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Ethics in Clinical Research

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Book cover Basic Methods Handbook for Clinical Orthopaedic Research

Abstract

Historically, medical research was conducted without formal regulations, supervision informed consent, or recognition of patient rights and interests. Ethical oversight has been implemented through the development of international, federal, and institutional guidelines to protect human subjects in clinical research. When proposing and conducting experiments involving human subjects, researchers must comply with these guidelines. Clinical research on human subjects must consider the ethical representation of vulnerable and minority populations to avoid misrepresentation and improve generalizability. Responsibilities concerning the ethics of clinical research also fall to publishers and editors of medical journals. Conflict of interest disclosures as well as the awareness of self-citation and predatory journals contribute to the prevention of data fraud and misconduct.

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References

  1. Beall J. Predatory publishers are corrupting open access: journals that exploit the author-pays model damage scholarly publishing and promote unethical behaviour by scientists, argues Jeffrey Beall. Nature. 2012;489(7415):179.

    Article  CAS  Google Scholar 

  2. Boden-Albala B, Carman H, Southwick L, Parikh NS, Roberts E, Waddy S, et al. Examining barriers and practices to recruitment and retention in stroke clinical trials. Stroke. 2015;46(8):2232–7.

    Article  Google Scholar 

  3. Burlew K, Larios S, Suarez-Morales L, Holmes B, Venner K, Chavez R. Increasing ethnic minority participation in substance abuse clinical trials: lessons learned in the National Institute on Drug Abuse’s Clinical Trials Network. Cult Divers Ethn Minor Psychol. 2011;7(4):345–56.

    Article  Google Scholar 

  4. Butler D. The dark side of publishing. Nature. 2013;495:433–5.

    Article  CAS  Google Scholar 

  5. Carlson RV, Boyd KM, Webb DJ. The revision of the declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004;57(6):695–713.

    Article  Google Scholar 

  6. Centers for Disease Control and Prevention. The Tuskegee timeline [Internet]. U.S. Public Health Service Syphilis Study at Tuskegee. 2017 [cited 2017 Oct 21]. https://www.cdc.gov/tuskegee/timeline.htm.

  7. Chen MS, Lara PN, Dang JHT, Paterniti DA, Kelly K. Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual: renewing the case for enhancing minority participation in cancer clinical trials. Cancer. 2014;120(Suppl 7):1091–6.

    Article  Google Scholar 

  8. Clarivate Analytics. Journal Impact Factor [Internet]. InCites Help. [cited 2017 Dec 19]. http://ipscience-help.thomsonreuters.com/inCites2Live/indicatorsGroup/aboutHandbook/usingCitationIndicatorsWisely/jif.html.

  9. Clark J. How to avoid predatory journals—a five point plan. BMJ Opin. 2015. https://blogs.bmj.com/bmj/2015/01/19/jocalyn-clark-how-to-avoid-predatory-journals-a-five-point-plan/.

  10. 104th Congress. Health Insurance Portability and Accountability Act of 1996 [Internet]. U.S. Department of Health and Human Services. 1996 [cited 2017 Oct 21]. https://aspe.hhs.gov/report/health-insurance-portability-and-accountability-act-1996.

  11. Corbie-Smith G. The continuing legacy of the Tuskegee Syphilis Study: considerations for clinical investigation. Am J Med Sci. 1999;317(1):5–8.

    Article  CAS  Google Scholar 

  12. Deer B. How the vaccine crisis was meant to make money. BMJ. 2011;342:c5258.

    Article  Google Scholar 

  13. Deer B. Revealed: secret payments to MMR doctor Wakefield at heart of vaccine crusade. 2006. briandeer.com.

  14. Durant RW, Wenzel JA, Scarinci IC, Paterniti DA, Fouad MN, Hurd TC, et al. Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT). Cancer. 2014;120(Suppl 7):1097–105.

    Article  Google Scholar 

  15. Eggertson L. Lancet retracts 12-year-old article linking autism to MMR vaccines. CMAJ. 2010;182(4):e199–200.

    Article  Google Scholar 

  16. Egleston BL, Pedraza O, Wong YN, Dunbrack RL, Griffin CL, Ross EA, et al. Characteristics of clinical trials that require participants to be fluent in English. Clin Trials. 2015;12(6):618–26.

    Article  Google Scholar 

  17. Frandsen TF. Journal self-citations -analysing the JIF mechanism. J Informetr. 2007;1(1):47–58.

    Article  Google Scholar 

  18. Garfield E. Journal self-citation in the Journal Citation Reports – Science Edition [Intranet]. Clarivate Analytics. 2002 [cited 2018 Nov 13]. https://clarivate.com/essays/journal-self-citation-jcr/.

  19. George SL, Buyse M. Data fraud in clinical trials. Clin Invest (Lond). 2015;5(2):161–73.

    Article  CAS  Google Scholar 

  20. Hakkalamani S, Rawal A, Hennessy MS, Parkinson RW. The impact factor of seven orthopaedic journals. J Bone Joint Surg [Br]. 2006;88(2):159–62.

    Article  CAS  Google Scholar 

  21. Horton R, Murch S, Walker-Smith J, Wakefield A, Hodgson H. A statement by the editors of the lancet. Lancet. 2004;363:P820–1.

    Article  Google Scholar 

  22. Hudson KL, Collins FS. Bringing the common rule into the 21st century. N Engl J Med. 2015;373(24):2293–6.

    Article  Google Scholar 

  23. ICMJE. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. 2017.

    Google Scholar 

  24. McGarry ME, McColley SA. Minorities are underrepresented in clinical trials of pharmaceutical agents for cystic fibrosis. Ann Am Thorac Soc. 2016;13(10):1721–5.

    PubMed  PubMed Central  Google Scholar 

  25. Murch S, Anthony A, Casson D, Malik M, Mark B, Dhillon A, et al. Retraction of an interpretation. Lancet. 2004;363:750.

    Article  Google Scholar 

  26. Muthuswamy V. The new 2013 seventh version of the declaration of Helsinki—more old wine in a new bottle? Indian J Med Ethics. 2014;11(1):2–4.

    PubMed  Google Scholar 

  27. National Institute of Environmental Health Sciences. Institutional Review Board [Internet]. National Institutes of Health. 2015 [cited 2017 Oct 21]. https://www.niehs.nih.gov/about/boards/irb/index.cfm.

  28. National Institutes of Health. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research [Internet]. Office of Extramural Research. 2017 [cited 2017 Dec 12]. https://grants.nih.gov/grants/funding/women_min/guidelines.htm.

  29. Ness RB. Influence of the HIPAA privacy rule on Health Research. JAMA. 2007;298(18):2164–70.

    Article  CAS  Google Scholar 

  30. Oh SS, Galanter J, Thakur N, Pino-Yanes M, Barcelo NE, White MJ, et al. Diversity in clinical and biomedical research: a promise yet to be fulfilled. PLoS Med. 2015;12(12):e1001918.

    Article  Google Scholar 

  31. Rao T, Andrade C. The MMR vaccine and autism: sensation, refutation, retraction, and fraud. Indian J Psychiatry. 2011;53(2):95–6.

    Article  Google Scholar 

  32. Rockwell DH, Yobs AR, Moore B Jr. The Tuskegee study of untreated syphilis: the 30th year of observation. Arch Intern Med. 1964;114(6):792–298.

    Article  CAS  Google Scholar 

  33. Santiago CD, Miranda J. Progress in improving mental health services for racial-ethnic minority groups: a ten-year perspective. Psychiatr Serv. 2014;65(2):180–5.

    Article  Google Scholar 

  34. Shuster E. Fifty years later: the significance of the Nuremberg code. N Engl J Med. 1997;337:1436–40.

    Article  CAS  Google Scholar 

  35. Shyam A. Predatory journals: what are they? J Orthop Case Rep. 2015;5(4):1–2.

    PubMed  PubMed Central  Google Scholar 

  36. Siebelt M, Siebelt T, Pilot P, Bloem RM, Bhandari M, Poolman RW. Citation analysis of orthopaedic literature; 18 major orthopaedic journals compared for impact factor and SCImago. BMC Musculoskelet Disord. 2010;11(4):1–7.

    Google Scholar 

  37. Sorokowski P, Kulczycki E, Sorokowska A, Pisanski K. Predatory journals recruit fake editor. Nature. 2017;543:481–3.

    Article  CAS  Google Scholar 

  38. Strielkowski W. Predatory journals: Beall’s list is missed. Nature. 2017;544:416.

    Article  CAS  Google Scholar 

  39. Thomas DR, Salmon RL, King J. Rates of first measles-mumps-rubella immunisation in Wales (UK). Lancet. 1998;351:1927.

    Article  CAS  Google Scholar 

  40. U.S. Department of Health and Human Services. Code of Federal Regulations Title 45 Part 46 [Internet]. Office for Human Research Protections. 2009 [cited 2017 Oct 21]. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#subparta.

  41. U.S. Department of Health and Human Services. HIPAA for Professionals [Internet]. Office for Civil Rights. 2017 [cited 2017 Oct 21]. https://www.hhs.gov/hipaa/for-professionals/index.html.

  42. U.S. Department of Health and Human Services. NPRM for revisions to the common rule. Federal Register. 2015.

    Google Scholar 

  43. U.S. Department of Health and Human Services. Summary of the HIPAA Privacy Rule [Internet]. Office for Civil Rights. 2013 [cited 2017 Oct 21]. https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html.

  44. U.S. Department of Health and Human Services. Summary of the HIPAA Security Rule [Internet]. Office for Civil Rights. 2013 [cited 2017 Oct 21]. https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html.

  45. Wakefield A, Murch S, Anthony A, Linnell J, Casson D, Malik M, et al. RETRACTED: ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet. 1998;351:P637–41.

    Article  Google Scholar 

  46. World Medical Association. WMA Declaration of Helsinki—ethical principles for medical research involving human subjects. Helsinki; 1964.

    Google Scholar 

  47. World Medical Organization. Declaration of Helsinki (1964). Br Med J. 1996;313(7070):1448–9.

    Google Scholar 

  48. Yale University Library. Choosing a journal for publication of an article: list of suspicious journals and publishers [Internet]. 2018 [cited 2017 Dec 19]. https://guides.library.yale.edu/c.php?g=296124&p=1973764.

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Authors and Affiliations

  1. Orthopedic Surgery, Hospital for Special Surgery, New York, NY, USA

    Naomi Roselaar, Niv Marom & Robert G. Marx

Authors
  1. Naomi Roselaar
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  2. Niv Marom
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  3. Robert G. Marx
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Corresponding author

Correspondence to Robert G. Marx .

Editor information

Editors and Affiliations

  1. UPMC Rooney Sports Complex, University of Pittsburgh, Pittsburgh, PA, USA

    Volker Musahl

  2. Department of Orthopaedics, Sahlgrenska Academy, Gothenburg University, Sahlgrenska University Hospital, Gothenburg, Sweden

    Jón Karlsson

  3. Department of Orthopaedic Surgery and Traumatology, Kantonsspital Baselland (Bruderholz, Laufen und Liestal), Bruderholz, Switzerland

    Michael T. Hirschmann

  4. McMaster University, Hamilton, ON, Canada

    Olufemi R. Ayeni

  5. Hospital for Special Surgery, New York, NY, USA

    Robert G. Marx

  6. Department of Orthopaedic Surgery, NorthShore University HealthSystem, Evanston, IL, USA

    Jason L. Koh

  7. Institute for Medical Science in Sports, Osaka Health Science University, Osaka, Japan

    Norimasa Nakamura

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Roselaar, N., Marom, N., Marx, R.G. (2019). Ethics in Clinical Research. In: Musahl, V., et al. Basic Methods Handbook for Clinical Orthopaedic Research. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-58254-1_6

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  • DOI: https://doi.org/10.1007/978-3-662-58254-1_6

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  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-662-58253-4

  • Online ISBN: 978-3-662-58254-1

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