Lung cancer patients’ perceptions of informed consent documents
Introduction
Before inclusion into biomedical research, researchers must obtain the informed consent of the eligible patients. The information in the trial includes both verbal and written elements, and a truly informed consent presupposes that the patients can understand written information before signing the consent document.
The Declaration of Helsinki recommends that the consent document should include information about the purpose of the trial, procedures, possible risks and benefits, sources of finance, potential conflicts of interest and the researchers’ institutional affiliation [1]. In addition, the documents should be written in accordance with directions from the Regional Committee for Medical Research Ethics, the Norwegian Social Science Data Services, and the Norwegian Medicines Agencies. The amount of directions for content in the consent documents has increased over the last years, and it could be a challenge to comply with all these instructions when writing a consent document.
Previous studies have revealed that many participants in clinical research fail to understand or recall central aspects in the information disclosed during the consent process [2], like risks, the right to withdraw [3], confidentiality [4], side effects [5] and the purpose of the trial [6]. Suggested explanations for this have been low literacy in some patient groups (e.g. high age and lower education), low health literacy among typical underrepresented groups in clinical research (e.g. ethnic minorities), the patients’ reduced health status, and technical and scientific language in the consent documents [5], [7], [8].
Another explanation for participants’ lack of understanding might be that the extensive instructions for writing consent documents result in complex documents consisting of too many elements of information. The amount of information could limit the readers’ ability to understand the main point of the consent document and to give a truly informed consent.
In order to enhance informed consent documents, it is important to study how the patients themselves perceive the documents. To our knowledge no studies have addressed which of the information elements the patients perceive as most relevant and important. Further, most patients are severely ill and elderly, and little is known about how sick, weak or old people perceive complex consent documents and which of the content elements they regard to most relevant.
In the present study, we compared patients’ perceptions and preferences of two different versions of informed consent documents written according to a set of formal requirements. Our primary research question was which content the patients considered relevant or important. A secondary question concerned the amount of information—did the patients find any of the information redundant? Or did they prefer additional information?
Section snippets
Intervention
The subjects were eligible for a randomized, phase III study by the Norwegian Lung Cancer Group comparing pemetrexed plus carboplatin versus gemcitabine plus carboplatin as first line chemotherapy of patients with stage IIIB/IV non-small cell lung cancer (the ‘PEG’ trial) [9]. The original consent document for the trial contained 1118 words, and was approved by all regulatory authorities (the Regional Committee for Medical Research Ethics, the Norwegian Medicines Agency, Norwegian Social
Patients
Twelve men and nine women participated. Ten received the standard consent document and eleven the shortened version. Background information about the participants in the two groups is presented in Table 2. The subjects’ median age was 69 years (range 44–84). All patients were considered decision-competent by their physicians. The interviews lasted between 6 and 42 min (median 12 min).
Deductive categories
Most participants were not able to assess the content in the documents when they were questioned directly about
Discussion
The present study indicated that the information in the consent document concerning research formalities was perceived of as less relevant compared to information about disease and treatment.
The comparison between patients who read the original consent document and patients who read a shortened consent document with fewer formalities showed few differences regarding the patients’ perceptions of the documents. However, the answers from two patients who read the original document indicated that
Acknowledgements
We are grateful to the doctors at the Department of Oncology and at the Department of Pulmonary Medicine at St. Olavs Hospital for their help in recruiting patients for this study.
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