Air Medical Journal
Volume 27, Issue 3 , Page 110 , May 2008

Ethics, Human Rights, and Clinical Research

  • Cheryl J. Erler, MSN, RN

      Affiliations

    • Cheryl Erler, MSN, RN, is a clinical assistant professor in the Indiana University School of Nursing in Indianapolis.
    • ,
  • Cheryl Bagley Thompson, PhD, RN

      Affiliations

    • Cheryl Bagley Thompson, PhD, RN, is an associate professor and assistant dean of Informatics & Learning Technologies and the director of UNMC Health Informatics at the University of Nebraska Medical Center College of Nursing in Omaha.

References 

  1. Green DST , Mackenzie CR . Nuances of informed consent: the paradigm of regional anesthesia . HSSJ . 2007;3:115–118
  2. Directives for Human Experimentation  . Nuremburg Code. Office of Human Subjects of Research (OHSR). National Institute of Health . Available at http://ohsr.od.nih.gov/guidelines/nuremberg.html Accessed October 20, 2007.
  3. Davis EA , Panacek EA , Thompson CB . Basics of research (part 5): Ethics and human rights . Air Med J . 1996;15:34–39
  4. Declaration of Helsinki. World Medical Association . Available at http://www.wma.net/e/ethicsunit/helsinki.htm Accessed October 28, 2007.
  5. Rohrich RJ . Ethical approval of clinical studies, informed consent, and the Declaration of Helsinki: What you need to know . Plast Reconstr Surg . 2007;119:2307–2309
  6. Beecher HK . Ethics and clinical research . N Engl J Med . 1966;274:1354–1360
  7. Lerner BH . Sins of omission: Cancer research without informed consent . N Engl J Med . 2004;351:628–630
  8. Testimony on Protection of Human Research Subjects by Dr. Gary Ellis. Office for Protection from Research Risks (OPRR). Reports Protection of Human Subjects Code of Federal Regulations 45 CFR 46. Available at http://www.hhs.gov/asl/testify/t960312a.html. Accessed October 28, 2007.
  9. Title 45, Public Welfare, Department OF Health and Human Services, Part 46: Protection of Human Subjects, Revised and effective June 23, 2005. Available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed October 28, 2007.
  10. Belmont Report: Office of Human Subjects Research. The Belmont Report:Ethical principles and guidelines for the protection of human subjects of research. Available at http://ohsr.od.nih.gov/guidelines/belmont.html. Accessed October 28, 2007.
  11. Responsibilities of the Office of Human Subjects Research. (OHSR) . Available at: http://ohsr.od.nih.gov/info/sheet1.html Accessed October 28, 2007.
  12. International Issues , Office of Human Research Protections (OHRP)  . Available at http://www.hhs.gov/ohrp/international Accessed October 28, 2007.
  13. Tri-council Policy Statement  . Ethical conduct for research involving humans . Available at http://www.pre.ethics.gc.ca/english/pdf/TCPS%20October%202005_E.pdf Accessed October 28, 2007.
  14. Koski G . Ethics, science and oversight of critical care research. The Office for Human Research Protections . AJRCCM . 2004;169:982–986
  15. Categories of research that may be reviewed by the institutional review board through an expedited review procedure . Available at http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm 1998; Accessed October 28, 2007.
  16. Researcher Computer–based Training. Office of Human Subjects Research, National Institute of Health. Available at http://ohsr.nih.gov/cbt. Accessed October 29, 2007.
  17. NIH funding National Institute of Health  . Required education in the protection of human research participants (2000) . Available at http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html Accessed October 29, 2007.
  18. Office of Research Integrity  . Department for Health and Human Services . Responsible Conduct of Research http://ori.hhs.gov/education Accessed October 29, 2007.
  19. CITI Collaborative Training Initiative . Registration Site for the CITI Program in the Protection of Human Research Subjects . Available at http://www6.miami.edu/citireg Accessed October 29, 2007.
  20. Braunschweiger P , Goodman K . The CITI Program: An international online resource for education in human subjects protection and the responsible conduct of research . Acad Med . 2007;82:861–864
  21. Information Sheets . Guidance for Institutional Review Boards and clinical investigators: Non-local IRB review. 1998 . Available at http://www.fda.gov/oc/ohrt/irbs/nonlocalreview.html Accessed November 1, 2007.
  22. 21 CFR Parts 50 and 56 protection of human subjects; informed consent: Standards for institutional review boards for clinical investigations [Docket No. 87N-0032] 53 FR 45678. November 10, 1998. Available at http://www.fda.gov/oc/gcp/preambles/53fr45678C.html. Accessed November 1, 2007.
  23. Greene SM , Geiger AM . A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval . J Clin Epidemiol . 2006;59:784–790
  24. Gold JL , Dewa CS . Institutional review boards and multisite studies in health services research: Is there a better way? . Health Serv Res . 2005;40:291–307
  25. Sherwood ML , Buchinsky FJ , Quigley MR , Donfack J , Choi SS , Conley SF , et al.   Unique challenges of obtaining regulatory approval for a multicenter protocol to study genetics of RRP and suggested remedies . Otolaryngol Head Neck Surg . 2006;135:189–196
  26. Roberts LM , Bowyer L , Homer CS , Brown MA . Multicentre research: negotiating the ethics approval obstacle course . Med J Aust . 2004;180:139
  27. Dewa CS , Durbin J . Considering a multisite study? How to take the leap and have a soft landing . Journal of Community Psychology . 1998;30:172–187
  28. Blustein J , Regenstein M , Siegal B , Billings J . Notes from the field: Jumpstarting the IRB approval process in multicenter studies . Health Serv Res . 2007;42:1773–1782
  29. Spivey WH , Abramson NS , Iserson KV , McCay CP , Cohen MP . Informed consent for biomedical research in acute care medicine . Ann Emerg Med . 1991;20:1251–1265
  30. Knox CA , Burkhart PV . Issues related to children participating in clinical research . J Pediatr Nurs . 2007;22:310–318
  31. Merz JF . The ethics of research on informed consent . Controlled Clinical Trials . 2002;23:172–177
  32. Title 21 Part 50 Section 24. Exception from informed consent requirements for emergency research. Available at http://www.cfsan.fda.gov/,lrd/cfr50.html. Accessed November 1, 2007.
  33. Salzman JG , Francone RJ , Godding BK , Provo TA , Gertner E . Implementing emergency research requiring exception from informed consent, community consultation and public disclosure . Ann Emerg Med . 2007;50:448–455
  34. Sava J , Ciesla D , Williams M , Street J , White P , Wang  . Is informed consent in trauma a lost cause? A prospective evaluation of acutely injured patients' ability to give consent . J Am Coll Surgeons . 2007;205:405–408
  35. Sloan EP , Koenigsberg M , Houghton J , Gens D , Cipolle M , Runge J , et al.   The informed consent process and the use of the exception to informed consent in the clinical trail of Diaspirin . Acad Emerg Med . 1999;5:1203–1208
  36. Gray JD . The problem of consent in emergency medicine research . CJEM . 2001;3:213–218
  37. Kipins Ken , King N , Nelson RM . Trials and errors: Barriers to oversight of research conducted under the emergency research consent waiver . IRB: Ethics and Human Research . 2006;28:16–19
  38. Halperin H , Paradis N , Mosesso V , Nichol G , Sayre M , Ornato JP , et al.   Recommendations for implementation of community consultation and public disclosure under the food and drug administration's exception from informed consent requirements for emergency research . Circulation . 2007;116:1855–1863
  39. Mika M . Aiding emergency research aim of report on exceptions to informed consent . JAMA . 2007;298:2608–2609

 Editors' note: This article is the eleventh in a multipart series designed to improve the knowledge base of readers, particularly novices, in the area of clinical research. A better understanding of these principles should help in reading and understanding the application of published studies. It should also help those involved in beginning their own research projects.

PII: S1067-991X(08)00052-7

doi: 10.1016/j.amj.2008.03.005

Air Medical Journal
Volume 27, Issue 3 , Page 110 , May 2008

Article Tools