DOT 49 CFR PART 11-2010 PROTECTION OF HUMAN SUBJECTS.pdf

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1、99 Office of the Secretary of Transportation 11.101 (c)(3) (Accounting of Certain Disclosures), (d) (Access to Records), (e)(4) (G), (H) and (I) (Agency Requirements), and (f) (Agency Rules) of 5 U.S.C. 552a: 1. Investigative Record System maintained by the Assistant Inspector General for Inves-tiga

2、tions in the Office of the Inspector Gen-eral (DOT/OST 100). 2. Personnel Security Records System, maintained by the Office of Investigations and Security, Office of the Secretary (DOT/ OST 016). 3. Civil Aviation Security System (DOT/ FAA 813), maintained by the Office of Civil Aviation Security, F

3、ederal Aviation Admin-istration. The purpose of these exemptions is to pre-vent the disclosure of material authorized to be kept secret in the interest of national de-fense or foreign policy, in accordance with 5 U.S.C. 552(b)(1) and 552a(k)(1). G. Those portions of the following systems of records

4、which consist of information prop-erly classified in the interest of national de-fense or foreign policy in accordance with 5 U.S.C. 552a(b)(1) are exempt from subsections (c)(3) (Accounting of Certain Disclosures) and (d) (Access to Records) of 5 U.S.C. 552a: 1. Investigative Record System (DOT/FAA

5、 815) maintained by the Federal Aviation Ad-ministration at the Office of Civil Aviation Security in Washington, DC; the FAA re-gional Civil Aviation Security Divisions; the Civil Aviation Security Division at the Mike Monroney Aeronautical Center in Oklahoma City, Oklahoma; the FAA Civil Aviation S

6、e-curity Staff at the FAA Technical Center in Atlantic City, New Jersey; and the various Federal Records Centers located throughout the country. The purpose of these exemptions is to pre-vent the disclosure of material authorized to be kept secret in the interest of national de-fense or foreign poli

7、cy, in accordance with 5 U.S.C. 552(b)(1) and 552a(k)(1). 45 FR 8993, Feb. 11, 1980, as amended at 58 FR 67697, Dec. 22, 1993; 59 FR 13662, Mar. 23, 1994; 60 FR 43983, Aug. 24, 1995. Redesignated at 62 FR 23667, May 1, 1997, as amended at 63 FR 2172, Jan. 14, 1998; 63 FR 4197, Jan. 28, 1998; 66 FR 2

8、0407, Apr. 23, 2001; 73 FR 33329, June 12, 2008; 75 FR 5244, Feb. 2, 2010 PART 11PROTECTION OF HUMAN SUBJECTS Sec. 11.101 To what does this policy apply? 11.102 Definitions. 11.103 Assuring compliance with this pol-icyresearch conducted or supported by any Federal Department or Agency. 11.10411.106

9、Reserved 11.107 IRB membership. 11.108 IRB functions and operations. 11.109 IRB review of research. 11.110 Expedited review procedures for cer-tain kinds of research involving no more than minimal risk, and for minor changes in approved research. 11.111 Criteria for IRB approval of research. 11.112

10、Review by institution. 11.113 Suspension or termination of IRB ap-proval of research. 11.114 Cooperative research. 11.115 IRB records. 11.116 General requirements for informed consent. 11.117 Documentation of informed consent. 11.118 Applications and proposals lacking definite plans for involvement

11、of human subjects. 11.119 Research undertaken without the in-tention of involving human subjects. 11.120 Evaluation and disposition of applica-tions and proposals for research to be conducted or supported by a Federal De-partment or Agency. 11.121 Reserved 11.122 Use of Federal funds. 11.123 Early t

12、ermination of research sup-port: Evaluation of applications and pro-posals. 11.124 Conditions. AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 300v1(b). SOURCE: 56 FR 28012, 28023, June 18, 1991, unless otherwise noted. 11.101 To what does this policy apply? (a) Except as provided in paragraph (b) of this sectio

13、n, this policy applies to all research involving human sub-jects conducted, supported or otherwise 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 civ

14、ilian employees or military personnel, except that each department or agency head may adopt such proce-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

15、 the United States. (1) Research that is conducted or sup-ported by a federal department or agency, whether or not it is regulated as defined in 11.102(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 su

16、bject to regulation as defined in 11.102(e) must VerDate Mar2010 10:00 Dec 22, 2010 Jkt 220212 PO 00000 Frm 00109 Fmt 8010 Sfmt 8010 Y:SGML220212.XXX 220212jdjones on DSK8KYBLC1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-100 49 CFR S

17、ubtitle A (10110 Edition) 11.101 be reviewed and approved, in compli-ance with 11.101, 11.102, and 11.107 through 11.117 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 o

18、r agency heads, research ac-tivities in which the only involvement of human subjects will be in one or 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) r

19、esearch on reg-ular and special education instruc-tional strategies, or (ii) research on the effectiveness 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, achievem

20、ent), survey proce-dures, interview procedures or observa-tion of public behavior, unless: (i) Information 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 out

21、side the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation. (3) Research involving the use of edu-cational tests (cognitive, diagnostic, aptitude, achievement), survey proce-dures, inter

22、view procedures, or obser-vation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) The human subjects are elected or appointed public officials or candidates for public office; or (ii) federal stat-ute(s) require(s) without exception that the confidentiality of th

23、e personally identifiable information will be main-tained throughout the research and thereafter. (4) 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 r

24、ecorded by the investigator in such a manner that subjects cannot be iden-tified, directly or through 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, evaluat

25、e, or otherwise exam-ine: (i) Public benefit or service pro-grams; (ii) procedures for obtaining benefits or services under those pro-grams; (iii) possible changes in or al-ternatives to those programs or proce-dures; or (iv) possible changes in meth-ods or levels of payment for benefits or services

26、 under those programs. (6) Taste and food quality evaluation and consumer acceptance studies, (i) if 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-viron

27、mental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved 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 pa

28、rticular activity is covered by this policy. (d) Department or agency heads may require that specific 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

29、 or all of the requirements of this policy. (e) Compliance with this policy re-quires compliance with 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 applica

30、ble and which provide additional protections for human subjects. (g) This policy does not affect any 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

31、countries, VerDate Mar2010 10:00 Dec 22, 2010 Jkt 220212 PO 00000 Frm 00110 Fmt 8010 Sfmt 8010 Y:SGML220212.XXX 220212jdjones on DSK8KYBLC1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-101 Office of the Secretary of Transportation 11.1

32、02 1Institutions with HHS-approved assur-ances on file will abide by provisions of title 45 CFR part 46 subparts AD. Some of 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 46.1

33、01(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving 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 beh

34、avior when the investigator(s) do not participate in the activities being observed. procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. An example is a foreign institution which complies with guidelines consistent with the W

35、orld Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by 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 proc

36、e-dures prescribed by the institution af-ford protections that are at least equivalent to those provided in this 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 require

37、d by statute, Executive Order, or the de-partment or agency head, notices of these actions as they occur will be 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 waiv

38、e the applicability of some or all of the provisions of this policy to specific re-search activities or classes 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

39、 actions to the Office for Human Research Protec-tions, Department of Health and Human Services (HHS), or any suc-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, 28023, June 18, 1991; 56 FR 29756

40、, June 28, 1991, as amended at 70 FR 36328, June 23, 2005 11.102 Definitions. (a) Department or agency head means 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 priv

41、ate entity or agency (including fed-eral, state, and other agencies). (c) Legally authorized representative means 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

42、research. (d) Research means a systematic in-vestigation, including research devel-opment, testing and evaluation, 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

43、 or supported under a program which is considered research for other purposes. For example, some demonstration and 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 departme

44、nt or agency has specific responsibility for regulating as a research activity, (for example, In-vestigational New 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

45、 as part of the depart-ments or agencys broader responsi-bility to regulate certain types of ac-tivities whether 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 investiga

46、tor (whether professional or student) con-ducting research obtains (1) Data through intervention or interaction with the individual, or VerDate Mar2010 10:00 Dec 22, 2010 Jkt 220212 PO 00000 Frm 00111 Fmt 8010 Sfmt 8010 Y:SGML220212.XXX 220212jdjones on DSK8KYBLC1PROD with CFRProvided by IHSNot for

47、ResaleNo reproduction or networking permitted without license from IHS-,-,-102 49 CFR Subtitle A (10110 Edition) 11.103 (2) Identifiable private information. Intervention includes both physical pro-cedures by which data are gathered (for example, venipuncture) and manipula-tions of the subject or th

48、e subjects en-vironment that are performed for re-search purposes. Interaction includes communication or interpersonal 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 ob

49、servation or recording is taking place, and informa-tion which has been provided for spe-cific purposes by an individual 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 order for obtaining the information to constitute