Attachment J.8 - NHTSA Order 700-5.pdf

U.S. Department ORDER #: 700-5 of Transportation Date of Issuance: November 8, 2006

National Highway Traffic Safety Administration

Subject: PROTECTION OF HUMAN SUBJECTS, HUMAN SURROGATES AND ANIMAL

SUBJECTS IN NHTSA CONDUCTED, SPONSORED OR REGULATED RESEARCH

PARAGRAPH: 1. Purpose 5. Policy

2. Effect on Other Directives 6. Responsibilities

3. References 7. Appendices

4. Definitions

1. PURPOSE. This Order establishes policy and procedures for the use and protection of human subjects, human surrogates and animal subjects in research performed, funded or regulated, in whole or in part, by the National Highway Traffic Safety Administration (NHTSA).

2. EFFECT ON OTHER DIRECTIVES. This Order supersedes NHTSA Orders 700-1, dated November 4, 1981 (Subject: Protection of the Rights and Welfare of Human Subjects in NHTSA-Sponsored Experiments), 700-3, dated June 30, 1980 (Subject: Human Use Review Panel), and 700-4, dated April 24, 1979 (Subject: Ethical Use of Human Surrogates in NHTSA-Sponsored Experiments). This Order is intended to set forth minimum requirements for the protection of human subjects, human surrogates and animal subjects in NHTSA conducted, sponsored or regulated research. It does not prevent entities conducting covered research from applying more rigorous review procedures or extending additional protections to research subjects, whether pursuant to institutional policy or state or local laws or regulations.

3. REFERENCES. The policy and procedures detailed in this Order incorporate by reference certain requirements of 45 C.F.R. Part 46 (the Department of Health and Human Services’ (HHS) Policy for Protection of Human Research Subjects) and 49 C.F.R. Part 11 (Department of Transportation (DOT) Policy for Protection of Human Subjects), primarily pertaining to the process for establishing an Institutional Review Board (IRB).

4.

DISTRIBUTION: NHTSA “C” – Headquarters thru Division level OPI: NCC-113 NHTSA Regional Offices

DEFINITIONS.

a. “Animal Subject” means a live, vertebrate animal used as an integral part of a test, experiment, or other evaluation procedure.

NHTSA Order 700-5 November 8, 2006

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b. “Certification” means an official statement by a contractor or funding recipient to NHTSA, affirming that research involving human subjects or human surrogates has been reviewed and approved by an Institutional Review Board (IRB) provided for in a current HHS-Approved Assurance, and will be subject to continuing review by the IRB. Certification as it relates to human research subjects and human surrogates is different than the Certification of Humane Care and Use of Animal Research Subjects required under this policy as it relates to use of animal subjects.

c. “Certification of Humane Care and Use of Animal Research Subjects” is the official set of assurances set forth in Appendix A that must be executed by an officer of the contractor or funding recipient authorized to bind the entity conducting the research prior to the commencement of any research activity covered under this policy involving animal subjects.

d. HHS-Approved Assurance” means a current assurance appropriate for the research in question, on file with the Office for Protection from Research Risks, HHS, and approved for federal-wide use by that office.

e. “Human Subject” means a living individual about whom an investigator conducting research obtains:

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

(2) Identifiable private information, which 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 its collection to constitute research involving human subjects.

d. “Human Surrogate” means a deceased person or portion thereof used as an integral part of a test, experiment, or other evaluation procedure.

5. POLICY.

a. Human Subjects and Human Surrogates

(1) No research activity performed, funded or regulated, in whole or in part, by NHTSA may involve human subjects or human surrogates unless:

(a) The research has been reviewed and approved by an Institutional Review Board (“IRB”), established in accordance with the requirements of 49 C.F.R. Part 11 and 45 C.F.R. Part 46, with a current assurance appropriate for the research in question approved by and on file with the Office for Protection from Research Risks, HHS;

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(b) The IRB that initially reviewed and approved the research will subject it to continuing review at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third-party observe the consent process and research; and

(c) Prior to commencement of the research, the contractor or funding recipient submits to

NHTSA a certification of IRB review and approval, and of continuing IRB review, and, unless NHTSA already has a copy of its current assurance on file with HHS, a copy of the applicable assurance, which shall be retained by the program office overseeing the research.

(2) This policy does not apply to research activity involving adult human subjects in which the only involvement of these subjects is in connection with the use of educational tests, survey procedures, interview procedures or observation of public behavior, unless:

(a) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to subjects; and

(b) Any disclosure of human subjects’ responses outside 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) This policy applies to all research activity with children involving survey or interview procedures or observations of public behavior, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

b. Animal Subjects

(1) No research activity performed, funded or regulated, in whole or in part, by NHTSA may involve animal subjects unless the contractor or funding recipient involved in the research has submitted to NHTSA the Certification of Humane Care and Use of Animal Research Subjects set forth in Appendix A, executed by an officer of the contractor or funding recipient authorized to bind the entity conducting the research; and

(2) The contractor or funding recipient planning to conduct the research has identified in its proposal the following information:

(a) The species and approximate number of animal subjects to be used;

(b) The rationale for involving animals, and the appropriateness of the species and numbers used;

(c) A complete description of the proposed use of the animals;

(d) A description of procedures to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that

-4-analgesic, anesthetic, and tranquilizing drugs will be used where appropriate to minimize discomfort and pain to animals;

(e) A description of any euthanasia methods to be used; and

(f) The education, training and experience of all animal health professionals who will be supervising the use of the animals and all treatments, drugs and procedures administered to such animals.

6. RESPONSIBILITIES.

a. The Senior Associate Administrator for the program responsible for the research involving human subjects, human surrogates or animal subjects shall:

(1) Prior to the approval of the research, notify the Administrator in writing of the proposed research;

(2) With respect to research involving human subjects or human surrogates, prior to the commencement of the research, ensure that the program office involved has obtained from the entity performing the research a certification of IRB review and approval satisfying the requirements of this Order and, unless NHTSA already has a copy of the current assurance on file with HHS, a copy of the applicable assurance;

(3) With respect to research involving animal subjects, prior to the commencement of the research, ensure that the program office involved has obtained from the entity performing the research a properly executed Certification of Humane Care and Use of Animal Research Subjects (see Appendix A).

b. The Director, Contracts and Procurement, shall ensure that each NHTSA solicitation, contract, cooperative agreement or grant that involves or may involve human subjects, human surrogates or animal subjects, contains the appropriate special contract provision set forth in Appendix B.

7. APPENDICES. Following and appended are the documents referenced in this Order.

a. Appendix A - Certification of Humane Care and Use of Animal Research Subjects

b. Appendix B - Special Provisions For Contracts or Assistance Agreements Involving the Use of Human Subjects, Human Surrogates or Animal Subjects

APPENDIX A

CERTIFICATION OF HUMANE CARE

AND USE OF ANIMAL RESEARCH SUBJECTS

It is the policy of the National Highway Traffic Safety Administration that all research using animal subjects performed, funded or regulated, in whole or in part, by the agency be performed in accordance with the following Principles:

I. The transportation, care, and use of animals should be in accordance with applicable Federal laws, guidelines, and policies.

II. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, and the good of society.

III. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.

IV. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in animals.

V. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.

VI. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.

VII. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.

VIII. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.

IX. Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.

I certify that, in conducting research using animal subjects, all involved researchers and personnel will adhere to the Principles on Humane Care and Use of Animal Research Subjects set forth above.

Signature Date

Name

Title

Contractor/Funding Recipient

NHTSA Contract or Agreement Number

APPENDIX B

SPECIAL PROVISIONS FOR CONTRACTS AND ASSISTANCE AGREEMENTS INVOLVING

THE USE OF HUMAN SUBJECTS, HUMAN SURROGATES AND ANIMAL SUBJECTS

Protection of Human Subjects (Special Provision #__)

The [contractor/funding recipient]* shall comply fully with 49 C.F.R. Part 11, DOT’s regulation governing Protection of Human Subjects, and with NHTSA Order 700-5, which sets forth the Agency’s policies and procedures for the protection of human subjects participating in research supported directly or indirectly by NHTSA, including through contracts, grants and cooperative agreements.

Protection of Human Surrogates (Special Provision #__)

The [contractor/funding recipient]* shall comply fully with NHTSA Order 700-5, which sets forth the Agency’s policies and procedures for the protection of human surrogates used in research supported directly or indirectly by NHTSA, including through contracts, grants and cooperative agreements.

Humane Care and Use of Animal Research Subjects (Special Provision #__)

The [contractor/funding recipient]* shall comply fully with NHTSA Order 700-5 which sets forth the Agency’s policies and procedures for the humane care and use of animal subjects used in research supported directly or indirectly by NHTSA, including through contracts, grants and cooperative agreements.

*Select “contractor” if the funding instrument is a contract or “funding recipient” if the funding instrument is a grant or cooperative agreement.