The NEAT Study: An Examination of a Novel Consent Form Design in a Real-world Setting
Phase: NA
Conditions: Comprehension, Informed Consent
Sponsor: Wake Forest University Health Sciences

Protocol version: 3/2/17 
Template updated 9.24.14 
1 
Official Title: The NEAT Study: An Examination of a Novel Consent Form Design in a Realworld 
Setting 
NCT03419832 
IRB-Approved Date: 3/3/2017

Protocol version: 3/2/17 
Template updated 9.24.14 
2 
Study Title: The NEAT Study: An examination of a novel consent form design in a real-world 
setting 
 
Principal Investigator: Joseph E. Andrews, Jr., PhD, CIP 
 
Co-investigator(s): J. Brian Moore, MS, CIP, Richard B. Weinberg, MD, and Lynne Wagenknecht 
DrPH 
Sponsor or funding source: Wake Forest Clinical and Translational Science Institute 
 
Background, Rationale and Context 
There is evidence that the current design and content provided by most biomedical research informed 
consent documents do not consistently meet the expectations researchers place on them to effectively 
inform research participants of information thought to be most important in facilitating their ability to 
make informed decisions about participation (Denzen et al., 2012).   The need for revisions to the 
informed consent document design is supported by empirical research.  Joffe et al. found in their 2001 
study of 200 people in the United States participating in cancer trials that 70% of those interviewed did 
not realize that the treatments they were undergoing had not yet been proven effective, and 63% did not 
understand that additional risks were posed by participating in the research.  In a manuscript published in 
2008, Bergenmar, Molin, Wilking, and Brandberg reported that over half of the 325 patients consenting to 
phase I and II cancer trials incorrectly responded to questions about the unapproved nature of the study 
treatment and risks of participation. 
 
The importance of informed consent in ensuring that participants in clinical research are provided the 
opportunity to make autonomous choices is a paramount ethical premise in human research.  The 
effectiveness of consent document design and consent process to accurately and fully convey the elements 
of informed consent is critical and deserves further study.  Development of an improved informed consent 
document design for clinical studies would be a valuable contribution to human research.  With this study 
we seek to collect pilot data on a novel consent form design that incorporates a modified version of the 
“chunking” theory of learning.  Clifton A. Casteel (1990) found that chunking sentences or phrases in text 
into related groupings resulted in a positive significant improvement in reading comprehension among 
students with poor reading skills.  Because the information contained in consent documents in large 
epidemiologic studies is complex, detailed, and novel for potential research participants, the use of a 
modified form of chunking (grouping the related sections of consent into smaller documents), may be an 
effective and low cost way of improving comprehension of the elements of consent. 
 
 
 

Protocol version: 3/2/17 
Template updated 9.24.14 
3 
Objectives 
This pilot study will examine the effectiveness of the New Executive and Appendix Template (NEAT) 
form when used in the consent process for individuals participating in the Atherosclerosis Risk in 
Communities (ARIC) Neurocognitive Study.  Specifically, the primary objective of the study is to:  
 
1. Determine if participants who receive the NEAT form report greater comprehension (as measured 
by the total score on the Comprehension tool instrument) at the end of the consent process, than 
participants who receive a standard form. 
 
The secondary objectives are to: 
1. Determine what types of characteristics participants value in a consent form, via a qualitative 
analysis of responses to the question “What do you like best, if anything about this consent form? 
and What do you like least, if anything about this consent form?” 
2. Determine what types of characteristics study team members find helpful or burdensome when 
utilizing a consent form during the consent process.   
 
Participation in the NEAT study will involve randomization of study participants to either the traditional 
consent form (detailing the ARIC study) or the NEAT form and the materials that accompany it (also 
detailing the ARIC study).  The consent process will be conducted in the usual manner using the 
document to which the participant was randomized (NEAT or Traditional).  Following the consent 
process, the interviewer will administer the Comprehension tool, a questionnaire which will measure 
participants’ comprehension (Part 1) and opinions about the layout of the tool (Part 2).  A qualitative 
analysis of the open-ended questions  (Part 2) will provide subjective data on participant’s opinions of the 
form design and arrangement, or other factors that they consider important.   The Comprehension tool 
score and the qualitative data about the consent form qualities make up the outcomes to be measured.  
Ultimately, these data will provide pilot data showing whether differences in comprehension or subject 
preference may exist between the two consent form designs. 
 
Methods and Measures 
 
Design 
This study will be conducted in conjunction with the consent process for the ARIC study in the Division 
of Public Health Sciences. The IRB approved consent forms will be presented to ARIC participants by the 
same study staff that would usually conduct the research consent process.  The consent form will be either 

Protocol version: 3/2/17 
Template updated 9.24.14 
4 
the regular IRB approved version, or the same form presented in components placed within a bi-fold 
folder.  The consent form wording will be unchanged between the two versions. 
 
The NEAT form consists of a clear and concise overview document containing information satisfying all 
elements of consent.  This is made up of IRB-approved wording from the regular consent form.  More 
detailed information, such as specific clinic measures are provided as additional material and are 
discussed during the consent process after the general overview has been provided with the NEAT form.  
The HIPAA Authorization is provided as a separate document. 
 
Approximately 200 participants will be randomized (via birth month) to receive either the regular form or 
the NEAT form.  Following the consent process, each participant will be interviewed using the 
Comprehension tool measure.  This design provides an opportunity to test a new consent form design in a 
real-world environment with all of the accompanying uncertainty that affects comprehension during the 
clinical research consent process. 
   
If a participant scores poorly on the comprehension tool,  elements of consent will be revisited in order to 
ensure appropriate understanding of the study information.  A copy of the Comprehension tool is included 
as an appendix to this protocol. 
 
Setting 
This study will take place at a place consistent with the plan approved by the IRB for the ARIC study .  
Potential subjects will be identified by ARIC study staff in accordance with the ARIC protocol.   
 
Subjects selection criteria 
 
• 
Inclusion Criteria 
Individuals who are eligible for the ARIC study, with which this pilot study is cooperating.   
 
• 
Exclusion Criteria 
Any individuals not eligible for the ARIC study.   
 
• 
Sample Size 

Protocol version: 3/2/17 
Template updated 9.24.14 
5 
The proposed study is intended to be a pilot study to examine the impact of a novel consent 
form methodology on participant comprehension.  The proposed enrollment is 100 
participants in each arm of the study for a total of 200. 
 
All study team members will be trained to administer the NEAT form and the comprehension tool. 
 
Outcome Measure(s) 
Following the consent process, participants will be administered the Comprehension tool to measure their 
comprehension. The summary scores will be used to address the primary aim of whether or not the NEAT 
consent form improves participant comprehension.    In addition, subjects will be asked the qualitative 
questions about what they liked and disliked regarding the consent form.  The study team member 
qualitative data about their opinion of using the form will also be collected at the end of the study.  The 
comprehension score and the qualitative data about the consent form qualities as perceived by participants 
and study team members make up the outcomes to be measured. 
 
Analytical Plan 
Study participants will be randomized 1:1 to either the traditional versus NEAT consent documents.  
Differences in comprehension will be assessed by the Comprehension tool, which is an instrument to 
assess research consent comprehension.   
 
Summary scores from the Comprehension tool will be analyzed initially using descriptive statistics which 
will be helpful in planning of a larger trial in the future.  To test the differences in comprehension 
between the two consent forms, we will use a t-test (assuming the assumptions of the test are met) and 
compare the summary scores.  The qualitative feedback will be reviewed to see if any consistent themes 
are present, both overall and by group.   
 
Human Subjects Protection 
 
Subject Recruitment Methods 
Describe how and where subjects will be identified and recruited.  Indicate who will do the recruiting, and 
tell how subjects will be contacted.  Describe efforts to ensure equal access to participation among 
women and minorities.  Describe how you will protect the privacy of potential subjects during 
recruitment.   
 

Protocol version: 3/2/17 
Template updated 9.24.14 
6 
o Under this limited waiver, you are allowed to access and use only the minimum amount 
of PHI necessary to review eligibility criteria and contact potential subjects.  What 
information are you planning to collect for this purpose?   
▪ 
Participants in this study are members of the ongoing ARIC study.     
 
o How will confidentiality/privacy be protected prior to ascertaining desire to participate?  
▪ 
Participants in this study are members of the ongoing ARIC study.  
 
o When and how will you destroy the contact information if an individual declines 
participation?   
▪ 
The IRB approved processes for the destruction of contact information will be 
utilized as usual with no necessary changes required by the NEAT study.  The 
NEAT study will not involve the recording of any subject identifiers at any time.  
 
Informed Consent 
A waiver of the requirements for signed informed consent is requested for the study team members who 
will provide anonymized feedback on the pros/cons of using the two consent forms.  The justification for 
a waiver of signed consent is presented below. 
The research presents no more than minimal risk of harm to subjects and involves no procedures 
for which written consent is normally required outside of the research context.  Study team 
members are simply providing information on the effectiveness of a form to communicate 
information (ARIC participants) and the usability of the form.   
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner.  To help ensure subject privacy 
and confidentiality, no identifying information will be collected with the Comprehension tool form or 
likes/dislikes feedback.  Subject identifiers will not be linked to any personally identifiable 
information.  The comprehension tool will be conducted on paper directly after the consent process.  
After the tools are collected, they will be scored by the PI and then entered into REDCap for analysis.  
Data access to the data collection forms and the transcribed information in the electronic system will 
be limited to study team members.  Data and records will be kept on the WF School of Medicine 

Protocol version: 3/2/17 
Template updated 9.24.14 
7 
campus in a locked office, and computer data will be password protected and secured on the WFBH 
network.  No reference to any individual participant will appear in reports, presentations, or 
publications that may arise from the study. 
 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants.  The principal investigator will be assisted by other members of the study staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to 
the IRB and sponsor or appropriate government agency if appropriate. 
 
References 
1. Denzen, E. M., Santibáñez, M. E. B., Moore, H., et al. (2012) Easy-to-Read Informed Consent 
Forms for Hematopoietic Cell Transplantation Clinical Trials. Biology of Blood and Marrow 
Transplantation 18(2):183-189.  
2. Joffe, S., Cook, E. F., Cleary, P. D. , Clark, J. W., Weeks, J. C. (2001) Quality of informed 
consent: a new measure of understanding among research subjects. Journal of the National 
Cancer Institute 93(2):139-47. 
3. Bergenmar, M., Molin, C. Wilking N., Brandberg, Y. (2008) Knowledge and understanding 
among cancer patients consenting to participate in clinical trials. European Journal of Cancer 
44(17):2627-33. 
3.   Casteel, C. A. (1990) Reading Improvement, v27 n4 p269-275  
 
Appendix 
A. Comprehension tool Form and Qualitative Assessment of Participant Perception