Challenges in surgical research – ethical and practical

The overarching ethical principles guiding medical research in humans are contained within the Declaration of Helsinki

The papers below address the particular problems of research in surgery. Surgical interventions are by definition invasive which presents unique challenges about how and when to introduce new procedures into clinical practice. Key issues include obtaining ethical approval for studies and informed consent from patients.

We include discussions of generic ethical and practical problems in surgical or new device research and include papers describing issues in particular clinical specialty areas where these demonstrate important issues.


Angelos P. Ethical issues of participant recruitment in surgical clinical trials. Ann Surg Oncol. 2013 Oct;20(10):3184-7. doi: 10.1245/s10434-013-3178-0. Epub 2013 Aug 22. PubMed PMID: 23975308

Freshwater MF. DOH: preventing ethical pitfalls while advancing plastic surgery research. J Plast Reconstr Aesthet Surg. 2013 Apr;66(4):589-91. doi:  10.1016/j.bjps.2012.12.013. PubMed PMID: 23517708

Fowler AJ, Agha RA. Response to: Failure of plastic surgical clinical trials to document compliance with international ethical guidelines – tip of the iceberg? J Plast Reconstr Aesthet Surg. 2013 May;66(5):738-9. doi: 10.1016/j.bjps.2013.01.004. Epub 2013 Feb 9. PubMed PMID: 23402934

Hofbauer M, Muller B, Murawski CD, Karlsson J, Fu FH. Innovation in orthopaedic surgery as it relates to evidence-based practice. Knee Surg Sports Traumatol Arthrosc. 2013 Mar;21(3):511-4. doi: 10.1007/s00167-012-2360-4. PubMed PMID: 23287893

Lee Char SJ, Hills NK, Lo B, Kirkwood KS. Informed consent for innovative surgery: a survey of patients and surgeons. Surgery. 2013 Apr;153(4):473-80. doi:
10.1016/j.surg.2012.08.068. Epub 2012 Dec 4. PubMed PMID: 23218878

Prokopetz JJ, Katz JN, Losina E, Thornhill TS, Wright J, Lehmann LS. Preceding the procedure: medical devices and shared decision making. Arthritis Care Res (Hoboken). 2013 Jan;65(1):148-51. doi: 10.1002/acr.21826. Review. PubMed PMID: 23042666

Wall A, Angelos P, Brown D, Kodner IJ, Keune JD. Ethics in surgery. Curr Probl Surg. 2013 Mar;50(3):99-134. doi: 10.1067/j.cpsurg.2012.11.004. PubMed PMID: 23445722


Johnson J, Rogers W. Innovative surgery: the ethical challenges. J Med Ethics. 2012 Jan;38(1):9-12. doi: 10.1136/jme.2010.042150. Epub 2011 Jun 22. PubMed PMID:21697295

Knight JL. Ethics: the dark side of surgical innovation. Innovations (Phila). 2012 Sep-Oct;7(5):307-13. doi: 10.1097/IMI.0b013e3182772a2e. PubMed PMID:23274862


Campbell MK, Entwistle VA, Cuthbertson BH, Skea ZC, Sutherland AG, McDonald  AM, Norrie JD, Carlson RV, Bridgman S; KORAL study group. Developing a  placebo-controlled trial in surgery: issues of design, acceptability and  feasibility. Trials. 2011 Feb 21;12:50. doi: 10.1186/1745-6215-12-50. PubMed  PMID: 21338481

Evans LA. A historical, clinical, and ethical overview of the emerging science of facial transplantation. Plast Surg Nurs. 2011 Oct-Dec;31(4):151-7. doi: 10.1097/PSN.0b013e31822f6611. Review. PubMed PMID: 22157604.

Pitak-Arnnop P, Dhanuthai K, Hemprich A, Pausch NC. Research and publication  ethics: what have we learned thus far? Oral Surg Oral Med Oral Pathol Oral Radiol
Endod. 2011 Jan;111(1):10-2. doi: 10.1016/j.tripleo.2010.10.001. PubMed PMID:

Tan VK, Chow PK. An approach to the ethical evaluation of innovative surgical  procedures. Ann Acad Med Singapore. 2011 Jan;40(1):26-9. Review. PubMed PMID:


Angelos P. The ethical challenges of surgical innovation for patient care. Lancet. 2010 Sep 25;376(9746):1046-7. PubMed PMID: 20879091

Brody BA. Ethical issues in surgical trials and in the diffusion of innovative therapies. Tex Heart Inst J. 2010;37(6):685-6. PubMed PMID: 21224947

Johnson J, Rogers W, Lotz M, Townley C, Meyerson D, Tomossy G. Ethical challenges of innovative surgery: a response to the IDEAL recommendations. Lancet. 2010 Sep 25;376(9746):1113-5. doi: 10.1016/S0140-6736(10)61116-6. PubMed PMID: 20870102

McDonald PJ, Kulkarni AV, Farrokhyar F, Bhandari M. Ethical issues in surgical  research. Can J Surg. 2010 Apr;53(2):133-6. PubMed PMID: 20334746

Ross S, Weijer C, Gafni A, Ducey A, Thompson C, Lafreniere R. Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery. BMC Med Ethics. 2010 Aug 26;11:14. doi:10.1186/1472-6939-11-14. PubMed PMID: 20738887

Thoma A, Farrokhyar F, McKnight L, Bhandari M. Practical tips for surgical research: how to optimize patient recruitment. Can J Surg. 2010 Jun;53(3):205-10. PubMed PMID: 20507795


Ashton CM, Wray NP, Jarman AF, Kolman JM, Wenner DM, Brody BA. Ethics and  methods in surgical trials. J Med Ethics. 2009 Sep;35(9):579-83. doi:  10.1136/jme.2008.028175. PubMed PMID: 19717699

Mavroudis C, Mavroudis CD, Jacobs ML, Jacobs JP. Ethics of innovation in surgery for congenital cardiac diseases. Cardiol Young. 2009 Nov;19 Suppl 2:100-5. doi: 10.1017/S1047951109991697. PubMed PMID: 19857357

Palma P, Rosenbaum T. The ethical challenge of surgical innovation. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Apr;20(4):375-6. doi:10.1007/s00192-009-0819-8. Epub 2009 Feb 14. PubMed PMID: 19219380

Woodcock TE. Surgical research in the UK. Ann R Coll Surg Engl. 2009  Apr;91(3):188-91. doi: 10.1308/003588409X392081. Review. PubMed PMID: 19335967


Cosgrove DM. Ethics in surgical innovation: vigorous discussion will foster future progress. Cleve Clin J Med. 2008 Nov;75 Suppl 6:S6. PubMed PMID: 19024951

Fins JJ. Surgical innovation and ethical dilemmas: precautions and proximity. Cleve Clin J Med. 2008 Nov;75 Suppl 6:S7-12. PubMed PMID: 19031570

Lieberman I, Herndon J, Hahn J, Fins JJ, Rezai A. Surgical innovation and ethical dilemmas: a panel discussion. Cleve Clin J Med. 2008 Nov;75 Suppl 6:S13-21. PubMed PMID: 19031571

Morgenstern L. Can surgical research be ethical? Surg Innov. 2008 Sep;15(3):157-60. doi: 10.1177/1553350608322061. PubMed PMID: 18757374

Ross S, Robert M, Harvey MA, Farrell S, Schulz J, Wilkie D, Lovatsis D, Epp A, Easton B, McMillan B, Schachter J, Gupta C, Weijer C. Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn’t mean we should. J Obstet Gynaecol Can. 2008 Jun;30(6):508-13. PubMed PMID: 18611303

Schultz D, McGrath MH, Murray TH, Greenberg RK, Fogarty TJ. New surgical devices and ethical challenges: a collection of perspectives and panel discussion. Cleve Clin J Med. 2008 Nov;75 Suppl 6:S74-81; discussion S82-4. PubMed PMID: 19024956


Mehta S, Myers TG, Lonner JH, Huffman GR, Sennett BJ. The ethics of sham surgery in clinical orthopaedic research. J Bone Joint Surg Am. 2007 Jul;89(7):1650-3. Review. PubMed PMID: 17606805


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