Do patients participating in oncology clinical trials understand the informed consent form? A Brown University Oncology Research Group study—BrUOG 274.

Aims: The purpose of this study was to analyze the content of informed consent forms for clinical trials in medical oncology to assess readability, determine their completeness, and identify any shortcomings. Methods: Informed consent forms for Phase I–III studies that were conducted at two tertiary care cancer centers over a 3-year period were reviewed. Information pertaining to length of the informed consent form, research regimen/methods, treatment agent, potential risks, and benefits was extracted. The reading level was assessed by Flesch–Kincaid and Gunning-Fog index readability tests. Results: All of the 112 informed consent forms clearly stated the voluntary nature of participation. Nearly one half of the forms (51.8%) were of Phase I studies. The median length of informed consent form was 20 pages (range: 8–28). A detailed estimation of the frequency or intensity of risks (range: 3–8 pages) was provided. The average reading level of the informed consent forms was high (Flesch–Kincaid Grade Level of 9.8), which corresponds roughly to 10th-grade reading level. Less than 15% of all consent forms were written at the recommended eighth-grade reading level. A substantial number of forms did not report a potential risk to pregnant/lactating women (16.9%), mechanism of action of the investigational agent (34.8%), study schema (77.6%), a possibility of receiving sub-therapeutic dose (37%), or death (12.5%). Nearly one half of the forms (49.1%) stated clearly that individual participants may not benefit. Conclusion: Overall, these informed consent forms provided a detailed description of the trials in accordance to international guidelines. However, there remains room for improvement, particularly in areas of readability and document length.

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Assesment of a written informed consent form in clinical trials

European Journal of Hospital Pharmacy ◽

10.1136/ejhpharm-2012-000074.363 ◽

2012 ◽

Vol 19 (2) ◽

pp. 223.3-224

Author(s):

P. Marrero Álvarez ◽

J. Ruiz Ramos ◽

J.E. Megías Vericat ◽

S. Rodríguez Capellán ◽

M. Tordera Baviera ◽

...

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Consent Form ◽

Informed Consent Form ◽

Written Informed Consent

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Improved participants’ understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials

European Journal of Clinical Pharmacology ◽

10.1007/s00228-016-2159-1 ◽

2016 ◽

Vol 73 (2) ◽

pp. 141-149 ◽

Cited By ~ 4

Author(s):

Nut Koonrungsesomboon ◽

Thipaporn Tharavanij ◽

Kittichet Phiphatpatthamaamphan ◽

Ratha-korn Vilaichone ◽

Sudsayam Manuwong ◽

...

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Consent Form ◽

Research Information ◽

Randomized Controlled ◽

Informed Consent Form

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Comparison of the Informed Consent Process for Randomized Clinical Trials in Pediatric and Adult Oncology

Journal of Clinical Oncology ◽

10.1200/jco.2004.10.034 ◽

2004 ◽

Vol 22 (13) ◽

pp. 2708-2717 ◽

Cited By ~ 55

Author(s):

Christian M. Simon ◽

Laura A. Siminoff ◽

Eric D. Kodish ◽

Christopher Burant

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Randomized Clinical Trials ◽

Human Subjects ◽

Decision Makers ◽

Phase Iii ◽

Ethical Framework ◽

Clinical Cancer Research ◽

Oncology Research ◽

Oncology Clinical Trials

Purpose To compare the informed consent processes for phase III pediatric and adult oncology clinical trials in view of the critical importance of human subjects protection in both pediatric and adult cancer care. Findings are discussed in terms of the opportunities for improving pediatric and adult oncology informed consent. Patients and Methods A total of 219 subjects are reported on. Adult oncology patients made up 36.1% (n = 79) of the sample. Pediatric surrogates made up the remaining 63.9% (n = 140). Subjects in both studies were observed and audiotaped in conversation with their oncologists, and interviewed afterwards. Comparisons between the adult and pediatric subjects were done using χ2 statistics and t tests. Results Differences between the pediatric and adult informed consent processes were found. Adult oncology decision makers were, on average, more fully informed and more actively engaged by their oncologists. Pediatric decision makers were, however, given more information about survival/cure, randomization, and voluntariness. Comprehension difficulties were more frequent among pediatric decision makers. Suggestions for improvement are made in view of the differences between adult and pediatric oncology research environments. Conclusion Ongoing efforts to improve the ethical framework of clinical cancer research need to take into account the key differences between pediatric and adult oncology informed consent. More research needs to be done to explore the differences between adult and pediatric informed consent processes in oncology.

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Do patients participating in oncology clinical trials understand the informed consent form? A Brown University Oncology Research Group study.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.34_suppl.23 ◽

2012 ◽

Vol 30 (34_suppl) ◽

pp. 23-23

Author(s):

Andrew Schumacher ◽

Carolyn Bartley ◽

Anne Kaplan ◽

Benjamin Murphy ◽

Howard Safran ◽

...

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Research Study ◽

Informed Consent Process ◽

Consent Process ◽

Research Participants ◽

Oncology Research ◽

Consent Document ◽

Oncology Clinical Trials ◽

Informed Consent Document

23 Background: The informed consent process is used to provide research participants information that includes the purpose and procedures of the research study, risks, benefits, potential alternatives and that participation is voluntary. The goal of informed consent to is to provide this information in language that is understandable to the research participant. The aim of this study is to evaluate whether research participants in adult hematology/oncology clinical trials understand the information presented during the informed consent process. Methods: Patients receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy were eligible to participate in this study. After informed consent was obtained, research participants are given a 14-question test. The questions evaluate whether patients understand the following elements on the informed consent related to their oncology treatment study: The purpose and procedures of the research study, risks, benefits, potential alternatives, research related injury compensation, study contact information, measures used to protect confidentiality, and that participation is voluntary. The possible answers to each question are disagree, unsure, and agree. Results: This study was initiated in June 2012. Eleven patients enrolled on this study within the first month. Participants include those on cooperative group studies, pharmaceutical industry trials and investigator initiated trials. The average length of the informed consent document exceeded 20 pages. An initial analysis of data is planned after the study has been open for six months. Conclusions: Informed consents are becoming increasingly lengthy and complex. Much of the language added is regulatory and legal in nature and used to protect the institutions conducting the research. This study will assess the readability of the informed consent and whether patients participating in oncology research trials understand the essential elements of the informed consent document. The first data analysis will be December 2012.

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