Culturally Competent Consent Concepts
Mark Hochhauser, Ph.D.
Readability Consultant
Golden Valley, Minnesota
Society of Clinical Research Associates: SoCRA Source, 2006,
49,42-43.
A dictionary defines 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-fits-all quality about them. Regulators, sponsors,
researchers and writers do not realize that the consent process and
consent forms have to be tailored to fit 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
figures, 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 defined as:
-
Below Basic = simple/concrete literacy skills
-
Basic = simple and everyday literacy skills
-
Intermediate = moderately challenging literacy activities
-
Proficient = 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/Pacific
Islanders, and 61% of adults 65 and older.
Table #1: US adult prose literacy skills by ethnic
background Literacy Skills
Ethnicity |
Below Basic |
Basic |
Intermediate |
Proficient |
White |
7% |
25% |
51% |
17% |
Black |
24% |
43% |
31% |
2% |
Hispanic |
44% |
30% |
23% |
4% |
Asian/Pacific Islander |
14% |
32% |
42% |
12% |
All Adults |
14% |
29% |
44% |
13% |
Adults 65+ |
23% |
38% |
34% |
4% |
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 "proficient" prose literacy
skills—which most US adults do not possess.
Conflicts 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 identification—such
as skin color—this article does not include specific 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 subject recruiting 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 influences their perception of the entire consent
process.
Table 2 Conflicts between informed consent values
vs multicultural values
Informed Consent Values |
Multicultural Values |
1. Emphasis on verbal and written
communication |
1. Emphasis on nonverbal communication |
2. Centered on the individual patient |
2. Centered on group identity |
3. Focused on the nuclear family |
3. Focused on the extended family,
often relying on the father |
4. Requires verbal openness |
4. Silence as respect |
5. Ask questions |
5. Respect authority; questions
may be seen as insulting to an authority, such as and MB
or PhD |
6. Task oriented |
6. Trust oriented |
7. Physical factors in health |
7. Spiritual factors in health/illness |
8. Independence |
8. Conformity |
9. Rely on data |
9. Rely on relationships |
10. Emphasis on rationality |
10. Inclusion of emotion |
There are plenty of books on multicultural communication, but none specifically
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 first, 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 benefited 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 find 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 benefits as they affect individual subjects; typical consent forms
usually have long lists of health risks, and vague statements about possible
benefits. I've never seen a consent form that included any information
about potential risks or benefits 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 benefits that might cause prospective subjects to participate
or not participate in clinical trials.
Mark Hochhauser