; Methods of administration; Safety monitoring ...
All research involving human subjects must be approved by an Institutional Review Board (IRB). Each IRB has protocol submission requirements, which typically involve an IRB application and informed consent document. A study cannot begin without IRB approval.