The voluntary informed consent of human subjects is essential for the conduct of ethical research. Although the elements of consent are easy to iterate, empirical studies suggest that effective communication between researchers and prospective subjects is much more difficult to achieve. A recent study (Appelbaum, IRB: Ethics and Human Research 2004;26(2):1-8.) found that “31% of participants in 44 selected clinical studies expressed inaccurate beliefs that their individualized needs would determine assignment to treatment condition or lead to modification of the treatment regimen, while 51.1% offered an unreasonable appraisal of the nature or likelihood of medical benefit from participation in the study due to a misperception of the nature of the research enterprise.”

To fulfill the ethical obligation of obtaining voluntary, informed consent, researchers must view consent as an educational process, not simply a form to be signed. There are three components key to this educational endeavor: 1) communications are understandable to the subject population and do not engender misconceptions; 2) communications are undertaken in appropriate settings with sufficient time for subjects to consider participation; and 3) the potential for coercion and/or undue influence is minimized so that individuals can exercise free choice.

This month we will discuss the need for effective communication and avoiding misconceptions. In future articles, we will focus on the consent discussion, timing and setting, and finally upon minimizing barriers to free choice.

Effective communication about research participation must begin when the prospective subject first learns about the project and should continue throughout research participation. Recruitment procedures should be designed to not only identify interested individuals but also to begin and then continue educating them about the research project. All of the information provided, in advertisements, letters to potential subjects, phone conversations, and the research consent document, must be understandable to the population under study, must carefully convey the intent of the research, and must avoid engendering misconceptions and misunderstandings.

Appelbaum et al first described “therapeutic misconception” in 1982. While his early research focused on characterizing this effect, his recent focus has been on why some patients who enter clinical trials confuse research with treatment and overestimate the nature or likelihood of benefit to them. Some investigators and scholars maintain that the therapeutic misconception is difficult to eradicate, because those who are ill and desperate will hear and believe what they want to hear and believe, no matter what they are told. Appelbaum’s goal was to assess how consent form language might promote or reduce the therapeutic misconception in early-phase research.

To examine how consent forms for early-phase trials addressed scientific uncertainty and described potential benefits, Applebaum analyzed 321 consent forms for gene transfer research (Appelbaum, IRB: Ethics and Human Research 2005;27(1):1-8.). He found that it was common for different sections of the same consent form to convey divergent information about potential direct benefits. For example, in 56 consent forms the Benefits section contained only indeterminate statements, such as “You may or may not benefit.” However, all 56 contained more specific descriptions of benefit in other sections. In one instance, the Purpose section for a Phase I trial in which the prospect of direct benefit was negligible included the following, “The hope is that we can improve your symptoms and prolong your life with this treatment…The purpose of this study is …to evaluate the effect of this treatment on your disease.”

Appelbaum also collected information about the use of research and treatment terminology in the consent forms. In large part, he found that research terminology (e.g., subject, investigator, study team, study procedure, investigational/study drug) was used interchangeably with treatment terminology (e.g., patient, doctor, treatment, treatment group) or mixed terminology (e.g., research patient, study doctor, study treatment, unproven treatment) throughout the consent forms. The data from this study and others clearly demonstrate that patient-subjects often have not been given clear and unambiguous information despite the efforts of researchers and IRBs.

The lessons from Appelbaum’s research should be kept in the forefront whenever researchers are engaged in the education of potential research subjects. Information must be understandable and stated clearly to avoid misperceptions not only in written documents but also in discussions between researchers and research subjects. For example, materials that tout a “new treatment” can create a therapeutic misconception about the research project, which may be difficult to dispel in later discussions. Using a research term such as “investigational or experimental drug” avoids the perceived promise of treatment and the implication that new is better.

Finally, medical or technical terms and complex ideas in oral presentations and written materials are best presented in simple terms even for the educated layperson. Each contact with potential and enrolled subjects should be considered an opportunity to educate them about the research project.

For additional information, refer to:
The PHRC web page "Informed Consent of Research Subjects" http://healthcare.partners.org/phsirb/infcons.htm

The PHRC web page "Consent Forms"
http://healthcare.partners.org/phsirb/consfrm.htm

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Writing Consent Forms In Plain Language

An Invitation to Departments and Units
In an effort to fulfill their obligation to obtain informed consent, close to 300 researchers have attended the Partners IRB plain language workshops in the past ten months. Convincing consent writers and editors of the need for plain language has not been difficult. As researchers have learned the facts about literacy in America, they have been eager to make changes that will help research subjects understand and use their consent forms.

If the consent form is well designed, and simply and clearly written, then the subject can refer to it over and over again as a resource document when questions arise during the course of the study. Having this handy resource at home may reduce the number of phone calls and emails to study staff and keep subjects on track with study requirements.

The 2003 National Adult Literacy Survey demonstrated that half of all Americans read at the 8th grade level or lower. In that same year, a consultant hired by the IRB found that Partners consent forms were routinely written at the 12th to 16th grade level, just as they were at the vast majority of research institutions. We now know that plain language and appropriate reading levels are no longer on the wish list--they are essential to the process of informed consent.

Our goal is for the research community to consistently produce plain language consent forms at the 8th-grade reading level or lower. Last summer, the IRB began offering plain language workshops each month at BWH and MGH. These three-hour sessions provide a review of plain language basics and of the regulatory requirements for informed consent. Participants learn tips and instructions for using our Partners consent form templates, as well as how to determine the grade level of their own consent form drafts. Submitting plain language consent forms at the 8th-grade reading level reduces the number of IRB-required modifications and helps facilitate the approval process.

We encourage all consent writers and editors to attend a workshop. Or, save travel time and let us bring one to you! At a special session held in your department, we will address procedures, risks, and issues specific to your research, and also deliver instruction in the fundamentals of plain language. Contact Ann Ogletree for more information.

Upcoming Consent Writer's Workshops.

To register, please email Ann Ogletree and specify which of these dates work for you. Include your phone number, please. Seating is limited to 12 at each session, so please list all acceptable dates. Feel free to take the course at either campus. A light breakfast (AM) or snacks (PM) will be available.

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What's New at the IRB?

eIRB Pilot Update!

Thanks to the participation of many volunteers, we have now met our target goal for the pilot phase of the Insight PHRC new submissions application. The pilot demonstrated that the online PHRC new submissions application allows users to prepare forms, attach protocol-related documents, and submit these to the PHRC electronically.

Overall, we have received valuable feedback from users that will be instrumental in improving the usability of the application. We have also learned that the tool we are using for forms development should be more flexible and robust so that we may more readily respond to changing requirements and user feedback.

In addition, we have identified some systems problems that need to be fixed before we can comfortably release the application for more widespread general use. Because of this, we have decided to take the current pilot application offline so that the people dedicated to this project can put all of their efforts into making the improvements necessary to enhance performance and usability.

Submit your PHRC Documents Electronically
While the pilot is offline and we are making these improvements, an interim solution has been put in place that will allow the research community to transmit their submission documents electronically to the PHRC. This solution is called the PHRC Document Submission Tool and is available from the link below as well as accessible from the PHRC home page.

http://insight.partners.org/IRBUpload

Please note you will need to login with your Partners user name and password, and it is only accessible from within the Partners network.

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Website Updates

The PHRC office has updated its “Contacts Page” on the website. This newly revised listing provides updated information on IRB staff and includes information on the “go to person” for your issue. To see the new contact information, please access our website: http://healthcare.partners.org/phsirb/home.htm

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Upcoming Events and Workshops

See the Partners Research Community Events Calendar for upcoming events and workshops: http://eventscalendar/EventsCalendar/ASP-HTML/index.asp

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Educational Bullet

Question:
Your clinical trial is going well. Enrollment is going smoothly, data are being collected and submitted on time. This study involves a series of blood tests that are to be collected for 6 consecutive weeks after the first dose of study drug. A new study subject, MJB, has decided to enroll. However, MJB has requested that his study blood be collected at his local doctor’s office rather than driving into the city. You decide that these are only blood draws and you can supply MJB with the study tubes, plus the local doctor can ask the questions about side effects. You are satisfied that this is the best thing to do for MJB. Any reason to double check with the IRB office?

Answer: YES!

Situations such as these may require that the local doctor have IRB approval. If the local doctor is collecting data and sharing it with you, the local doctor may be engaged in research. However, if the local doctor is only collecting a blood sample, a standard clinical service and not otherwise collecting data or assessing the patient, s/he may not be considered engaged in the research project. Better call the local IRB office.

For more information about Engagement of Institutions in Research, refer to: http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm

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Coming Soon!

The “Research and HIPAA” section of the PHRC website is in the process of being revised and updated. When complete it will contain guidance on how to “operationalize” HIPAA in research. Stay tuned!

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Job Opportunity

Have you ever considered working in an IRB office? The Partners HRC office has an opening for a Senior Protocol Administrator. This position is responsible for screening continuing review submissions; preparing and organizing continuing review materials for the IRB meetings and managing records related to these responsibilities.
For a full job description, please go to the Partners job website and type in requisition # 23126. Alternatively, you can send your resume to Maria Sundquist or Jo O’Driscoll-Davis.

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In Closing...

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