Abstract
In the twentieth century, ethical evaluation of human subject research was dependent on various guidelines, each developed in response to unethical behavior to avoid repetition of past misdeeds. This piecemeal system left gaps that continued to permit ethical flaws and failure in research. In 2001, Emanuel et al. proposed a set of requirements that now serves as the “gold standard” for ethical conduct of human subject research. These guidelines apply to all forms of investigation, including surgical interventions. Investigators must be familiar with these guidelines and the context in which they arose to prevent future ethical violations.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Meakins JL. Innovation in surgery: the rules of evidence. Am J Surg. 2002;183:399–405.
Axelrod DA, Goold SD. Maintaining trust in the surgeon-patient relationship: challenges for the new millennium. Arch Surg. 2000;135:55–61.
Brock C. Risk, responsibility and surgery in the 1890s and early 1900s. Med Hist. 2013;57:317–37.
Shuster E. Fifty years later: the significance of the Nuremberg code. N Engl J Med. 1997;337:1436–40.
World Medical Association (AMM). Helsinki declaration. Ethical principles for medical research involving human subjects. Assist Inferm Ric. 2001;20:104–7.
Reverby SM. Listening to narratives from the Tuskegee syphilis study. Lancet. 2011;377:1646–7.
Rothstein MA. Currents in contemporary ethics. Research privacy under HIPAA and the common rule. J Law Med Ethics. 2005;33:154–9.
Menikoff J, Kaneshiro J, Pritchard I. The common rule, updated. N Engl J Med. 2017;376:613–5.
Human D. Conflicts of interest in science and medicine: the physician’s perspective. Sci Eng Ethics. 2002;8:273–6.
Kass NE, et al. The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight. Hastings Cent Rep. 2013;Spec No:S4–S15.
Snyder J, Gauthier C. Evidence-based medical ethics: cases for practice-based learning. New York: Humana Press; 2008.
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283:2701–11.
Horton R. Surgical research or comic opera: questions, but few answers. Lancet. 1996;347:984–5.
Weil RJ. The future of surgical research. PLoS Med. 2004;1:e13.
Bennett CL, Stryker SJ, Ferreira MR, Adams J, Beart RW Jr. The learning curve for laparoscopic colorectal surgery. Preliminary results from a prospective analysis of 1194 laparoscopic-assisted colectomies. Arch Surg. 1997;132:41–4.; discussion 45.
Paradis C. Bias in surgical research. Ann Surg. 2008;248:180–8.
McCulloch P, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374:1105–12.
Strasberg SM, Brunt LM. Rationale and use of the critical view of safety in laparoscopic cholecystectomy. J Am Coll Surg. 2010;211:132–8.
Lynn J, et al. The ethics of using quality improvement methods in health care. Ann Intern Med. 2007;146:666–73.
Varkey P, Reller MK, Resar RK. Basics of quality improvement in health care. Mayo Clin Proc. 2007;82:735–9.
Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003;348:721–6.
Horng S, Grady C. Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB. 2003;25:11–6.
Sihvonen R, et al. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013;369:2515–24.
Ruffin JM, et al. A co-operative double-blind evaluation of gastric "freezing" in the treatment of duodenal ulcer. N Engl J Med. 1969;281:16–9.
Cobb LA, Thomas GI, Dillard DH, Merendino KA, Bruce RA. An evaluation of internal-mammary-artery ligation by a double-blind technic. N Engl J Med. 1959;260:1115–8.
Horng S, Miller FG. Is placebo surgery unethical? N Engl J Med. 2002;347:137–9.
Surgeons, A.C.o. Revised statement on health care industry representatives in the operating room. (2016).
Djulbegovic B, et al. The uncertainty principle and industry-sponsored research. Lancet. 2000;356:635–8.
Editors, I.C.o.M.J. Recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals. (2017).
Agel J, DeCoster TA, Swiontkowski MF, Roberts CS. How many orthopaedic surgeons does it take to write a manuscript? A vignette-based discussion of authorship in orthopaedic surgery. J Bone Joint Surg Am. 2016;98:e96.
Marusic A, Bosnjak L, Jeroncic A. A systematic review of research on the meaning, ethics and practices of authorship across scholarly disciplines. PLoS One. 2011;6:e23477.
Jagsi R, et al. The “gender gap” in authorship of academic medical literature--a 35-year perspective. N Engl J Med. 2006;355:281–7.
Capri A. E.A. Scientific Ethics. Visionlearning. 2009;2
Piwowar HA, et al. Towards a data sharing culture: recommendations for leadership from academic health centers. PLoS Med. 2008;5:e183.
Peng GC. Moving towards model reproducibility and reusability. IEEE Trans Biomed Eng. 2016;63(10):1997–8.
Casadevall A, Fang FC. Reproducible science. Infect Immun. 2010;78:4972–5.
Suggested Literature
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283(20):2701–11.
Horng S, Miller FG. Is placebo surgery unethical. NEJM. 2002;347:137–9.
Lynn J, Baily MA, Bottrell M, Jennings B, Levine RJ, Davidoff F, et al. The ethics of using quality improvement methods in health care. Ann Intern Med. 2007;146(9):666–73.
McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105–12.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Glossary
- Human subject research
-
A systematic investigation designed to produce generalizable knowledge from observations of human subjects. This term applies broadly, and investigations classified as human subject research are generally subject to IRB review.
- Protected health information (PHI)
-
Personally identifiable health information (by which the identity of a study subject could be ascertained) maintained in a medical record that includes data on physical health, mental health, payment information, or genetic information.
- Clinical equipoise
-
A state in which two or more therapeutics exist that could treat a given condition; however a lack of strong evidence regarding superiority of either treatment exists. Equipoise is essential to the ethical conduct of clinical research.
- Internal validity
-
The relative truth of conclusions drawn through experimentation. Internal validity is directly related to the accuracy with which experimental conditions eliminate confounding and minimize bias. A study with high internal validity can make strong claims regarding causality, rather than simple associations.
- External validity
-
The extent to which the results of a study apply to the population being modeled. A study with high external validity is highly generalizable to large patient populations.
- Quality improvement
-
Any systematic, data-guided analysis of healthcare processes to improve the quality of care by measuring adherence to evidence-based guidelines of clinical best practice.
Rights and permissions
Copyright information
© 2019 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Jacobson, R., Mulder, L., Alverdy, J. (2019). Ethical Issues in Surgical Research. In: Ferreres, A. (eds) Surgical Ethics. Springer, Cham. https://doi.org/10.1007/978-3-030-05964-4_10
Download citation
DOI: https://doi.org/10.1007/978-3-030-05964-4_10
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-05963-7
Online ISBN: 978-3-030-05964-4
eBook Packages: MedicineMedicine (R0)