Client Informed consent is required by both state mandate and professional association ethical codes to assure the care and research, and protection of patient rights. Often lengthy and somewhat confusing, consent forms vary substantially across settings. Traditionally paper and now electronic medium are used to provide protection for clients and patients. The problem is that many research studies show that patient and research subjects have difficulty understanding consent forms when obtained in-person. Offering a digitized version of such forms can only lead to yet more complications. This article then, offers a few of the most relevant studies to help the reader.
The study Developing a Transparent, Participant Navigated Electronic Informed Consent for Mobile Mediated Research by Megan Doerr, Christine Suver and John Wilbanks points out that electronic client informed consent provides increased flexibility, greater comprehension and patient engagement, reduced provider workload and higher satisfaction among patients and providers.
Ways to Improve Comprehension of Client Informed Consent Documents
A study posted online in JAMA Pediatrics by Allen R. Tait, PhD, Director of Clinical Research in the Division of Anesthesiology at the University of Michigan Medical School, highlighted the importance of including comprehension aiding techniques when creating client informed consent documents. Dr. Tait refers to “positive message attributes” as aids to improving consent forms such as:
- Text written at an eighth grade level
- Graphics included in the form
- Bigger type, i.e., 14 font size and wider margins
- Oral explanation of the forms
- Shorter forms
Consent Forms Growing Longer
In an editorial comment attached to the JAMA Pediatrics study, Dr. Mark S. Schreiner, MD stated:
Instead of simplicity and plain language, subjects face an overwhelming deluge of information written in technical and legalistic terms. Instead of brevity, consent forms remain verbose in increasing in length by approximately 1.5 pages per decade, with some well in excess of 20 pages.
Further, in the study: Reading Levels and Comprehension of Research Consent Forms: An Integrative Review by Gabriella Foe and Elaine L. Larson, the authors confirmed that reading levels in consent forms are at a higher level than the recommended 6-8th grade. The study also points out that one of the most difficult areas of the consent form for clients to understand is the risks and benefits section. Research shows patients have a better chance of understanding the forms when they include pictures/graphics showing risk information.
Special Consent Considerations for Behavioral Health
In a study published in the AMIA Annual Proceedings Archive, 4/16/2018, Current State of Electronic Consent Processes in Behavioral Health: Outcomes from an Observational Study, a particular concern raised is the need for client informed consent requirements to be comprehensible for patients with behavioral health conditions, especially those that impair intellectual functioning. The authors point out that their research showed current consent processes are not easily understandable. Issues they identified include:
- The process was time consuming and burdensome, with a range of 5 to 11 forms to read and taking between 3 and 36 minutes to complete.
- The readability level was too high for the average American patient. Most patients read at a 7th– 8th grade level whereas many consent forms are written on average at the 12th grade level. It has been suggested that the more useful reading level would be grade 6 to 8 and perhaps even as low as 4th to 6th grade for some patient populations.
- Consent forms vary by terminology and layout which can cause confusion for the patient who may visit multiple medical facilities which require their own unique consent documents.
- The space where clients complete the consent documents does not often encourage communication between the client and provider.
A major obstacle to creating simpler, understandable forms is the fear of medical liability that is harbored by research sponsors and institutional medical review boards. Taking specialized training in how to use digitized client informed consent forms is recommended.