§46.101. To what does this policy apply? — Inbound Citations

(2) The part 2 program or other lawful holder of data under this part is a HIPAA covered entity or business associate, and the use or disclosure is made in accordance with the requirements at 45 CFR 164.512(i).

(iii) Research for which a determination was made that the research was exempt under § 46.101(b) of the pre-2018 Requirements before January 21, 2019.

Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Except for research waived under § 46.101(i) or exempted under § 46.104, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research.

(b) The pre-2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2016. The 2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2018.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) through (6) of the pre-2018 Requirements are applicable to this subpart.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1) through (8) of the 2018 Requirements may be applied.

(b) This subpart applies to all research involving children as subjects, conducted or supported by the Department of Health and Human Services.

(1) This includes research conducted by Department employees, except that each head of an Operating Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint.

(2) It also includes research conducted or supported by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under § 46.101(i) of the pre-2018 Requirements or the 2018 Requirements, waive the applicability of some or all of the requirements of this subpart for research of this type.

(b) The pre-2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2016. The 2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2018.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) through (6) of the pre-2018 Requirements are applicable to this subpart.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1) through (8) of the 2018 Requirements may be applied.

(b) This subpart applies to all research involving children as subjects, conducted or supported by the Department of Health and Human Services.

(1) This includes research conducted by Department employees, except that each head of an Operating Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint.

(2) It also includes research conducted or supported by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under § 46.101(i) of the pre-2018 Requirements or the 2018 Requirements, waive the applicability of some or all of the requirements of this subpart for research of this type.

(b) The pre-2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2016. The 2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2018.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) through (6) of the pre-2018 Requirements are applicable to this subpart.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1) through (8) of the 2018 Requirements may be applied.

(b) This subpart applies to all research involving children as subjects, conducted or supported by the Department of Health and Human Services.

(1) This includes research conducted by Department employees, except that each head of an Operating Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint.

(2) It also includes research conducted or supported by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under § 46.101(i) of the pre-2018 Requirements or the 2018 Requirements, waive the applicability of some or all of the requirements of this subpart for research of this type.

(b) The pre-2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2016. The 2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2018.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) through (6) of the pre-2018 Requirements are applicable to this subpart.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1) through (8) of the 2018 Requirements may be applied.

(b) This subpart applies to all research involving children as subjects, conducted or supported by the Department of Health and Human Services.

(1) This includes research conducted by Department employees, except that each head of an Operating Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint.

(2) It also includes research conducted or supported by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under § 46.101(i) of the pre-2018 Requirements or the 2018 Requirements, waive the applicability of some or all of the requirements of this subpart for research of this type.

(b) The pre-2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2016. The 2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2018.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) through (6) of the pre-2018 Requirements are applicable to this subpart.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1) through (8) of the 2018 Requirements may be applied.

(b) This subpart applies to all research involving children as subjects, conducted or supported by the Department of Health and Human Services.

(1) This includes research conducted by Department employees, except that each head of an Operating Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint.

(2) It also includes research conducted or supported by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under § 46.101(i) of the pre-2018 Requirements or the 2018 Requirements, waive the applicability of some or all of the requirements of this subpart for research of this type.

(b) The pre-2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2016. The 2018 Requirements means 45 CFR part 46, subpart A, as revised October 1, 2018.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) through (6) of the pre-2018 Requirements are applicable to this subpart.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1) through (8) of the 2018 Requirements may be applied.

(b) This subpart applies to all research involving children as subjects, conducted or supported by the Department of Health and Human Services.

(1) This includes research conducted by Department employees, except that each head of an Operating Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint.

(2) It also includes research conducted or supported by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under § 46.101(i) of the pre-2018 Requirements or the 2018 Requirements, waive the applicability of some or all of the requirements of this subpart for research of this type.

(c) The provisions of § 46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in § 46.101(f) is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) and (b)(3) through (6) of the pre-2018 Requirements are applicable to this subpart. The exemption at § 46.101(b)(2) of the pre-2018 Requirements regarding educational tests also is applicable to this subpart. However, the exemption at § 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1), (4), (5), (6), (7), and (8) of the 2018 Requirements are applicable to this subpart. The exemptions at § 46.104(d)(2)(i) and (ii) of the 2018 Requirements may only apply to research subject to this subpart that involves educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. The exemptions at § 46.104(d)(2)(iii) and (d)(3) of the 2018 Requirements may not be applied to research subject to this subpart.

(c) The provisions of § 46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in § 46.101(f) is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) and (b)(3) through (6) of the pre-2018 Requirements are applicable to this subpart. The exemption at § 46.101(b)(2) of the pre-2018 Requirements regarding educational tests also is applicable to this subpart. However, the exemption at § 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1), (4), (5), (6), (7), and (8) of the 2018 Requirements are applicable to this subpart. The exemptions at § 46.104(d)(2)(i) and (ii) of the 2018 Requirements may only apply to research subject to this subpart that involves educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. The exemptions at § 46.104(d)(2)(iii) and (d)(3) of the 2018 Requirements may not be applied to research subject to this subpart.

(c) The provisions of § 46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in § 46.101(f) is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.

(c) The provisions of § 46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in § 46.101(f) is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) and (b)(3) through (6) of the pre-2018 Requirements are applicable to this subpart. The exemption at § 46.101(b)(2) of the pre-2018 Requirements regarding educational tests also is applicable to this subpart. However, the exemption at § 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1), (4), (5), (6), (7), and (8) of the 2018 Requirements are applicable to this subpart. The exemptions at § 46.104(d)(2)(i) and (ii) of the 2018 Requirements may only apply to research subject to this subpart that involves educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. The exemptions at § 46.104(d)(2)(iii) and (d)(3) of the 2018 Requirements may not be applied to research subject to this subpart.

(c) The provisions of § 46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in § 46.101(f) is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) and (b)(3) through (6) of the pre-2018 Requirements are applicable to this subpart. The exemption at § 46.101(b)(2) of the pre-2018 Requirements regarding educational tests also is applicable to this subpart. However, the exemption at § 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1), (4), (5), (6), (7), and (8) of the 2018 Requirements are applicable to this subpart. The exemptions at § 46.104(d)(2)(i) and (ii) of the 2018 Requirements may only apply to research subject to this subpart that involves educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. The exemptions at § 46.104(d)(2)(iii) and (d)(3) of the 2018 Requirements may not be applied to research subject to this subpart.

(c) The provisions of § 46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in § 46.101(f) is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.

(1) For research subject to the pre-2018 Requirements and this subpart, the exemptions at § 46.101(b)(1) and (b)(3) through (6) of the pre-2018 Requirements are applicable to this subpart. The exemption at § 46.101(b)(2) of the pre-2018 Requirements regarding educational tests also is applicable to this subpart. However, the exemption at § 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.

(2) For research subject to the 2018 Requirements and this subpart, the exemptions at § 46.104(d)(1), (4), (5), (6), (7), and (8) of the 2018 Requirements are applicable to this subpart. The exemptions at § 46.104(d)(2)(i) and (ii) of the 2018 Requirements may only apply to research subject to this subpart that involves educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. The exemptions at § 46.104(d)(2)(iii) and (d)(3) of the 2018 Requirements may not be applied to research subject to this subpart.

(ii) Research for which IRB review was waived pursuant to § 46.101(i) of the pre-2018 Requirements before January 21, 2019; and

Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Except for research waived under § 46.101(i) or exempted under § 46.104, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research.

Except for research waived under § 46.101(i) or exempted under § 46.104, in the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted by the institution to the Federal department or agency component supporting the research, and final approval given to the proposed change by the Federal department or agency component.

(c) The provisions of § 46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in § 46.101(f) is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.

(2) It also includes research conducted or supported by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under § 46.101(i) of the pre-2018 Requirements or the 2018 Requirements, waive the applicability of some or all of the requirements of this subpart for research of this type.