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
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.
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.
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.
Butler D. The dark side of publishing. Nature. 2013;495:433–5.
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.
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.
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.
Clarivate Analytics. Journal Impact Factor [Internet]. InCites Help. [cited 2017 Dec 19]. http://ipscience-help.thomsonreuters.com/inCites2Live/indicatorsGroup/aboutHandbook/usingCitationIndicatorsWisely/jif.html.
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/.
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.
Corbie-Smith G. The continuing legacy of the Tuskegee Syphilis Study: considerations for clinical investigation. Am J Med Sci. 1999;317(1):5–8.
Deer B. How the vaccine crisis was meant to make money. BMJ. 2011;342:c5258.
Deer B. Revealed: secret payments to MMR doctor Wakefield at heart of vaccine crusade. 2006. briandeer.com.
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.
Eggertson L. Lancet retracts 12-year-old article linking autism to MMR vaccines. CMAJ. 2010;182(4):e199–200.
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.
Frandsen TF. Journal self-citations -analysing the JIF mechanism. J Informetr. 2007;1(1):47–58.
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/.
George SL, Buyse M. Data fraud in clinical trials. Clin Invest (Lond). 2015;5(2):161–73.
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.
Horton R, Murch S, Walker-Smith J, Wakefield A, Hodgson H. A statement by the editors of the lancet. Lancet. 2004;363:P820–1.
Hudson KL, Collins FS. Bringing the common rule into the 21st century. N Engl J Med. 2015;373(24):2293–6.
ICMJE. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. 2017.
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.
Murch S, Anthony A, Casson D, Malik M, Mark B, Dhillon A, et al. Retraction of an interpretation. Lancet. 2004;363:750.
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.
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.
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.
Ness RB. Influence of the HIPAA privacy rule on Health Research. JAMA. 2007;298(18):2164–70.
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.
Rao T, Andrade C. The MMR vaccine and autism: sensation, refutation, retraction, and fraud. Indian J Psychiatry. 2011;53(2):95–6.
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.
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.
Shuster E. Fifty years later: the significance of the Nuremberg code. N Engl J Med. 1997;337:1436–40.
Shyam A. Predatory journals: what are they? J Orthop Case Rep. 2015;5(4):1–2.
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.
Sorokowski P, Kulczycki E, Sorokowska A, Pisanski K. Predatory journals recruit fake editor. Nature. 2017;543:481–3.
Strielkowski W. Predatory journals: Beall’s list is missed. Nature. 2017;544:416.
Thomas DR, Salmon RL, King J. Rates of first measles-mumps-rubella immunisation in Wales (UK). Lancet. 1998;351:1927.
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.
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.
U.S. Department of Health and Human Services. NPRM for revisions to the common rule. Federal Register. 2015.
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.
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.
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.
World Medical Association. WMA Declaration of Helsinki—ethical principles for medical research involving human subjects. Helsinki; 1964.
World Medical Organization. Declaration of Helsinki (1964). Br Med J. 1996;313(7070):1448–9.
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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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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