Easy-to-Read Informed Consent Forms for Hematopoietic Cell Transplantation Clinical Trials

Abstract

Informed consent is essential to ethical research and is requisite to participation in clinical research. Yet most hematopoietic cell transplantation (HCT) informed consent forms (ICFs) are written at reading levels that are above the ability of the average person in the US. The recent development of ICF templates by the National Cancer Institute, National Institutes of Health and the National Heart Blood and Lung Instituthas not resulted in increased patient comprehension of information. Barriers to creating Easy-to-Read ICFs that meet US federal requirements and pass Institutional Review Board (IRB) review are the result of multiple interconnected factors. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) formed an ad hoc review team to address concerns regarding the overall readability and length of ICFs used for BMT CTN trials. This paper summarizes recommendations of the review team for the development and formatting of Easy-to-Read ICFs for HCT multicenter clinical trials, the most novel of which is the use of a two-column layout. These recommendations intend to guide the ICF writing process, simplify local IRB review of the ICF, enhance patient comprehension and improve patient satisfaction. The BMT CTN plans to evaluate the impact of the Easy-to-Read format compared to the traditional format on the informed consent process.

Participation in Clinical Research: Perspectives of Adult Patients and Parents of Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation

“…Although ability to recall study details is expected to decay over time, 16 our findings suggest that study participants did not fully comprehend the implications of what they consented to, which is in accordance with prior work. 17,18 Additional challenges persist in HSCT due to complicated treatment plans or protocols that are not easy to explain in layman's language. 19 …”

“…24 The Blood and Marrow Transplant Clinical Trials Network is developing educational interventions to facilitate the use of these Easy-to-Read informed consent forms and is currently conducting a randomized, controlled trial of evaluating the effectiveness of the 2-column format. 18 …”

“…30 Nevertheless, educational interventions and efforts to improve the process, targeting the HSCT population specifically, are underway. 18 While the boundaries between research and clinical care are not entirely clear, 31 extended discussions between investigators and research participants have been shown to improve understanding, 32 and incorporating novel strategies, such as follow-up telephone calls, in-person conversations, or use of health information technology tools, are likely required.…”

Is ‘informed consent’ an ‘understood consent’ in hematopoietic cell transplantation?

“…30 Denzen et al . 31 provide recommendations for readability in consent forms for BMT clinical research trials. Examples of these include the use of a two-column format, balancing text with white space, use of specific and larger font sizes and use of plain language with consistency throughout the document.…”

“…Examples of these include the use of a two-column format, balancing text with white space, use of specific and larger font sizes and use of plain language with consistency throughout the document. 31 To this end, the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) is conducting the BMT CTN 1205, a randomized, multicenter, prospective study of easy-to-read informed consent for HCT clinical trials. This study uses a novel consent form based on the above recommendations 31 and will assess patient comprehension of the clinical trial in addition to satisfaction and anxiety related to the consent process.…”