-CITE- 45 CFR Sec. 46.101 -EXPCITE- Title 45 SUBTITLE A PART 46 Subpart A -HEAD- Sec. 46.101 To what do these regulations apply? -TEXT- (a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving human subjects conducted by the Department of Health and Human Services or funded in whole or in part by a Department grant, contract, cooperative agreement or fellowship. (1) This includes research conducted by Department employees, except each Principal Operating Component head may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint. (2) It also includes research conducted or funded by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under paragraph (e) of this section waive the applicability of some or all of the requirements of these regulations for research of this type. (b) Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from these regulations unless the research is covered by other subparts of this part: (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (3) Research involving survey or interview procedures, except where all of the following conditions exist: (i) Responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) the subject's responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and (iii) the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol. All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office. (4) Research involving the observation (including observation by participants) of public behavior, except where all of the following conditions exist: (i) Observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) The observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and (iii) The research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol. (5) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (6) Unless specifically required by statute (and except to the extent specified in paragraph (i)), research and demonstration projects which are conducted by or subject to the approval of the Department of Health and Human Services, and which are designed to study, evaluate, or otherwise examine: (i) Programs under the Social Security Act, or other public benefit or service programs; (ii) Procedures for obtaining benefits or services under those programs; (iii) Possible changes in or alternatives to those programs or procedures; or (iv) Possible changes in methods or levels of payment for benefits or services under those programs. (c) The Secretary has final authority to determine whether a particular activity is covered by these regulations. (d) The Secretary may require that specific research activities or classes of research activities conducted or funded by the Department, but not otherwise covered by these regulations, comply with some or all of these regulations. (e) The Secretary may also waive applicability of these regulations to specific research activities or classes of research activities, otherwise covered by these regulations. Notices of these actions will be published in the Federal Register as they occur. (f) No individual may receive Department funding for research covered by these regulations unless the individual is affiliated with or sponsored by an institution which assumes responsibility for the research under an assurance satisfying the requirements of this part, or the individual makes other arrangements with the Department. (g) Compliance with these regulations will in no way render inapplicable pertinent federal, state, or local laws or regulations. (h) Each subpart of these regulations contains a separate section describing to what the subpart applies. Research which is covered by more than one subpart shall comply with all applicable subparts. (i) If, following review of proposed research activities that are exempt from these regulations under paragraph (b)(6), the Secretary determines that a research or demonstration project presents a danger to the physical, mental, or emotional well-being of a participant or subject of the research or demonstration project, then federal funds may not be expended for such a project without the written, informed consent of each participant or subject. (46 FR 8386, Jan. 26, 1981; 46 FR 19195, Mar. 27, 1981, as amended at 48 FR 9269, Mar. 4, 1983)