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Misconduct and Consent: The Importance of Informed Consent in Medical Research

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Integrity of Scientific Research

Abstract

Human subject research in the medical arena offers an indisputable contribution to society. However, all medical research needs to be conducted through maintaining strict levels of research standards and by complying with applicable regulations and guidelines. Despite this, medical research misconduct has been around for centuries, with countless examples of gross ethical oversights and morally flawed decisions made by both medical practitioners and researchers. One area of such misconduct is within that of informed consent. Despite the continually evolving rules and regulations surrounding informed consent in medical research, countless breaches are present surrounding the topic. In this paper, we discuss the origins of informed consent, the regulations and guidelines surrounding it, the common types of informed consent necessary to be gathered, and the potential pitfalls therein. We conclude with an overview of a selection of breaches in informed consent in the area of medical research and their likely reasons.

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References

  1. Gupta A (2013) Fraud and misconduct in clinical research: a concern. Perspect Clin Res 4(2):144–147

    Article  PubMed  PubMed Central  Google Scholar 

  2. Polanin-Huk J, Huk J, Filip R (2010) Fraud and misconduct in clinical research. J Pre-Clin Clin Res 4(2):158–160

    Google Scholar 

  3. George SL, Buyse M (2015) Data fraud in clinical trials. Clinical Investigation 5(2):161–173

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Capron AM (2018) Where did informed consent for research come from? J Law Med Ethics 46:12–29

    Article  PubMed  PubMed Central  Google Scholar 

  5. Green DST, MacKenzie CR (2007) Nuances of informed consent: the paradigm of regional anesthesia. HSS J 3:115–118

    Article  PubMed  PubMed Central  Google Scholar 

  6. Wolf SM, Clayton EW, Lawrenz F (2018) The past, present, and future of informed consent in research and translational medicine. J Law Med Ethics 46:7–11

    Article  Google Scholar 

  7. Dankar FK, Gergely M, Dankar SK (2019) Informed consent in biomedical research. Comput Struct Biotechnol J 17:463–474

    Article  PubMed  PubMed Central  Google Scholar 

  8. Pratt v Davis (1905). https://www.ravellaw.com/opinions/967d63e3e4aceb0c7ccc62e78af2d543. Accessed 23 March 2021

  9. Schloendorff v. Soc’y of N.Y. Hospital (1914). https://www.ravellaw.com/opinions/13aa93a26f08eeced5264b5eaa468369?query=Schloendorff%20v.%20Soc%27y%20of%20N.Y.%20Hospital%2C%201914. Accessed 23 March 2021

  10. Plant R, Pons AP (2006) MIS research involving human subjects: processes and IRB requirements. Commun Assoc Inf Syst 17:1–46

    Google Scholar 

  11. Haney C, Banks WC, Zimbardo PG (1973) A study of prisoners and guards in a simulated prison. Naval Res Rev 30:4–17

    Google Scholar 

  12. Jones JH, Tuskegee Institute (1981) Bad blood: the Tuskegee syphilis experiment. Free Press, New York

    Google Scholar 

  13. Dankar FK, Gergely M, Malin B, Badji R, Dankar SK, Shuaib K (2020) Dynamic-informed consent: a potential solution for ethical dilemmas in population sequencing initiatives. Comput Struct Biotechnol J 18:913–921

    Article  PubMed  PubMed Central  Google Scholar 

  14. Bester J, Cole CM, Kodish E (2016) The limits of informed consent for an overwhelmed patient: clinicians’ role in protecting patients and preventing overwhelm. AMA J Ethics 18(9):869–886

    Article  PubMed  Google Scholar 

  15. Nandra R, Brockie AF, Hussain F (2020) A review of informed consent and how it has evolved to protect vulnerable participants in emergency care research. Effort Open Reviews 5:73–79

    Article  Google Scholar 

  16. Reeves J (2021) Vaccine skepticism lurks in town famous for syphilis study. AP News. https://apnews.com/article/coronavirus-vaccine-skepticism-us-eae3315d2dfecd6443b56a2dc7bcb887. Accessed 23 March 2021

  17. Vaidya A (2020) How Tuskegee experiment puts extra burden on black physicians during pandemic. Becker’s Hospital Review https://www.beckershospitalreview.com/hospital-physician-relationships/how-tuskegee-experiment-puts-extra-burden-on-black-physicians-during-pandemic.html. Accessed 23 March 2021

  18. Dankar FK, Ptitsyn A, Dankar SK (2018) The development of large-scale de-identified biomedical databases in the age of genomics—principles and challenges. Hum Genomics 12(19):1–15

    Google Scholar 

  19. Mittelstadt BD, Floridi L (2016) The ethics of big data: current and foreseeable issues in biomedical contexts. Sci Eng Ethics 22(2):303–341

    Article  PubMed  Google Scholar 

  20. Check Hayden E (2013) Privacy protections: the genome hacker. Nature 497(7448):172–174

    Article  CAS  Google Scholar 

  21. Fuchs RE, Robinson SG (2018) Strict liability for lack of informed consent in clinical trials. Troutman Pepper Hamilton Sanders LLP. https://www.troutman.com/insights/strict-liability-for-lack-of-informed-consent-in-clinical-trials.html. Accessed 23 March 2021

  22. Weyzig F, Schipper I (2008) SOMO briefing paper on ethics in clinical trials #1: examples of unethical trials. Centre for Research on Multinational Corporations (SOMO) https://www.somo.nl/examples-of-unethical-trials/. Accessed 23 March 2021

  23. Crown J (2000) breast-cancer treatment put into question. Lancet 355(9217):1828–1829

    Article  CAS  PubMed  Google Scholar 

  24. Weir C, Murray G (2011) Frauds in clinical trials: detecting it and preventing it. Significance 8(4):164–168

    Article  Google Scholar 

  25. Bhakuni H (2020) Informed consent to clinical research in India: a private law remedy. Medical Law International 20(3):256–283

    Article  Google Scholar 

  26. Lakhani N (2011) From tragedy to travesty: drugs tested on survivors of Bhopal. Independent. https://www.independent.co.uk/news/world/asia/tragedy-travesty-drugs-tested-survivors-bhopal-6262412.html. Accessed 23 March 2021

  27. Bagla P (2013) Indian Parliament comes down hard on cervical cancer trial. Science. https://www.sciencemag.org/news/2013/09/indian-parliament-comes-down-hard-cervical-cancer-trial. Accessed 23 March 2021

  28. Chatterjee S (2017) MCI suspends 8 Indore doctors’ registration over unethical drug trial. News18 https://www.news18.com/news/india/mci-suspends-8-indore-doctors-registration-over-unethical-drug-trial-1482739.html. Accessed March 23, 2021

  29. Krishnan V (2012) MP govt to act against 11 Indore doctors. Mint. https://www.livemint.com/Politics/NxmwzRufEq2Efjcl888OFJ/MP-govt-to-act-against-11-Indore-doctors.html. Accessed 23 March 2021

  30. Bhuyan A (2021) How covaxin trial participants in Bhopal were misled. The Wire. https://science.thewire.in/health/peoples-hospital-bhopal-covaxin-clinical-trials-exploitation-ethics-ground-report/. Accessed 23 March 2021

  31. Mitra E, Hollingsworth J (2021) More than a dozen slum residents in an Indian city say they thought they were being vaccinated. They were part of clinical trials. CNN https://edition.cnn.com/2021/02/25/asia/india-vaccine-trials-covid-ethics-intl-dst-hnk/index.html. Accessed 23 March 2021

  32. Nair A (2015) Clinical research: regulatory uncertainty hits drug trials in India. The Pharmaceutical J. https://pharmaceutical-journal.com/article/feature/clinical-research-regulatory-uncertainty-hits-drug-trials-in-india. Accessed 23 March 2021

  33. Prainsack B, Buyx A (2013) A solidarity-based approach to the governance of research biobanks. Med Law Rev 21(1):71–91

    Article  PubMed  Google Scholar 

  34. Grishin D, Raisaro JL, Troncoso-Pastoriza JR et al (2021) Citizen-centered, auditable and privacy-preserving population genomics. Nat Comput Sci 1:192–198

    Article  Google Scholar 

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Correspondence to Fida K. Dankar .

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Gergely, M., Dankar, F.K., Alrabaee, S. (2022). Misconduct and Consent: The Importance of Informed Consent in Medical Research. In: Faintuch, J., Faintuch, S. (eds) Integrity of Scientific Research. Springer, Cham. https://doi.org/10.1007/978-3-030-99680-2_9

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  • DOI: https://doi.org/10.1007/978-3-030-99680-2_9

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-99679-6

  • Online ISBN: 978-3-030-99680-2

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