Resources/Referral/Follow Up: Health Literacy in the Research Genetic Counseling Setting

Thanks to Carrie Prochniak, Master’s candidate in Genetic Counseling at the University of Cincinnati, Cincinnati, Ohio, for her work as a contributing author for this case.

Expert Commentary by Jacqueline Avila, MPH, MS, CGC, Genetic Disease Screening Program, Richmond, CA

Learning Objectives:

By the end of this case, genetic counselors will be able to

1. Discuss three ways to address the needs of research participants with limited English proficiency or low health literacy.

2. Identify three factors that contribute to health disparities experienced by immigrants .

3. Know where to obtain professional recommendations about counseling consanguineous clients.

4. Identify five characteristics of patient education materials written in “plain language.”

Shawn Miller is a genetic counselor who has recently been asked to take over an ongoing research project for a colleague who is going on maternity leave. Shawn’s responsibilities will include enrolling patients in an international multi-center genome-wide association study hunting for recessive alleles involved in susceptibility to pancreatic cancer. Because the study is looking for recessive contributions, the target population is commonly offspring of consanguineous couples. In this geographic area, candidates for the study tend to be first or second generation low-income immigrants from the Middle East. The research team posted flyers at local community markets, the bus station, and neighborhood activities centers to identify candidates for the study. Since the city is economically depressed, the researchers anticipate that some people may volunteer to be in the study hoping to get free health care. Shawn’s supervisor has called a meeting to discuss the cultural and ethical issues involved in this study.

Personal Reflections

What are your personal experiences in coordinating genetic research studies?

What are your experiences in explaining or offering to refer clients to national or local genetic research studies?

Have you ever personally been a participant in a genetic research study?

What experiences do you have working with consanguineous couples?

What are your personal thoughts and feelings about consanguineous unions?

Have you worked with first or second generation immigrants before? If yes, where were the immigrants from? What challenges did you face?

What thoughts and emotions do you have when preparing to counsel a “Middle Eastern” client?

Have you ever been uninsured?

What is your experience working with people who are poor?

How does your institution capture patient race and ethnicity information? Do these standards vary in specific genetics clinical or research settings at your institution? If so, how and why do they differ?

Perspectives

What ethical concerns come to mind with studies like these?

What are the potential ties of this study with the clients’ religious background?

What are the potential benefits to the client of participating in this study?

What are the potential risks to the client of participating in this study?

What questions should Shawn be prepared to answer about the study, in both oral and written communications with potential participants?

What potential roles can/should local community representatives play in the design and implementation of genetic research studies?

Immigration and Acculturation

The “Middle East” is a non-specific identifier for the region of southwest Asia and Egypt. More than 20 countries and many more languages are included in this region. There is debate about the exact borders that define this region. Immigrants from the Middle East may identify with various religious and spiritual beliefs; the major religions of Judaism, Islam, and Christianity and other religious sects emerged and thrive in the region. The region includes a complex mix of cultures, health beliefs, social customs, and practices (http://www.culturediversity.org/mide.htm). In general, Middle Easterners may approach time, power distance, male/female roles, personal space, and privacy in ways that differ from many Westerners (Carteret, 2009). Health care providers working with clients from “the Middle East” will only be able to effectively use this general information when it is carefully combined with an assessment of client-specific information gained from observing, interacting with, and questioning each client.

The Office of Management and Budget (OMB) definition for the White race is “a person having origins in any of the original peoples of Europe, the Middle East, or North Africa” and the Census Bureau definition provides examples including “Irish, German, Italian, Lebanese, Near Easterner, Arab or Polish” (http://www.ahrq.gov/research/iomracereport/reldata2a.htm). Therefore, while non-specific, “Middle Eastern” is a commonly used identifier for gathering information and determining trends about health at the population level. National, religious, and ethnic identifiers may be uncertain, incorrect, or non-specific due to lack of official identifiers for Middle East ethnicities in data generated from screening forms and public health databanks (Nasseri, Mills & Allan, 2007). In studies of health and disparities,

length of U.S. residence has been used as a proxy for acculturation in ethnically diverse U.S. immigrants (Koya & Egede, 2007). Compared to length of U.S. residence, the more complex entities of language and health practices are more sensitive indicators of acculturation, but they are more difficult to obtain and measure.

Immigrants to the U.S. have been shown to be burdened by a range of health disparities, which may have little to do with their country of origin. Their employment and insurance status may be more important. Most immigrants are in the U.S. legally; undocumented immigrants account for only about 26% of immigrants. Even when working, immigrants are often low-income, and are less likely to have health insurance coverage. Immigrants often work in low-wage jobs, small firms, or occupations that are less likely to offer health benefits. The uninsured are more likely to report problems obtaining needed medical care and are less likely to get preventive care (Immigrants, 2004). Lack of health insurance coverage and access to a regular primary care doctor is a significant factor in determining health care status of immigrants (Siddiqi, Zuberi, & Nguyen, 2009).

Poverty drives health disparities more than any other factor (Freeman, 2004). There is a disproportionate representation of minorities in lower socioeconomic tiers. “Socioeconomic position in and of itself is correlated with health status, independent of individual risk factors, as people in each ascending step along the socioeconomic gradient tend to have better health, even when individual health factors are accounted for” (Unequal Treatment, 2003). However, cultural factors play a complex role in health disparities for immigrants. The health of some first generation immigrant groups has been shown to be better than those of their U.S. born peers (Unequal Treatment, 2003). Environmental living conditions, social, and behavioral risk factors contribute to health in general.

Exercise: Purchase or borrow this short paperback book, A Framework for Understanding Poverty, by Ruby K. Payne, published by aha! Process, Inc, Highlands, TX (www.ahaprocess.com). It is commonly available in used bookstores for a nominal cost. Take the “Hidden Rules among Classes” quiz. This exercise assesses survival skills of individuals living in poverty, in middle class, and in wealth. Taking the quiz is an engaging way to point out how hidden rules are taken for granted by individuals in a particular class, which leads to assuming that these are the rules known by everyone.

Cancer health disparities have been shown to be driven by economic, social, economic, and health system factors (Freeman, 2004). “To understand the influence of culture on cancer, it is first necessary to untangle the confusion over definitions of race, biology, ethnicity, and culture and to carefully examine the assumption that socioeconomic factors trump race, culture, and ethnicity. Instead, it is the interaction of all these factors that determine health disparities and more clarity will increase the scientific basis for clinical practice and research among diverse populations” (Kagawa-Singer et al., 2010). Minorities are less likely to participate in cancer screening, genetic testing, and other prevention programs (Health Disparities in the United States, 2009). Poorer outcomes of cancer treatment due to delays from lack of access to care and lower quality medical services, result in minority populations as a whole having a higher total incidence of cancer and a higher total death rate (Health Disparities in the United States, 2009).

Exercise: Take a minute to consider the personal actions you have undertaken in your lifetime to reduce health disparities. List 3 ways that you would like to become more involved at the community level in reducing health disparities due to poverty.

Working with Consanguineous Couples

Attitudes of medical professionals towards consanguinity are often negative, apparently based in health concerns (Shiloh et al., 1995). However, as the health ramifications of consanguinity have been proven to be less than expected, much of this negative attitude may be due to cultural differences.

Although many Western cultures hold negative attitudes about consanguineous unions and some have even legally restricted these unions, consanguineous unions are customary and even preferred in some populations. This includes the Middle East and South Asia (which includes Pakistan, India, Bangladesh and Sri Lanka), along with other smaller communities, some even within the United States. It is estimated that at least 20% of the world’s population has a culturally-grounded preference for consanguineous unions, and that at least 8.5% of all children have consanguineous parents (Modell and Darr, 2002). In communities that prefer consanguineous marriage, rates of these unions may be as high as 50-70%, and due to the genetic implications, up to 85% of couples from these communities who seek genetic counseling may be consanguineous (Modell and Darr, 2002; Fathzadeh et al., 2008).

From a cultural perspective, there are many perceived advantages to consanguineous marriage. Many individuals from cultures without preferences towards consanguineous unions erroneously assume that these unions are rooted in religious and economic reasons (Hussain, 1999). Instead, individuals from cultures with preferences for consanguineous unions may believe that these unions are the best opportunity for a compatible marriage between husband and wife, since the parties are well known to their families. This practice helps preserve the power of the wife with her husband’s family, as brides unknown to the family may be more highly scrutinized throughout the marriage (Hussain, 1999).

From a genetic perspective, consanguineous marriage increases the chances that both members of the union will carry recessive variants being passed through the family, which increases the chance that their offspring will be affected by a recessive disease (Modell and Darr, 2002). Although the western health care focus of public health campaigns may be to actively discourage consanguineous unions based on these health concerns, the cultural benefits of consanguineous unions decrease the likelihood that these campaigns will actually dissuade such unions. Instead, the campaigns may ultimately lead to stigmatization of consanguineous couples and decrease the likelihood that couples will receive appropriate genetic services, due to underutilization of available services and inappropriate risk estimation. For example, due to the perceived stigma in the genetics community against consanguinity, families may underreport complex consanguinity to minimize disapproval (Shaw and Hurst, 2008).

Additionally, in a public health model that stigmatizes consanguineous couples on the basis of genetic factors, couples may not seek out preventative care. The only contact couples may have with geneticists and genetic counselors is when a child is born with an intellectual or physical disability. These couples may be told that the disability was caused by their consanguinity (Modell and Darr, 2002). Whether or not consanguinity is the actual medical reason for the disability, couples often feel blamed by the

geneticist or the genetic counselor, increasing the perception that consanguineous couples produce genetically unfit children.

The NSGC published recommended practice guidelines on appropriate care for premarital, prenatal and pediatric care for consanguineous couples (Bennett et al., 2002). The approach of the NSGC is consistent with statements released by the WHO in 1994 and 1996, which discourage blanket recommendations against consanguineous unions and instead recommend tailoring genetic counseling to each couple, by focusing on recessive variants known to be in the family.

Since this is an international study, there may be a variety of target groups, as well as numerous institutional review board policies and procedures. When working with his institution’s IRB office, Shawn will be asked to explain how he will inform patients that they are being asked to participate in the study because there is a higher rate of consanguinity among members of their specific ethnic group. Shawn will need to formulate the exact language he plans to use, orally and in writing, to explain why they are part of his target population.

When working with consanguineous couples or children of consanguineous unions, it is important for the genetic counselor to avoid implying negative personal perspectives. When drawing the pedigree of the family, the counselor is responsible for appropriately documenting the consanguineous union, the terminology used to denote how the couple is related, and calculating the coefficient of inbreeding (covered in the NSGC consensus statement on working with consanguineous couples). A counselor’s hesitations and/or inadequate skills can make clients feel different or unusual. Being able to draw and interpret complex pedigrees as adeptly as simple pedigrees makes all clients feel more comfortable.

Exercise: Consider how often and adeptly you draw consanguineous pedigrees. If you stumble or take too long, increase your familiarity and speed by practicing. Try drawing a particularly challenging pedigree, perhaps involving consanguinity, such as for double first cousins.

Although asking about ethnicity and consanguinity is a routine component of taking a family history, the order and manner in which the genetic counselor broaches these questions can be important. Instead of asking about ethnicity and then asking about consanguinity, ask about consanguinity first. That way the client does not feel as if the only reason you are asking is because he/she disclosed an ethnicity that is related to higher rates of consanguinity. When asking about consanguinity, the more matter-of-factly you ask, the better. Instead of asking “Is there any chance that you and your partner may be related?” and then explaining this is a routine question (as you might be inclined to say with a European-American couple), it is preferable to ask “Are you and your partner related in any way?”. This manner of questioning normalizes the union, instead of potentially making the client feel that the union is “different.”

Additionally, couples of consanguineous unions may be from cultures that are defined by a patriarchal hierarchy. As these cultures emphasize the strength of paternal ties over maternal ties, some individuals from these cultures may discount family history from the mother’s side of the family, believing that it does not strongly influence them (Shaw and Hurst, 2008). Therefore, it is important for Shawn to ask specifically about maternal family members.

Individuals in consanguineous families may be more reluctant to discuss genetic diagnoses or other problems that seem to ‘run in the family.’ A genetic diagnosis can be stigmatizing for the individual, as well as having ramifications for the whole family. A genetic diagnosis may adversely affect other family members’ marriages or marriage prospects (Shaw and Hurst, 2008). Shawn must also consider whether and how results from gene hunting studies will be shared with each participant. The results may carry multiple layers of significance for members of a consanguineous family.

Health Literacy

An important component of genetic counseling is assessing your patient’s general health literacy. Health literacy is defined as “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions” (Healthy People 2010). Almost half of the population of the United State has inadequate health literacy (National Assessment of Adult Literacy, 2003), which can impact their ability to participate fully in the genetic counseling process and to give informed consent to participate in research studies.

There are a variety of well known factors that can influence health literacy. Influential factors include an individual’s level of general literacy, his/her level of experience with the health care system, the complexity of the information, cultural and linguistic factors, and how the information is communicated (Cornett, n.d.). Even for well educated individuals with high general literacy, navigating the nuances jargon in the medical system can be challenging. Meeting with a genetics professional may require an even higher level of medical understanding than most health care appointments, making assessing and improving the health literacy of our patients an important facet of the genetic counseling process.

Emotional factors can pose additional barriers to understanding when the patient might ordinarily be able to comprehend the words and concepts. When all factors are considered, the negative consequences of not being able to understand instructions regarding a chronic condition are well documented. Health literacy is the single best predictor of an individual’s health status, surpassing even age, income, employment status, education level or racial/ethnic group (Cornett, n.d.). Additionally, even though genetic counselors can do very little to change these other predictors of health status, it is the genetic counselor’s explicit role to interpret and communicate complex health information in a manner that can be understood and used by the patient. Throughout the genetic counseling session, there are many ways that the genetic counselor can aim to improve the health literacy of their patients.

During the appointment, the genetic counselor should assess the patient’s health literacy. This can begin during the introductory exchanges with the patient through social history assessment. This assessment continues during the family history section of the appointment, especially if the history screens positive for learning or developmental differences in the family. During contracting, it is also important to elicit the patient’s beliefs regarding genetic principles and the journey through the medical system that led him/her to genetic counseling. For an excellent tip sheet on assessing health literacy, please review http://medicine.osu.edu/sitetool/sites/pdfs/ahecpublic/Learning_Assessment.pdf.

Once you have a sense of the patient’s level of health literacy, there are several tools that a genetic counselor can use while discussing genetics principles to ensure the discussion is at an appropriate level

for this individual. Although genetic counseling appointments often incorporate a significant amount of jargon, it is important to use as much “plain language” as possible. Some tips for orally communicating complex health information to people of low health literacy include (adapted from Cornett, 2005):

Slow down and frame the message first.

o Consider what your patient told you when discussing his/her lay beliefs regarding genetics. Ground the explanation you provide in terms and ideas that are already familiar to this patient whenever possible.

Limit, organize, and repeat 3-5 most important key points, teaching one step at a time.

o Think to yourself, what are the five most important points that my patient needs to take away from this appointment? How can I convey these five things in the clearest way possible?

Use commonly understood words whenever possible.

o If you must use genetics jargon, be sure to present terms along with a commonly understood definition. It is especially useful to provide a visual aid of both the concept and the word along with the oral definition.

For example, when explaining chromosomes, an appropriate explanation may sound something like this: “This is a picture of our chromosomes. Chromosomes are the parts of our body that store our personal inherited (genetic) information in all of our cells. It may be useful to think of chromosomes like a filing cabinet: chromosomes make sure all of our genetic information is present, organized, and stored in the right place.” It is also useful to show a labeled picture of chromosomes, with the written word displayed near the picture.

Limit the amount of information given at a time and break down complex information into short segments.

o Whenever possible, regularly break up your explanations with prompts to allow patients to ask questions. Individuals with low health literacy may have difficulty asking questions. Expressly prompting the patient by asking, “What questions do you have at this point?” can be helpful.

o At important points in the session, such as after you present a key take-home message, ask your patient to recall and restate what you have said by incorporating teach-back. Teach-back reinforces learning, provides an opportunity for the counselor to assess the patient’s understanding, and breaks the session into more memorable short segments.

Teach-back should not make patients feel they are being put on the spot. One way of lessening the pressure is to ask patients how they would explain what we just discussed to a friend or family member who wasn’t able to come to the session. Another approach is to present the “teach-back moment” in the following manner: “We covered a lot of ground so far, and I want to make sure that I explained this information in a way that makes sense to you. If not, I can explain it in a different way. Can you tell me what you understood from my explanation?”

Activity: Work with a colleague on this activity. Each person should choose one or more of the following counseling topics. Write down 3-5 “need to know” points for the topic before you begin counseling. Practice communicating the concepts to your partner, who has low health literacy.

1. Describe genes and chromosomes.2. Describe a 13/14 balanced translocation. 3. Describe dominant and recessive inheritance. 4. Describe congenital adrenal hyperplasia.5. Describe BRCA1 testing. 6. Describe Down syndrome.

Reflection: De-brief with your colleague. Did you agree on “need to know” points? How did you modify your counseling? Evaluate the counseling role play from the perspective of the counselor and the client. What aspects of the counseling went really well? Which aspects of the counseling need improvement? How did the counseling experience feel?

Developing Written Materials

Another way to reinforce your patient’s learning is through written resources. These resources may be in the form of patient letters routinely used by genetic counselors, fact sheets about specific conditions or procedures, information about support groups, or internet resources. However, it is essential that these resources also be easy-to-read and understandable, since they may be referred to as a permanent record of the oral conversation in the future. Additionally, nearly half of Americans read below an eighth grade reading level, while the general health education material is written above a 10 th grade reading level (OSU, “Write it in Plain Language”). In general, when creating or reviewing resources, begin by brainstorming what your patient wants and needs to know about the topic. Think about the following topics:

How might my patient use this information?

Who needs to know this information and why?

When will they need to know this information?

What do I expect the reader to know and do after reviewing this information?

After getting a general idea of what your text should include, there are two ways to more specifically assess the readability of health resources: using formal readability formulas and informal readability checklists.

Readability formulas, such as the simple SMOG and FRY readability formulas (see links below), measure both vocabulary difficulty and sentence length. These formulas are generally easy to use and are useful in predicting the general reading difficulty (plus or minus one grade level). Readability formulas can also help you analyze how word choice and sentence length affect the difficulty of the resource. That being said, readability tests cannot speak to the clarity of the writing, the complexity of the ideas, the factual correctness of the information, the organization of the content, the level of vocabulary, the design of the resource or the cultural sensitivity of the resource (Cornett, 2005). Therefore, readability formulas are helpful in giving a specific grade level if needed (e.g., for informed consent documents), but they cannot ensure that a resource is appropriate for an individual with low health literacy.

SMOG:

http://www.readabilityformulas.com/smog-readability-formula.php

http://english.slss.ie/resources/SMOG_Readability_Formula_G._Harry_McLaughlin_%281969%29.pdf

FRY:

http://www.ohiohealth.com/documents/university/fry%20directions%20and%20graph.pdf

http://www.readabilityformulas.com/fry-graph-readability-formula.php

Alternatively, when examining the overall readability of a document, the following checklist may be useful in guiding the selection and development of documents appropriate to individuals with low health literacy (adapted from Cornett, 2005 and Maine AHEC Health Literacy Center’s “Checklist for easy to read materials”):

Appearance/Appeal: The piece “grabs” the reader and looks easy to read.

o Design elements (size, shape, color, pictures, and text layout) work together to attract attention.

o Cover or masthead includes a title and behavior-focused core message framed from an audience perspective.

o Page layout and illustrations draw in/engage the reader.

Layout: Looks uncluttered. Has ample white space, generous margins, short line

length (2-5 inches).

Balances white space with words and illustrations. All 3 elements are proportional to each other.

Uses highly visible subheads (section titles) that are concrete and informative, to guide readers unfamiliar with the context.

Emphasizes key points with restrained use of boxes, rule lines, bolding, different typeface, and/or increased print size. Does not use all capital letters or italics.

Uses upper and lower case letters in 12-14 point serif typeface.

Illustrations:

Attract attention, reinforce key points, and are appropriately located close to the text.

Are culturally suitable and meaningful for the target audience.

Include captions when needed.

Are simple, without adding unnecessary clutter.

o The piece is interactive. It actively engages the reader by using creative formats—story, dialogue, check list, self quiz, etc.

Organization: Text is structured and sequenced so readers can “get the message” quickly.

o Key messages are action-focused, up front, and repeated.

o Major points are limited (3-5). “Need to know” information is stressed; “nice to know” information is limited.

o Information is sequenced and presented in a way that is logical to the intended user.

o Paragraphs and/or sections are short, visually distinct, appropriately labeled with subheads, and stick to one point.

Writing style: Strong, clear, concrete nouns and verbs create visual images the reader can remember.

o Writing style uses active voice, conversational style, pronouns and friendly tone. Do not be afraid to use a personal, conversational style, even it means using the pronouns “you”, “we”, and “I”.

o There is little or no technical jargon, and when necessary, it is explained. Terms are used consistently throughout the piece.

o The piece emphasizes concrete examples rather than abstract principles. Common words/analogies explain difficult concepts.

o Provide context before presenting new information. Words and sentences are short and simple, but not to the point of being choppy. Important information is not hidden in complex sentence construction. Lists are bulleted and short.

o Instead of using medical generalizations (e.g., “premature births and newborn illnesses are decreased by getting early pregnancy care”), give concrete recommendations for action (e.g., “make an appointment to see your doctor as soon as you can.”).

For more information regarding health literacy, please review the many excellent articles on the Ohio State University’s Health Literacy Program’s website: http://medicine.osu.edu/ahec/8478.cfm. We also suggest reviewing “Tools for Assessing Readability and Quality of Health-Related Web Sites,” which provides multiple online resources (Shedlosky et al., 2008).

Exercise: Use the pointers in this section to begin developing a new patient educational material. Decide on the focus based on prevalence of conditions on which you counsel, as well as specific needs of the patients served in your center. Consider developing a brochure, a fact sheet, or a web-based resource. Outline the content and design of the new material and develop an evaluation checklist. Use the checklist results to revise the content and or design as needed. Ask a colleague to use the checklist to evaluate the item. Pilot the evaluated materials with several patients, and re-revise. Share your final educational product with your colleagues.

Creating culturally sensitive written materials

Concerns about health literacy and the readability of health resources are compounded when the resources are intended for an individual whose first language is not English. There are many good resources available online, some of which we list in the resources section of this case under Foreign Language Educational Materials. However, it is important for genetic counselors to evaluate any materials you have not personally created to verify that it is appropriate for your patient population. A brief checklist for assessing foreign language materials follows (from Shaw and Ahmed, 2004):

Are easy, everyday words and phrases from the target language used?

Are English technical terms explained?

Is there a corresponding English text (so the English-speaking health professional can select and evaluate the correct resource)?

Is the print large enough to read easily?

Is the sequence of information clear?

Do diagrams make sense to lay readers?

Can a health professional who does not speak the target language identify the leaflet?

Are there contact details for relevant agencies and target-language speaking professionals?

As evaluating foreign language materials can be difficult if you do not speak the target language, consider involving a translator in this process (or a cultural broker, if possible). A translator can help determine if both the language is correct and the information, and its presentation, would be culturally appropriate for your patient. These professionals may also help you search the Internet for materials in the target language. Navigating websites in a foreign language may not be within your skillset. On the other hand, the translator may not have a strong knowledge of genetics. Thus, it is important to work closely with the translator to ensure that the meaning of a resource is not lost in translation.

If materials are not already available in the target language, consider working with translator services at your institution when creating new patient materials. The content addressed in English written resources may need to be adapted based on the cultural context of the target language (Shaw and Ahmed, 2004). It may not be sufficient to translate patient material word-for-word; even the visual layout needs to be culturally sensitive. When translating a prenatal intake form into another language, the counselor should consider common prenatal exposures specific to the ethnic group that speaks the target language (Simpson, Gawron, Mull and Walker, 1994). Cultural brokers and translators can work with you to create medically accurate, culturally sensitive patient materials. Once this material is generated, it is important to field-test any newly developed materials. For more information on field-testing resources, see OSU’s “Write it in Plain Language” handout.

Exercise: Take one copy of your clinic’s intake forms and/or the most commonly used patient education materials to the translation center at your institution. Discuss the process of translating these materials into the two most common non-English languages spoken by the patients served by your center. Also consider how you might engage members of the community (leaders and/or clients) in the process.

Exercise: Develop one new low literacy patient counseling aid. Review the visual aid with a health literacy expert in your area and with your colleagues. Use it in clinic and get client feedback. Share the counseling aid with genetic counseling colleagues.

Lay Beliefs Regarding Genetics

It is well known to genetic counselors that many people in the general population have a limited understanding of genetics. Yet, as genetics has become a favored topic in the media, many people commonly use genetics terminology in their daily lives, referring to diseases as “genetic” or “hereditary” among other uses (Lanie et al., 2004). However, many adults lack the science education to appreciate the sophisticated applications of genetics that may influence their health care (Lanie et al., 2004). For example, Lanie and colleagues (2004) asked patients to define the meaning of “genetic.” More than a third of their respondents had difficulty answering the question and over half of the participants gave multiple, conflicting answers. When participants in this study were asked to describe where genes were located, some participants were able to discuss DNA and chromosomes, but they often used these terms incorrectly or overly simplistically.

Lanie’s study suggests that we cannot assume that patients have the ability to grasp genetics concepts simply because they are familiar with some genetic terminology. It is essential to gauge your patient’s general understanding and beliefs regarding medical and genetics concepts. This will allow you as the provider to correct any misconceptions that they may have, as well as allow you to build on their knowledge by using shared concepts and language (Lanie et al., 2004). While most genetic counselors are well aware of the technical misunderstandings surrounding genetics in the general population, it is also important to consider the various cultural beliefs surrounding health care in general and genetics specifically held by individuals in the community.

The genetic counselor will need to transmit information that is not only simplified, but that fits within the patients’ prior understanding of how illness is caused, how illnesses are passed through families, and genetic risk (Shaw and Hurst, 2008). Individuals from some cultures may believe more strongly in environmental causes or spiritual causes for illness than medical or genetic explanations. For many individuals, medical and spiritual explanations are not incompatible (Shaw and Hurst, 2008). Shawn may want to explain that the research study is searching for the genetic risk factors that cause pancreatic cancer. However, some patients may feel that developing cancer is the will of God. Thus, Shawn will want to assess his patient’s prior beliefs regarding the cause of their illness and then incorporate these beliefs into his explanation. Shawn can acknowledge a patient’s view of why cancer happens (due to the will of God), and add that the study is looking for how this cancer occurs in the body (due to small genetic changes).

However, even in cultures or families that accept Western views of how illness is caused, there can be many ‘lay’ or ‘everyday’ explanations regarding inheritance and genetic risk (Shaw and Hurst, 2008). It is well known to cancer genetic counselors that families have many ways of explaining the inheritance of cancer through their families. These patterns of inheritance can include incorrectly believing that the cancer can only come from the mother’s side or that it ‘skips generations.’ The phenomenon of ‘pre-

selection,’ where families decide who will be affected by cancer in the next generation based on who they look like or other arbitrary factors, is another example of an incorrect lay explanation regarding genetic risk.

These ‘lay’ or ‘everyday’ explanations may also be influenced by culture. In families that are largely patrilineal, such as those in South and South East Asia, individuals may perceive that the father’s genetic information takes precedence, instead of the Mendelian concept of equal contribution from each parent (Shaw and Hurst, 2008). This concept is often true in regions where consanguineous marriage is common, which can complicate the genetic explanation of why consanguinity increases the risk for recessive conditions. In a qualitative study regarding genetics beliefs of British Pakistanis, participants explained that the influence of the father was largely genetic and the influence of the mother was derived from her health during the prenatal period (Shaw and Hurst, 2008).

While participants in Shaw and Hurst’s (2008) study willingly discussed their everyday understandings of illness causality, inheritance and risk during their interviews, this information was rarely discussed during the genetics appointment itself. Patients rarely spoke up to point out that the geneticist’s explanation did not match their own. Thus, the genetic counselor should actively assess how culture influences ‘everyday’ explanations of genetics in order to best explain Mendelian genetics to families. When the patient’s own explanation of inheritance is not assessed, misconceptions cannot be corrected. Using cultural assessment tools such as Kleinman’s questions can help counselors explore client perspectives on health and illness. See the cultural assessment tools in the “Clinical Tools” section of this website.

Research and Patients with Limited English Proficiency

Genetic research is based on the common principles of bioethics (autonomy, beneficence, non-maleficence, justice), which are nearly universally accepted among most individuals and religious groups (Aksoy & Elmali, 2002). Yet, the general topic of scientific research has various cultural implications. The target population may have no previous experience in participating in research, resulting in few opportunities for word of mouth recruitment through trusted community and family sources. The history of past research events may also be an important factor affecting research recruitment rates. In a study by Sheikh et al. (2009) exploring factors that influence recruitment of minorities into research studies, one participant stated, “The Tuskegee study is still a legacy that sticks with our community in terms of research especially when a lot of our researchers are White.” A recent study exploring African-Americans’ responses to genetic explanations of lung cancer health disparities indicated that explanatory messages focusing on gene-environment interactions instead of genetics-only messages may be more acceptable to minority populations and a buffer against skepticism about the use of genetic research to foster discrimination (White, et al., 2010).

Exercise: Watch the movie “Miss Ever’s Boys” with genetic counseling colleagues. Be sure to allow time to discuss the legacy of the Tuskegee study that you and your colleagues may have personally encountered. Give one example of what you are doing to change the legacy for the future.

The necessary criteria for obtaining fully informed consent include four basic elements: voluntariness, provision of adequate information, discussion of alternatives including risks and benefits, and competency to understand the relevant information and make a decision (Hunt & de Voogd, 2006). The specific required elements include the following (accessed from <a href="http://education.stateuniversity.com/pages/2073/Human-Subjects-Protection.html">Protection of Human Subjects - Vulnerable Populations, Institutional Review Boards, Informed Consent</a>):

informing subjects that the study is research

the purpose of the research including why the potential participant was selected and the expected duration of participation

study procedures

anticipated risks, discomforts, and inconveniences

anticipated benefits to the subject and society

who to contact to address questions

a statement that participation is voluntary and the subject may withdraw at anytime without consequence

an invitation to ask questions before deciding to participate.

Researchers may assume that informed consent is a well-known process that can be completed by quickly glancing at a form and then providing one’s signature. However, participants may not feel comfortable providing such a decisive, individualistic decision consistent with the Western concept of “informed consent.” This concept may carry greater emphasis on the interests of the family, the community, or society over individual rights (Zahedi & Larijani, 2008). Individuals may wish to consult with other family members or religious leaders, or they may want more time to reach a decision (Al Aqeel, 2007). Shawn should be conscious of his participants’ views regarding the decision making process, and, if appropriate, give them more time to make a decision about participating. The inclination to judge decisions and coping styles as adaptive or maladaptive from our personal cultural worldview must be kept in check until deep cultural understanding is achieved (Kagawa-Singer et al., 2010).

Working with participants of limited English proficiency brings a new set of challenges to the basic research protocol. Low-cost strategies for improving understanding and communication with limited English proficiency patients include testing providers for bilingual skills, using interpreters, translating key documents, including informed consent forms, and providing line by line translations when translated documents are not available (Hunt & de Voogd, 2007).

Once the language skills of the providers and needs of the study participants have been assessed, it is essential that the proper documentation protocol be followed. If an interpreter is needed for the

patient during any other medical visit, an interpreter is certainly needed for the recruitment session of a research study. From an ethical perspective, it is appropriate to adapt informed consents according to the target population (Verastegui, 2006). In a study where a small number of target languages is anticipated, it is essential that all documents be prepared in the languages of the participants. It may be beneficial to identify designated interpreters who are familiar with the research enrollment protocol. As this is an international study, developing translated documents with uniform criteria for all centers can be a daunting, but very important, task.

The primary investigator should plan to work with translator services to translate the research documents that participants will be asked to read or sign into the target languages of the patient population. Translated documents for research studies must be more alike their English counterparts than other resources, which can be translated more freely to adapt to the patient population. The translator must be able to certify that the translated document is equivalent to the English document in order to use the translated version as a substitute.

If a translated informed consent document is available, the patient should be asked to sign the form in their language. If necessary, the form should also be signed by the interpreter present, stating that through their interpreter services the participant was afforded the opportunity to ask questions and have the information explained in their language. However, it is still the enrolling genetic counselor’s responsibility to summarize the consent, and to review all important points of the informed consent document. If the participant has any questions regarding the specific text of the consent, the interpreter should assist by directing the patient to the document in their primary language.

If possible, it is ideal to combine the English and target language consent forms into one bilingual document. If not, both the English copy used by the consenting genetic counselor and the target language copy used by the participant should be placed in the participant’s chart. If the consenting genetic counselor’s signature is needed to witness the patient’s signature, this signature should be present on the same document that holds the participant’s signature (i.e., the target language document). However, if translated consent forms are not available, the text may be sight translated and read to a client in his/her language by the interpreter (participating in-person or remotely). An interpreter must have special training in sight translation (translating text in written form in one language into oral form in another language) to provide proper consent protocol. (The counselor cannot assume that an interpreter will be able to translate an English informed consent document into the target language at will, since many interpreters are not trained in the art of sight translation.) The consenting genetic counselor should provide a summary of the consent form, and then the interpreter sight translates the full document to the participant. The participant then signs the English form of the consent document, which should bear a witness signature from the interpreter. The interpreter should also provide a statement such as “I, name, provided sight translation of this form and interpreter services to (name of participant). Through my interpreter services they were afforded the opportunity to ask questions and to have information explained.”

Sudore et al. (2006) point out that obtaining informed consent from ‘vulnerable patients’ may require modification of typical procedures to achieve complete client understanding. Patients whose native

language is not English, or who have low English proficiency, low health literacy, educational barriers, or who harbor distrust of the health care system and/or research may not easily achieve understanding. Sudore and co-authors suggest improving the readability and design of consent forms, allowing extended time for discussion of consent information, and using an iterative educational approach with repeated passes through targeted education until understanding is obtained (“teach to goal”). These strategies should be considered when developing genetic research protocols.

Research on Vulnerable Populations

Research on vulnerable populations is generally understood as research on prisoners, children, or incompetent adults who cannot make independent decisions. However, other groups and individuals may be “vulnerable” to exploitation by research because they lack basic rights and freedoms such as food or health care (Zion, Gillam, & Loff, 2000). It is incumbent upon the researchers to determine that subjects completely understand the nature of the research and that they do not consent out of feelings of coercion or desperation. The consent procedure is not sufficient to ensure the ethics of a research study.

Economically disadvantaged subjects may be easily exploited when research participation offers goods and services not otherwise available (Zion, Billam, & Loff, 2000). In Verastegui’s (2006) study of informed consent in a Mexican population, where 83% of the participants lived in poverty, none of the participants thought that the purpose of informed consent was to protect their rights. Rather, they thought signing the document was a requirement to receive free health care within a cancer clinical trial study. Patients and health care professionals generally consider informed consent forms as legal requirements and not intended to facilitate patient autonomy in decision making (Corbie-Smith, 1999). Efforts to help potential participants fully appreciate their right to refuse, to question the benefits, and to fully understand what to expect, may require extended discourse with other trusted health care professionals or community members.

Creative approaches to address the challenge of recruiting marginalized groups into research have been noted, including hiring community leaders as study personnel, going into homes or community centers, hosting free community events, or setting up study sites in accessible places such as shopping areas or near bus stops (Sheikh et al., 2009). Using short culturally and linguistically appropriate video clips about patients’ rights might help introduce potential participants to the research process and clarify the purpose of informed consent (Verastegui, 2006). Incentives can motivate certain individuals to participate in research, such as offering free medical care, free medications, providing food, and/or providing transportation or child care. Incentives deserve careful evaluation, however. Do they simply provide a welcome incentive, or are they (inadvertently) coercive due to the underlying needs of the target group?

Engage community groups, before, during, and after the study as appropriate. It is particularly important to share the results of the study with participating groups, or clearly state if subjects should not expect any further information. Their past experience may have been similar to the thoughts offered by this potential research participant: “You know, after years and years of taking part and then

thinking ‘Well you know what does happen with all that stuff?’ Nobody ever gets back to us about it…So, since then I have been very cynical and very careful and I ask a lot of questions and I would want to know what it is that we are going to get out of this” (Sheikh et al., 2009). It is our responsibility to create a new history of trust and collaboration with vulnerable populations when designing and implementing genetic research.

Case Summary: Resources/Referral/Follow Up

Current genetic counseling job tasks were determined by the American Board of Genetic Counseling as the outcome of a Genetic Counseling Practice Analysis (Hampel et al., 2009). The following is a list of the Resources and Follow Up tasks, as well as the Ethical/Legal and Research/Study Coordination tasks, many of which are relevant to this case:

A. Resources and Follow Up

1. Communicate follow up plan2. Present case information (e.g., to clients, to healthcare providers, to insurers)3. Deliver oral case summary4. Compose written case summary5. Adhere to the medical and legal requirements of case documentation6. Advocate for clients in medical and non-medical settings7. Evaluate resources and services

a. support groupsb. community agenciesc. client education materials

8. Refer to other professionals and agencies

B. Ethical/Legal1. Comply with privacy and confidentiality regulations regarding personal health

information 2. Inform clients of potential limitations to maintaining privacy and confidentiality of

genetic information3. Discuss real and potential discrimination risks4. Comply with National Society of Genetic Counselors Code of Ethics5. Employ ethical principles to address clinical dilemmas6. Seek consultation with experts (e.g., hospital ethics board, NSGC Ethics Committee)7. Practice in accordance with published position statements (e.g., testing of minors, duty

to re-contact)8. Practice in accordance with published practice guidelines

C. Research/Study Coordination1. Comply with federal regulations for protection of human subjects in research2. Maintain a database

The case invites thought about the conversation between Shawn and his supervisor.

What personal and professional preparations should Shawn pursue before taking on the role of study coordinator?

What actions should they take to protect and respect the privacy of potential study subjects and prevent discrimination and stigma at the personal and community levels?

To what extent are these actions and preparations universal and to what extent are they culturally-specific to this location and/or this study?

What obligations do the researchers have to address these questions before, during, and after the study is complete?

Identification and evaluation of appropriate patient educational resources is an important task for the genetic counselor. When appropriate resources do not exist, materials will need to be developed. The focus of this case has been in evaluating, developing, and presenting client educational materials and informed consent documents using principles of health literacy. Counselors should work with the interpreters, translators, and cultural brokers at their institutions when developing and translating literature, forms, letters, etc. We listed below several excellent resources for individuals involved in ensuring the proper translation of health care documents, including informed consent forms. These resources provide useful information for genetic counselors working in a variety of settings, and especially for providing services to patients with language barriers of any kind.

A Practical Guide to Informed Consent

http://www.templehealth.org/ICTOOLKIT/

Hablamos Juntos More Than Words Toolkit

http://www.hablamosjuntos.org/mtw/default.toolkit.asp

IMIA (International Medical Interpreters Association) Guide on Medical Translation

http://www.imiaweb.org/uploads/pages/438.pdf

Clear & Simple: Developing Effective Print Materials for Low-Literate Readers

http://www.cdc.gov/dhdsp/cdcynergy_training/content/activeinformation/resources/Clear_n_Simple.pdf

Pink Book: Making Health Communications Programs Work

http://www.cancer.gov/PDF/41f04dd8-495a-4444-a258-1334b1d864f7/Pink_Book.pdf

Cultural Competence

Self-assess for bias, countertransference, and stereotyping when working with consanguineous clients, individuals with low health literacy, and/or those living in poverty.

Approach all pedigree drawing tasks as routine, no matter how complex.

Respect consanguinity as a preferred choice in some cultures.

Explore the patient’s lay understanding of genetics, illness, inheritance and risk.

Listen for concerns expressed by community leaders and group members about research.

Engage community members in designing and implementing research.

Clearly define the study’s benefits to the community and the participants.

Use familiar and accessible community settings for study recruitment and implementation.

Consider providing incentives to compensate research participants for time and inconvenience.

Allow ample time for client decision making by allowing for return visits.

Write all patient materials, including informed consent forms, using principles of health literacy regarding the content, wording, layout, and organization. Evaluate all developed materials.

Translate informed consent forms into the participants’ target languages.

Use culturally and linguistically appropriate multi-media resources to supplement verbal and written explanations of the research study and the purpose of informed consent. Modify informed consent procedures to ensure patient understanding by using an individualized iterative review process and teaching to goal.

Incorporate teach-back into study consent forms to assess true client understanding.

When appropriate, report research results to participants and the community.

Resources

Culture, Poverty, and Health Disparities

Carteret, M. (2009) Healthcare for Middle Eastern Patients and Families. Dimensions of Culture, Carteret Communications. Accessed July 22, 2010 from http://www.dimensionsofculture.com/home/healthcare_for_middle_eastern_patients_families

Freeman, H.P. (2004). Poverty, Culture, and Social Injustice: Determinants of Cancer Disparities. CA Cancer J Clin 54; 72-77.

Health Disparities in the United States: Facts and Figures. (2009). ASCO American Society of Clinical Oncology. Accessed August 3, 2010 from http://www.asco.org/ASCO/Downloads/Cancer%20Policy%20and%20Clinical%20Affairs/Quality%20of%20Care/Health%20Disparities%20Fact%20Sheet.pdf

Immigrants and Health Coverage: A Primer. Kaiser Commission on Medicaid and the Uninsured. June 2004.

Kagawa-Singer, M. , Dadia, A.V., Yu, M.C., & Surbone, A. (2010). Cancer, Culture, and Health Disparities: Time to Chart a New Course? CA Cancer J Clin 60; 12-39.

Koya, D.L. & Egege, L.E. (2007). Association Between Length of Residence and Cardiovascular Disease Risk Among an Ethnically Diverse Group of United States Immigrants. Society of General Internal Medicine 22: 841-846.

Nasseri, K., Mills, P.K., & Allan, M. (2007). Cancer Incidence in the Middle Eastern Population of California, 1988-2004. Asian Pac J Cancer Prev 8(3): 405-411.

Payne, Ruby K. A Framework for Understanding Poverty, Fourth Edition, 2005. Aha! Process, Highlands, Tx.

Siddiqi, A., Zuberi, D, & Nguyen, Q.C. (2009. The role of health insurance in explaining immigrant versus non-immigrant disaparities in access to health care: Comparing the United States to Canada. Social Science and Medicine Vol 69, Issue 10, 1452-1459.

Unequal Treatment (2003). Smedley, B.D., Stith, A.Y., & Nelson, A.R. Editors, Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care, The National Academies Press.

Working with Consanguineous Couples

Bennett, R.L., et al. (2002). Genetic counseling and screening of consanguineous couples and their offspring: Recommendations of the National Society of Genetic Counselors. Journal of Genetic Counseling, 11(2), 97-119.

Fathzadeh, M., Ali Babaie Bigi, M., Bazrgar, M., Tavarian, M., Reza Tabatabaee, H., & Akrami, S.M. (2008). Genetic counseling in Southern Iran: Consanguinity and reason for referral. Journal of Genetic Counseling, 17, 472-479.

Hussain, R. (1999). Community perceptions of reasons for preference for consanguineous marriages in Pakistan. Journal of Biosocial Science, 31, 449-461.

Modell, B. & A. Darr. (2002). Genetic counseling and customary consanguineous marriage. Nature Reviews Genetics, 3, 225-229.

Shaw, A., & J.A. Hurst. (2008). “What is this genetics, anyway?” Understandings of genetics, illness causality and inheritance among British Pakistani users of genetic services. Journal of Genetic Counseling, 17, 373-383.

Shiloh, S., Reznik, H., Bat-Miriam-Katznelson, M., & Goldman, B. (1995). Pre-marital genetic counseling to consanguineous couples: Attitudes, beliefs and decisions among counseled, non-counselled and unrelated couples in Israel. Social Science in Medicine, 41(9), 1301-1310.

Foreign Language Health Information Resources

Sampson, A. (2006). Language services resource guide for healthcare providers. Prepared for the National Health Law Program and the National Council on Interpreting in Health Care. Available online at http://www.healthlaw.org/library/attachment.89928

This guide has excellent online resources organized by topic including women’s health, cancer, etc. The guide also provides a summary of national and all state laws relating to LEP services in health care.

Consumer Health Information in Many Languages, compiled by the National Network of Libraries in Medicine: http://nnlm.gov/outreach/consumer/multi.html

Provides links to outside websites that house compilations of resources in multiple target languages. Searchable by language.

RHIN: http://www.rhin.org

The Refugee Health Information Network (RHIN is a national collaborative partnership managed by refugee health professionals whose objective is to provide quality multilingual health information resources for those providing care to resettled refugees and asylees.

EthnoMed: http://ethnomed.org

EthnoMed provides free access to patient education materials and information about numerous language and cultural groups.

Health Information Translations: http://www.healthinfotranslations.com/about.php

This site offers patient information in 17 languages on topics such as disaster preparedness, surgeries, pregnancy and various other subject areas.

Healthy Roads Media: http://www.healthyroadsmedia.org

This portal houses materials in 18 different languages in many formats, including print materials, audio, multimedia, web video, and mobile video.

24 Languages Project: http://library.med.utah.edu/24languages

This site has audio recording and brochures in English as well as 24 other languages.

Language Services Resource Guide for Healthcare Providers

http://www.healthlaw.org/library/item.118835-Language_Services_Resource_Guide_for_Health_Care_Providers_Oct_06

MedlinePlus: Health information in Multiple Languages http://www.nlm.nih.gov/medlineplus/languages/languages.html

The Diversity Health Institute Clearinghouse: http://www.dhi.gov.au/clearinghouse

This is a central access point for information on multicultural health in Australia and contains links to a range of translated health information.

Health Literacy

AMA Video on Health Literacy: http://www.ama-assn.org/ama/no-index/about-ama/8035.sthml

This video focuses on health literacy and its impact on health care.

Baker, D.L., Eash, T., Schuette, J.L., & Ulhmann, W.R. (2002). Guidelines for writing letters to patients. Journal of Genetic Counseling, 11(5), 399-418.

AHEC Health Literacy Program, The Ohio State University. (2005). Assessing Reading Ability. Retrieved from http://medicine.osu.edu/sitetool/sites/pdfs/ahecpublic/HL_assessing_reading_ability.pdf

AHEC Health Literacy Program, The Ohio State University. (2005). Health Literacy Web Resources. Retrieved from http://medicine.osu.edu/sitetool/sites/pdfs/ahecpublic/HL_Resources_for_Website.pdf. A nine page guide of websites appropriate for patients with low health literacy.

AHEC Health Literacy Program, The Ohio State University. (2005). Tips from Literacy Experts: How to Get Your Message Across. Retrieved from http://medicine.osu.edu/sitetool/sites/pdfs/ahecpublic/HL_Literacy_Tips.pdf

AHEC Health Literacy Program, The Ohio State University. (2005). Write it in Plain Language. Retrieved from http://medicine.osu.edu/sitetool/sites/pdfs/ahecpublic/HL_Write_It_In_Plain_Language.pdf

Cornett, S. (n.d.). Health literacy: End the Confusion and Help Your Patients Understand. AHEC Health Literacy Program, The Ohio State University, Columbus, OH.

Shedlosky-Shoemaker, R., Sturm, A.C., Saleem, M., & Kelly, K.M. (2009). Tools for Assessing Readability and Quality of Health-Related Web Sites. Journal of Genetic Counseling, 18:49-59.

Creating Culturally Sensitive Written Materials

Shaw, A., & M. Ahmed. (2004). Translating genetics leaflets into languages other than English: Lessons from an assessment of Urdu materials. Journal of Genetic Counseling, 13(4), 321-342.

Simpson, E., Gawron, T., Mull, D., & Walker, A.P. (1994). A Spanish-language prenatal family history evaluation questionnaire: Construction and pilot implementation. Journal of Genetic Counseling, 3(1), 39-62.

Lay Understanding of Genetics

Armeli, C., Robbins, S.J., & Eunpu, D. (2005). Comparing knowledge of B-thalassemia in samples of Italians, Italian-Americans, and Non-Italian-Americans. Journal of Genetic Counseling, 14(5), 365-376.

Boyd, J.H., Watkins, A.R., Price, C.L., Fleming, F., & DeBaun, M.R. (2005). Inadequate community knowledge about sickle cell disease among African-American women. Journal of the National Medical Association, 97(1), 62-67.

Chapple, A., May, C., & Campion, P. (1995). Lay understanding of genetic disease: A British study of families attending a genetic counseling service. Journal of Genetic Counseling, 4(4), 281-300.

Condit, C., Dubriwny, T., Lynch, J., & Parrott, R. (2004). Lay people’s understanding and preference against the word “mutation.” American Journal of Medical Genetics, 130A, 245-250.

Kessler, L., Collier, A., & Hughes Halbert, C. (2007). Knowledge about genetics among African Americans. Journal of Genetic Counseling, 16(2), 191-200.

Lanie, A.D., Jayaratne, T.E., Sheldon, J.P., Kardia, S.L.R, Anderson, E.S., Feldbaum, M., & Petty, E.M. (2004). Exploring the public understanding of basic genetic concepts. Journal of Genetic Counseling, 13(4), 305-320.

McAllister, M. (2003). Personal theories of inheritance, coping strategies, risk perception and engagement in hereditary non-polyposis colon cancer families offered testing. Clinical Genetics, 64, 179-189.

Research

Aksoy, S. & Elmali, A. (2002). The core concept of the four principles of bioethics as found in Islamic tradition. Med Law 21:211-214.

Al Aqeel, A. (2007). Islamic ethical framework for research into and prevention of genetic disease. Nature Genetics, 39(11), 1293-8.

Corbie-Smith, G. (1999). The Continuing Legacy of the Tuskegee Syphilis Study: Considerations for Clinical Investigation. American Journal of the Medical Sciences, 317(1): 5-8.

Hunt, L. M. & de Voogd, K. B. (2007). Are Good Intentions Good Enough?: Informed Consent Without Trained Interpreters. Society of General Internal Medicine 22: 598-605.

Sheikh, A., Halani, L., Bhopal, R., Netuveli, G., Partridge, M. R., Car, J., Griffiths, C. & Levy, M. (2009). Facilitating the Recruitment of Ethnic People into Research: Qualitative Case Study of South Asians and Asthma. PLoS Med 6 (10), e1000148.

Sudore, R. L., Landefeld, C. S., Williams, B. A., Barnes, D. El, Lindquist, K., Schillinger, D. (2006). Use of a Modified Informed Consent Process among Vulnerable Patients. J. Gen Intern Med 21:867-873.

Verastegui, E. L. (2006). Consenting of the Vulnerable: The Informed Consent Procedure in Advanced Cancer Patients in Mexico. BMC Medical Ethics 7:13. Accessed on August 17, 2010 from: http://www.biomedcentral.com/1472-6939/7/13.

White, D.B., Koehly, L.M., Omogbehin, A. & McBride, C.M. (2010). African-Americans’ responses to genetic explanations of lung cancer disparities and their willingness to participate in clinical genetics research. Genetics in Medicine, Vol. 12, No. 8, p. 496-502.

Zahedi, F. & Larijani, B. (2008). National bioethical legislation and guidelines for biomedical research in the Islamic Republic of Iran. Bulletin of the World Health Organization Vol. 86, No. 8, August.

Zion, D., Gillam, L., Loff, B. (2000). The Declaration of Helsinki, CIOMS and the ethics of research on vulnerable populations. Nature Medicine, 6(6):615-617.

Assessment and Evaluation Questions

Resources/Referral/ Follow Up: Health Literacy in the Research Genetic Counseling Setting

1. True/False

The health of immigrants to the U.S. is generally poorer than their U.S. born peers.

2. True/False

Length of U.S. residence is the best proxy for assessing acculturation of immigrants.

3. True/False

Health literacy is the single best predictor of an individual’s health status, surpassing age, income, employment status, education level or racial/ethnic group.

4. True/False

Sight translation of informed consent documents is an option when the documents are not available in a patient’s target language.

5. True/False

The SMOG Readability Formula is a validated tool for assessing health literacy.

6. True/False

The FRY Readability Formula is a validated tool for assessing health literacy.

7. True/False

Teach-to-goal and teach-back are educational strategies that are rarely applicable in clinical situations.

8. True/False

The legacy of the Tuskegee study continues to negatively impact participation of minority clients in genetic research studies.

9. True/False

Sudore suggests that obtaining informed consent from vulnerable patients may require modification of typical procedures to achieve complete client understanding.

10. True/False

Lanie’s study showed that clients who used genetic terminology in conversation generally had a good grasp of the underlying concepts.

11. True/False

The appearance and format of a brochure is as important as the content when assessing its appropriateness for patients with low health literacy.

The following questions are for CEU learners only:

1. I feel I have achieved the following objective as a result of this learning activity:

Discuss three ways to address the needs of research participants with limited English proficiency or low health literacy.

4= Great extent 3= Moderate extent 2= Slight extent 1= Not at all

2. I feel I have achieved the following objective as a result of this learning activity:

Identify three factors that contribute to health disparities experienced by immigrants.

4= Great extent 3= Moderate extent 2= Slight extent 1= Not at all

3. I feel I have achieved the following objective as a result of this learning activity:

Know where to obtain professional recommendations about counseling consanguineous clients.

4= Great extent 3= Moderate extent 2= Slight extent 1= Not at all

4. I feel I have achieved the following objective as a result of this learning activity:

Identify five characteristics of patient education materials written in “plain language.”

4= Great extent 3= Moderate extent 2= Slight extent 1= Not at all

5. Please rate the overall effectiveness of this case in promoting learning.

4= Great extent 3= Moderate extent 2= Slight extent 1= Not at all

6. Please rate the overall quality of this case.

4= Great extent 3= Moderate extent 2= Slight extent 1= Not at all

7. The content of this case was presented without bias of any commercial drug or product.

4= Great extent 3= Moderate extent 2= Slight extent 1= Not at all

8. The technology used was appropriate and effective.

4= Great extent 3= Moderate extent 2= Slight extent 1= Not at all

DisclaimerThe purpose of the Genetic Counseling Cultural Competence Toolkit (GCCCT) is to improve the delivery of culturally responsive, client-centered genetic counseling to diverse populations and to reduce health

disparities. The GCCCT is an educational resource; any suggestions do not define the standards of clinical or educational practice. All cases and scenarios are hypothetical. The JEMF, NSGC and Nancy Steinberg Warren, MS, CGC will not be liable for any medical or psychosocial applications connected with the use

of or reliance upon any information obtained from this website or associated links and resources.________________________________________________________

This work has been supported by the Jane Engelberg Memorial Fellowship, the 2009 grant from the Engelberg Foundation to the National Society of Genetic Counselors, Inc.

© 2010 Nancy Steinberg Warren, MS, CGC, all rights reserved.