Rationale. Consent forms for clinical trials have expanded and now often range from 25 – 30 pages, in spite of the fact that studies have documented the inability of most research participants to retain this amount of information. In addition, many consent forms include technical, medical, and legal language that is difficult for a lay person to understand. When these consent forms are reviewed by the Committee on Human Research (CHR), concerns about their length, readability and complexity are often raised. Investigators may consequently spend a great deal of time editing consent forms to satisfy CHR requests. However, much of this language is mandated by study sponsors, so investigators may struggle between meeting sponsor requirements and revisions requested by the CHR to improve readability. Although investigators or study staff review study procedures and consent forms with patients, these long, complex forms are unlikely to be conducive to true informed consent, particularly among patients from vulnerable populations.
Plan. We propose to test the feasibility, acceptability, and usefulness of a simple 2-page summary sheet, written in plain language, to improve the consent process, enhance subject understanding of the research study and its risks, and the CHR review process.
This project has the following primary goals:
- Develop a template and guide for investigators to use to create the research summary, and evaluate the ease of preparing the summary among a sample of investigators and their research staff.
- Evaluate the readability and literacy level of summaries prepared by investigators and/or their staff.
- Evaluate differences in subjects' understanding of the research protocol through use of the summary, using a short knowledge test after the standard consent procedure and then after reviewing the summary.
- Assess research subjects’ evaluation of the summary in terms of comprehension of the research protocol and the study risks, and their satisfaction with the consent process.
- Assess both investigators’ and CHR members’ satisfaction with the review process when the summary sheet is included.
An unintended effect of this process may be to heighten investigator awareness of using plain language in consent forms.
Criteria and metrics for success
- A template for creation of a research summary is developed.
- Using the template, creation of the research summary is judged by investigators to require little time.
- Readability of research summaries is found to be at 8th grade level of lower.
- Research participants report that the summaries improve their understanding of the research study and its risk and benefits.
- Investigators and study staff report that the summaries improve the consent process and perceive that patients have a better understanding of the study.
- Investigators report fewer difficulties with consent form review process.
- Investigators report that sponsors did not object to the 2-page summary or delay the study as a result.
- Investigators report that they would continue to use the summaries.
- CHR members report that the summaries improve their understanding of research protocols and lessen their concerns about complex consent forms.
Approximate cost and justification
Total Budget: $48,854. Salary support for UCSF faculty and research assistant involved in developing and evaluating the materials. Incentives for investigator, research staff, and research subject participation.
Collaborators. Patricia Katz is Prof of Medicine, has been a member of the Laurel Heights CHR Committee for 10 years, and is currently Vice-Chair of that committee. John Heldens is the Director of UCSF’s Human Research Protection Program. Jennifer Barton is Asst Prof of Medicine whose primary research focus is health literacy. We especially seek clinical trial investigators willing to test the new materials as collaborators.
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