Email this Page
Print this PageEngage participants in the Informed Consent Process
Use plain language
- Researchers are used to talking about cancer and scientific studies every day. But, most people are not. In addition, the average adult in the U.S. reads between the 8th and 9th grade reading levels. Add to that the stresses of cancer and you can see how important it is to simplify and avoid jargon when presenting a clinical trial. If possible, rehearse what you will say so you can talk about the trial in a way that is confident, balanced, and easy to understand.
Use participant-friendly materials
- Use active voice and personal pronouns (Instead of “The patient may contact his or her physician at any time….,” say “You may call me any time….”). Use white space, figures, diagrams, calendars, and simple outlines to make your document easier to read and understand. Leave wide margins and space so that participants or their friends and family can take lots of notes.
Present the trial in a culturally appropriate manner
-
The racial and ethnic backgrounds of potential participants play an important role in the feelings, viewpoints, and communication needs they bring to conversations with you about a trial. For example, ethnically diverse populations may have issues related to trust, differing cultural values, language barriers, and feelings about medical professionals that will impact their thinking about any trial you present. Take into account these perspectives and any culturally-rooted communication preferences as you present the trial.
Seek the help of translators when needed
- There have been times when a participant and a clinical trial seemed a perfect fit, but language barriers made informed consent impossible so the participant could not even be given the option to join. Even after informed consent, participants whose primary language is not English will likely need the aid of a translator to get answers and refresh their understanding of the trial over time.
Emphasize the key role of the physician presenting the trial
- The research is clear. The majority of participants enroll in trials because a physician asks them to join. Make sure key physicians are involved in talking with potential participants about the trial as early as possible.
Present the trial in a balanced manner—both pros and cons
-
It can be easy to overstate the pluses of a particular trial when talking with potential participants. The pressures of accrual or even a clinician’s heartfelt enthusiasm about the value of the trial itself can play a role. By preparing your materials and what to say about a trial, you can be sure to present it in a balanced way—so potential participants can make informed choices.
Provide continued support as people consider their decision to participate and continue on the trial
- The informed consent document and the informed consent discussion are critical. Yet, they represent only the start of the consent process. People need time to make thoughtful decisions about joining a trial. As they consider this decision, provide access to any additional information or resources they may need. The two-way communication flow that helps participants feel comfortable and informed when originally joining the trial should continue throughout the study.
Manage communication of screening results and failures
- It is important to remember that participants, and their primary care providers, require communication about both successes and failures. Consistently “close the loop” with potential participants—both those who are screened into and out of the trial. Doing so is common courtesy and, for those who are eligible, this step starts building your relationship. For those who are not eligible, thoughtful communication can help keep open the possibility of future trial participation.
Be aware of and monitor regulatory issues such as HIPAA regulations
-
Regulatory and IRB issues can be fluid, so it is important to keep on top of potential changes that may be occurring, both at your site and on a national level.
Literature and Tools (243)
