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 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 Protection of Human Subjects - Vulnerable Populations, Institutional Review Boards, Informed Consent):

• 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.