Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms
Original Contribution
Yahya Almodallal, Quyen Duong, Daniel Satele, Paul Novotny, Kathryn D. Cook , Cynthia Chauhan, Michelle K. Daiss, Jennifer Le-Rademacher, Sherry Looker, Nichole Martin, Michanda F. Smestad, Stacey J. Winham, Sumithra J. Mandrekar, Aminah Jatoi
JCO Oncology Practice, 14 June 2021
Abstract
Purpose
This randomized, double-blind study sought to understand whether cancer clinical trial consent form verbosity detracts from patients’ decision making on trial enrollment.
Methods
This trial tested mock consent forms of 2,000, 4,000, and 6,000 words. The first two comprised the two experimental arms and the third the control arm. Phase II was conducted to identify the promising arm, which, in phase III, was compared with the control arm. Each consent form described the same trial. Eligible adult patients reported a cancer history and English literacy. The primary end point used a patient-reported Likert scale to assess the relationship between information in the consent form and trial decision making.
Results
In phase II, 93 patients were accrued and prompted the selection of the 2,000-word consent form for phase III. In phase III, 182 patients were recruited, resulting in 240 total evaluable patients to compare the 2,000-word versus the 6,000-word arm (control). For the primary end point, 103 (84%) and 107 (91%) patients in the 2,000- and 6,000-word arms, respectively, strongly agreed or agreed with the following: “The information in this consent form helped me make a decision about whether or not to enroll in the trial” (two-sided, P = .14). Median time to read each consent form was 8 and 12 minutes, respectively (two-sided, P < .0001). Among those assigned these consent forms, 84% and 73%, respectively (two-sided, P = .04) signed or expressed a willingness to sign.
Conclusion
This study’s primary end point was not met. However, secondary outcomes suggest a need to further study the efficiency and efficacy of shorter consent forms for cancer clinical trial enrollment.

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials
Guillermo Pechero Jr., Branden Pfaff, Mayank Rao, David Pogorzelski, Paula McKay, Ella Spicer, Andrea Howe, Haley K. Demyanovich, Debra L. Sietsema, Michael F. McTague, Lolita Ramsey, Martha Holden, Joshua Rudnicki, Jeff Wells, Michelle Medeiros, Gerard P. Slobogean, Sheila Sprague
Contemporary Clinical Trials Communications, 14 June 2021; 22
Abstract
Introduction
Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant’s before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.
Methods
The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have.
Results
Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.
Discussion
Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

‘To say no wasn’t something we could do’; Reflexive accounts and negotiations of the ethical practice of informed consent during the research process and beyond [BOOK CHAPTER]
Johanna Sixtensson
The Politics and Ethics of Representation in Qualitative Research, Routledge, 2021
Abstract
In this chapter, the implementation of the formal ethical principle of informed consent in the research process is discussed. By analyzing encounters and exchanges with a young research participant, both during the fieldwork and after publication, the text examines the meaning of the concept of consent and discloses complexities and ambivalences inherent in asking for and giving consent. It shows that giving consent or ‘saying no’ is a complicated practice that should not be reduced to a single act or signature on a consent form. Rather, consenting to participate in research is an open-ended, situated, ambivalent and not necessarily verbal process. It might also have an impact on participants beyond the actual research process: for instance, when faced with the researcher’s representations of personal interview accounts in research reports. The text captures the relationality that exists between researchers and those we research, especially regarding how dependent researchers are on participants’ consent, their acts and the quality of the empirical material that participants ‘generate’.