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NASA Program and Astronaut Badges, 81221.202 Description of the medal. and the NASA Flags as provided

The description of the Congressional herein, a report of each suspected vio

Space Medal of Honor, which was delation of this subpart (including the

signed by the Institute of Heraldry, uses of unauthorized NASA Insignias)

U.S. Army, is set forth in Appendix A or of questionable uses of the NASA

to this subpart. Each person awarded Seal, the NASA Insignia, the NASA

the Medal also shall receive a citation Logotype, NASA Program and Astro

describing the basis for the award. naut Badges, or the NASA Flags shall be submitted to the Inspector General, 8 1221.203 Nominations. NASA Headquarters, in accordance

(a) Formal nominations for award of with NASA Management Instruction

the Congressional Space Medal of 9950.1, “The NASA Investigations Pro

Honor on behalf of NASA will be gram.

made by the Administrator to the

President. Subpart 1221.2—The Congressional (b) Any person may recommend to Space Medal of Honor

the Administrator that an astronaut

be nominated for award of the Medal. AUTHORITY: Pub. L. 91-76, September 29, Such a recommendation must be in 1969.

writing, and must describe in concise SOURCE: 43 FR 15624, Apr. 14, 1978, unless detail the events believed to warrant otherwise noted.

award of the Medal. The recommenda

tion should, if appropriate, be accom8 1221.200 Scope.

panied by supporting documentation, This subpart establishes procedures

such as eyewitness statements, exfor nominating an astronaut for the

tracts from official records, sketches, Congressional Space Medal of Honor.

photographs, etc.

(c) All recommendations for nomina8 1221.201 Basis for award of the medal. tions submitted to the Administrator

or made on his own initiative will be (a) The standard of award for the

referred to the NASA Incentive Congressional Space Medal of Honor

Awards Board for the purpose of inis established by Pub. L. 91-76 (42

vestigating and making findings of U.S.C. 2461) which provides that the

fact and giving advice to the AdminisPresident may award the Medal to any

trator. "astronaut who in the performance of

(d) Any recommendation involving his duties has distinguished himself by

an astronaut who is a member of the exceptionally meritorious efforts and

armed services on active duty or who contributions to the welfare of the

is employed by another agency of the Nation and of mankind.”

Federal Government but temporarily (b) Only one Congressional Space

assigned or detailed to NASA shall Medal of Honor may be awarded to a also be transmitted to the Secretary of person. However, for each succeeding Defense or the head of the employing act that would otherwise justify the agency, as appropriate, for his or her award of the Medal, the President recommendation. may award a suitable bar or other (e) The Administrator will forward device.

to the President his recommendation, (c) The Medal may be awarded to and that of the astronaut's employing any person who is or has been desig agency, as appropriate. nated to travel in space and who has distinguished himself or herself while § 1221.204 Proceedings of the NASA Inundertaking duties in preparation for,

centive Awards Board. execution of, or subsequent to, but in The NASA Incentive Awards Board connection with, a space flight.

shall thoroughly consider the facts (d) The Medal may be awarded for giving rise to a recommendation for actions occurring before the effective nomination and shall prepare a report date of this Subpart 1221.2, and, when for the Administrator. The Board appropriate, posthumously.

should, to the extent practicable, co

CABLE NOS. OF COLORS

ordinate its efforts with those of the astronaut's employing agency, as appropriate. Its final report must take

Gold.. into account any pertinent information submitted by the employing Red ...... agency.

White...

Dark Blue ......... Blue..........

65021 (old gold). 70076 (independence blue). 65014 (light blue). 65006 (scarlet). 65005.

APPENDIX A TO PART 1221CONGRESSIONAL SPACE MEDAL OF HONOR

OBVERSE

DESCRIPTION A circular green enamel wreath of laurel surmounted by a five-pointed gold star (with vertical point downward) and issuing from between each point a gold flame, the star surmounted by a light blue enamel cloud bank with five lobes edged in gold bearing a five-pointed dark blue enamel star fimbriated gold and charged in center with a diamond; standing upon the wreath at top center a gold eagle with wings displayed.

SYMBOLISM The scarlet center line on the white band symbolizes the courage of the astronauts in the nation's manned space program and the fire power of rockets that carry the crew through the earth's atmosphere (light blue); the light blue is the same color as the chief of the shield of the coat of arms of the United States which appears on the President's flag. The dark blue symbolizes the hostile environment of space, the gold edge representing success and accomplishment. Red, white and blue are also the national colors of the United States.

MINIATURE

DESCRIPTION A one-half size replica of the medal and suspension ribbon approximately 256 inches in overall length.

LAPEL EMBLEM

SYMBOLISM The laurel wreath, a symbol of great achievement, with the overlapping star points, simulates space vehicles moving to greater accomplishments through space. The flames signify the dynamic energy of the rocket era and the imagination of the men in the space program of the United States. The stylized glory cloud alludes to the glory in the coat of arms of the United States and to the high esteem of the award. The dark blue voided star symbolizes the vast mysteries of outer space while the bril. liancy of the feat is represented by a diamond. The eagle with wings raised in the spirit of peace represents man's first landing on another planet.

DESCRIPTION A miniature of the obverse of the medal, %6 inch in diameter, all gold with a diamond in center.

ROSETTE

DESCRIPTION One-half inch in diameter in the colors of the ribbon.

REVERSE

PART 1230 PROTECTION OF

HUMAN SUBJECTS

DESCRIPTION The reverse bears in center the inscription “CONGRESSIONAL” arranged in a semicircle above the inscription “SPACE MEDAL PRESENTED TO"; in base is space for the name of the recipient and the date all within an outer circle of fifty stars.

SUSPENSION RIBBON

Sec. 1230.101 To what does this policy apply? 1230.102 Definitions. 1230.103 Assuring compliance with this

policy-research conducted or supported

by any Federal Department or Agency. 1230.104 [Reserved) 1230.105 (Reserved) 1230.106 (Reserved) 1230.107 IRB Membership. 1230.108 IRB functions and operations. 1230.109 IRB review of research. 1230.110 Expedited review procedures for

certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

DESCRIPTION A ribbon 1% inches in width consisting of the following vertical stripes: gold 46 inch, dark blue 44 inch, light blue %2 inch, white Yno inch, red 410 inch, white Yuo inch, light blue %2 inch, dark blue Y4 inch, gold 416 inch.

Sec.

$ 1230.107 through $ 1230.117 of this 1230.111 Criteria for IRB approval of re

policy, by an institutional review search.

board (IRB) that operates in accord1230.112 Review by institution. 1230.113 Suspension or termination of IRB

ance with the pertinent requirements approval of research.

of this policy. 1230.114 Cooperative research.

(b) Unless otherwise required by de1230.115 IRB records.

partment or agency heads, research 1230.116 General requirements for in activities in which the only involveformed consent.

ment of human subjects will be in one 1230.117 Documentation of informed con

or more of the following categories are sent. 1230.118 Applications and proposals lack

exempt from this policy: ing definite plans for involvement of

(1) Research conducted in estabhuman subjects.

lished or commonly accepted educa1230.119 Research undertaken without the tional settings, involving normal edu

intention of involving human subjects. cational practices, such as (i) research 1230.120 Evaluation and disposition of ap on regular and special education inplications and proposals for research to

structional strategies, or (ii) research be conducted or supported by a Federal

on the effectiveness of or the compariDepartment or Agency. 1230.121 (Reserved)

son among instructional techniques, 1230.122 Use of Federal funds.

curricula, or classroom management 1230.123 Early termination of research methods.

support: Evaluation of applications and (2) Research involving the use of proposals.

educational tests (cognitive, diagnos1230.124 Conditions.

tic, aptitude, achievement), survey AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 300v procedures, interview procedures or 1(b).

observation of public behavior, unless: SOURCE: 56 FR 28012, 28019, June 18, 1991, (i) Information obtained is recorded unless otherwise noted.

in such a manner that human subjects

can be identified, directly or through 8 1230.101 To what does this policy apply? identifiers linked to the subjects; and

(a) Except as provided in paragraph (ii) any disclosure of the human sub(b) of this section, this policy applies jects' responses outside the research to all research involving human sub could reasonably place the subjects at jects conducted, supported or other risk of criminal or civil liability or be wise subject to regulation by any fed- damaging to the subjects' financial eral department or agency which takes standing, employability, or reputation. appropriate administrative action to (3) Research involving the use of make the policy applicable to such re educational tests (cognitive, diagnossearch. This includes research con- tic, aptitude, achievement), survey ducted by federal civilian employees or procedures, interview procedures, or military personnel, except that each observation of public behavior that is department or agency head may adopt not exempt under paragraph (b)(2) of such procedural modifications as may this section, if: be appropriate from an administrative (i) The human subjects are elected standpoint. It also includes research or appointed public officials or candiconducted, supported, or otherwise dates for public office; or (ii) federal subject to regulation by the federal statute(s) require(s) without exception government outside the United States. that the confidentiality of the person

(1) Research that is conducted or ally identifiable information will be supported by a federal department or maintained throughout the research agency, whether or not it is regulated and thereafter. as defined in § 1230.102(e), must (4) Research, involving the colleccomply with all sections of this policy. tion or study of existing data, docu

(2) Research that is neither conduct ments, records, pathological speci. ed nor supported by a federal depart mens, or diagnostic specimens, if these ment or agency but is subject to regu sources are publicly available or if the lation as defined in g 1230.102(e) must information is recorded by the investi. be reviewed and approved, in compli- gator in such a manner that subjects ance with $ 1230.101, § 1230.102, and cannot be identified, directly or through identifiers linked to the sub (h) When research covered by this jects.

policy takes place in foreign countries, (5) Research and demonstration procedures normally followed in the projects which are conducted by or foreign countries to protect human subject to the approval of department subjects may differ from those set or agency heads, and which are de- forth in this policy. (An example is a signed to study, evaluate, or otherwise foreign institution which complies examine:

with guidelines consistent with the (1) Public benefit or service pro

World Medical Assembly Declaration grams; (ii) procedures for obtaining (Declaration of Helsinki amended benefits or services under those pro 1989) issued either by sovereign states grams; (iii) possible changes in or al. or by an organization whose function ternatives to those programs or proce for the protection of human research dures; or (iv) possible changes in meth

subjects is internationally recognized.) ods or levels of payment for benefits In these circumstances, if a departor services under those programs.

ment or agency head determines that (6) Taste and food quality evaluation

the procedures prescribed by the instiand consumer acceptance studies, (i) if tution afford protections that are at wholesome foods without additives are least equivalent to those provided in consumed or (ii) if a food is consumed

this policy, the department or agency that contains a food ingredient at or head may approve the substitution of below the level and for a use found to the foreign procedures in lieu of the be safe, or agricultural chemical or en procedural requirements provided in vironmental contaminant at or below

this policy. Except when otherwise rethe level found to be safe, by the Food

quired by statute, Executive Order, or and Drug Administration or approved the department or agency head, noby the Environmental Protection tices of these actions as they occur will Agency or the Food Safety and Inspec

be published in the FEDERAL REGISTER tion Service of the U.S. Department of

or will be otherwise published as proAgriculture.

vided in department or agency proce(c) Department or agency heads

Department or agency heads dures. retain final judgment as to whether a (i) Unless otherwise required by law, particular activity is covered by this

department or agency heads may policy.

waive the applicability of some or all (d) Department or agency heads

of the provisions of this policy to spemay require that specific research ac

cific research activities or classes of retivities or classes of research activities

search activities otherwise covered by conducted, supported, or otherwise

this policy. Except when otherwise resubject to regulation by the depart quired by statute or Executive Order, ment or agency but not otherwise cov. the department or agency head shall ered by this policy, comply with some forward advance notices of these acor all of the requirements of this

tions to the Office for Protection from policy.

Research Risks, Department of Health (e) Compliance with this policy re

and Human Services (HHS), and shall quires compliance with pertinent fed

also publish them in the FEDERAL REGeral laws or regulations which provide

ISTER or in such other manner as proadditional protections for human sub

vided in department or agency procejects.

dures. |(f) This policy does not affect any state or local laws or regulations 1 Institutions with HHS-approved assurwhich may otherwise be applicable ances on file will abide by provisions of title and which provide additional protec 45 CFR part 46 subparts A-D. Some of the tions for human subjects.

other Departments and Agencies have in(g) This policy does not affect any

corporated all provisions of title 45 CFR

part 46 into their policies and procedures as foreign laws or regulations which may

well. However, the exemptions at 45 CFR otherwise be applicable and which 46.101(b) do not apply to research involving provide additional protections to prisoners, fetuses, pregnant women, or human subjects of research.

Continued

(56 FR 28012, 28019, June 18, 1991; 56 FR 29756, June 28, 1991)

8 1230.102 Definitions.

(a) Department or agency head means the head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated.

(b) Institution means any public or private entity or agency (including federal, 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 prospective subject to the subject's participation in the procedure(s) involved in the research.

(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research 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 and service programs may include research activities.

(e) Research subject to regulation, and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal de partment or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or nonresearch in nature (for example, Wage

and Hour requirements administered by the Department of Labor).

(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) Data through intervention or interaction with the individual, or

(2) Identifiable private information. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

(g) IRB means an institutional review board established in accord with and for the purposes expressed in this policy.

(h) IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

(i) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

(j) Certification means the official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or

human in vitro fertilization, subparts B and 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 chil. dren, subpart D, except for research involv. ing observations of public behavior when the investigator(s) do not participate in the activities being observed.

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