Abstract

Mini Review

Is the informed consent form only a symbolic document in clinical trials?

Buket Gungor*

Published: 19 December, 2022 | Volume 6 - Issue 1 | Pages: 035-036

Being one of the basic principles of clinical research, informed consent is definitely a legal responsibility and ethical duty for health professionals.

Read Full Article HTML DOI: 10.29328/journal.apps.1001035 Cite this Article Read Full Article PDF

References

  1. Cheung WY, Pond GR, Heslegrave RJ, Enright K, Potanina L, Siu LL. The contents and readability of informed consent forms for oncology clinical trials. Am J Clin Oncol. 2010 Aug;33(4):387-92. doi: 10.1097/COC.0b013e3181b20641. PMID: 19884804.
  2. Ennis L, Wykes T. Sense and readability: participant information sheets for research studies. Br J Psychiatry. 2016 Feb;208(2):189-94. doi: 10.1192/bjp.bp.114.156687. Epub 2015 Sep 17. PMID: 26382948; PMCID: PMC4837385.
  3. Sreenivasan G. Does informed consent to research require comprehension? Lancet. 2003 Dec 13;362(9400):2016-8. doi: 10.1016/S0140-6736(03)15025-8. PMID: 14683665.
  4. Tam NT, Huy NT, Thoa le TB, Long NP, Trang NT, Hirayama K, Karbwang J. Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ. 2015 Mar 1;93(3):186-98H. doi: 10.2471/BLT.14.141390. Epub 2015 Jan 22. PMID: 25883410; PMCID: PMC4371493.
  5. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Integrated addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2). Current Step 4 version. 2016. ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html. Date of access:23.09.2022.
  6. Gupta UC, Kharawala S. Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations. Perspect Clin Res. 2012 Jan;3(1):8-15. doi: 10.4103/2229-3485.92301. PMID: 22347696; PMCID: PMC3275995.
  7. Kadam RA. Informed consent process: A step further towards making it meaningful! Perspect Clin Res. 2017 Jul-Sep;8(3):107-112. doi: 10.4103/picr.PICR_147_16. PMID: 28828304; PMCID: PMC5543760.
  8. Abdussalam M. Informed consent in clinical practice and biomedical research. In: Mansourian BP (Editors), Global Perspectives In Health. (2), EOLSS, Geneva, Switzerland. 2009; 221-234.
  9. Schumacher A, Sikov WM, Quesenberry MI, Safran H, Khurshid H, Mitchell KM, Olszewski AJ. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study. PLoS One. 2017 Feb 24;12(2):e0172957. doi: 10.1371/journal.pone.0172957. PMID: 28235011; PMCID: PMC5325585.
  10. Gungor B, Aylin M, Asena A, Somuncuoglu EI, Bozkurt NB, Ucku SR, Gelal A. Evaluation of Legal Legislation Compliance and Readability of Clinical Trial Informed Consent Forms. Ther Innov Regul Sci. 2020 Mar;54(2):468-475. doi: 10.1007/s43441-019-00078-2. Epub 2020 Jan 8. PMID: 32072599.
  11. Pietrzykowski T, Smilowska K. The reality of informed consent: empirical studies on patient comprehension-systematic review. Trials. 2021 Jan 14;22(1):57. doi: 10.1186/s13063-020-04969-w. PMID: 33446265; PMCID: PMC7807905.
  12. Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009 Sep;198(3):420-35. doi: 10.1016/j.amjsurg.2009.02.010. PMID: 19716887.
  13. Almodallal Y, Duong Q, Satele D, Novotny P, Cook KD, Chauhan C, Daiss MK, Le-Rademacher J, Looker S, Martin N, Smestad MF, Winham SJ, Mandrekar SJ, Jatoi A. Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms. JCO Oncol Pract. 2021 Oct;17(10):e1460-e1472. doi: 10.1200/OP.21.00071. Epub 2021 Jun 14. PMID: 34125586.
  14. Kim EJ, Kim SH. Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level. Clin Trials. 2015 Jun;12(3):232-6. doi: 10.1177/1740774515571139. Epub 2015 Feb 19. PMID: 25701156.

Similar Articles

Recently Viewed

  • Pattern of Eye Disease in Nenwe Rural Eye Clinic, Nigeria: A Seven Year Review
    Nnenna Maureen Ozioko*, Nkiru Mary Okoloagu, Emmanuel Sunday Onah and Catherine Nnenna Maureen Ozioko*, Nkiru Mary Okoloagu, Emmanuel Sunday Onah, Catherine. Pattern of Eye Disease in Nenwe Rural Eye Clinic, Nigeria: A Seven Year Review. Int J Clin Exp Ophthalmol. 2024: doi: 10.29328/journal.ijceo.1001056; 8: 004-015
  • Retinopathy of prematurity - Intersibling divergence of risk factors among twins
    Sudeep Navule Siddappa*, Kavitha Chikknayakanahalli Venugopal, Pavana Acharya and Tintu Susan Joy Sudeep Navule Siddappa*,Kavitha Chikknayakanahalli Venugopal,Pavana Acharya ,Tintu Susan Joy . Retinopathy of prematurity - Intersibling divergence of risk factors among twins. Int J Clin Exp Ophthalmol. 2020: doi: 10.29328/journal.ijceo.1001026; 4: 009-011
  • Effectiveness of levocetirizine in treating allergic rhinitis while retaining work efficiency
    Dabholkar Yogesh, Shah Tanush, Rathod Roheet, Paspulate Akhila, Veligandla Krishna Chaitanya, Rathod Rahul, Devesh Kumar Joshi* and Kotak Bhavesh Dabholkar Yogesh, Shah Tanush, Rathod Roheet, Paspulate Akhila, Veligandla Krishna Chaitanya, Rathod Rahul, Devesh Kumar Joshi*, Kotak Bhavesh. Effectiveness of levocetirizine in treating allergic rhinitis while retaining work efficiency. Arch Asthma Allergy Immunol. 2023: doi: 10.29328/journal.aaai.1001031; 7: 005-011
  • Hepatic Pseudolymphoma Mimicking Neoplasia in Primary Biliary Cholangitis: A Case Report
    Jeremy Hassoun, Aurélie Bornand, Alexis Ricoeur, Giulia Magini, Nicolas Goossens and Laurent Spahr* Jeremy Hassoun,Aurélie Bornand,Alexis Ricoeur,Giulia Magini,Nicolas Goossens,Laurent Spahr*. Hepatic Pseudolymphoma Mimicking Neoplasia in Primary Biliary Cholangitis: A Case Report. Arch Case Rep. 2024: doi: 10.29328/journal.acr.1001115; 8: 152-155
  • Other Applications of Amniotic Membranes: Case Series
    Linda Guerrero* Linda Guerrero*. Other Applications of Amniotic Membranes: Case Series. Arch Case Rep. 2024: doi: 10.29328/journal.acr.1001117; 8: 159-162

Read More

Most Viewed

Read More

Help ?