Guidelines and Documentation Requirements for Research Involving Human and Animal Subjects

APPENDIX 1

Applicable Authorities

Federal statutes, Executive Orders, federal regulations, policies, and guidelines have been issued concerning many types of research activities involving human subjects. Although NIST may not be directly named in these authorities, to ensure that research involving human subjects funded by NIST is consistent with national policy, NIST hereby declares that it will fully adhere to these authorities. Shown below is a partial list of the statutes, regulations, policies, and guidelines applicable to research involving human subjects and research involving vertebrate animal subjects. The proposer is advised to read and comply with all applicable authorities when submitting a proposal.

• Animal Welfare Act. 1966. Pub. L. No. 89-544, as amended, codified at 7 U.S.C. §§ 2131-2159. Available at
  http://www.aphis.usda.gov/ac/publications.html#awa.
• National Research Council. 1996. Guide for the Care and Use of Laboratory Animals. Washington, DC: National Academies Press. Available at
  http://www.nap.edu/readingroom/books/labrats.
• Research on Transplantation of Human Fetal Tissue:
  http://ohrp.osophs.dhhs.gov/humansubjects/guidance/publiclaw103-43.htm.
• Office of Laboratory Animal Welfare of the Public Health Service:
  http://grants.nih.gov/grants/olaw/olaw.htm.
• U.S. Department of Commerce. Protection of Human Subjects. 15 C.F.R. Part 27. Available at
  http://www.access.gpo.gov/nara/cfr/waisidx_99/15cfr27_99.html.
• U.S. Department of Health and Human Services. Protection of Human Subjects. 45 C.F.R. Part 46. Available at
  http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

Return to Table of Contents or go to Appendix 2.

Date created: February 3, 2004
Last updated: February 23, 2004