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Informed Consent Additional Resources
Requirements for Human Subjects Research
- Office for Human Research Protections (OHRP) [hhs.gov]:
The Office for Human Research Protections (OHRP) protects the rights, welfare, and well-being of subjects involved in research conducted or supported by the Department of Health and Human Services (HHS) and helps ensure that such research is carried out in accordance with the regulations described in the Code of Federal Regulations: Title 45, Part 46 [hhs.gov]; also referred to as 45 CFR 46 [hhs.gov].
Such research must abide by the Protection of Human Subjects requirements in 45 CFR 46.
OHRP has tips for informed consent at Tips On Informed Consent [hhs.gov] and at OHRP Informed Consent Frequently Asked Questions [hhs.gov]. OHRP also has tips for other elements of the research process at Human Research Questions & Answers [hhs.gov]
- Food and Drug Administration (FDA):
The U.S. Food and Drug Administration (FDA), through its Office of Health Affairs, has developed its own set of regulations on the protection of human subjects (Code of Federal Requlations: Title 21, Part 50 [access.gpo.gov] and Title 21, Part 56 [access.gpo.gov]; also referred to as 21 CFR 50, 56).
The regulations apply to any clinical trial that involves an investigational drug, biological product, or other device that is regulated by the FDA under the Food, Drug, and Cosmetics Act - regardless of whether or not the trial receives Federal funding. If a trial is supported by the Department of Health and Human Services and involves an FDA-regulated drug or device, then it is subject to both organizations' regulations. (For more information, see Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors [fda.gov]).
Guidance Documents
Additional Consent Form References and Examples
Other Organizations and Resources
- Group Health Center for Health Studies
The Project to Review and Improve Study Materials (PRISM) is a Group Health Center for Health Studies initiative to improve the quality of print materials used in communication with research participants. The primary goal is to create written study materials that are readable and participant-centered through the PRISM Readability Toolkit [centerforhealthstudies.org]
- Public Responsibility in Medicine and Research (PRIM&R) [primr.org]
PRIM&R helps to educate medical personnel and the public about the ethical, legal, and policy issues involved in clinical research.
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Last Updated: May 4, 2009
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