Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies: Volume 2: Workshop and Commissioned Papers (1994) / Chapter Skim
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20 Ethical and Legal Issues Relating to the Inclusion of Asian/Pacific Islanders in Clinical Studies
20 Ethical and Legal Issues Relating to the Inclusion of Asian/Pacific Islanders in Clinical Studies
Pages 216-231
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From page 216... ...
The purpose of this paper is to complement some of the points made in the paper by Gamble (19943 and to present an Asian/Pacific Islander minority perspective to the ethical and legal issues of including APIA populations in clinical studies. A description of the APIA population is presented below, followed by a general overview of the sources of epidemiologic and health data on this special ethnic minority.
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From page 217... ...
Nationally, Asian Americans make up about 95°/0 of the APIA population and Pacific Islanders about 5°/O. Among Asians, Chinese and Filipinos-with about 1.6 and 1.4 million members, respectively are the two largest subpopulations, composing 23% and 19% respectively of the total APIA population.
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; (3) local or regional studies of Asian Americans and Pacific Islanders are very few and seldom published in widely accessible journals.
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Unfortunately, a number of factors-such as the historical backgrounds of Asian/Pacific Islanders' immigration to the United States, the sociocultural contexts oftheir medical manpower development, and the pest history of medical research in Asia and the Pacific Islands, significantly affects how individuals in this special population will perceive and interpret the new research emphasis. Lack of knowledge about how to define and identify the different subpopulations of APIAs, ignorance of the morbidity risks of this ethnic minority, and lack of baseline epidemiologic data also severely constrain the scientific justification for clinical studies, especially clinical trials.
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From page 220... ...
This author considers the following issues important. Definition of the Study Population The term Asian Americans and Pacific Islanders covers a myriad of cultures and at least 45 linguistic groups whose ancestries can be traced to places that include Mongolia to the north, the islands near Australia to Me south, India and Pakistan to the west, and Hawaii to the east.
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From page 221... ...
In the latter case, being able to classify the study subjects in terms of their ethnic group identity may be preferred to "race," for the former would shed light on the group membership and normative lifestyles of the study subjects that may be salient in explaining a particular health outcome. The Myth of a Healthy Minority Due to lack of research and inadequate information, findings from available studies on APIAs may have unwittingly sustained the myth-begun in the 1960s~hat Asian Americans are quite healthy compared with black or white Americans.
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H YU an extremely large percentage of English speakers and also the highest socioeconomic attainment of all Asian Americans represent the APIAs-an ethnic minority characterized by a heavy representation of persons from low socioeconomic status and nonnative English speakers.
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From page 223... ...
Clinical studies, and specially clinical trials, by design involve far more risk than mere descriptive surveys. The potential for ethnic misunderstandings is great because the scientific community, which is predominantly white, and which previously showed lack of interest in collecting descriptive epidemiologic data on the APIA populations, now encourages the inclusion of minorities in their clinical trials.
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From page 224... ...
Moreover, how do we ensure and enforce informed consent in clinical trials? Dissemination of Information from Existing Studies A few studies have been conducted on Asians and Pacific Islanders in their home countries as part of the U.S.
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. But where are the poor Puerto Rican women now who were the human subjects for the clinical studies of the "pill" 2~30 years ago?
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In what follows, we discuss the problems of obtaining informed consent from Asian Americans and Pacific Islanders, leaving aside the issue of legal liabilities because of lack of expertise on this subject. The Issue of Informed Consent The concept of informed consent, adopted by the USPHS in medical experiments only in 1966, refers to a person's ability to consent freely to participate in a study in which he or she adequately understands both what is required and the "cost" or risk for participating in the study ~Nolfensberger, 1967~.
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From page 227... ...
But in dealing with special populations such as the poor, the uneducated, and recent immigrants and refugees from Asia and the Pacific Islands, chances are great that for one reason or another, a sizable number are unable to absorb the information necessary for them to meaningfully grant informed consent, even where the interviewers are "racially" matched with the study subjects ~urh and Kim, 1982~. The problem of informed consent is more serious among the APIA population tin among black Americans in the sense that many Asians and Pacific Islanders, being predominantly foreign-loom, lack a general idea of what their basic human rights are in this country.
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From page 228... ...
In the absence of any good descriptive baseline data about Asian Americans and Pacific Islanders, and evidence of an inadequate record of training minorities to become principal investigators of large-scale studies, the USPHS effort to include a large sample of APIA populations in clinical studies is scientifically premature and viewed with considerable suspicion by the educated members of the APIA community. Every effort must be made to answer the fundamental question research for what purpose and to whose berteJit.7-before embarking on any major clinical trials involving vulnerable populations.
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In: Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, A Mastroianni, R
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1984. Epidemiologic studies of coronary heart disease and stroke in Japanese men living in Japan, Hawaii, and California: Incidence of stroke in Japan and Hawaii.
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U.S. National Heals Data on Asian Americans and Pacific Islanders: A Research Agenda for the 1 990s.
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