Informed Consent: the Basics
For a number of years, the FDA has stressed the importance of Informed Consent (IC) during Audits, and the leading types of findings have involved IC. The FDA has listed what information must be included in the IC Document and how it must be executed, so the basics of Informed Consent are well known. What is not as clear are the gray areas surrounding effective communication, learning theory, and assessing whether study subjects have an adequate level of understanding to give truly informed consent.
Informed Consent: Advanced Topics
Please share how you, your site or institution manage some of the current issues surrounding IC such as:
Technology: Modern technology gives us many presentation choices. These vary from just paper documents to giving subjects CDs to take home to watch or listen to, tutorials on computers or iPads, and information sent to smart phones. Creativity has produced tools such as comic books and coloring books for children, audio tapes or Braille documents for the blind, streaming videos in study site rooms and many other “tools” to help the study population understand information about participating in a trial.
- How do you, your site, or institution present the Informed Consent process? What other ideas do you have?
- What challenges have you, your site, or institution faced with presenting the Informed Consent process to study subjects?
PI Involvement: Philosophies vary about the role PIs should play. Some PIs present the entire IC discussion, others are involved with part of the process such as answering questions, and some PIs never are involved, delegating it to the Study Coordinator (SC) or other site staff. Rationale exists to support all these scenarios. Survey results indicate that study subjects want the PI to be heavily involved. Regulatory expectations are that PIs are active in the important conduct of studies rather than absentee figures and current emphasis by the FDA is that staff must be appropriately trained for responsibilities for which they are delegated. On the other hand, some contend that study subjects are more comfortable with SCs and might not be as likely to ask the PI questions, and even might feel pressure to enroll in a trial if the PI is administering IC. This is especially the case if the PI has also been the subject’s private medical physician unless therapeutic misconception is avoided, allowing study subjects as well as study staff to clearly understand the difference between participating in clinical trials and receiving medical care as a patient.
- What is the PI’s role in the Informed Consent process at your site/ institution? What do you think it should be?
- What challenges have you encountered regarding the PI’s involvement in the Informed Consent process?
Assessment of Understanding: Due to the importance of the concept of Informed Consent, it is incumbent upon those obtaining IC from study subjects to ensure they have a level of understanding that allows them to make an informed decision about participating. What must they know, and how should this be assessed? While the FDA is now focusing on whether subjects were adequately informed, there is no definition of how to assess this. Study sites may just ask subjects if they have any questions, but many will reply they do not, while others don’t know enough to know what they don’t know. Other methods of assessment include discussion about the information, asking subjects specific questions, quizzes which must be passed prior to enrollment, computer tests, and other techniques. There are advantages and disadvantages to each. Study subjects vary in many ways, including language, reading skills, knowledge of clinical research and scientific information, technical competency, cultural values, motivation for volunteering for a trial, personality and how they each learn best.
- What are some ways you, your site or institution assess subjects’ understanding of the Informed Consent information?
- What challenges has your site had in the assessment of study subjects’ understanding of Informed Consent?
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