Medical Research Regulations

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Regulations: Good Clinical Practice and Clinical Trials

https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials

The Federal Register notice explains the legal issues and basis for the proposal, and provides information about how interested persons can submit written data, views, or arguments on the proposal....

Clinical Research Regulation For United States | ClinRegs

https://clinregs.niaid.nih.gov/country/united-states

The RevComRule applies to all human subjects research that is federally funded or sponsored by a Common Rule department/agency (as identified in USA-65 ), and: 1) was …

Regulations | HHS.gov

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/index.html

OHRP makes available the full text of the HHS regulations for the protection of human subjects in research (45 CFR 46), the Common Rule (45 CFR 46 Subpart A), and FDA …

Regulating Research | AAMC

https://www.aamc.org/what-we-do/mission-areas/medical-research/regulating-research

Biomedical research conducted at medical schools and teaching hospitals is regulated by both state and federal agencies with the goals of protecting the safety of research …

FDA Takes Steps to Further Harmonize Clinical …

https://www.fda.gov/news-events/fda-voices/fda-takes-steps-further-harmonize-clinical-research-regulations-hhs-common-rule

It is with these goals in mind that we approach the modernization of the FDA’s oversight of clinical research and harmonizing with the U.S. Department of Health and …

Research | HHS.gov

https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html

Currently, most research involving human subjects operates under the Common Rule (45 CFR Part 46, Subpart A) and/or the Food and Drug Administration’s (FDA) human …

Laws & Regulations | HHS.gov

https://www.hhs.gov/regulations/index.html

The HIPAA Privacy Rule protects personal health information and gives patients a variety of rights. Human Subjects Research Protections Institutions engaging in most HHS …

Federal Policy for the Protection of Human Subjects …

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html

Dec 13, 2022

Why Regulations | HHS.gov

https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/protecting-research-volunteers/why-regulations/index.html

As a result of the public outcry from publicized cases of unethical research, Congress passed a law requiring federal rules to protect people who participate in research. The rules rely on ethical principles that were laid …

8 Health Care Regulations in United States | Regis College

https://online.regiscollege.edu/blog/8-important-regulations-united-states-health-care/

The Department of Health and Human Services (HHS) oversees the general health issues and concerns of all American citizens, spearheading initiatives that improve public health and further medical …

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