Ethics, Regulations, Policies and Good Clinical Practice
Ethics | Regulations | Policies | Good Clinical Practice
Ethics
This section identifies the current ethical principles that must be followed in the conduct of behavioral and biomedical research involving human subjects.
The Belmont Report: This document summarizes three basic ethical principles of respect for persons, beneficence and justice. The application of these principles to informed consent, the assessment of risks and benefits, and selection of subjects are also described.
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Regulations
Federal Regulations
This section identifies the current regulatory requirements regarding the conduct of a study approved by an Institutional Review Board.
Federal Regulations Related to the Protection of Human Subjects
45 CFR 46 (DHHS Regulations): This part applies to institutions and investigators that are engaged in human subjects research that is supported or conducted by the Department of Health and Human Services.
21 CFR 50 (FDA Regulations): This part applies to clinical investigations regulated by the Food and Drug Administration as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, such as drugs, medical devices and biological products for human use.
45 CFR 164 (HIPAA Regulations): This part applies to investigators using protected health information during the course of a clinical investigation.
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For additional information about HIPAA and clinical research, visit these websites:
MCW HIPAA Web Site (coming soon): The site provides MCW Faculty, Staff, Residents, Students, Volunteers and others access to pertinent information on HIPAA.
Clinical Research and the HIPAA Privacy Rule: This NIH website provides comprehensive information describing the relationship between the HIPAA Privacy Rule and the conduct of research. |
FDA Regulations Specifically Related to Drug and Device Studies
21 CFR 54 (Financial Disclosure): This part describes the requirements for disclosing certain financial arrangements between the sponsor and the investigator as well as certain interests the investigator may have in the product under study or the sponsor of the study.
21 CFR 56 (Institutional Review Boards): This part contains the general standards for the composition, operation and responsibilities of Institutional Review Boards.
21 CFR 312 (Investigational New Drug Application): This part describes the procedures and requirements governing the use of investigational new drugs. Sponsor and investigator responsibilities are also described in this part.
21 CFR 314 (Applications for FDA Approval to Market a New Drug): This part describes the procedures and requirements for submitting marketing applications to the FDA. FDA review of the applications is also included in this part.
21 CFR 812 (Investigational Device Exemptions): This part provides procedures for the conduct of clinical investigations of devices. Sponsor and investigator responsibilities are also described in this part.
21 CFR 814 (Premarket Approval for Medical Devices): This part provides procedures for premarket approval of medical devices intended for human use. Humanitarian Use Devices (HUDs) are described in Subpart H.
|Click HERE to search the FDA's CFR Title 21 database|
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Policies & MCW Standard Operating Procedures
This section identifies the current standard operating procedures regarding the conduct of studies approved by a MCW/FH IRB.
MCW Standard Operating Procedure (SOP) for Institutional Review Boards: This document describes the requirements that both the IRB and clinical investigators must satisfy. Contents include IRB organization and approval criteria, informed consent requirements, and investigator responsibilities. The addendum is also incorporated and includes the MCW/FH recruitment policy.
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Good Clinical Practice
This section identifies the suggested good clinical practices in the conduct of FDA governed studies. Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
Good Clinical Practice in FDA-Regulated Clinical Trials: These guidances and information sheets represent the FDA's current guidance on GCP and the conduct of clinical trials. Content includes information for IRBs, investigators and sponsors regarding the conduct of research, the use of drugs, biologics and devices, and FDA operations
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The FDA provides a list of Good Clinical Practice contacts who can answer questions regarding GCP in the conduct of clinical trials. Visit the FDA's "Good Clinical Practice Contacts" webpage for these contacts and the types of questions they can answer. |
International Conference on Harmonization (ICH) E6 - Good Clinical Practice: Consolidated Guidance: ICH GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects. This guidance document provides a unified standard in order to facilitate the mutual acceptance of clinical data by regulatory authorities in the US, Europe and Japan.
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