Quality of informed consent in clinical trials
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Department of Ethics and Medical Law, Medical University of Lublin, Poland
Corresponding author
Anna Zagaja   

Department of Ethics and Medical Law, Medical University of Lublin, Poland
J Pre Clin Clin Res. 2020;14(1):22-24
Introduction and objectives:
Obtaining consent prior to any medical intervention is currently a necessity, the omission of which may lead to litigation. Years of analyses have resulted in strict policies as to what should the patient be informed about and who should provide such information. It would seem reasonable to assume that the concept of informed consent does not lead to any more quarries, however within the past few years a new concept pertaining to the quality of informed consent emerged. The aim of the article is to bring this concept closer.

Description of state of knowledge:
Quality of informed consent pertains to the information a patient understood during the consent process and the conditions under, which consent was obtained. Recent publications underline a discrepancy between what the patient knows and what the patient should know under the set requirements of informed consent. Research indicates that many clinical trial participants do not understand the provided information and are unable to enumerate basic items such as risk or benefits of the trial. What is more, the forms they obtain are too elaborate and do not facilitate the decision making process. All this undermines the essence of informed consent and decreases its quality.

Despite years of working on the process of obtaining informed consent and elaborate forms that should facilitate decision making for patients, the information the patients have prior to entering the clinical trial are frequently insufficient to term the consent they make informed.

The author expresses thanks Jakub Pawlikowski for his expert review.
Oriel JD. Eminent venereologists. 1. Albert Neisser. Genitourin Med.v1989; 65(4): 229–234. doi:10.1136/sti.65.4.229.
Vollmann J, Winau R. Informed consent in human experimentation before the Nurenberg code. BMJ 1996; 313(7070): 1445–1449. doi: 10.1136/bmj.313.7070.1445.
Czarkowski M, Różyńska J. Świadoma zgoda na udział w eksperymencie medycznym. Poradnik dla badacza. Warszawa: Naczelna Izba Lekarska, Ośrodek Bioetyki Naczelnej Rady Lekarskiej, 2008.
Kodeks Etyki Lekarskiej Dostępny. pdf_file/ 0003/4764/Kodeks-Etyki-Lekarskiej.pdf (accessed 10.03.2019).
Konstytucja RP Rzeczypospolitej Polskiej z dnia 2 kwietnia 1997 r. (DzU 1997 nr 78 poz. 483).
Ustawa z dnia 5 grudnia 1996 r. o zawodach lekarza i lekarza dentysty (t.j. DzU z 2019 r. poz. 537, 577, 730, 1590).
Ustawa z dnia 6 listopada 2008 r. o prawach pacjenta i Rzeczniku Praw Pacjenta (DzU 2009 Nr 52, poz. 417).
Alfidi RJ. Controversy, Alternatives, and Decisions in Complying with the Legal Doctrine of Informed Consent. Radiology 1975; 114(1): 231–234. doi: 10.1148/114.1. 231.
Katz J. Informed consent--a fairy tale? Law’s vision. Univ Pittsbg Law Rev. 1977; 39(2): 137–174.
The United States Federal Food, Drug, and Cosmetic https://www.fda. gov/patients/clinical-trials-what-patients-need-know/informed-conse nta-clinical-trials (accessed 10.03.2019).
de la Mora-Molina H, Barajas-Ochoa A, Sandoval-Garcia L, Navarrete- Lorenzon M, Castańeda-Barragan EA, Castillo-Ortiz JD, Aceves- Avila FJ, Yańez J, Bustamante-Montes LP, Ramos-Remus C. Trends of informed consent forms for industry-sponsored clinical trials in rheumatology over a 17-year period: readability, and assessment of patients’ health literacyand perception Semin Arthritis Rheum. 2018; 48(3): 547–552. doi: 10.1016/j.semarthrit.2018.03.008.
Bloswick A, Skowron A. Length and format of informed consent forms in clinical trials in different patient populations (pediatric, adult, elderly) based on samples from Poland. Ethics & Medicine 2017; 33: 97–105.
Cohen O, Mishel M, Lugassy G. Informed Consent Form in Israel Clinical Trials, UNESCO Chair in Bioethics 12th World Conference, Limassol, Cyprus, March 2017.
Bloswick A, Skowron A. Informed Consent Documentation in Pharmaceutical Industry – Sponsored Clinical Trials. Ethics & Medicine 2015; 31: 51–58.
Wen G, Liu X, Huang L, Shu J, Xu N, Chen R, Huang Z, Yang G, Wang X, Xiang Y, Lu Y, Yuan H. Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China. PLoS One. 2016; 11(10): e0164251. doi:10.1371/journal.pone.0164251.
Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst. 2001; 93(2): 139–47. https: //
Tam NT, Huy NT, Thoale TB, Long NP, Trang NT, Hirayama K, Karbwang J. Participants’ understanding of informed consentin clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ 2015; 93(3): 186–98H. doi: 10.2471/BLT.14.141390.
Kim SH, Tanner A, Friedman DB, Foster C, Bergeron C. Barriers to Clinical Trial Participation: Comparing Perceptions and Knowledge of African American and White South Carolinians. J Health Commun. 2015; 20(7): 816–26. doi:10.1080/10810730. 2015.1018599.
Choi YJ, Beck SH, Kang WY, Yoo S, Kim SY, Lee JS, Burt T, Kim TW. Knowledge and perception about clinical research shapes behavior: face to face survey in Korean general public. J Korean Med Sci. 2016; 31(5): 674–681. doi: 10.3346/jkms. 2016.31.5.674.
Final Rule: Federal Policy for the Protection of Human Subjects. Federal Register. 2017; 82(12): 7149–7274. 2017-01-19/pdf/2017-01058.pdf. (herein after “Revised Common Rule”).
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