« PreviousContinue »
ticipation, a description of the procedures to be followed, and identifica. tion of any procedures which are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject;
(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed
sent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
(3) Any additional costs to the subject that may result from participation in the research;
(4)The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
(6) The approximate number of subjects involved in the study.
(c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:
(1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) Public benefit of 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; and
(2) The research could not practicably be carried out without the waiver or alteration.
(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could not practicably be carried out without the waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
(e) The informed consent require- (c) An IRB may waive the requirements in this policy are not intended ment for the investigator to obtain a to preempt any applicable federal, signed consent form for some or all state, or local laws which require addi. subjects if it finds either: tional information to be disclosed in (1) That the only record linking the order for informed consent to be legal subject and the research would be the ly effective.
consent document and the principal (f) Nothing in this policy is intended
risk would be potential harm resulting to limit the authority of a physician to
from a breach of confidentiality. Each provide emergency medical care, to
subject will be asked whether the subthe extent the physician is permitted
ject wants documentation linking the to do so under applicable federal,
subject with the research, and the substate, or local law.
ject's wishes will govern; or (Approved by the Office of Management (2) That the research presents no and Budget under control number 9999– more than minimal risk of harm to 0020)
subjects and involves no procedures 8 1230.117 Documentation of informed
for which written consent is normally
required outside of the research conconsent.
text. (a) Except as provided in paragraph
In cases in which the documentation (c) of this section, informed consent
requirement is waived, the IRB may shall be documented by the use of a
require the investigator to provide written consent form approved by the
subjects with a written statement reIRB and signed by the subject or the
garding the research. subject's legally authorized representative. A copy shall be given to the (Approved by the Office of Management person signing the form.
and Budget under control number 9999(b) Except as provided in paragraph
0020) (c) of this section, the consent form may be either of the following:
8 1230.118 Applications and proposals (1) A written consent document that
lacking definite plans for involvement embodies the elements of informed
of human subjects. consent required by $1230.116. This Certain types of applications for form may be read to the subject or the grants, cooperative agreements, or subject's legally authorized represent contracts are submitted to departative, but in any event, the investiga ments or agencies with the knowledge tor shall give either the subject or the that subjects may be involved within representative adequate opportunity the period of support, but definite to read it before it is signed; or
plans would not normally be set forth (2) A short form written consent in the application or proposal. These document stating that the elements of include activities such as institutional informed consent required by type grants when selection of specific $ 1230.116 have been presented orally projects is the institution's responsibilto the subject or the subject's legally ity; research training grants in which authorized representative. When this the activities involving subjects remain method is used, there shall be a wit to be selected; and projects in which ness to the oral presentation. Also, the human subjects' involvement will IRB shall approve a written summary depend upon completion of instruof what is to be said to the subject or ments, prior animal studies, or purifithe representative. Only the short cation of compounds. These applicaform itself is to be signed by the sub tions need not be reviewed by an IRB ject or the representative. However, before an award may be made. Howevthe witness shall sign both the short er, except for research exempted or form and a copy of the summary, and waived under $1230.101 (b) or (i), no the person actually obtaining consent human subjects may be involved in shall sign a copy of the summary. A any project supported by these awards copy of the summary shall be given to until the project has been reviewed the subject or the representative, in and approved by the IRB, as provided addition to a copy of the short form. in this policy, and certification submitted, by the institution, to the depart. prescribed in applicable program rement or agency.
quirements, when the department or
agency head finds an institution has 8 1230.119 Research undertaken without
materially failed to comply with the the intention of involving human sub
terms of this policy. jects.
(b) In making decisions about supIn the event research is undertaken porting or approving applications or without the intention of involving proposals covered by this policy the human subjects, but it is later pro- department or agency head may take posed to involve human subjects in the into account, in addition to all other research, the research shall first be re eligibility requirements and program viewed and approved by an IRB, as criteria, factors such as whether the provided in this policy, a certification applicant has been subject to a termisubmitted, by the institution, to the nation or suspension under paragarph department or agency, and final ap- (a) of this section and whether the approval given to the proposed change plicant or the person or persons who by the department or agency.
would direct or has have directed the
scientific and technical aspects of an 8 1230.120 Evaluation and disposition of activity has have, in the judgment of applications and proposals for research
the department or agency head, mateto be conducted or supported by a Fed rially failed to discharge responsibility eral Department or Agency.
for the protection of the rights and The department or agency head will welfare of human subjects (whether or evaluate all applications and proposals not the research was subject to federal involving human subjects submitted to regulation). the department or agency through such officers and employees of the de- 8 1230.124 Conditions. partment or agency and such experts with respect to any research project and consultants as the department or or any class of research projects the agency head determines to be appro department or agency head may priate. This evaluation will take into impose additional conditions prior to consideration the risks to the subjects, or at the time of approval when in the the adequacy of protection against judgment of the department or agency these risks, the potential benefits of head additional conditions are neces. the research to the subjects and sary for the protection of human subothers, and the importance of the jects. knowledge gained or to be gained.
(b) On the basis of this evaluation, PART 1232_CARE AND USE OF ANIthe department or agency head may
MALS IN THE CONDUCT OF NASA approve or disapprove the application
ACTIVITIES or proposal, or enter into negotiations to develop an approvable one.
Sec. 8 1230.121 (Reserved]
1232.101 Applicability. 8 1230.122 Use of Federal funds.
1232.103 Definitions. Federal funds administered by a de
1232.104 Implementation procedures by partment or agency may not be ex
non-NASA institutions. pended for research involving human 1232.105 Implementation procedures by subjects unless the requirements of NASA field installations. this policy have been satisfied.
1232.106 Management authority and re
sponsibility. 8 1230.123 Early termination of research 1232.107 Sanctions. support: Evaluation of applications
AUTHORITY: 42 U.S.C. Sec. 2451; Pub. L. and proposals.
89-544, as amended; 7 U.S.C. Sec. 2131; 39 (a) The department or agency head U.S.C. Sec. 3001; 9 CFR Subchapter A Parts may require that department or 1, 2, 3, and 4; and Pub. L. 99–158, Sec. 495. agency support for any project be ter- SOURCE: 54 FR 35870, Aug. 30, 1989, unless minated or suspended in the manner otherwise noted.
8 1232.100 Scope.
This rule establishes the policy, implementation procedures, and management authority and responsibility for the care and use of vertebrate animals (hereinafter referred to as “animal subjects”) in the conduct of NASA activities.
8 1232.101 Applicability.
This rule applies to NASA Headquarters and NASA field installations and will be followed in all activities using animal subjects that are supported by NASA, conducted in NASA facilities, aircraft, or spacecraft, or which involve NASA to any degree. All activities using animal subjects conducted under a contract, grant, cooperative agreement, memorandum of understanding, or joint endeavor agreement entered into by NASA and another Government agency, private entity, non-Federal public entity, or foreign entity are included within the scope of this rule.
Use of Laboratory Animals (hereinafter referred to as PHS Policy) effective November 1, 1986.1
(b) This rule authorizes NASA to have the same authority for NASAsupported programs as that delegated to PHS by the PHS Policy, including the functions and responsibilities of the Animal Care and Use Committees (ACUC's).
(c) All research supported by N that involves activities using animal subjects shall be conducted under protocols that conform to this rule and that are reviewed and approved as prescribed in this rule. 8 1232.103 Definitions.
The following definitions of terms comply with the PHS Policy and apply to the conduct of all NASA activities related to the care and use of animal subjects.
(a) Activity includes research, testing of hardware for animal use, flight experimentation, and any other tasks involving the use of animal subjects.
(b) Animal is any live vertebrate animal.
(c) Animal Care and Use Committee (ACUC) is the committee established at each institution and NASA field installation involved in research with animal subjects. It is responsible for evaluating the care and use of animal subjects at the facility and for ensuring that the care and use of animal subjects at the facility is in compliance with this rule and PHS Policy.
(d) Authorized NASA Official is the Director, Life Sciences Division, NASA Headquarters, or designee, who is the NASA Administrator's representative and is responsible for all NASA activiand is responsible for all NA ties involving animal subjects. This individual is responsible for implementation of the provisions of this rule and for ensuring that agency programs involving animal subjects comply fully with all applicable laws, regulations, and guidelines.
8 1232.102 Policy.
(a) It is NASA policy to require its laboratories and the institutions performing NASA-supported activities using animal subjects to comply with the Animal Welfare Act of 1966 (Pub. L. 89-544), as amended (Pub. L. 91-579, Pub. L. 94-279, and Pub. L. 99-198), 7 U.S.C. 2131 et seq., and 39 U.S.C. 3001, and with the regulations promulgated thereunder by the Secretary of Agriculture (9 CFR Subchapter A Parts 1, 2, 3, and 4) pertaining to the care, handling, and treatment of animal subjects held or used for research, testing, teaching, or other activities supported by the Federal government. Investigators shall follow the guidelines described in the National Institutes of Health (NIH) Publication No. 85-23 (Rev. 1985), “Guide for the Care and Use of Laboratory Animals” (the Guide) or subsequent revisions. Attention is called to the U.S. Government "Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training” on pp. 81-83 of the Guide. In order to implement these guidelines and principles, investigators will comply with the revised Public Health Service (PHS) Policy on Humane Care and
1 Available from the Office of Protection from Research Risks (OPRR), National Institutes of Health, 9000 Rockville Pike, Bldg. 31, Room 5B59, Bethesda, MD 20892, Telephone 301-496–7005.
(e) Field Installation Director is the research involving the use of animal Director of a NASA Field Installation, subjects will be considered for NASA or designee, who is the institutional support, the NASA Headquarters Reofficial responsible for the care and search or Flight Program Manager use of animal subjects in research con must receive a statement that the reducted at that field installation and search has been reviewed in accordfor ensuring compliance with this rule ance with the PHS Policy (IV.C.) and at that field installation.
approved by the appropriate ACUC at (f) Investigator is any person who
the participating institution. uses or proposes to use live animal
(c) Proposal Approval for Flight Exsubjects in NASA-supported activities,
periments. In addition to the institue.g., receives funds, salaries, or support
tion's ACUC review, activities involvunder a grant, award, agreement, con
ing animal subjects to be flown on tract, or direct employment by NASA,
NASA spacecraft will be subject to or the use of any NASA facilities, air
review and approval by the Ames Recraft, or spacecraft for the purpose of
search Center (ARC) ACUC. The ARC carrying out research, tests, or experi
ACUC will submit each evaluation ments using animal subjects.
report to the ARC Director who will (g) PHS Assurance is a document
transmit the report with his/her recprepared by an awardee institution as
ommendation to the Authorized NASA suring its compliance with PHS Policy.
Official, NASA Headquarters. Animal (h) Research of Flight Program Man
activities to be flown onboard NASA ager is the NASA Headquarters man
manned spacecraft may also be subject ager of each program in which NASA
to review by the Human Research has a manifest interest. (i) Supported pertains to activities
Policy and Procedures Committee either funded in part or in whole by
(HRPPC) at the Johnson Space NASA or an approved activity that is
Center (JSC). Animal activities utiliznot funded by NASA but that utilizes
ing the facilities of any NASA field inNASA facilities, including spacecraft
stallation are also subject to approval and aircraft.
of that field installation's ACUC (j) Veterinarian is the NASA attend
(8 1232.105(d)). ing veterinarian, a person who has
(d) Institutions with PHS Assurance graduated from a veterinary school ac
on File. The institution, by an apcredited by the American Veterinary
proved or provisionally acceptable As
proved or provisi Medical Association's Council on Edu. surance on file at the NIH Office for cation or has a certificate issued by Protection from Research Risks the American Veterinary Medical As (OPRR), Department of Health and sociation's Education Commission for Human Services (HHS), assures NASA Foreign Veterinary Graduates, has re
that it will comply with the PHS ceived training and/or experience in Policy. The Assurance file number the care and management of the spe- must be included in the research procies being attended, and who has
posal submitted to NASA. direct or delegated authority and re (e) Institutions with no PHS Assursponsibility for activities involving ance on File. Proposals from instituanimal subjects at the NASA field in tions without an approved Assurance stallation.
on file with the NIH OPRR will first
be peer-reviewed for scientific merit. If 8 1232.104 Implementation procedures by the proposed research is deemed non-NASA institutions.
worthy of support, NASA will arrange (a) Proposal Information. No animal for a special Assurance to be negotiatsubjects may be utilized unless a pro ed by the Director, Life Sciences Diviposal justifying and describing their sion, NASA Headquarters. The aruse is submitted to NASA for approv- rangements for a special Assurance al. The required proposal information review by NIH should be undertaken is outlined in the PHS Policy in consultation with the NASA repre(IV.D.1.a.-e.).
sentative to the Interagency Research (b) Proposal Approval by the Insti- Animal Committee (IRAC) and will be tutional ACUC. Before a proposal for handled on a case-by-case basis.