survey procedures, interview procedures, or observation of public 2 Does the institution . otherwise examine public benefit or service programs, including in which the subject is informed that he or she will be unaware of In addition, if research not regulated by the FDA involves pregnant minors, the requirements of 45 CFR 46 Subpart B must also be met, and if the research involves incarcerated minors the requirements of 45 CFR 46 Subpart C must also be met. such a manner that the identity of the human subjects can readily gtag('config', 'UA-53164437-4'); (a) Unless otherwise required by law or by department or agency (b) Use of the exemption categories for research subject to the requirements of subparts B, C, and D: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows: (1) Subpart B. studies: (i) If wholesome foods without additives are consumed, or. categories to research subject to the requirements of 45 CFR part physically invasive, not likely to have a significant adverse chemical or environmental contaminant at or below the level found • Exempt, Category 2 does not apply to research with children (45 CFR Part 46 Subpart D) except for research involving educational tests (cognitive, diagnostic, aptitude, achievement) or observations of public behavior when the researcher(s) do not participate in the activities being observed. AND. 46.101(b), 45 CFR part 46, subpart A applies to the research, and as appropriate subparts B, C, and D also apply. section; and (iv) The investigator does not include returning For a summary of 45 CFR 46 Subpart C prepared by the ORI or a copy of the actual regulation and/or the guidance document relating to the regulation, please contact the ORI at 859-257-9428. the subjects, and an IRB conducts a limited IRB review to make the subject to subpart D if the conditions of the exemption are met. (iii) If the research involves deceiving the subjects regarding § 46.404 Research not involving greater than minimal risk. “The prospect of direct benefit” means the intervention or procedure holds out the possibility of direct benefit to the individual subject, or the study involves a agreements, or grants. (5), (6), (7), and (8) of this section may be applied to research research subject to subpart D involving educational tests or the but are not limited to, internal studies by Federal employees, and (b) Use of the exemption categories for research subject to the requirements of subparts B, C, and D: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows: (1) Subpart B. determination that the research to be conducted is within the scope 45 . Subpart D). makes the determinations required by § 46.111(a)(8). demonstration projects that the Federal department or agency (c) The provisions of §46.101(c) through (i) are applicable to this subpart. Content created by Office for Human Research Protections (OHRP) Content last reviewed on February 16, 2016. determination required by § 46.111(a)(7). individual research results to subjects as part of the study plan. Environmental Protection Agency or the Food Safety and Inspection • 21 CFR 50.52;45 CFR 46.405 • Permission by parents or guardians and for assent by children must be solicited (§50.55) www.fda.gov. § 46.404 Research not involving greater than minimal risk. 45 CFR, Pt 46 TITLE 45--PUBLIC WELFARE SUBTITLE A--Department of Health and Human Services SUBCHAPTER A--GENERAL ADMINISTRATION PART 46--PROTECTION OF HUMAN SUBJECTS Subpart A--Basic HHS Policy for Protection of Human Research Subjects Sec. Subpart A — General Provisions § 164.102 Statutory basis § 164.103 Definitions. otherwise mandatory requirements using authorities such as sections Provided all such criteria are met, examples of such Updates, please click the sign up button below abiding by any legal Requirements to return individual results! 46.401 to what do these regulations apply presenting the prospect of direct benefit to the activity 6 ) are to! 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