Delineando a pesquisa clínica 4a Ed

(AlbertoBarroso) #1

  1. National Commission for the Protection of Human Subjects of Biomedical and
    Behavioral Research. The Belmont Report: Ethical principles and guidelines for the
    protection of human subjects of biomedical and behavioral research. 1979.
    Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html, accessed
    8/27/12.

  2. Department of Health and Human Services. Protection of human subjects 45 CFR
    part 46. 2005. Available at:
    http://www.dhhs.gov/ohrp/humansubjects/guidance/45cfr46.html, accessed 9/27/12.

  3. Emanuel EJ, Menikoff J. Reforming the regulations governing research with human
    subjects. N Engl J Med 2011; 365:1145–50.

  4. Lo B, Barnes M. Protecting research participants while reducing regulatory burdens.
    JAMA 2011;306:2260–2261.

  5. Department of Health and Human Services. Protocol review. 2005. Available at:
    http://www.dhhs.gov/ohrp/policy/protocol/index.html, accessed 9/27/12.

  6. King NMP, Churchill LR. Assessing and comparing potential benefits and risks of
    harm. In: Emanuel EJ, Grady C, Crouch RA, et al., editors. The Oxford textbook of
    clinical research ethics. New York: Oxford University Press, 2008, 514–526.

  7. Henderson GE, Churchill LR, Davis AM, et al. Clinical trials and medical care:
    defining the therapeutic misconception. PLoS Med 2007;4:e324.

  8. Federman DD, Hanna KE, Rodriguez LL. Responsible research: a systems approach
    to protecting research participants. 2002. Available at: http://www.nap.edu/catalog.php?
    record_id=10508, accessed 9/29/12.

  9. Flory J, Emanuel E. Interventions to improve research participants’ understanding
    in informed consent for research: a systematic review. JAMA 2004;292:1593–1601.

  10. Lomax GP, Hall ZW, Lo β. Responsible oversight of human stem cell research: the
    California Institute for Regenerative Medicine’s medical and ethical standards. PLoS
    Med 2007;4:e114.

  11. Woodsong C, Karim QA. A model designed to enhance informed consent:
    experiences from the HIV prevention trials network. Am J Public Health
    2005;95:412–419.

  12. Wolf LE, Dame LA, Patel MJ, et al. Certificates of confidentiality: legal counsels’
    experiences with perspectives on legal demands for reseasch data. J Empir Res Hum
    Res Ethics 2012;7:1–9.

  13. Nass SJ, Leavitt LA, Gostin LO. Beyond the HIPAA Privacy Rule: enhancing
    privacy, improving health through research. 2009. Available at:
    http://iom.edu/Reports/2009/Beyond-the-HIPAA-Privacy-Rule-Enhancing-Privacy-
    Improving-Health-Through-Research.aspx, accessed 9/29/12.

  14. National Bioethics Advisory Commission. Ethical and policy issues in research
    involving human participants. Rockville, MD: National Bioethics Advisory
    Commission, 2001.

  15. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal

Free download pdf