Session 2: Adventures in Empirical Ethics

Instructors

Laura B. Dunn, M.D.

Aims

The overall goal of this session is to review the concepts of informed consent, discuss assessment of decision-making capacity, and highlight the importance and necessity of empirical evidence when considering the ethical issues inherent in research with human subjects.

Objectives

By the end of this session, students will be able to:
  • Describe the concept and components of informed consent.
  • Discuss potential influences on abilities to provide informed consent, including influences on voluntarism.
  • Describe different methods to enhance informed consent in potentially vulnerable research populations.
  • Consider how to integrate methods of enhancing informed consent into their research projects.

Key Terms

  • Informed Consent: Informed consent requires patients to understand all the possible risks and benefits to a study before deciding whether or not they want to participate.  The patient must be given the opportunity to have any questions answered prior to participation.  Additionally, the patient must understand that they can leave the study at any time if they so desire.  Informed consent is a process, not just a signature on a consent form.
  • Proxy Consent: When a patient is unable to provide informed consent, proxy consent can be provided in lieu of informed consent.  A proxy is typically a highly involved family member who has been informed of all the potential risks and benefits of the study.  For best study results, it is important to solicit patient assent in conjunction with proxy consent.
  • Patient Assent: Patient assent is achieved when the patient expresses willingness to accept the proposed care. Patient assent is often used in conjunction with proxy consent in pediatrics, and in some cases, the cognitively impaired.
  • Therapeutic Misconception: A therapeutic misconception occurs when a patient fails to properly distinguish between research and usual treatment or holds inaccurate beliefs about the degree of individualization of treatment.   A therapeutic misconception can also be seen when a patient believes that the research study is primarily intended to benefit individual participants.

Agenda

  1. Discuss vulnerable populations with whom students are working
  2. Group discussion of ethical issues that have arisen in conduct of research, to provide examples to return to during the course of the session
  3. Presentation (see Aims above)
  4. Continue group discussion of issues raised during presentation, as they apply to the students’ own research projects
  5. Discuss examples of ways to enhance the consent process and assess capacity as part of students’ research
  6. Questions and any further discussion

Readings (Optional)

Teaching Materials

Supplemental Resources

Assignments

  • Students are asked to bring a description of their research project, their research population, and to describe potential vulnerabilities of their research population in terms of informed consent and capacity to consent.

Summaries of Objectives

  1. Describe the concept and components of informed consent.

  2. Discuss potential influences on abilities to provide informed consent, including influences on voluntarism.

  3. Describe different methods to enhance informed consent in potentially vulnerable research populations.
    1. In the context of informed consent to a research study, repeated learning trials and corrective feedback improve both comprehension and retention in patients with schizophrenia.  When information has been provided using multimodal techniques (e.g., PowerPoint, instructional videotapes, or educational modules) as compared to a traditional paper consent form, comprehension and understanding improved in patients with schizophrenia and other serious mental illnesses.
    2. Patients assess both the scientific importance and the level of potential harm when deciding whether or not to participate in a study.  These assessments often differ from psychiatrists’ assessments.
  4. Consider how to integrate methods of enhancing informed consent into their research projects.
    1. Ethically informed consent may be difficult to obtain for students who are conducting CBPRs in cognitively or psychiatrically impaired populations. Techniques to assess a patient’s decisional capacity include clinical interviews, but briefer, structured assessment screening methods can be used, augmented by further assessment for subjects whose capacity is marginal. Some methods that have been shown to enhance informed consent include repeated learning trials (review sessions), and multimodal presentations. Students should be able to integrate these methods into their CBPRs.

Assessment Data and Learner Feedback

  • Participant comprehension is best assessed by providing ample time for discussion of each objective.

Teaching Tips/FAQ

  • Students tend to be very engaged by discussing ethical issues they have encountered, or think they may have encountered, during their own research. Having ample time for discussion, and presenting ethical issues as “tensions” among principles rather than rigid rules to be followed, encourages discussion and thoughtful reflection.

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