What is 45 CFR 46?
45 CFR 46 (Title 45 of the Code of Federal Regulations, Part 46) are the regulations for the protection of human subjects in research which include the composition of review boards, criteria for protocol review, regulations for informed consent, requirements for record-keeping, special protections for vulnerable populations, types of review, and reporting requirements for non-compliance. The regulations are based on the ethical principles identified in the Belmont Report.As written,45 CFR 46applies only to federally supported research, however, CUMC maintains an agreement with DHHS that extends the protections of45 CFR 46to all research conducted by University personnel, regardless of the source of funding, or lack thereof. This agreement is theFederalwide Assurance(FWA) and is required before the institution may receive federal research funds.
45 CFR 46 (Title 45 of the Code of Federal Regulations, Part 46) are the regulations for the protection of human subjects in research which include the composition of review boards, criteria for protocol review, regulations for informed consent, requirements for record-keeping, special protections for vulnerable populations, types of review, and reporting requirements for non-compliance. The regulations are based on the ethical principles identified in the Belmont Report. As written, 45 CFR 46 applies only to federally supported research, however, CUMC maintains an agreement with DHHS that extends the protections of 45 CFR 46 to all research conducted by University personnel, regardless of the source of funding, or lack thereof. This agreement is the Federalwide Assurance (FWA) and is required before the institution may receive federal research funds.
45 CFR 46 (Title 45 of the Code of Federal Regulations, Part 46) are the regulations for the protection of human subjects in research which include the composition of review boards, criteria for protocol review, regulations for informed consent, requirements for record-keeping, special protections for vulnerable populations, types of review, and reporting requirements for non-compliance. The regulations are based on the ethical principles identified in the Belmont Report. As written, 45 CFR 46 applies only to federally supported research, however, CUMC maintains an agreement with DHHS that extends the protections of 45 CFR 46 to all research conducted by University personnel, regardless of the source of funding, or lack thereof. This agreement is the Federalwide Assurance (FWA) and is required before the institution may receive federal research funds. • What is a Form 310? Form 310 is the former name for Assurance Identification/IRB Certification/Declaration of Exemption form required
