Julian Jane Atim, MBChB, MPH
Uganda Health Marketing Group (UHMG)

Stephanie Cantu
Harvard Medical School

Jonelle Wright, PhD, RN
University of Miami

Introduction

This module consists of four (4) sections. After completing the training, you will take a short quiz on the training content. After completing the quiz, we ask you to answer a few optional questions to give your view of this training module.

Learning Objectives

By the end of this module, you should be able to:

Describe the concept of Cultural Competence in Research
Explain the importance of Cultural Competence in Research
Describe ways to enhance the engagement of diverse populations and communities in research
Identify cultural competence challenges faced by researchers when working with culturally diverse populations
Cultural Competence in Research

Culture is fundamental to everyone's perceived identity. It is a mix of one's values, beliefs, standards, norms, behaviors, language, communication styles, and thinking patterns.[1] Cultural competence refers to understanding the importance of social and cultural influence on the beliefs and behaviors of the patient, student, colleague or client.[2] Cultural competence in health care describes the ability of systems and health care professionals to provide high quality care to patients with diverse backgrounds, values, beliefs, and behaviors, including communicating effectively and tailoring delivery to meet patients' social, cultural and linguistic needs and perspectives.[3] By definition, diversity can include differences in race, ethnicity, age, gender, size, religion, sexual orientation, and physical and mental ability.[4]

Many terms are used to describe cultural competence: awareness[5], responsiveness, safety[6] and sensitivity. But, unlike cultural responsiveness, sensitivity[7], or appropriateness, cultural competency requires more than simply being sensitive to or aware of cultural differences. It necessitates taking action to improve one's competence. Becoming culturally competent is an on-going process of developing skills, values, and the capacity to function effectively in cross-cultural situations.[8] It is said that cultural competence starts with awareness, grows with knowledge, is enhanced with specific skills, and becomes polished through actual cross-cultural encounters.[1]

Cultural Competence in Research is the ability of researchers and research staff to provide high quality research that takes into account the culture and diversity of a population when developing research ideas, creating the theoretical and conceptual framework, designing the study, conducting research, interpreting and exploring the applicability of the research findings, and disseminating the results. Cultural Competence in Research plays a critical role in study design and implementation processes, including the development of research questions and hypotheses, outreach and recruitment strategies, consent activities, data collection protocols, analyzing and interpreting research findings, drawing conclusions and presenting the results. Altogether, cultural congruence in these research processes helps to ensure the research is applicable to diverse populations and if necessary can be adapted to meet the target population's social, cultural, and linguistic needs[9]. Cultural competence can be crucial to successfully recruiting and retaining diverse individuals as study subjects.[10]

Cultural competency standards can apply to all kinds of researchers (that is, basic and clinical scientists, health service and community based participatory researchers, social and behavioral researchers, and other research professionals, etc.). However, the direct or indirect applicability of cultural competence will vary for each type of researcher and for each study. For purposes of this training module, Cultural Competence in Research should be an expectation of any individual who conducts research with the goal of improving the health and well-being of all.

It is important to differentiate Cultural Competence in Research from Community Based Participatory Research and Community Engagement. We consider Cultural Competence in Research an overarching principle, which encompasses traditional modes of scientific research including, but not limited to, basic science research, clinical research (including clinical trials), community-based participatory research (CBPR), and community engagement.

CBPR, however, begins with a research topic of importance to a specific community, with the aim of combining knowledge and action for social change to improve community health and perhaps address health disparities[11]. Community engagement is a core element of CBPR research. It requires academic members to become part of the community and community members to become part of the research team, thereby creating a unique working and learning environment.[12] An understanding of Cultural Competence in Research is thus not only required for successful and culturally safe CBPR and community engagement, but also for effective research design, implementation, and recruitment of research participants for traditional modes of scientific research.

Importance of Cultural Competence in Research

It is important that research keeps pace with and is fully responsive to the challenges that arise as a result of the rapidly increasing diversity of U.S. demographics. Research findings from studies conducted only in homogenous populations are not always applicable to diverse groups. That is why it is important that a study's subject enrollment reflect as closely as possible the population of those affected by the health problem being studied.

While the general health of our nation has improved, health disparities disproportionately affect minority populations and the medically underserved. It is clear that good health is connected to ethnicity, gender, and cultural factors.[13] The actual focus of the research should also address cultural factors and their effect on the health of diverse populations. Today's dramatic demographic shifts require researchers to understand, clearly, how cultural differences among groups influence the actual process of designing and conducting research. Researchers will need to learn how best to understand and perhaps engage diverse populations in study design, implementation, analysis, and data interpretation processes. Researchers who are culturally competent are in a better position to design research methodology, analyze and interpret results that may be influenced by cultural differences.

Engaging Diverse Individuals, Populations, and Communities in Research

Federal Requirements for Minority Population Participation in Research

In 1994, the National Institutes of Health (NIH) established policy for the inclusion of women, children, and members of minority groups and their subpopulations in biomedical and behavioral clinical studies. Public Law 103-43 requires that women and minority subjects "be included in all clinical research studies, as appropriate for the scientific goals of the work proposed."[14] The goal is to ensure that minority individuals are included in clinical trials "in numbers adequate to allow for valid analyses of gender and/or racial/ethnic differences in intervention effects."[10] Further, investigators must develop outreach efforts to recruit these groups into clinical trials.[15]

As a result, researchers complying with these requirements will interact more than ever before with study subjects from diverse cultural perspectives. The quality of these interactions is extremely important. It will directly affect the overall equitability of the research, the quality and generalizability of data generated, subjects' willingness to complete the study, researchers' ability to translate research findings into practice, and ultimately, the public's willingness to accept research-based interventions.

Conducting Research Ethically-The Belmont Report [16]

In 1979, the National Commission for the Protection of Humans Subjects of Biomedical and Behavioral Research established ethical principles and guidelines for protecting human subjects in research. The three principles, respect for persons, beneficence, and justice, and their application, as outlined in the Belmont Report, require culturally competent research-related interactions with study participants.

Specifically, respect for persons requires researchers to assure autonomy and protect those with diminished autonomy. Researchers meet this obligation by allowing those who can to make informed choices about taking part in research and by instituting added protections for those who do not have the capacity to decide. In diverse communities, the former can only be accomplished when information is tailored to subjects' linguistic needs, comprehensible, and delivered in a culturally congruent manner.

Second, beneficence requires favorably balancing physical, emotional, economic, stigmatization, and confidentiality risks and potential benefits of research participation. Risks and benefits differ according to multiple factors and circumstances that vary widely across diverse communities and minority populations are more vulnerable to risks. Researchers need to engage community leaders in the process of estimating risk/benefit ratios to gain a full appreciation for how participation might affect individuals participating in studies conducted with diverse populations.

Third, justice for the individual requires fair recruitment practices. Researchers should be impartial when it comes to the enrollment of study subjects. No single group or populations should be favored. No group or population should be exposed to riskier interventions due to their circumstances. Social justice requires decisions be made by researchers in light of the ability of certain ethnic and economic classes to bear added burdens of research. Disadvantaged groups should be protected from being asked to participate in research for convenience or socioeconomic status. In such cases, only less burdened groups should be asked to accept the risks of research except when the study relates directly to conditions specific to the disadvantaged group.

Trust, Transparency, and Impartiality

When conducting research with diverse communities, involving community members in decisions about key aspects of the research, promoting feelings of ownership within the community, maintaining public accountability and transparency, and assuring appropriate ethics oversight creates trust in study subjects.[17]

A poignant example of minority Americans being used to advance medical research without considering trust, transparency, and the need for consent from families or loved ones is the story of Henrietta Lacks. Scientists know her as HeLa. Born to a poor Southern tobacco farmer who worked the same land as her slave ancestors, her cells were taken without her or her family's knowledge and made into one of the most important research tools in medicine. Later, it was acknowledged that "…HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer, viruses, and the effects of the atom bomb; helped lead to important advances like in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions."[18]

The uncomfortable irony of this example is best stated by Henrietta's daughter Deborah, "Truth be told, I can't get mad at science, because it help people live, and I'd be a mess without it. I'm a walking drugstore! . . . But I won't lie, I would like some health insurance so I don't got to pay all that money every month for drugs my mother cells probably helped make."[18]

Unfortunately, there have been several examples of misconduct in cultural competence including the Tuskegee Syphilis Experiment [19], the unfortunate history of medical experimentation on slaves in the 18th and 19th centuries [20],[21] and Nazi physicians conducting experiments on Jewish prisoners. These scenarios demonstrate the importance of understanding historical contexts for study populations before initiating research. Culturally competent study design is critical in order to better develop trust and transparency with certain study populations. Diverse populations more easily adopt interventions that were developed in research in which they may have participated, developed trust through transparency, and was aligned as closely as possible to prevailing cultural factors. Study design should include (1) well-qualified researchers who are themselves from diverse racial and ethnic backgrounds as Principal and Co-Investigators, (2) incorporating diverse and culturally competent researchers into various levels, such as project coordinator who may work more closely with the study population as well as (3) ensuring adequate numbers of diverse participants to ensure that studies are effectively powered to produce meaningful results.

Improving behavioral and health outcomes

Appreciating and integrating culturally diverse perspectives among providers (health workers, educators, researchers, and others) improves communication and builds confidence among minority populations, thus increasing access to resources among minority populations. [22],[23] Increased access to health care and willingness to adopt culturally sensitive health interventions developed from research conducted by culturally competent researchers improves health outcomes. This process is vitally important in the success of translating basic science and clinical research to better health outcomes for patients.

Challenges in Cultural Competence in Research

Despite the importance of Cultural Competence in Research, its full integration in the conduct of research faces several challenges. Foremost, is the underestimation, often misunderstanding, of what it takes to ensure trust and understanding in diverse individuals participating in research. Examples of common misperceptions are listed below with corresponding clarifying statements.

Common Misperception
Clarifying Statement

"My basic or preclinical research does not directly apply to diverse communities so this does not really apply to me." *

Some research may not hold immediate clinical relevance or application to practice, but such studies lay the scientific foundation for research that develops treatments or directly influences health interventions. It is important that early-phase studies build an understanding of, and take into account, differences that can be attributed to race, gender, age, and other cultural factors.

"Cultural competence is not that important because there are only a few minorities in the U.S."

The U.S. Census tells us that current minorities will make up the majority of the population in 2040.[24]

"My research deals with a disease that affects mostly non Hispanic whites, so this does not apply to me."

Even in a disease affecting proportionally more Caucasian patients than minorities, the inclusion of minority patients is important both scientifically to explore the role of race and ethnicity on disease susceptibility, and to fulfill the ethical requirement of just conduct of research.

"Once we have designed our study and obtained the research funding needed, we will be able to dedicate the appropriate amount of time and effort required to do a good job at identifying and recruiting minorities for participation in our study."

Engaging diverse communities in research requires building trust and, as importantly, understanding, that can be developed only over time. Inclusion of diverse study subjects should occur early in the study development process to increase cultural congruence of study methods and likelihood of success in study recruitment and retention. (ref)

"Once we have designed the study and obtained the funding, we'll hire a minority research assistant who will help with recruiting minorities."

While a diverse research team can be a valuable component for the recruitment of minority patients, considerations about cultural sensitivity are important, and are better addressed at the study design and the budget process stages.

"Cultural competency is a new "concept" and it will interfere with how we currently conduct research."

Federal guidelines on inclusion of women and minorities in clinical research were established in 1994.[25] These requirements, which are now updated regularly, dramatically changed how research was designed and implemented in the 1990s and will continue to shape the way we conduct research in the future.

"I do not need to be concerned about cultural competence because my research does not involve interaction with study subjects."

Research-driven health interventions are more likely to be successful when they are culturally sensitive and congruent and take into consideration diverse target populations for which they may be designed.

*Quotes are a compilation of common themes and statements from researchers involved in the piloting of the module and members of the Advisory Committee that helped guide the development of the work in Harvard Catalyst.

Summary

Essentials of Cultural Competence in Research

We define Cultural Competence in Research as the ability of researchers and research staff to provide high quality research that takes into account the diversity of a study population's values, beliefs and behaviors when developing research ideas, conducting research and exploring applicability of their findings.

Rapid changes in the US demographics and subsequently research study populations call for adjustments in research study design, analysis and interpretation processes.

Understanding historical contexts for study populations before initiating research study design is critical.[26],[27]

Building trust and understanding with specific populations that are being recruited to participate in research is critical. Having a working knowledge of the important customs, values, beliefs, and communication styles, without stereotyping, is of utmost importance.[28],[29],[30]

Building the skills to communicate effectively to explore customs, values, and health beliefs will prepare one to develop inclusive study designs and enable one to work with a variety of study populations.

What can Institutional Review Boards (IRB's) and researchers do to support this work?

IRBs should:

Review IRB membership to determine if there are large communities or cultures that participate in the research they approve and seek an IRB member that can help represent that community

Seek consultants as needed to help them understand the cultural issues as they pertain to a particular protocol

Consider educational initiatives on cultural competence

When appropriate, as part of a protocol application, ask questions regarding what efforts the researcher has made to work with and understand the communities being studied

Researchers should:

Look for members of specific communities to help identify areas of concern for research

Seek guidance from representatives of the community when developing and implementing protocols with communities

Consider adding members with expertise in the community under study as part of the research team

Additional Resources

Quality Interactions:
Quality Interactions is an e-learning program that provides case-based instruction on cross-cultural health care. This interactive program focuses on common clinical and/or cross-cultural scenarios that build a framework of knowledge and skills for delivering quality care to diverse patient populations

Annotated Bibliography in Cultural Competence in Research

The Joint Commission: Hospitals, Language and Culture:
The Joint Commission provides links and resources regarding cultural competence in research and health care, in the context of patient safety.

References

Agramonte, T. (2010). Suspending judgment: A key to being culturally competent. U. S. Department of Veterans Affairs. Retrieved 10 May 2010.
Betancourt, R. J., Green, A. R., & Ananeth-Firempong II, O. (2003). Defining cultural competence: A practical framework for addressing racial/ethnic disparities in health and health care. Public Health Reports, 118, 293-302.
Betancourt, J, Green, A, & Carrillo, E. (2002). Cultural competence in health care: Emerging frameworks and practical approaches. The Commonwealth Fund.
The American Heritage® New Dictionary of Cultural Literacy. (2005). Third Edition. Boston: Houghton Mifflin Company.
Shiu-Thronton, S. (2003). Addressing cultural competency in research: Integrating a community-based participatory research approach. Alcohol Clinical Research, 27(8), 1361-1364.
Crampton, P., Dowell, A., Parkin, C., & Thompson, C. (2003). Combating effects of racism through a cultural immersion medical education program. Academic Medicine, 78(6), 595-598.
Cook, C.T., Kosoko-Lasaki, O., & O'Brien, R. (2005) Satisfaction with and perceived cultural competency of healthcare providers: The minority experience. Journal of the National Medical Association, 97(8), 1078-1087
Office of Minority Health. (2002). Teaching cultural competence in health care: A review of current concepts, policies and practices. Washington D.C.: U. S. Department of Health and Human Services. Contract Number: 282 - 98 - 0029.
U.S. Department of Health and Human Services. (2001). Mental health: Culture, race, and ethnicity-A supplement to Mental health: A report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Mental Health Service.
O'Brien, R.L., Kosoko-Lasaki, O., Cook, C. T., Kissell, J, Peak, F., & Williams, E. H. (2006). Self-assessment of cultural attitudes and competence of clinical investigators to enhance recruitment and participation of minority populations in research. Journal of the National Medical Association, 98(5), 674-682.
Kellogg Community Health Scholars Program, 2001.
Jones L., & Wells K. (2007). Strategies for academic and clinician engagement in community-participatory partnered research. Journal of the American Medical Association, 297(4), 407-410.
U.S. Department of Health and Human Services. (2001). HHS fact sheet: Reshaping the health of minority communities and underserved populations. Accessed 11 May 2010.
U.S. Department of Health and Human Services. (2010). Human Subjects Protection and Inclusion of Women, Minorities, and Children Guidelines for Review of NIH Grant Applications. p. 1. Retrieved 11 May 2010.
U.S. Department of Health and Human Services. (1994). NIH Guidelines on inclusion of women and minorities as subjects in clinical research. NIH Guide, 23 (11).
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved 11 May 2010 from Office for Human Research Protections.
Shore, N., Wong, K., Seifer, S., Grignon, J., & Gamble, V. (2008). Introduction to special issue: Advancing the ethics of community based participatory research. Journal of Empirical Research on Human Research Ethics, 3(2),1-4
Skloot, R. (2010). The immortal life of Henrietta Lacks. New York: Random House, Inc.
Jones, J. (1992). Bad blood: The Tuskegee Syphilis experiment, new and expanded edition. New York: Free Press.
Washington, H. (2008). Medical apartheid: The dark history of medical experimentation on Black Americans from colonial times to the present. New York: Doubleday.
Byrd, M., & Clayton, L. (2001). An American health dilemma: Race, medicine, and health care in the United States 1900-2000. New York: Routledge.
Guidry, J., & Decuir A. (1997). Cultural sensitivity training module for health providers to increase cultural competence in working with African-Americans. Abstr Book Assoc Health Serv Res Meet. 1997; 14: 65.
Weisman, J. S., Betancourt, J., Campbell, E. G., Park, E. R., Kim, M., Clarridge, B. . . & Miana, A.W. (2005) Resident physicians' preparedness to provide cross-cultural care. Journal of the American Medical Association, 294(9), 1058-1067
Day, J. C. (1996). Population projections of the United States by age, sex, race, and Hispanic origin: 1995 to 2050. U.S. Bureau of the Census, Current Population Reports, 25-1130.
U.S. Department of Health and Human Services. (2001). NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research - Amended, October 2001. Retrieved 11 May 2010.
Corbie-Smith, G., Ammerman, A. S., Katz, M. L., St. George, D. M., Blumenthal, C., Washington, C. . . & Switzer, B. (2003). Trust, benefit, satisfaction, and burden: a randomized controlled trial to reduce cancer risk through African-American churches. Journal of General Internal Medicine, 18(7), 531-41.
Thomas, S. B., & Quinn, S. C. (1991). The Tuskegee Syphilis Study, 1932 to 1972: Implications for HIV education and AIDS risk education programs in the black community. American Journal of Public Health, 81(11), 1498-505.
Shelton, D. (2008). Establishing the public's trust through community-based participatory research: a case example to improve health care for a rural Hispanic community. Annual Review of Nursing Research, 26, 237-59.
Moreno, G., Rodriguez, M. A., Lopez, G. A., Bholat, M.A., & Dowling, P. T. (2009). Eight years of building community partnerships and trust: The UCLA family medicine community-based participatory research experience. Academic Medicine, 84(10), 1426-33.
Christopher, S., Watts, V., McCormick, A. K., & Young, S. (2008). Building and maintaining trust in a community-based participatory research partnership. American Journal Public Health, 98(8), 1398-406.
Last Updated: 08-01-12