P R Ferguson1. 1. Department of Law, University of Dundee, Dundee, UK. p.r.ferguson@dundee.ac.uk
Abstract
BACKGROUND: According to the Declaration of Helsinki, patients who take part in a clinical trial must be adequately informed about the trial's aims, methods, expected benefits, and potential risks. The declaration does not, however, elaborate on what "adequately informed" might amount to, in practice. Medical researchers and Local Research Ethics Committees attempt to ensure that the information which potential participants are given is pitched at an appropriate level, but few studies have considered whether the patients who take part in such trials feel they have been given adequate information, or whether they feel able to understand that information. OBJECTIVES: To explore trial participants' views (i) on the amount of information provided, and (ii) of their own understanding of that information. DESIGN: Structured interviews of patients participating in clinical trials for the treatment of chronic medical condition. FINDINGS: Patients generally felt they were given an appropriate amount of information, and that they were able to understand all or most of it. They felt they were given adequate time to ask questions before agreeing to take part. In comparison with treatment given out with the research setting, patients generally felt they received more information when participating in a clinical trial. CONCLUSIONS: Researchers sometimes complain that patients are given too much information during clinical trials, and have limited understanding of that information. The present study shows that this perception is not necessarily shared by patients. More research is needed in this area, particularly to gauge whether patient understanding is indeed accurate.
BACKGROUND: According to the Declaration of Helsinki, patients who take part in a clinical trial must be adequately informed about the trial's aims, methods, expected benefits, and potential risks. The declaration does not, however, elaborate on what "adequately informed" might amount to, in practice. Medical researchers and Local Research Ethics Committees attempt to ensure that the information which potential participants are given is pitched at an appropriate level, but few studies have considered whether the patients who take part in such trials feel they have been given adequate information, or whether they feel able to understand that information. OBJECTIVES: To explore trial participants' views (i) on the amount of information provided, and (ii) of their own understanding of that information. DESIGN: Structured interviews of patients participating in clinical trials for the treatment of chronic medical condition. FINDINGS:Patients generally felt they were given an appropriate amount of information, and that they were able to understand all or most of it. They felt they were given adequate time to ask questions before agreeing to take part. In comparison with treatment given out with the research setting, patients generally felt they received more information when participating in a clinical trial. CONCLUSIONS: Researchers sometimes complain that patients are given too much information during clinical trials, and have limited understanding of that information. The present study shows that this perception is not necessarily shared by patients. More research is needed in this area, particularly to gauge whether patient understanding is indeed accurate.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: D T Penman; J C Holland; G F Bahna; G Morrow; A H Schmale; L R Derogatis; C L Carnrike; R Cherry Journal: J Clin Oncol Date: 1984-07 Impact factor: 44.544
Authors: Andrew Schumacher; William M Sikov; Matthew I Quesenberry; Howard Safran; Humera Khurshid; Kristen M Mitchell; Adam J Olszewski Journal: PLoS One Date: 2017-02-24 Impact factor: 3.240
Authors: Juntra Karbwang; Nut Koonrungsesomboon; Cristina E Torres; Edlyn B Jimenez; Gurpreet Kaur; Roli Mathur; Eti N Sholikhah; Chandanie Wanigatunge; Chih-Shung Wong; Kwanchanok Yimtae; Murnilina Abdul Malek; Liyana Ahamad Fouzi; Aisyah Ali; Beng Z Chan; Madawa Chandratilake; Shoen C Chiew; Melvyn Y C Chin; Manori Gamage; Irene Gitek; Mohammad Hakimi; Narwani Hussin; Mohd F A Jamil; Pavithra Janarsan; Madarina Julia; Suman Kanungo; Panduka Karunanayake; Sattian Kollanthavelu; Kian K Kong; Bing-Ling Kueh; Ragini Kulkarni; Paul P Kumaran; Ranjith Kumarasiri; Wei H Lim; Xin J Lim; Fatihah Mahmud; Jacinto B V Mantaring; Siti M Md Ali; Nurain Mohd Noor; Kopalasuntharam Muhunthan; Elanngovan Nagandran; Maisarah Noor; Kim H Ooi; Jebananthy A Pradeepan; Ahmad H Sadewa; Nilakshi Samaranayake; Shalini Sri Ranganathan; Wasanthi Subasingha; Sivasangari Subramaniam; Nadirah Sulaiman; Ju F Tay; Leh H Teng; Mei M Tew; Thipaporn Tharavanij; Peter S K Tok; Jayanie Weeratna; Tri Wibawa; Renu Wickremasinghe; Phanthipha Wongwai; Subhash Yadav Journal: BMC Med Ethics Date: 2018-09-15 Impact factor: 2.652