helpful Links

Patients rights overviews

45 CFR 46. The ultimate, comprehensive law that defines federal regulations governing protection of human subjects.

Belmont Report
The Belmont Report was issued in 1979 by the Department of Health, Education, and Welfare (now Health and Human Services). It describes the three ethical principles that should be embodied in human subjects research.  These principles are fundamental in IRB review.

Health information privacy. The Office of Civil Rights enforces the HIPAA Privacy Rule.


OHRP

OHRP—Office of Human Research Protections
The OHRP is a federal office that oversees the protection of human subjects in research.  The OHRP interprets and enforces 45 CFR 46.

The OHRP Policy and Guidance library can be found here. 

Frequently Asked Questions submitted to the OHRP.

IRB Guidebook. Though still useful, the IRB Guidebook was last updated by the OHRP in 1993 and therefore must be supported with additional documentation when a procedure is in question.

OHRB decision charts. These charts will help you know if your research requires IRB approval.


 National Institutes of Health

NIH FAQs. NIH FAQs are listed here, and additional FAQs are here.

NIH Policies.  The NIH policies page can be found here. 

Vulnerable populations. These are specific policies protecting women and fetuses, prisoners, and children.


U.S. Food and Drug Administration

Fda.gov. The FDA, which is housed within Health and Human Services, is the federal office that oversees the safety of the U.S. food supply, medical product safety, and emerging health hazards, as well as bringing new technologies to market.

Center for Biologics and Evaluation. CBER is the center within FDA that regulates biological products for human use. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/default.htm

Good clinical practice. This office is the regulatory agency for clinical trials.

Clinical trials. This question and answer page was designed for consumers.

Why volunteer for a clinical trial. This site was also designed for consumers.

FDA forms. Form 1571, Investigational New Drug (IND) Application, and Form 1572, Statement of Investigator, can be found here.