Informed consent in clinical trials

Main Article Content

G P Kovane
V C Nikoderm
O Khondowe

Abstract





Background. Informed consent (IC) is not only a regulatory but also an ethical requirement to participate in any clinical trial. It is essential to determine that research participants understand what they consent to. Studies that evaluate participants’ understanding of IC conclude that recall and understanding of IC is often low, and researchers recommend that interactive multimedia interventions should be implemented to optimise understanding.


Objectives. To assess participants’ understanding of IC of the research trial that they agreed to participate in.
Methods. A descriptive survey design, within a quantitative research approach, was used to conduct the study at two government hospitals in the Eastern Cape Province. A semi-structured, self-administered questionnaire was used to collect information from 170 participants in research studies. Descriptive statistics were used to analyse the results.
Results. Participants were recruited from among women who enrolled in any of the three studies that were ongoing at the two sites during the recruitment period. The study participants had a mean age of 25.9 years. Nearly one-third (30%) could not recall the purpose of the original trial that they consented to. The concept of randomisation was not understood by any of the participants.
Conclusion. Regardless of extensive efforts to ensure that participants understood their participation, this study unveiled poor recall of essential information on IC. It is proposed that IC should be short and only address essential components such as purpose, procedure, possible risks or benefits, alternative options if not participating and explaining the concept of voluntary participation.





Article Details

How to Cite
Informed consent in clinical trials. (2022). South African Journal of Bioethics and Law, 15(2), 48-53. https://doi.org/10.7196/SAJBL.2022.v15i2.802
Section
Research Articles

How to Cite

Informed consent in clinical trials. (2022). South African Journal of Bioethics and Law, 15(2), 48-53. https://doi.org/10.7196/SAJBL.2022.v15i2.802

References

Colombo C, Mayrhofer MT, Kubiak C, et al. The CORBEL matrix on informed consent in clinical studies: A multidisciplinary approach of research infrastructures building enduring life-science services. BMC Med Ethics 2021;22:95. https://doi.org/10.1186/ s12910-021-00639-x

SchloendorffMEvThesocietyofNewYorkHospital1914105N.E.92,211N.Y.125.

UnitedStatesofAmericavBrandtKetal(CaseI)November21,1946-August20,1947.

SalgovLelandStandfordJuniorUniversityBoardofTrustees1957154Cal.App.2d.560,

P. 2d 170.

RichterandanothervEstateHammann1976(3)SA226(C).

CastellvDeGreef1994(4)AllSA63(C).

SouthAfrica.NationalHealthActNo.61of2003.

ConstitutionoftheRepublicofSouthAfrica,1996.

Olejarczyk JP, Young M. Patient Rights And Ethics. StatPearls, 2021. https://www.ncbi.

nlm.nih.gov/books/NBK538279 (accessed 16 September 2022).

Neff MJ. Informed consent: What is it? Who can give it? How do we improve it? Respir

Care 2008;53(10):1337-1341.

WorldMedicalAssociation.WMADeclarationofHelsinki–ethicalprinciplesformedical

research involving human subjects. WMA, 2013.

DiemertDJ,LobatoL,StycznskiA,etal.Acomparisonofthequalityofinformedconsent

for clinical trials of an experimental hookworm vaccine conducted in developed and developing countries. PLoS Negl Trop Dis 2017;11(1):e0005327. https://doi. org/10.1371/journal.pntd.0005327

Appelbaum PS, Roth LH, Lidz CW, et al. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Cent Rep 1987;17(2):20- 24. https://doi.org/10.2307/3562038

Wilkins JM, Forester BP. Informed consent, therapeutic misconception, and clinical trials for Alzheimer’s disease. Int J Geriatr Psychiatr 2020;35(5):430-435. https://doi.org/10.1002/gps.5262

Gota V, Nookala M, Yadav A, et al. Quality of informed consent in cancer clinical trials in India: A cross-sectional survey. Natl Med J India 2018;31(6):334-338. https://doi.org/10.4103/0970-258X.262900

Moloi GP. Informed consent: Communication and miscommunication in clinical trials. MCur dissertation. Stellenbosch: Stellenbosch University, 2012.

Varkey B. Principles of clinical ethics and their application to practice. Med Princ Pract 2021;30(1):17-28. https://doi.org/10.1159/000509119

Broude v McInosh and Another 1998 (3) SA 60 (SCA).

World Data Atlas South Africa. South African mean age of childbearing.

https://knoema.com/atlas/SouthAfrica/topics/Demographics/Fertility/Age-of-

childbearing (accessed 24 December 2021).

García-García EM, Sánchez-Sabater B, Medrano, et al. Sociodemographic factors

affecting the comprehension of clinical information by inpatients undergoing trauma surgery. Rev Esp Cir Ortop Traumatol (Engl Ed) 2019;63(5):355-360. https://doi.org/10.1016/j.recot.2019.04.001

Burks AC, Keim-Malpass J. Health literacy and informed consent for clinical trials: A systematic review and implications for nurses. Nursing Res Rev 2019;9:31-40. https://doi.org/10.2147/NRR.S207497

Britz R, le Roux-Kemp A. Voluntary informed consent and good clinical practice for clinical research in South Africa: Ethical and legal perspectives. S Afr Med J 2012;102(9):746-748. https://doi.org/10/7196.SAMJ.5498

Reuters. Eastern Cape back to worst unemployment in SQA with nearly half without jobs. Reuters, 2021. https://www.dispatchlive.co.za/news/2021-08-25- sas-unemployment-rate-climbs-to-new-record-high-above-34/ (accessed 20 December 2021).

Alexa-Stratulat T, Neagu M, Neagu A-I, et al. Consent for participating in clinical trials – is it really informed? Dev World Bioeth 2018;18(3):299-306. https://doi. org/10.1111/dewb.12199

Cassell EJ. The Principles of the Belmont Report Revisited: How Have Respect for Persons, Beneficence and Justice Been Applied to Clinical Medicine? Hasting Cent Rep 30, no. 4. 2000:12-21. https://doi.org/10.2307/3527640

Wendler D. Must research participants understand randomization? Am J Bioeth 2009;9(2):3-8. https://doi.org/10.1080/15265160802654145

Appiah R. Gurus and Griots: Revisiting the research informed consent process in rural African contexts. BMC Med Ethics 2021;22(1):98. https://doi.org/10.1186/ s12910-021-00659-7

Most read articles by the same author(s)

1 2 3 4 5 6 7 8 > >>