Surgery
Volume 145, Issue 6 , Pages 626-630 , June 2009

The effect of the current regulatory environment on clinical research: An overview

  • Samuel R.G. Finlayson, MD, MPH

      Affiliations

    • Corresponding Author InformationReprint requests: Samuel R. G. Finlayson, MD, MPH, 1 Medical Center Drive, Lebanon, NH 03756.

,Accepted 13 March 2009.

References 

  1. Jones J. Bad blood: the Tuskegee syphilis experiment. New York: Free Press; 1993;
  2. Administrative Procedure Act (5 U.S.C. Subchapter II). Available from: http://www.archives.gov/federal-register/laws/administrative-procedure/.
  3. U.S. Department of Health and Human Services. Available from: http://www.hhs.gov/.
  4. Office of Science and Technology Policy. Federal Register. 2000;65:76260;Available from: http://www.sc.doe.gov/misconduct/finalpolicy.pdf
  5. NIH Grants Policy Statement. Available from: http://grants.nih.gov/grants/policy/NIHGPS/part_ii_2.htm.
  6. National Science Foundation Grant Policy Manual. Available from: http://www.nsf.gov/pubs/manuals/gpm05_131/gpm5.jsp#bfn10.
  7. AAMC Principles for Protecting Integrity. Available from: http://www.aamc.org/research/clinicaltrialsreporting/start.htm.
  8. National Academy of Sciences, National Academy of Engineering, Institute of Medicine . On being a scientist: responsible conduct in research. 2nd ed.. Washington, DC: The National Academies Press; 1995;
  9. Bulger RE, Heitman E, Reiser S. The ethical dimensions of the biological and health sciences. New York: Cambridge University Press; 2002;
  10. Steneck N. Introduction to the Responsible Conduct of Research. Revised ed. Washington, DC: US Government Printing Office; 2004. Available from: http://ori.dhhs.gov/documents/rcrintro.pdf.

PII: S0039-6060(09)00140-8

doi: 10.1016/j.surg.2009.03.007

Surgery
Volume 145, Issue 6 , Pages 626-630 , June 2009