IDEAS home Printed from https://ideas.repec.org/a/plo/pone00/0295784.html
   My bibliography  Save this article

Participants’ understanding of informed consent in clinical trials: A systematic review and updated meta-analysis

Author

Listed:
  • Chengai Wu
  • Na Wang
  • Qianqian Wang
  • Chao Wang
  • Zhenjie Wei
  • Zhimin Wu
  • Shunan Yu
  • Xieyuan Jiang

Abstract

Obtaining written informed consent from participants before enrolment in a study is essential. A previous study showed that only 50% of the participants in clinical trials understood the components of informed consent, and the methods of participants’ understanding of informed consent were controversial. This updated meta-analysis aimed to estimate the proportion of participants in clinical trials who understand the different informed consent components. PubMed, EMBASE, the Cochrane Library, and Scopus were searched till April 2023. Therapeutic misconception, ability to name one risk, knowing that treatments were being compared, and understanding the nature of the study, the purpose of the study, the risks and side-effects, the direct benefits, placebo, randomization, voluntariness, freedom to withdraw, the availability of alternative treatment if withdrawn from the trial, confidentiality, compensation, or comprehension were evaluated. This meta-analysis included 117 studies (155 datasets; 22,118 participants). The understanding of the risks and side-effects was investigated in the largest number of studies (n = 100), whereas comparehension was investigated in the smallest number (n = 11). The highest proportions were 97.5%(95% confidence interval (CI): 97.1–97.9) for confidentiality, 95.9% (95% confidence interval (CI): 95.4–96.4) for compensation, 91.4% (95% CI: 90.7–92.1) for the nature of study, 68.1% (95% CI: 51.6–84.6) for knowing that treatments were being compared, and 67.3% (95% CI: 56.6–78) for voluntary nature of participants. The smallest proportions were the concept of placebo (4.8%, 95%CI: 4.4–5.2) and randomization(39.4%, 95%CI: 38.3–40.4). Our findings suggested that most participants understood the fundamental components of informed consent (study confidentiality, nature, compensation, voluntariness, and freedom to withdraw). The understanding of other components, such as placebo and randomization was less satisfactory.

Suggested Citation

  • Chengai Wu & Na Wang & Qianqian Wang & Chao Wang & Zhenjie Wei & Zhimin Wu & Shunan Yu & Xieyuan Jiang, 2024. "Participants’ understanding of informed consent in clinical trials: A systematic review and updated meta-analysis," PLOS ONE, Public Library of Science, vol. 19(1), pages 1-23, January.
    • Handle: RePEc:plo:pone00:0295784
    DOI: 10.1371/journal.pone.0295784
    as

    Download full text from publisher

    File URL: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0295784
    Download Restriction: no
    File URL: https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0295784&type=printable
    Download Restriction: no
    File URL: https://libkey.io/10.1371/journal.pone.0295784?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    1. repec:plo:pone00:0172957 is not listed on IDEAS
    2. Snowdon, Claire & Garcia, Jo & Elbourne, Diana, 1997. "Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial," Social Science & Medicine, Elsevier, vol. 45(9), pages 1337-1355, November.
    3. Lidz, Charles W. & Appelbaum, Paul S. & Grisso, Thomas & Renaud, Michelle, 2004. "Therapeutic misconception and the appreciation of risks in clinical trials," Social Science & Medicine, Elsevier, vol. 58(9), pages 1689-1697, May.
    4. Leach, A. & Hilton, S. & Greenwood, B. M. & Manneh, E. & Dibba, B. & Wilkins, A. & Mulholland, E. K., 1999. "An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in The Gambia, West Africa," Social Science & Medicine, Elsevier, vol. 48(2), pages 139-148, January.
    5. Harth, S. C. & Thong, Y. H., 1995. "Parental perceptions and attitudes about informed consent in clinical research involving children," Social Science & Medicine, Elsevier, vol. 40(11), pages 1573-1577, June.
    6. Harth, S. C. & Thong, Y. H., 1995. "Parental perceptions and attitudes about informed consent in clinical research involving children," Social Science & Medicine, Elsevier, vol. 41(12), pages 1647-1651, December.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Snowdon, Claire & Elbourne, Diana & Garcia, Jo, 2006. ""It was a snap decision": Parental and professional perspectives on the speed of decisions about participation in perinatal randomised controlled trials," Social Science & Medicine, Elsevier, vol. 62(9), pages 2279-2290, May.
    2. Barata, Paula C. & Gucciardi, Enza & Ahmad, Farah & Stewart, Donna E., 2006. "Cross-cultural perspectives on research participation and informed consent," Social Science & Medicine, Elsevier, vol. 62(2), pages 479-490, January.
    3. Morris, Norma & Bàlmer, Brian, 2006. "Volunteer human subjects' understandings of their participation in a biomedical research experiment," Social Science & Medicine, Elsevier, vol. 62(4), pages 998-1008, February.
    4. Dixon-Woods, Mary & Ashcroft, Richard E. & Jackson, Clare J. & Tobin, Martin D. & Kivits, Joelle & Burton, Paul R. & Samani, Nilesh J., 2007. "Beyond "misunderstanding": Written information and decisions about taking part in a genetic epidemiology study," Social Science & Medicine, Elsevier, vol. 65(11), pages 2212-2222, December.
    5. Hallowell, Nina & Cooke, Sarah & Crawford, Gill & Lucassen, Anneke & Parker, Michael, 2009. "Distinguishing research from clinical care in cancer genetics: Theoretical justifications and practical strategies," Social Science & Medicine, Elsevier, vol. 68(11), pages 2010-2017, June.
    6. Lawrence, David S. & Ssali, Agnes & Moshashane, Neo & Nabaggala, Georgina & Maphane, Lebogang & Harrison, Thomas S. & Meya, David B. & Jarvis, Joseph N. & Seeley, Janet, 2022. "Decision making in a clinical trial for a life-threatening illness: Therapeutic expectation, not misconception," Social Science & Medicine, Elsevier, vol. 305(C).
    7. Hedgecoe, Adam, 2005. "'At the point at which you can do something about it, then it becomes more relevant': Informed consent in the pharmacogenetic clinic," Social Science & Medicine, Elsevier, vol. 61(6), pages 1201-1210, September.
    8. Tengbeh, Angus Fayia & Enria, Luisa & Smout, Elizabeth & Mooney, Thomas & Callaghan, Mike & Ishola, David & Leigh, Bailah & Watson-Jones, Deborah & Greenwood, Brian & Larson, Heidi & Lees, Shelley, 2018. "“We are the heroes because we are ready to die for this country”: Participants' decision-making and grounded ethics in an Ebola vaccine clinical trial," Social Science & Medicine, Elsevier, vol. 203(C), pages 35-42.
    9. Lawton, Julia & Jenkins, Nicholas & Darbyshire, Julie & Farmer, Andrew & Holman, Rury & Hallowell, Nina, 2012. "Understanding the outcomes of multi-centre clinical trials: A qualitative study of health professional experiences and views," Social Science & Medicine, Elsevier, vol. 74(4), pages 574-581.
    10. repec:plo:pone00:0128209 is not listed on IDEAS
    11. Sarradon-Eck, Aline & Sakoyan, Juliette & Desclaux, Alice & Mancini, Julien & Genre, Dominique & Julian-Reynier, Claire, 2012. ""They should take time": Disclosure of clinical trial results as part of a social relationship," Social Science & Medicine, Elsevier, vol. 75(5), pages 873-882.
    12. Zvonareva, Olga & Engel, Nora & Martsevich, Sergey & de Wert, Guido & Horstman, Klasien, 2015. "International clinical trials, cardiovascular disease and treatment options in the Russian Federation: Research and treatment in practice," Social Science & Medicine, Elsevier, vol. 128(C), pages 255-262.
    13. Sariola, Salla & Simpson, Bob, 2011. "Theorising the 'human subject' in biomedical research: International clinical trials and bioethics discourses in contemporary Sri Lanka," Social Science & Medicine, Elsevier, vol. 73(4), pages 515-521, August.
    14. Abhyankar, Purva & Velikova, Galina & Summers, Barbara & Bekker, Hilary L., 2016. "Identifying components in consent information needed to support informed decision making about trial participation: An interview study with women managing cancer," Social Science & Medicine, Elsevier, vol. 161(C), pages 83-91.
    15. Dawson, Liza & Kass, Nancy E., 2005. "Views of US researchers about informed consent in international collaborative research," Social Science & Medicine, Elsevier, vol. 61(6), pages 1211-1222, September.
    16. Rosemann, Achim, 2014. "Standardization as situation-specific achievement: Regulatory diversity and the production of value in intercontinental collaborations in stem cell medicine," Social Science & Medicine, Elsevier, vol. 122(C), pages 72-80.
    17. Molyneux, C.S. & Wassenaar, D.R. & Peshu, N. & Marsh, K., 2005. "'Even if they ask you to stand by a tree all day, you will have to do it (laughter)...!': Community voices on the notion and practice of informed consent for biomedical research in developing countrie," Social Science & Medicine, Elsevier, vol. 61(2), pages 443-454, July.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:plo:pone00:0295784. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: plosone (email available below). General contact details of provider: https://journals.plos.org/plosone/ .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.