2013 CTSI Annual Pilot Awards to Improve the Conduct of Research

To facilitate the development, conduct or analysis of clinical & translational research

Improving the consent process for complex studies: making the study understandable to subjects

Proposal Status: 

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.


Great idea. Since this isn't my field, I'm wondering if there is a prior literature on this approach to improving the informed consent process?

There is literature demonstrating that information from consent forms longer than about 4 pages is not retained.  I'm not aware of studies using this approach -- will have to search the literature a little more.

This is a critical issue to address as consent forms have become incredibly long and often more confusing than helpful to study participants. I like the idea of a brief study summary to help potential participants improve their understanding of the study procedures. Do the investigators have any concern that the 2 page summary might be used in lieu of the complete consent form? That is, if all of the information in the complete consent form is deemed necessary by the CHR for participants to review, will the 2 page summary provide an "easy out" for PIs and research coordinators to only discuss those key items listed in the summary, rather than reviewing the more complete and detailed information in the consent form?

That's a valid concern.  I think we would have to depend on the good faith and intent of investigators to conduct the consent process using the entire consent form.  We do that now, assuming that the complex forms are supplemented by investigator/staff explanations.  The summary would only be intended to facilitate patient understanding.

I love this idea, and agree that the consent form process has become a big issue. 


I'd also love it if the UCSF Subject Authorization document could be incorporated into the regular consent.  It's difficult for patients to understand why they need to sign multiple consents, and the current language of that document scares many potential study patients off.

Interesting suggestion.  The summary could easily add a "boilerplate" statement concerning the HIPAA form.

I highly agree with the above comments that this is a really important issue and a simple summary sheet may be helpful in providing research participants additional clarity about what they are signing.  One question I have is how you will be evaluating whether participants have "better understanding" with use of the summary sheets?  Is the plan to do a comparison within studies where some patients receive the summary sheet and some do not and then see who knows more about the study?  I'm curious because we're in the planning stages of a RCT of various forms of consent for biobanking and we're still trying to figure out the best way to evaluate understanding.

Ideally, I would follow your suggestion of doing a comparison within studies.  But given the time and budgetary constraints, and viewing this as a pilot project, I plan to use a short knowledge questionnaire about the study after the regular consent process, and repeat it after presentation of the summary, along with asking subjects' to provide their subject ratings of the helpfulness of the summary sheet.


For your RCT, a knowldge questionnaire might be helpful.  Rebecca Sudore has done this, so you might talk with her.

I've written many informed consent documents, and to meet the present requirements is quite difficult and time-consuming.  So the idea of making it "shorter" is appealing.  This is from the point of view of the scientist.  From the Subject's point of view, short is appealing, but undesirable if there are parts that are unclear or not even mentioned, that the subject may be concerned about.


The conundrum is this:  How can you be both "simple" and "detailed" in the same document?  I've been working on this for years, and there IS a solution, which I call the ExpandingOutline.  This works especially well on Computer presentations.  You can see the idea AND the presentation at: http://expandingoutline.webcompendia.org .  If this method is used on a computer, you can also monitor what parts the Subject has expanded, thus indicating interest.  You might even want to place some requirement that the Subject MUST have opened "Risks" or the Subject cannot participate.  Another use of a computer to monitor what is read, would be to document the parts that the Subject did NOT look at, so that the recruiter could call attention to those parts as part of the consent process. This data would also be important for re-writes and changes in terminology, since it might identify what does or does not work in terms of alerting the Subject to the items that concern the CHR.  I suspose that if the software were available to summarize each Subject's path through the ExpandingOutline, and then to summarize across Subjects, this information would be of considerable interest to the CHR, so that they could offer critiques based upon data, rather than their own impressions from reading the Consent Form. (I've been on a CHR for a few years, myself.)

this is an important an interesting idea.  the literature is replete with examples of readability of consent forms being too high for potential participants.  this is an even bigger issue with vulnerable populations and in health disparities research.


one approach is to add a simple short plain language summary for potential participants (not instead of the consent form mandated by sponsors or campus policies but in addition to). 


we took this approach with HIPAA Notices of Privacy Policies in US Dental Schools creating a simple plain language addendum to supplement the ones approved by institutions' lawyers (Ha & Gansky, 2007). 


what steps will you take to enhance sustainability after the pilot is over?  training materials including tips on how to write short, simple plain language summaries might be one way to increase the usefulness beyond the boilerplates developed during the project for future needs.




How to enhance uptake and sustainability is an important question.  As part of the pilot, we want to evaluate how well investigators are able to adhere to the simple plain language.  This should guide efforts for training after the pilot.

This is an important topic with, as others have noted, especially for vulnerable populations. Also as noted, there has been considerable work in this arena, including this study in the Emergency Medicine literature (Dresden GM, Levitt MA. Acad Emerg Med. 2001 Mar;8(3):246-52). With its high volume and many patients who could  benefit from a simplified consent process, the SFGH emergency department is a prime area to include in such a study. We have a robust research assistant program and would be happy to be collaborate or assist in any manner. 

Thank you.  The SFGH ED would be a great place to test this.

I think this is a great idea. Do we happen to have a current evaluation of the ROI from implementing this  improvment?  The time and/or $$ savings from study teams and CHR could be significant. 

I don't think we can get an estimate of ROI until we do the pilot project.  That would give an idea of time savings, if any.  But, even without time savings, I think it would be worthwhile if it improved patient understanding and satisfaction with the consent process.

Great idea and definitely a tool that can be used campus-wide. Many participants get lost in all the pages of a consent form - simplifying the informed consent document will benefit participants understanding of study involvement and expectations. Providing templates is a great tool for investigators and will hopefully speed up the review process on the CHR end.  I do agree with others comments that this is a huge bonus of vulnerable populations and emergency room care; but can see the challenge in evaluating what is "detailed enough" for the info sheet. It might be a good idea to test with a sampling of protocols with different levels of complexity, phase I-IV, and variety of therapeutic areas to see if the template still holds.  

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