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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers Recruitment and Retention of Women of Color in Clinical Studies Janet L. Mitchell The focus on the underrepresentation of women of color in clinical studies has benefitted from the scrutiny of the underrepresentation of women and minorities in AIDS research and recent public attention highlighting the practice of routinely excluding all women from certain studies. While others will discuss the reasons for the exclusion of women as a whole, minority status and economic circumstance represent unique aspects that need to be addressed separately. Before one begins to discuss these issues, it is important to examine a few fundamental questions. The focus on the exclusion of women from clinical studies has as its basis rejection of the concept that men or "maleness" is the norm and that women are fundamentally no different from men and therefore findings in male subjects can be generalized to all persons whether male or female. Since until very recently men—white men—dominated the research field, including the setting of priorities, it stands to reason that they would view themselves as the standard. Although the numbers of women in the research arena have been increasing, again the increase has been basically "white women." It is important to examine how research "norms" are then defined. In fact, is important to examine how society defines itself and all ''norms," if one is to critically focus on issues related to people of color and by extension women of color. While those parties concerned with the exclusion of women from clinical studies are quite willing to recognize the premise of men being the standard as flawed, they are less willing to consider the possibility that defining society and norms on the basis of white Anglo- or Euro-centric beliefs may also be flawed. This country is not the melting pot that many would like to believe it is and, in fact, it is comprised of many diverse cultures, races, and ethnicities—all of which have the same right to define society and norms from
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers their own unique perspective. It is this premise that allows for the following perspective on the underrepresentation of women of color in clinical studies. Although it is important to understand that women of color are a very heterogeneous group, as are all groups, certain historical experiences are common and account for certain attitudes and perceptions. Distrust of the "intent" of the white community can be found at all educational and economical levels. While many are aware of the Black Power movement of the 1960s and 1970s, there is a similar movement today that is less visible to the white community but is well-known in the African American community. It is described by the adjective "Afro-centric" but has a philosophy rooted in distrust of anything that is ''Euro-centric"; calls for self-reliance and self-determination. The medical community encountered the movement in the controversy around Kemron.* The perception that Kemron was a treatment developed by an African and the belief, again regardless of educational or economic status, that the virus that causes AIDS may be man-made has as much to do with the underrepresentation of minorities in AIDS clinical studies as does the circumstance of gender, economics, or drug use. A review of the literature on the recruitment of minorities into clinical studies revealed that authors are more comfortable discussing issues that related to economic and institutional barriers than they are discussing attitudinal barriers. This is even true of the one recent article that addresses, in a real way, most of the barriers encountered when recruiting and retaining minorities in clinical studies. I refer you to the article written by two colleagues at Harlem Hospital Center, who at that time were responsible for the NIH-/NIAID-funded Community Program for Clinical Research on AIDS (CPCRA), entitled "The Challenge of Minority Recruitment in Clinical Trials for AIDS."1 This is by far the most comprehensive discussion of many of the barriers to minority recruitment and retention with recommendations that would be endorsed by anyone who has ever worked with this population. However, while mentioning the distrust of the community and citing the Tuskegee experiment, the authors chose to focus on economic barriers. They also chose to focus on the idea that the underrepresentation of minorities in studies can lead to confusion in * Kemron is the trade name for a drug, alpha interferon, discovered by an American but first used in AIDS patients by a researcher from Kenya, Davy Koech. Koech reported that AIDS patients taking the drug improved remarkably; however, the U.S. scientific community dismissed his claims as based on small, uncontrolled studies. There were protests from the African American community that the white, U.S. scientific establishment had rejected a promising African innovation (Cowley, G., "The Angry Politics of Kemron," Newsweek, Jan. 4, 1993, 43–44). Although both NIAID and the WHO have now refuted Koech's claims, NIH has begun clinical trials of Kemron in the United States (F-D-C Reports, Inc., The Blue Sheet, June 9, 1993, 12). — Ed.
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers interpretation. Just as there can be gender-specific differences in response to treatment, there can also be racial/ethnic differences as has been demonstrated in racial differences in response to antihypertension therapy. The authors lead one to believe that the refusal of many of their patients to take zidovudine (AZT) was due to the result of one study that concluded that the drug may not benefit African Americans or Latinos. What my colleagues failed to mention was that even before the release of that study, African Americans did not truly believe that the drug was of benefit. The release of the study only gave them the scientific ammunition needed to confront the medical establishment. As committed and dedicated as my colleagues are, and they are, they are neither African American nor Latina. Therefore they share the same discomfort as many in the white community of not wanting to confront issues that highlight the inherent racism in this country, even in medicine. One other article that examined psychosocial influences on recruitment and retention of women attending a family planning clinic did not look at these differences across races despite the fact that the study includes 4,781 women—18 percent of whom were African American.2 Another historical experience that cuts across all educational and economic levels in communities of color, which can be perceived as a barrier to recruitment and retention, is that of spirituality. "I will leave it in God's (Allah's) hands" is an expression medical providers hear often from their patients of color. Spirituality is seen as a major cornerstone in the foundation for survival. It is especially called upon when one is faced with life-and-death crises, such as a terminal illness. Many providers, regardless of color, have learned to use that spirituality to the benefit of science by making it a partner. "It is God (Allah) that helped me become a physician (nurse, etc.)." "It was God (Allah) that enabled the treatment to be developed." Communities of color are less enamored with traditional science and technology. The reliance on spirituality and alternative treatments, often as the first choice in communities of color, is now recognized and being viewed less negatively by traditional science, as evidenced by the establishment at the National Institutes of Health of an Office on Alternative Therapies. One paper that looked at recruitment strategies for multiethnic families found the use of religious associations and their leaders as purveyors of the message more effective in recruiting African American families for participation than media, posters, and telephone contacts.3 What is often not seen as a barrier but can be a significant deterrent in communities of color is the time involved in participation in clinical studies. This barrier can be related to loss of income or lack of time. While there is a growing middle class in communities of color, there is still a gap in the earning potential and job status. The middle class status of many families is dependent on two incomes or multiple jobs. The job position may not allow for much flexibility. This translates for many into loss of income for the time needed for
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers follow-up or the inability to find the time for follow-up because of multiple responsibilities. While these first three issues are generic to communities of color in general, women of color have specific issues that may be viewed as barriers in recruitment and retention into clinical studies. Again, regardless of educational or economic status, women of color are more accepting of the traditional roles of women as caregivers and caretakers. The statistics that highlight the large number of single-female-headed households in communities of color lead to false assumptions about the role and philosophy of that single female. Some would like to believe that that status has brought her closer to a philosophy of taking care of self first. In reality, most women of color are single by circumstances, not by choice. Despite that status of "single female head of (one) household," at any given time they are responsible in a very traditional sense for their own children (if they are mothers), other children in the family, other members of their family, their partner (be that male or female), or a neighbor. Whether employed outside the home or not, women of color still bear the primary responsibility of providing sustenance, comfort, and support. This can be in any combination—financial, spiritual, moral, and/or physical. All of this leads to their putting the needs of others before their own. Using the example of AIDS again, successful programs targeted to women recognized the importance of providing care for children (infected or not) in conjunction with care for their mothers. Some programs have also extended this to partners. All programs know that when asked about missed appointments, women often report needing to attend to the needs of some other person. Because this traditional role extends to providers, women of color, especially those less well educated or less well-off economically are reluctant to admit that there may be a conflict of time or philosophy. This is especially true if there was no initial discussion that allowed the woman to feel she was a partner in the process and that her opinion was important. Because of this traditional role (often interpreted as passivity) and the historical exploitation of this population by medicine, many have concerns about their vulnerability to coercion. Unfortunately, the potential for this still exists, despite the existence of institutional review boards. It is important to again view this from a historical perspective. Just as spirituality has been a cornerstone in the foundation of survival of communities of color, so too has sacrifice. The incentives that most clinical studies are beginning to offer for participation may be of more importance from the perspective of the participant than the study intended. This is especially true for parents (mothers). The offer of disposable diapers, cribs, and strollers may be the overriding reason for participation. While this is a concern and should be considered when including incentives, it is also important to understand that communities of color are much less trusting and in fact quite suspicious still of "research." While reasons to participate or not may differ from that of the white community, the reasons are usually just as sound,
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers albeit from a different cultural context. It is important to understand that there is often a direct link to the "lost to follow-up" and the perception of coercion. If the perception is that care and service depends upon participation in a clinical study in which one does not want to participate, one goes elsewhere. Be careful as to how data on this population have been interpreted in the past. The use of the emergency room and episodic care has as much to do with the attitude of the clinic staff (especially the clerk), the ability to be seen by the same provider, and the flexibility of the clinic's hours, as do the complexities in the individual's life. Given the fiscal situation in most publicly run facilities, this will only get worse. Across all educational and economic strata the numbers of women of color enrolled in clinical studies are low. Attempts to analyze this phenomenon have focused mainly on low-income women of color. The identification of many barriers such as transportation, child care, language, etc., are well documented. Even the element of distrust is noted. Yet numbers are low for educated, higher-income women as well. This issue has received less attention. In this group the attitudinal barriers may dominate. There are also institutional barriers that have not been given enough importance. To answer the question of how to increase the participation of women of color in clinical studies, we must first revisit an assumption. I suggest we first seek answers to the following questions from a representative sample across all educational and economic levels: Do women of color feel that participation in clinical studies is important? Why or why not? Do women of color feel that their participation is important? Why or why not? For women who were offered an opportunity to participate but declined, why? For women who were not offered an opportunity to participate, why do you feel you were not offered the opportunity? For the provider, why was the opportunity not offered? NOTES 1. El-Sadr, W., and Capps, L. 1992. Special communication: The challenge of minority recruitment in clinical trials for AIDS. Journal of the American Medical Association 267:954–957. 2. Young, C. L., and Dombrowski, M. 1989. Psychosocial influences on research subject recruitment, enrollment and retention. Social Work in Health Care 14:43–57. 3. Hooks, P.C., Tsong, Y., Baranowski, T., et al. 1988. Recruitment strategies for multiethnic family and community health research. Family and Community Health 11:48–59.
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