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Wanted: single, white male for medical research.

In June 1990, congressional investigators issued a startling report. The General Accounting Office revealed that despite a 1986 federal policy to the contrary, women continued to be seriously underrepresented in biomedical research study populations. According to the National Institutes of Health, this practice "has resulted in significant gaps in [our] knowledge" of diseases that affect both men and women. [1] In short, many of the important human health data generated by the modern biomedical research revolution are data about men.

The failure to include women in research populations is ubiquitous. An NIH-sponsored study showing that heart attacks were reduced when subjects took one aspirin every other day was conducted on men, and the relationship between low cholesterol diets and cardiovascular disease has been almost exclusively studied in men. Yet coronary heart disease is the leading cause of death in women. Similarly, the first twenty years of a major federal study on health and aging included only men. Yet two-thirds of the elderly population are women. The recent announcement that aspirin can help prevent migraine headaches is based on data from males only, even though women suffer from migraines up to three times as often as men. [2]

The list goes on: studies on AIDS treatment frequently omit women, the fastest growing infected population. An investigation of the possible relationship between caffeine and heart disease involved 45,589 male research subjects. Most amazing is the pilot project on the impact of obesity on breast and uterine cancer conducted--you guessed it--solely on men. Moreover, the customary research subject not only is male, but is a white male. African-Americans, Latinos, and other racial and ethnic groups have typically been excluded from studies, again in spite of a formal NIH guideline encouraging the inclusion of such groups in study populations. Children and elderly persons also have received short shrift, particularly in the testing of new drugs. And in basic research, even female rats are frequently excluded as research subjects! [3]

The physiology of women and men differs in ways that can affect how disease and treatment manifest themselves. Beyond the obviously sex-linked diseases such as uterine and prostate cancer, there is evidence that heart disease, AIDS, depression, and numerous other ostensibly "general-neutral" conditions are expressed differently in women and men. A similar situation exists among different racial and ethnic groups. Lupus, for example, reportedly affects one in 750 women generally, but its incidence is one in 245 among African-American women and one in 500 among Latinas. [4] Such differences make it inappropriate simply to generalize findings based on one gender or racial group to all human beings. As a result of the past over-representation of white men in research populations, physicians now frequently lack adequate evidence on whether women and people of color will be helped, harmed, or not affected at all by numerous therapies now endorsed as promoting "human health."

NIH officials have admitted that the agency's policy on expanding study populations was inadequately publicized as well as substantively feeble, simply recommending that investigators proposing studies "consider" the inclusion of women and minority groups. In the four years that elapsed between the policy's announcement and the GAO report, NIH continued to review numerous proposals that either gave no information on the gender of their study populations, or proposed all-male studies without a rationale for doing so. The GAO report also notes that the NIH itself had no policy to ensure the inclusion of women in its intramural research program. Indeed, according to Science correspondent Joseph Palca, Acting Director William Raub said that a small group of NIH staff still had "disdain" for the policy encouraging inclusion.

After the GAO report was released, NIH officials did attempt to mend fences. In December 1990 they issued special instructions to grant applicants providing that clinical research grants "will be required to include minorities and women in study populations." Omission or inadequate representation of these groups must be accompanied by "a clear compelling rationale." [5] Raub also established an office of research on women's health, which will coordinate a new women's health study involving several thousand women. [6]

Time will tell whether these actions reduce reliance on the white male subject. But disturbing questions remain. In a country that prides itself on its progress in promoting gender and racial equality, how could the federal government sanction such a nakedly discriminatory practice? Why wasn't the original NIH policy more strongly worded and more effectively implemented? Moreover, why was a special NIH policy necessary at all? Why didn't the researchers themselves adopt a more inclusive practice? And finally, why didn't the institutional review boards charged with research oversight demand on more inclusive approach? During the twenty-plus years of intense analysis and debate on the ethics of research on human subjects, how did this glaring moral mistake elude our scrutiny? In this paper, I examine some of the possible sources of this national ethical blindspot.

Alleged Justifications for the

Exclusionary Practice

Some scientists and officials have explained that there often is "scientific" justification for studying only white males. Clean, simple data are needed for studies; the more alike the subjects, the more any variation can be attributed to the experimental intervention. Including women would "complicate" a study due to the hormone changes of the menstrual cycle. I have two responses to this claim. First, even if it is scientifically justifiable to study humans who have a similar physiology, why study white men? Perhaps the choice of racial group can be supported by its dominant proportion in the U.S. population, but not so for the choice of gender. In this country, women are numerically in the majority. Why then the choice of the minority white male? Why is it female, but not male, hormones that "complicate" research? Second, focusing on one type of human physiology reduces the generalizability of the experimental data. Although there is probably a place for such narrowly focused projects, why have they so rarely been conducted on anyone but white men? Again, what accounts for the relative infrequency of studies on homogeneous populations of other kinds of people?

One can also challenge the notion that a study conducted on physiologically close subjects is usually the "best" scientific approach. Such a judgment divorces the concept of scientific merit from its broader context. A project may be designed with the greatest of scientific elegance, but if the data it produces have little value to society, it is not necessarily a meritorious project. Merit, at least in the context of government funding decisions, is tied to a proposal's promise of benefit to society. [7] If NIH's goal is to award support to the projects most likely to advance our knowledge of important human health concerns, it would seem that white-male-only clinical investigations of widespread conditions such as coronary artery disease and aging would have less merit than studies that provided data with broader applicability. In fact, the latest NIH directive explicitly instructs its scientific reviewers to consider inclusion of women and minorities in study populations when they evaluate a proposal's scientific merit.

Two other explanations have been offered for the practice of excluding women from study populations. One is concern for the condition of women who could become pregnant while enrolled as research subjects. Threats of miscarriage, birth defects, and so forth are cited as justifications for omitting women. Exclusion is appropriate, it is alleged, to protect potentially pregnant women and their potential children. The Department of Health and Human Services regulations governing human subjects research sets special conditions on research involving fetuses and pregnant women, and the Food and Drug Administration guidelines for clinical evaluation of drugs restricts but does not ban participation of "women of childbearing potential" in clinical trials. [8] Certainly caution is warranted here. But is maternal-fetal protection always a valid reason for failing to include female subjects?

Our nation has a long history of excluding women from various activities on grounds that participation would harm the "weaker sex," and thus often denying women the significant benefits of participation. Likewise, the failure to conduct biomedical research on women denies them the benefits of research. The vast majority of women who are not pregnant cannot with sufficient confidence take advantage of numerous health recommendations that have emerged from men-only research studies. In the name of potential protection for potentially pregnant women and their fetuses, all women have lost opportunities to improve and extend their lives.

Complete exclusion of women subjects is an unnecessarily blunt instrument to accomplish the goal of maternal-fetal protection. The exclusionary approach, as Carol Levine notes, "assumes that all women are alike, that all women are sexually active, and that all are unreliable in their contraceptive practices." [9] To the contrary, as one physician pointed out, "Most female cardiac patients are not planning to get pregnant." [10] Neither are the women likely to be subjects in an aging study!

If a study poses a legitimate threat to the potential offspring of women participants, two options come to mind. One is simply to exclude fetile women of reproductive age. Again, however, this seems overbroad; indeed, this is the approach the Supreme Court recently struck down in Johnson Controls as violating federal law prohibiting sex discrimination in the workplace. [11] It would be better to adopt a more nuanced approach. In her recent article on the underrepresentation of women in HIV/AIDS research, for example, Levine endorses a three-tiered categorization system to address the problem. Many, perhaps most, human studies fail to pose a foreseeable risk to future children. The unknown and unforeseeable teratogenic risk that accompanies practically any physiological intervention fails to justify excluding fertile women from studies in this category. Similarly, women should have the opportunity to enroll in studies that present known risks to future children, but also have the potential for significantly benefiting the research participants. In these two categories of research, adequate disclosure of the risks and potential benefits of research participation, together with the availability of highly reliable contraceptives and abortion, would give women a reasonable choice regarding whether to accept the risks of participating. The possibility that a few women might become pregnant, might choose against abortion, and might have a child who is harmed by exposure to an experimental intervention is too small to justify the current exlusionary practices. The risk of tort liability in such cases is also small. Women who consent to the risk of harm to potential offspring and who decide against abortion when they become unexpectedly pregnant would be unlikely to recover damages. Any injured children might themselves have a claim, however. Perhaps some form of legislative immunity is needed here. But it should be recognized that the current approach also fails to protect health professionals and drug manufacturers against liability. The present practice merely moves the source of the claims to the damaged future children of women patients who receive drugs and other treatments in the clinical setting.

A third research category is more complicated, however. Levine argues that sexually active fertile women should be excluded from studies that present both a known significant risk to potential offspring and minimal or unknown benefit to women subjects, because parents have a moral responsibility to make reasonable efforts to protect their future children's health and the knowledge sought from such studies is obtainable through other means. Given the ever-present danger of contraceptive failure, the misunderstandings "informed" subjects may have about a protocol's risks and potential benefits, and the possibility that subjects' awareness or appreciation of their exposure to risk could decline over time, it is better to conduct such studies on other groups, Levine contends. If early results reveal a possible substantial benefit for women participants, she suggests that the intervention could be made available to individual women off-protocol.

This would be appropriate, in my view, as long as the same approach is applied to sexually active fertile men. Researchers have been extremely concerned about reproductive risks to women, while largely neglecting the reproductive risks research participation may pose to men. There is growing evidence that many substances may be damaging to sperm, thereby creating the possibility of birth defects in offspring. [12] The emphasis on reproductive hazards to women thus is an unjustifiably narrow means of protecting children's health. If society deems the health of potential future children to justify the blanket exclusion of fertile women from certain research protocols, the exclusion should cover all fertile subjects whose offspring could be endangered, not just female ones. Furthermore, men's lengthier reproductive capacity could lead to their exclusion from risky studies for many more years than women.

The final rationale for women's exclusion from study populations involves alleged recruitment difficulties. For example, researchers in the aspirin and heart disease study claimed that they wanted to include women, but were unable to find enough potential subjects to do so. Their study population was physicians over age forty, they explained, and women comprised only 10 percent of this group. [13] Moreover, according to one NIH official, it was doubtful that a sufficient number of women would be "interested in participating and be content to go through the hassle of taking a placebo." [14] In other heart disease studies, researchers have asserted that they could not locate enough women with the condition. Although this is partly due to the lower overall incidence and later development of this disease among women, it turns out that another factor is the medical community's failure to recognize serious heart disease in women. [15]

Blaming the scarcity of potential women subjects for the exclusionary practice is unacceptable. In effect, this adds insult to injury by building on past bias to justify its perpetuation in a different realm. The traditional exclusion of women from the medical profession is the source of the small number of middle-aged women physicians. Health stereotypes about women--"women just don't get heart disease"; "women somaticize their emotional problems"--are one source of physicians' failure to recognize heart disease in women. As one physician put in,

If a fifty-year-old man goes to the doctor complaining of chest pains, the next day he will be on a treadmill taking a stress test. If a fifty-year-old woman goes to the doctor and complains of chest pains, she will be told to go home and rest. [16]

When heart disease studies exclude women, they only reinforce physicians' misplaced assumptions. And why was it assumed that women would be less interested than men in "go[ing] through the hassle of taking a placebo?" Women who were adequately informed of their risk of heart disease would have as much incentives as men to participate in the study.

Biomedical research studies should be designed to surmount the alleged difficulties in recruiting women. If enough female physicians are not available, why not study female nurses, or some other reasonably accessible group of women? (A recent observational study suggesting that low-dose aspirin could reduce cardiovascular disease in women was conducted on female nurses, but the authors emphasize the need for a randomized, controlled clinical trial to verify that a benefit exists, rule out serious risks, and determine an appropriate dose for women.) [17] If scientists conducting heart disease research are afraid that physicians will not refer enough women patients, then extra recruiting measures should be taken to ensure that they do. Research costs may go up, but the benefits of including women subjects are worth the expense.

What's Wrong with Exclusion

The current disparity between the health information we have about white males and the information we have about women and people of color contravenes basic ethical principles governing human experimentation. Most clearly violated is the principle of beneficence, which holds that biomedical research should be designed to maximize benefit and minimize harm. Proposals promising to advance knowledge of important human health and welfare concerns should receive funding priority. Awarding support to studies on white males withholds research benefits from other groups of people and possibly exposes such people to risk when they and their physicians follow recommendations based on data from white male subjects. When diseases disproportionately affecting women and people of color are given low funding priority, knowledge that could alter current ineffective or detrimental routine medical care is never produced.

The harm produced by the exclusionary practices is not easily dismissed. Simple extrapolation from white males to everyone else can be dangerous. One study, for example, found that due to physiological differences, African-Americans given the "normal" dose of lithium (established in trials on white men) frequently experienced toxic reactions, heightening their already high risk of renal failure. the male-only studies of heart disease and cholesterol led the American Heart Association to recommend a diet that could actually exacerbate the risk of heart disease for women. Oral contraceptives can cause excessive cholesterol levels, yet it has not been systematically demonstrated that the cholesterol-lowering medication proven effective in men works when taken in conjunction with oral contraceptives. [18] The current lack of knowledge on the connection between diet and breast cancer denies women a potential opportunity to protect themselves against a frequently lethal disease that strikes one in nine women. Antiseizure and antidepressant drugs may require different doses over the menstrual cycle to achieve their desired effect, and the failure to calibrate asthma medication to this cycle may contribute to the existing premenstrual rise in asthma deaths.

Scientists and policymakers must recognize that the choice is not whether to protect women and people of color from research risks. Instead, the choice is whether to expose some consenting members of these groups to risk in the closely monitored research setting, or to expose many more of them to risk in the clinical setting without these safeguards, which is the result of the current approach.

The present situation also is unjust. The justice principle mandates fair distribution of the benefits and burdens of biomedical research. But instead, taxpayers excluded deom study populations have been charged for research without the assurance that they will share in any health benefits it might produce. Historically disadvantaged groups have subsidized health benefits for the more privileged, while being denied similar benefits for themselves.

The modern response to past injustice in the selection of human subjects may have contributed to the current imbalance in study populations. Ethical codes governing experimentation on human subjects arose primarily in reaction to the horrors of the Nazi experiments, the Tuskegee syphilis study, and other research on vulnerable populations that exposed uninformed and unconsenting persons to extreme hard for the benefit of the better off. Hence, the overall reform goal was to eliminate such practices. This may have led to the notion that white middle- and upper-class men were the best people to bear the burdens of research participation. But these burdens have now been substantially reduced, while participation offers significant benefit to the members of other racial and ethnic groups. A move perhaps designed to protect disadvantaged groups has simply shifted potential harm away from research subjects and imposed it on people in the community who may be receiving inappropriate health information and medical treatment.

"Tuskegee fallout" probably has contributed in an additional way to the present underrepresentation of people of color in study populations. In light of past scandals, some members of disadvantaged communities are justifiably suspicious of the research establishment's motivation in seeking their participation as subjects. But this product of past abuses ought not excuse the current underrepresentation. People of color also continue to experience a dispoportionate share of economic, health care, and other deprivation that creates barriers to their research participation. Today's researchers face the task of educating these communities on the positive dimensions of research participation. Special support services may be necessary to faciliate the participation of those who wish to serve as subjects, including child care and transportation assistance. Furthermore, society has an obligation to ensure that members of these communities actually have access to any health care benefits produced by the research in which they participate.

The Hidden Roots of Exclusion

How did white males come to be the prototype of the human research subject? Like the pronoun "he," it was taken for granted that the while male subject stood for all of us. In her examination of how the law treats differences among people, Martha Minow suggests some reasons for this. As individuals, she points out, we are all different from everyone else in countless ways. In society, however, certain differences are deemed relevant to how people are regarded. The choice of which differences "matter" inevitably reflects and reinforces existing social structures, and normality and abnormality are determined by the most powerful social group's (usually unstated) point of reference. Accordingly, "women are different in relation to the unstated male norm. Blacks, Mormons, Jews, and Arabs are different in relation to the unstated white Christian norm." [19] Members of the dominant group making decisions in reliance on this norma may discount or be oblivious to the influence of their particular perspective. To the contrary, they see themselves as "objective," and the existing social structure as "natural."

It is easy to see this process at work in the research setting. NIH officials and biomedical researchers have, consciously or unconsciously, defined the white male as the normal, representative human being. From this perspective, the goal of advancing human health can be achieved by studying the white male human model. Physical differences between males and females, or between whites and people of color, are unacknowledged or irrelevant in this world view. Including women and people of color would simply complicate the work, thus making it more difficult and costly, which would detract fromthe researchers' mission of improving human health and welfare. According to this world view, "special money" must be raised to study women and people of color, so that the "regular money" can be reserved for "normal" research. [20]

Perhaps there was also a more insidious influence on the decisions about study populations. At least some scientists and government officials might have beleived it was not important even to find out whether data from studies on white males applied to women and people of color. We cannot dismiss the possibility that the exclusionary practice reflected implicit social worth judgments on who ought to have priority in obtaining the fruits of biomedical research. An emphasis on the economic costs of human disease could also have inadvertently contributed to the view that research should focus on the "normal" economic contributor, that is, the young or middle-aged white male. [21]

In attempting to trace the origins of the exclusionary practice, we must consider as well the identity of the major players in the research establishment. Science has been and to some extent still is largely populated by white males. The same is true of NIH officialdom, although the agency's new director is Bernadine Healy, who has initiated a new program focusing on the specific health needs of women. A white male-dominated group will assess the nation's biomedical research priorities from a particular vantage point. Decisions by such a group could intentionally or inadvertently undervalue the health concerns of "outsiders." When one researcher asked investigators about th exclusion of African-Americans from clinical trials, many respondend that they simply had "never thought about" the matter. [22] Congresswoman Olympia Snow put it succinctly in her comment on the choice to study men to assess obesity's impact on breast and uterine cancer: "Somehow, I find it hard to believe that the male-dominated medicla community would tolerate a study of prostate cancer that used only women as research subjects." [23]

An overly simplistic concept of equality might also have helped to create homogeneous study populations. In many social contexts, advancing the ideal of equality requires decisionmakers to disregard gender, racial, and ethnic differences among people. If all human beings have equal moral value, then in some sense they are identical and interchangeable. If all people are identical, then it might appear that any human subject could adequately represent the general human population. In this framework, it would be unnecessary to recruit research subjects according to their gender, race, or ethnicity; the white male subject could stand for everyone. Gender, racial, and ethnic differences that affect health and disease must, however, be recognized if women and people of color are to have truly equal access to the health benefits of biomedical research.

Remedying the Situation:

The Downside

Even though there are compelling reasons to conduct research on the possible health effects of gender, race, and ethnicity, one must also acknowledge that adverse consequences could flow from such research. Studies of women and particular racial and ethnic groups could indicate that these populations are most susceptible to conditions that reinforce group stereotypes. Thus, for example, research suggesting that monthly hormone fluctuations make women more prone than men to depression and other emotional disturbances could become potent ammunition for those seeking to exclude women from important policy positions. Certain evidence indicating significal physiological differences between men and women could trigger controversy similar to that surrounding Carol Gilligan's work on gender differences in psychological and moral development, which some feminists see as strengthening the traditional picture of women as nurturing, sacrificing, and passive. When gender, racial, and ethnic differences are characterized as "natural," they may be deemed impervious to change. The role of environment in shaping human physiology and behavior can be ignored, thus reducing the pressure to minimize the environmental sources of difference.

Moreover, as Gilligan reminds us, our culture "hasn't been able to represent difference without hierarchy." [24] There is a danger that studies finding gender, racial, and ethnic health differences will be used to support unjust discrimination against historically excluded groups. The employment and other discrimination experienced by African-Americans carrying sickle-cell trait is just one example of this pattern. Meanwhile, the potential value of certain health differences found in these groups could be ignored. For instance, women's relative physical endurance and longivity are differences that could justify a female-dominated workforce in at least some settings. Yet this biological advantage has had virtually no influence on employment policy; instead, policies tend to focus on pregnancy- and family-related "problems" of employing women.

The Lessons of Exclusion

The revelations of gender and other biases in the study of human health reminds us of how far we are from fully escaping the discriminatory legacies of the past. Much of our current social structure still embodies, albeit often inadvertently, the idea that the white man is the best to represent all people. Yet in many significant respects, he is not. Biomedical research must respond to this reality.

The immediate task for scientists and government officials involves revamping study design and reordering funding priorities to remedy past exclusionary practices. The NIH and other funding agencies should back up their paper policies with concrete implementation measures, including the added financial expenditures that may be necessary to ensure more representative study populations. There is also a need for more carefully reasoned policies governing the inclusion of women--and men--of reproductive potential in clinical research. Institutional review boards ought to consider explicitly the composition of proposed study populations in determining whethr the selection of subjects is equitable. But the remedies also extend beyond this realm. One task is to continue and to redouble the effort to reduce the disproportionate representation of white men in important scientific and policy positions. Diversity among powerful decisionmakers is one of the best methods to guard against conscious as well as unconscious discriminatory practices.

Second is the challenge to use the emerging knowledge about biological differences for the benefit of historically disadvantaged groups. Perhaps we have come far enough to recognize such differences without transforming them into tools for maintaining the traditional social hierarchy. Particular biological characteristics of women and members of nonwhite racial and ethnic groups must not be viewed through the narrow prism of the status quo, which too frequently labels "difference" as "problem." From a wider perspective, the contributions of people who are "different" can in some cases be "better." Moreover, sometimes, as Martha Minow has noted, it is the system that should adjust to embrace the difference. The goal is to move beyond the restrictive traditional patterns of labeling difference toward a richer, more expansive view.

Last is a message for bioethicists. The discovery of bias in selecting human subjects hints at the existence of other as yet unrevealed forms of bias in medicine and biomedical research. In this vein, a recent analysis of court decisions suggests that judges give less weight to incompetent women's prior statements on life-sustaining treatment than they do to men's. According to the authors, judges characterized men's remarks as mature, rational choices; in contrast, women's statements were deemed unreflective and emotional. [25]

Many of us in bioethics have been surprised by the recent disclosures of bias in clinical studies and practice. They serve notice that unjust discrimination in medicine and science can be more subtle than many of the issues on which we have focused our attention. Dramatic issues like surrogate motherhood and sex-selection indisputably raise serious ethical questions about the position of women in our society. The lesson of the recent revelations about research subject populations, however, is that we must also keep our eyes open to the subtler gender and other biases still plaguing contemporary medicine and science.


[1] U.S. General Accounting Office, Statement of Mark Nadel, "National Institutes of Health: Problems in Implementing Policy on Women in Study Populations," 18 June 1990.

[2] Andres Purvis, "A Perilous Gap," Time, Special Issue on Women (Fall 1990), pp. 66-67; Joseph Placa, "Women Left Out at NIH," Science 248 (29 June 1990): 1601; Judy Grande, "Gender Gap Plagues U.S. Health Studies," Cleveland Plain Dealer, 30 July 1990; "Aspirin Every Two Days Found to Reduce Migraines," New York Times, 3 October 1990. According to one NIH official, the study of breast and uterine cancer was considering the effects of particular nutrients on estrogen metabolism, and researchers chose male subjects in the belief that estrogen metabolism is similar in men and women.

[3] Bruce Nussbaum, "Under-the-Counter Drug Testing," New York Times, 19 February 1991; Paul Cotton, "Is There Still Too Much Extrapolation from Data on Middle-Aged White Men?" JAMA 263 (23 Februrary 1990): 1049-50; Kathleen Nolan, "AIDS and Pediatric Research," Evaluation Review 14 (October 1990): 464-81; Greg Sachs and Christine Cassel, "Biomedical Research Involving Older Human Subjects," Law, Medicine and Health Care 18 (Fall 1990): 234-43.

[4] Warren Leary, "Uneasy Doctors Add Race-Consciousness to Diagnostic Tools," New York Times, 25 September 1990.

[5] National Institutes of Health, Priority Announcement, "Special Instructions to Applicants Using Form PHS 398 Regarding Implementation of the NIH/ADAMHA Policy Concerning Inclusion of Women and Minorities in Clinical Research Study Populations," 1 December 1990.

[6] Bernadine Healy, "Women's Health, Public Welfare," JAMA 226 (24 July 1991): 566-68.

[7] Rebecca Dresser, "Measuring Merit in Animal Research," Theoretical Medicine 10 (1990): 21-34.

[8] Food and Drug Administration, General Considerations for the Clinical Evaluation of Drugs (Washington, D.C.: U.S. Government Printing Office, 1977); Carol Levine, "Women and HIV/AIDS Research: The Barriers to Equity," IRB: A Review of Human Subjects Research 13, no. 1-2 (1991); 18-22.

[9] Levine, "Women and HIV/AIDS Research."

[10] Purvis, "A Perilous Gap."

[11] Automobile Workers v. Johnson Controls, 111 S. Ct. 1196, 1991.

[12] Mary Becker, "Can Employers Exclude Women to Protect Children?" JAMA (24 October 1990): 2113-17.

[13] Palca, "Woment Left Out."

[14] Paul Cotton, "Examples Abound of Gaps in Medical Knowledge," JAMA 263 (23 February 1990): 1051-55.

[15] Purvis, "A Perilous Gap"; "Sex Bias in Treatment of CAD Reported in SAVE Trial Review," The Newspaper of Cardiology, June 1990, p. 11; Richard Steingart, Milton Packer, Peggy Hamm, et al., "Sex Differences in the Management of Coronary Artery Disease," NEJM 325 (25 July 1991): 226-30.

[16] Judy Grande, "Cleveland Clinic Struggles to Find Women for Heart Study," Cleveland Plain Dealer, 5 August 1990.

[17] JoAnn Manson, Meir Stampfer, Graham Colditz, et al., "A Prospective Study of Aspirin Use and Primary Prevention of Cardiovascular Disease in Women," JAMA 266 (24 July 1991): 521-27.

[18] Cotton, "Examples Abound."

[19] Martha Minow, Making All the Difference: Inclusion, Exclusion, and American Law (Ithaca, N.Y.: Cornell University Press, 1990), pp. 49-74.

[20] Cotton, "Examples Abound."

[21] Council on Ethical and Judicial Affairs, American Medical Association, "Gender Disparities in Clinical Decision Making," JAMA 226 (24 July 1991): 559-62.

[22] Cotton, "Is There Still Too Much Extrapolation?"

[23] Grande, "Gender Gap."

[24] Anastasia Toufexis, "Coming from a Different Place," Time, Special Issue on Women (Fall 1990), pp. 64-66.

[25] Steven Miles and Allison August, "Courts, Gender and the 'Right to Die,'" Law, Medicine and Health Care 18 (Spring/Summer 1990): 85-95.

Rebecca Dresser is professor at the Law School and the Center for Biomedical Ethics, Medical School, Case Western Reserve University.
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Title Annotation:males as prototype of human research subject
Author:Dresser, Rebecca
Publication:The Hastings Center Report
Date:Jan 1, 1992
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