Culturally Competent Consent Concepts
Mark Hochhauser, Ph.D.
Golden Valley, Minnesota
A dictionary defi nes culture as “the sum total of ways of living built up by a group of human beings and transmitted from one generation to another.” In the worldwide conduct of clinical trials and informed consent, subjects are often viewed as a single, homogeneous group, so that different ways of living are neither acknowledged nor included. Lacking multicultural insights, current informed consent forms have a one-size-fi ts-all quality about them. Regulators, sponsors, researchers and writers do not realize that the consent process and consent forms have to be tailored to fi t the needs of prospective subjects who have different ways of living based on education, ethnicity, religion, spirituality, family and community values, etc.
The United States is comprised not just of homogeneous “subjects,” but of patients from an increasingly wide range of cultural backgrounds. Ethnicity—”the sharing of common and distinctive culture, religion or language, especially in groups that are minorities with larger society” --reflects different ways of thinking about health, illness, research, medical authority fi gures, etc. For example, some cultures maintain a fatalistic view of life and death—whatever happens is God’s will and, therefore, cannot be affected by human intervention. In the US, ethnicity (and age) are linked to education; prospective subjects must be able to read and understand the consent form, and possess complex intellectual skills to interpret the massive amount of information given them during the consent process.
What can patients read and understand?
Consent form writers assume that patients can read and understand at levels that will allow them to make sense of the consent form. But data from the 2003 “National Assessment of Adult Literacy” (http://nces.ed.gov/ naal) shows prose literacy skills vary considerably based on ethnicity and age.
Literacy skills were defi ned as:
• Below Basic = simple/concrete literacy skills
• Basic = simple and everyday literacy skills
• Intermediate = moderately challenging literacy activities
• Profi cient = complex and challenging literacy activities About 43% of all adults have below basic or basic prose literacy skills, as do 32% of whites, 67% of blacks, 74% of Hispanics, 46% of Asian/Pacifi c Islanders, and 61% of adults 65 and older.
I included prose literacy skills for adults 65 and older because our IRB often reviews clinical trials where subject age range is 18-80 or even 18 to no upper limit. Because consent forms are usually long, complicated and hard to understand, I suspect that understanding written consent materials requires “profi cient” prose literacy skills—which most US adults do not possess.
Confl icts Between Culture and Consent
Perceptions about health care and research are a part of a patient’s cultural knowledge, attitudes, beliefs and behaviors. Because it’s too easy to stereotype patients based on a simple ethnic identifi cation—such as skin color—this article does not include specifi c examples for different ethnic groups. While some cultures may have much in common, no two cultures are completely identical. For example, although Native Americans and Alaskan natives may be thought of as a single homogeneous culture, there are over 500 individual, federally recognized tribes. Although these 500+ tribes have much in common they cannot be considered identical.
Black patients include not only US-born Blacks, but people from the Caribbean, Central and South America, Nigeria, Ethiopia, Somalia, Nigeria, etc. Hispanic patients include Cuban, Mexican, Puerto Rican, Central American, South American, etc. The Asian American population includes Chinese, Korean, Japanese, Vietnamese, Cambodian, Thai, Hmong, etc. There can be tremendous cultural and ethnic variation among people given the same ethnic label; do not assume that all patients from the same ethnic background think or behave in the same way.
Because these diverse ethnic groups are part of American culture, a considerable effort has gone into the development of corporate cultural diversity programs, but such efforts have not been widely used in clinical trials research. Table #2 illustrates some key differences between the informed values of regulators, sponsors, bioethicists, researchers and consent form writers and the multicultural values of ethnic patients.
What can you do?
Take a look at the multicultural values in Table #2. Has your research project taken these into account for your ethnic subjectrecruiting and consent process? Probably not. Recognize that multicultural values exist, and that recruiting ethnic patients may be very hard if you don’t understand how their ethnicity infl uences their perception of the entire consent process.
There are plenty of books on multicultural communication, but none specifi cally dealing with informed consent. The best way to improve your multicultural understanding is to work with multicultural organizations. Spend some time talking with the organization’s staff, and then spend some time talking with multicultural patients. Recognize the important difference between “talking to” someone and “talking with” someone. Be patient. It may take time for trust levels to develop if you’re working with multicultural groups that put trusting relationships fi rst, tasks second. Be prepared to take some time before you both get to the mutually agreed upon important issues; what’s most important to you may not be most important to them. You may not be aware of how research risks are perceived among those in different cultures. Current research can’t be separated from their history of research experiences. Multicultural peoples have often felt exploited and used for research that benefi ted researchers, but portrayed their ethnicity or their community in very negative ways. They’re sensitive to researchers using them and then abandoning them when the research is over or the funds run out. So you may fi nd prospective ethnic subjects being concerned about how clinical trials affect not only their own health, but also their family and community. This could be a major problem for those clinical trials that involve collection of blood or tissue for later genetic analysis if ethnic groups believe that this kind of information will be used later to stigmatize them.
Clinical trial researchers are used to thinking about research risks and benefi ts as they affect individual subjects; typical consent forms usually have long lists of health risks, and vague statements about possible benefi ts. I’ve never seen a consent form that included any information about potential risks or benefi ts to the subject’s family or community, probably because the FDA doesn’t require that as a “basic” or “when appropriate” element of informed consent. But unless researchers become aware of perceived family and community risks of research participation, addressing only medical risks will not begin to approach all the ethnic risks and benefi ts that might cause prospective subjects to participate or not participate in clinical trials.