REG 7 CFR PART 1C-2012 PROTECTION OF HUMAN SUBJECTS.pdf

1、121 Office of the Secretary, USDA 1c.101 1b.4 Exclusion of agencies. (a) The USDA agencies and agency units listed in paragraph (b) of this sec-tion conduct programs and activities that have been found to have no indi-vidual or cumulative effect on the human environment. The USDA agen-cies and agenc

2、y units listed in para-graph (b) of this section are excluded from the requirements of preparing procedures to implement NEPA. Ac-tions of USDA agencies and agency units listed in paragraph (b) of this sec-tion are categorically excluded from the preparation of an EA or EIS unless the agency head de

3、termines that an ac-tion may have a significant environ-mental effect. (b)(1) Agricultural Marketing Service (2) Economic Research Service (3) Reserved (4) Federal Corp Insurance Corpora-tion (5) Food and Consumer Service (6) Food Safety and Inspection Serv-ice (7) Foreign Agricultural Service (8) G

4、rain Inspection, Packers and Stockyards Administration (9) National Agricultural Library (10) National Agricultural Statistics Service (11) Office of the General Counsel (12) Office of the Inspector General 60 FR 66481, Dec. 22, 1995, as amended at 76 FR 4802, Jan. 27, 2011 PART 1cPROTECTION OF HUMA

5、N SUBJECTS Sec. 1c.101 To what does this policy apply? 1c.102 Definitions. 1c.103 Assuring compliance with this pol-icyresearch conducted or supported by any Federal Department or Agency. 1c.1041c.106 Reserved 1c.107 IRB membership. 1c.108 IRB functions and operations. 1c.109 IRB review of research.

6、 1c.110 Expedited review procedures for cer-tain kinds of research involving no more than minimal risk, and for minor changes in approved research. 1c.111 Criteria for IRB approval of research. 1c.112 Review by institution. 1c.113 Suspension or termination of IRB ap-proval of research. 1c.114 Cooper

7、ative research. 1c.115 IRB records. 1c.116 General requirements for informed consent. 1c.117 Documentation of informed consent. 1c.118 Applications and proposals lacking definite plans for involvement of human subjects. 1c.119 Research undertaken without the in-tention of involving human subjects. 1

8、c.120 Evaluation and disposition of applica-tions and proposals for research to be conducted or supported by a Federal De-partment or Agency. 1c.121 Reserved 1c.122 Use of Federal funds. 1c.123 Early termination of research sup-port: Evaluation of applications and pro-posals. 1c.124 Conditions. AUTH

9、ORITY: 5 U.S.C. 301; 42 U.S.C. 300v1(b). SOURCE: 56 FR 28012, 28018, June 18, 1991, unless otherwise noted. 1c.101 To what does this policy apply? (a) Except as provided in paragraph (b) of this section, this policy applies to all research involving human sub-jects conducted, supported or otherwise

10、subject to regulation by any federal de-partment or agency which takes appro-priate administrative action to make the policy applicable to such research. This includes research conducted by federal civilian employees or military personnel, except that each department or agency head may adopt such pr

11、oce-dural modifications as may be appro-priate from an administrative stand-point. It also includes research con-ducted, supported, or otherwise subject to regulation by the federal govern-ment outside the United States. (1) Research that is conducted or sup-ported by a Federal department or agency,

12、 whether or not it is regulated as defined in 1c.102(e), must comply with all sections of this policy. (2) Research that is neither con-ducted nor supported by a Federal de-partment or agency but is subject to regulation as defined in 1c.102(e) must be reviewed and approved, in compli-ance with 1c.1

13、01, 1c.102, and 1c.107 through 1c.117 of this policy, by an in-stitutional review board (IRB) that op-erates in accordance with the pertinent requirements of this policy. (b) Unless otherwise required by de-partment or agency heads, research ac-tivities in which the only involvement of human subject

14、s will be in one or VerDate Mar2010 11:10 Feb 02, 2012 Jkt 226012 PO 00000 Frm 00131 Fmt 8010 Sfmt 8010 Y:SGML226012.XXX 226012pmangrum on DSK3VPTVN1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-122 7 CFR Subtitle A (1112 Edition) 1c.1

15、01 more of the following categories are exempt from this policy: (1) Research conducted in established or commonly accepted educational set-tings, involving normal educational practices, such as (i) Research on reg-ular and special education instruc-tional strategies, or (ii) research on the effecti

16、veness of or the comparison among instructional techniques, cur-ricula, or classroom management methods. (2) Research involving the use of edu-cational tests (cognitive, diagnostic, aptitude, achievement), survey proce-dures, interview procedures or observa-tion of public behavior, unless: (i) Infor

17、mation obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) Any disclosure of the human sub-jects responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be d

18、amaging to the subjects financial standing, employability, or reputation. (3) Research involving the use of edu-cational tests (cognitive, diagnostic, aptitude, achievement), survey proce-dures, interview procedures, or obser-vation of public behavior that is not exempt under paragraph (b)(2) of thi

19、s section, if: (i) The human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) with-out exception that the confidentiality of the personally identifiable informa-tion will be maintained throughout the research and thereafter. (4

20、) Research, involving the collection or study of existing data, documents, records, pathological specimens, or di-agnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be iden-tified, directly or throug

21、h identifiers linked to the subjects. (5) Research and demonstration projects which are conducted by or sub-ject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise exam-ine: (i) Public benefit or service pro-grams; (ii) Procedures for obtaining ben

22、efits or services under those programs; (iii) possible changes in or alter-natives to those programs or proce-dures; or (iv) Possible changes in methods or levels of payment for benefits or serv-ices under those programs. (6) Taste and food quality evaluation and consumer acceptance studies, (i) if

23、wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or en-vironmental contaminant at or below the level found to be safe, by the Food and Drug Administration or app

24、roved by the Environmental Protection Agency or the Food Safety and Inspec-tion Service of the U.S. Department of Agriculture. (c) Department or agency heads re-tain final judgment as to whether a particular activity is covered by this policy. (d) Department or agency heads may require that specific

25、 research activities or classes of research activities con-ducted, supported, or otherwise subject to regulation by the department or agency but not otherwise covered by this policy, comply with some or all of the requirements of this policy. (e) Compliance with this policy re-quires compliance with

26、 pertinent fed-eral laws or regulations which provide additional protections for human sub-jects. (f) This policy does not affect any state or local laws or regulations which may otherwise be applicable and which provide additional protections for human subjects. (g) This policy does not affect any

27、foreign laws or regulations which may otherwise be applicable and which pro-vide additional protections to human subjects of research. (h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ

28、 from those set forth in this policy. An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) VerDate Mar2010 11:10 Feb 02, 2012 Jkt 226012 PO 00000 Frm 00132 Fmt 8010 Sfmt 8010 Y:SGML226012.XXX

29、226012pmangrum on DSK3VPTVN1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-123 Office of the Secretary, USDA 1c.102 1Institutions with HHS-approved assur-ances on file will abide by provisions of title 45 CFR part 46 subparts AD. Some o

30、f the other Departments and Agencies have incor-porated all provisions of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving

31、 survey or interview procedures or observation of public behavior, does not apply to research with children, subpart D, except for research in-volving observations of public behavior when the investigator(s) do not participate in the activities being observed. issued either by sovereign states or by

32、 an organization whose function for the protection of human research subjects is internationally recognized. In these circumstances, if a department or agency head determines that the proce-dures prescribed by the institution af-ford protections that are at least equivalent to those provided in this

33、 policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the proce-dural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the de-partment or agency head, notices of these actions as they occur will be

34、 pub-lished in the FEDERAL REGISTER or will be otherwise published as provided in department or agency procedures. (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific re-search activities or classes

35、of research activities otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de-partment or agency head shall forward advance notices of these actions to the Office for Human Research Protec-tions, Department of Health and Human Services (HHS), or any su

36、c-cessor office, and shall also publish them in the FEDERAL REGISTER or in such other manner as provided in de-partment or agency procedures.156 FR 28012, 28018, June 18, 1991; 56 FR 29756, June 28, 1991, as amended at 70 FR 36328, June 23, 2005 1c.102 Definitions. (a) Department or agency head mean

37、s the head of any federal department or agency and any other officer or em-ployee of any department or agency to whom authority has been delegated. (b) Institution means any public or private entity or agency (including fed-eral, state, and other agencies). (c) Legally authorized representative mean

38、s an individual or judicial or other body authorized under applicable law to consent on behalf of a prospec-tive subject to the subjects participa-tion in the procedure(s) involved in the research. (d) Research means a systematic in-vestigation, including research devel-opment, testing and evaluatio

39、n, de-signed to develop or contribute to gen-eralizable knowledge. Activities which meet this definition constitute re-search for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration a

40、nd service programs may include research activities. (e) Research subject to regulation, and similar terms are intended to encom-pass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, In-vestigational N

41、ew Drug requirements administered by the Food and Drug Ad-ministration). It does not include re-search activities which are inciden-tally regulated by a federal department or agency solely as part of the depart-ments or agencys broader responsi-bility to regulate certain types of ac-tivities whether

42、 research or non-re-search in nature (for example, Wage and Hour requirements administered by the Department of Labor). (f) Human subject means a living indi-vidual about whom an investigator (whether professional or student) con-ducting research obtains: (1) Data through intervention or interaction

43、 with the individual, or (2) Identifiable private information. Intervention includes both physical pro-cedures by which data are gathered (for VerDate Mar2010 11:10 Feb 02, 2012 Jkt 226012 PO 00000 Frm 00133 Fmt 8010 Sfmt 8010 Y:SGML226012.XXX 226012pmangrum on DSK3VPTVN1PROD with CFRProvided by IHS

44、Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-124 7 CFR Subtitle A (1112 Edition) 1c.103 example, venipuncture) and manipula-tions of the subject or the subjects en-vironment that are performed for re-search purposes. Interaction includes communication or interpe

45、rsonal con-tact between investigator and subject. Private information includes infor-mation about behavior that occurs in a context in which an individual can rea-sonably expect that no observation or recording is taking place, and informa-tion which has been provided for spe-cific purposes by an in

46、dividual and which the individual can reasonably expect will not be made public (for ex-ample, a medical record). Private infor-mation must be individually identifi-able (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the in-formation) in or

47、der for obtaining the information to constitute research in-volving human subjects. (g) IRB means an institutional review board established in accord with and for the purposes expressed in this pol-icy. (h) IRB approval means the deter-mination of the IRB that the research has been reviewed and may

48、be con-ducted at an institution within the constraints set forth by the IRB and by other institutional and federal require-ments. (i) Minimal risk means that the prob-ability and magnitude of harm or dis-comfort anticipated in the research are not greater in and of themselves than those ordinarily e

49、ncountered in daily life or during the performance of rou-tine physical or psychological exami-nations or tests. (j) Certification means the official no-tification by the institution to the sup-porting department or agency, in ac-cordance with the requirements of this policy, that a research project or activ-ity involving human subjects has been reviewed and approved by an IRB in ac-cordance with an approved assurance. 1c.103 Assuring compliance with t