Informed Consent and Health Literacy Workshop Summary (2015) / Chapter Skim
Currently Skimming:
2 Overview of the Key Issues Involved in Informed Consent
2 Overview of the Key Issues Involved in Informed Consent
Pages 5-22
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 5... ...
Horowitz Center for Health Literacy and associate professor in behavioral and community health at the University of Maryland, College Park, discussed a commissioned paper reviewing the impact of informed consent regulations on health-literate communications that she and her team wrote for the roundtable (Aldoory et al., 2014)
|
From page 6... ...
Various scandals involving human research -- the Tuskegee Syphilis Study perhaps being the most infamous example -- triggered more formal efforts to strengthen and codify informed consent regulations. Treatment-associated informed consent owes its origins to a case from the turn of the 20th century that involved a patient in New York with a large abdominal mass, Sugarman said.
|
From page 7... ...
"They are there in large part to serve as a reminder to meet the ethical goal." However, he added, "the conceptual models for consent do not quite capture all of the things that happen in the informed consent process and why we ought to care." There are other considerations, for example, such as whether a patient knows something about herself or himself that can change a side-effect profile. "They may know that if any pill makes them nauseous at all, they are not going to take it," he said, or a research subject might have a moral objection to the use of a human embryonic stem cell line as a therapy for their illness.
|
From page 8... ...
In some instances, said Sugarman, patients may know more or think they know more than their doctors or the person obtaining consent because of research they have done prior to the consent process. "It is not always information giving -- sometimes it's information correcting," he said.
|
From page 9... ...
The final step in the consent process is to give the individuals the consent document for them to examine. Giving the consent document to the patient can accomplish two things.
|
From page 10... ...
As an example of how technology is being used to improve the health literacy of the informed consent process, though not necessarily as a best practice, Aldoory cited the Enroll system developed by Mytrus. This interactive electronic informed consent learning tool measures an individual's understanding of the risks and benefits of participation while delivering the necessary information to obtain informed consent.
|
From page 11... ...
Best practices check to make sure that informed consent documents are written at or below an eighth-grade reading level -- research has shown repeatedly that documents are often written at more than a high school reading level, Aldoory explained -- and they use teach-back and teachto-goal techniques to increase understanding of the information in these documents. Not only do best practices involve asking patients to recite what they learned or how they are interpreting information, but they do that continually through the consent process until the patient or participant understands each piece of the informed consent procedure.
|
From page 12... ...
There are mixed findings on the efficacy of these methods, however, and every situation is different and must take into account different factors, such as low health literacy. Aldoory said that research on low health literacy has not yet found solid evidence that alternative formats beyond verbal and written communications have been effective and that, further PROS CONS •User-centered •Mixed findings •Perceived control •Low health literacy •Consistency •Dependent on •Audit trail education level •Lowered anxiety •Age dependent •Reduced staff time •Computer experience and costs needed FIGURE 2-1 Pros and cons of the effectiveness of multimedia and online approaches.
|
From page 13... ...
The first model, which assumes that the target participants have low health literacy, uses a roadmap to health-literate informed consent and is a step-by-step visualization of the sequential order of larger process phases to complete in order to reach patient understanding regardless of the level of health literacy (see Figure 2-2)
|
From page 14... ...
"Authors continue to talk about the restrictive federal guidelines and how challenging it is to reach meaningful informed consent." She said that her hope is that the commissioned paper and the discussions at this workshop
|
From page 15... ...
would increase meaningful dialogue about these barriers and identify ways to improve health-literate communication during the informed consent process. DISCUSSION Cindy Brach, senior health policy researcher with AHRQ and a roundtable member, started the discussion by saying that she has been working on moving from the AHRQ toolkit for informed consent and authorization for minimal-risk research to a set of trainings for hospital staff or for clinical practice and that she has been getting bogged down in some of the practicalities to make this transition.
|
From page 16... ...
"That's an empirical question that needs to be asked," he said. Sugarman went on to describe that he and his colleague Philip Lavori put together the Brief Informed Consent Evaluation Protocol, which serves as a tool for measuring the quality of the informed consent process independent of the experience of a research participant (Sugarman et al., 2005)
|
From page 17... ...
In the end, they used a 15-page consent document that had three sentences and pictures per page, and they used two dice to explain randomization. With two or three rolls of the dice, people without education could understand randomization.
|
From page 18... ...
Researchers may have years of experience with the informed consent process, whereas people involved in a clinical trial may be doing so for the first time or may not have the expertise to know what they are doing, she explained. Another gap was that there has been little work done on the role of situational factors such as risk levels and how they affect informed consent.
|
From page 19... ...
She acknowledged that she does not have answers yet to Isham's questions but noted that these questions are indeed on the table for study. Sugarman added that enormous debates in court cases have led to the development of consent processes for the clinical setting.
|
From page 20... ...
She also noted that the paper does list a few best practices that do relate to community-based work, as does the example she discussed about holding group meetings prior to obtaining individual consent Roundtable member Winston Wong, medical director for Community Benefit and director of Disparities Improvement and Quality Initiatives at Kaiser Permanente, asked how political power factors into the conversations around informed consent, particularly with regard to safety net organizations that may be seeing significant numbers of undocumented individuals who may come in seeking care. Aldoory said that research in this area has not panned out, at least in the context of health literacy, though she noted that there is a much broader body of knowledge around issues of informed consent that do not address health literacy and that were not part of her review.
|
From page 21... ...
Aldoory replied that most of the research on health literacy and informed consent focused on the literacy end and that there was only one formalized empirical study looking at self-efficacy. Sugarman added that one way of reducing the power differential is to have people other than the doctor or nurse involved in the consent process.
|
From page 22... ...
"I think the dominant paradigm for conflicts of interest is that it is critical to simply disclose them during the consent process, but I think we need to come up with management strategies for conflicts of interest and research rather than rely on the consent process to solve all of the issues with it." He noted in closing the discussion that his summary paper (Weinfurt, 2009) made reference to language that IRBs and investigators can use to describe different financial interests and that he and his colleagues have used this language with thousands of people.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.