Journal of Medical Ethics 1999;25:31-36

Selecting subjects for participation inclinical research: one sphere of justiceCharles Weijer Dalhousie University, Halifax, Nova Scotia, Canada

AbstractRecent guidelines from the US National Institutes ofHealth (NIH) mandate the inclusion of adequatenumbers ofwomen in clinical trials. Ought suchstandards to apply internationally? Walzer's theoryofjustice is brought to bear on the problem, the firstuse of the theory in research ethics, and it argues forbroad application of the principle of adequaterepresentation. A number ofpractical conclusions forresearch ethics committees (RECs) are outlined.Eligibility criteria in clinical trials ought to bejustified by trial designers. Research ethics committeesought to question criteria that seem to excludeunnecessarily women from research participation.The issue of adequate representation should beconstrued broadly, so as to include consideration ofthe representation of the elderly, persons with HIVmental illness and substance abuse disorders inclinical research.(7ournal ofMedical Ethics 1999;25:31-36)Keywords: Cinical trials; eligibility determination; patientparticipation; medical ethics; justice; women; US NationalInstitutes of Health

Research ethics committees have long beenconcerned with ethical issues arising from theselection of subjects for research participation.Research ethics committees scrutinise study eligi-bility criteria to ensure that research neither preysupon the vulnerable nor excludes without goodreason subjects who may benefit from studyparticipation. In 1992, Dresser drew attention to anew ethical problem: the systematic exclusion ofwomen from clinical research.' Women have beenexcluded from certain types of clinical research foryears, she claimed, and as a result there is a rela-tive lack of knowledge regarding optimal treat-ment for some medical conditions affectingwomen. In response, the United States NationalInstitutes of Health now require the proportionaterepresentation of women in NIH-funded clinicaltrials and give institutional review boards (theREC equivalent in the US) part of the responsibil-ity to enforce this requirement.2

The enforcement of the NIH guidelines as suchis limited by the jurisdiction of the National Insti-tutes of Health to NIH-funded clinical trials. Theapplicability of the principles articulated in theNIH guidelines depends on moral justificationsoffered in their support. Thus, in order to drawlessons from the NIH guidelines for RECsinternationally, we must examine the ethicalunderpinnings of the impetus to include womenin representative numbers in clinical trials.While ethical issues related to subject selection

for study participation are typically framed interms of distributive justice, ie, the equitable allo-cation of goods to individuals, alternative ap-proaches to justice may provide a richer moralaccount. One alternative approach is taken byfeminist theorists who understand justice as theelimination of oppression.3 Thus, the inclusion orexclusion of individuals from research participa-tion is just insofar as it eliminates oppression.The argument to include adequate numbers of

women in clinical trials may be strengthened if yetanother approach to justice can be marshalled infavour of the cause. First, a moral conclusion maybe viewed as more robust if different ethical theo-ries argue for it. Second, a non-feminist approachmay be more convincing to those ill-disposed tofeminist theory. Walzer presents an appealing andnovel approach to justice in Spheres of Justice.4Walzer's view of justice as the elimination ofdomination is influential in political philosophy.According to the results of a Bioethicsline search(1973 to 1997), however, his theory has yet to beapplied in research ethics. Does Walzer's view ofjustice support the representative inclusion ofwomen in clinical trials? And if so what implica-tions follow for RECs?

Spheres of justiceFor Walzer, justice is not about ensuring that eve-ryone has an equal number of things (ie, simpleequality), rather its aim is to free society fromdomination. Domination manifests itself in differ-ent ways in various societies, but it is always medi-ated by some social good whether money, or birthand blood. Accordingly, he sets himself the task of

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32 Selecting subjects for participation in clinical research: one sphere ofjustice

describing a society that has been freed ofdomination, a complex egalitarian society. Settinghimself apart from other justice theorists, Walzerapproaches the question through a careful exam-ination of history and culture. Goods are distrib-uted in accord with their meaning for members ofa particular society. For example, a bit offood mayrepresent sustenance or a religious offering; andwhat is to be done with it depends on which ofthese meanings it is given.'

It follows that the just distribution of socialgoods cannot be understood by a rule universal inapplication. Rather each set of goods (communitymembership, security and welfare, money andcommodities, office, hard work, free time, educa-tion, kinship and love, divine grace, recognition,and political power) operates within a sphere gov-erned by its own rules of distribution. Thus, onetype of injustice is a failure to distribute a particu-lar good in accord with the norms of its particularsphere.A second type of injustice is domination, that is,

a transgression of the boundaries betweenspheres. Domination exists when one good is con-verted into another when there exists no intrinsicconnection between the two, for example, buyingvotes with money. In other words, dominationexists when one good commands control of a widerange of goods. The elimination of dominationrenders such transactions impermissible, but doesnot prevent unequal distributions of individualgoods. In the complex egalitarian society "no citi-zen's standing in one sphere or with regard to onesocial good can be undercut by his standing insome other sphere, with regard to some othersocial good".6

Conventional approaches to distributive justicehave not focused on the elimination of domina-tion, rather they have targeted monopoly, the con-trol of a dominant good by a small group of peo-ple. They ask: how can money be distributed morefairly or more equally? Merely redistributingwealth, however, is a false or, at best a temporary,solution. Some people will save their money, oth-ers will spend it, still others will, through their ownentrepreneurship, accumulate wealth; and so, thedistribution would soon be unequal again. If gov-ernment intervened repeatedly to ensure an equaldistribution, money would no longer be the domi-nant good, political power would be. Walzer'ssolution is to address domination directly.

Medical care and researchMedical care is classified in the sphere of securityand welfare, a sphere containing goods which thecommunity must provide for its members. But forwhich needs must the community provide? Sepa-

rate communities at different times have answeredthis question in disparate ways: for some, commondefence is a priority and caring for the poor andthe sick is not. Priorities can change over time aswell.

In contemporary Canada, the United Statesand the United Kingdom, medical care is animportant social good. But providing medical careand conducting medical research is expensiveand, thus, communal effort is required. The com-munity has stepped in to pay for basic medicalcare. Once communal provision of a good occurs,the good must be distributed in accord with needand in recognition of the underlying equality ofcommunal membership.7 Thus, the good ofhealthcare must be distributed in accord with need, thatis, proportionate to illness.

Other benefitsOf course the provision of medical care not onlyaids the sick, it generates other benefits. Healthcare workers derive incomes from their work; skil-ful practitioners derive prestige and respect; and,in turn, this may translate into other goods such aspolitical office. Viewed this way, a number ofspheres of justice seem to vie for control of thedistribution of health care. This conundrumrequires scrutiny of the meaning of that good forthis community to determine its primary meaningand thus its primary distributive rules. Within oursociety, health care is provided by the communitybecause health and longevity - not the income,prestige, or career advancement of, for example,physicians - is a communal priority. One canimagine communities in which these other goodsmight be key, but it seems unlikely that health carewould be provided communally.

Walzer places medical research in the sphere ofsecurity and welfare because it is part of the com-mon effort required to provide medical care.7Without research we could not be sure that treat-ments in use actually work nor could we developeffective treatments for currently untreatable dis-ease. Thus, research is a necessary means to theprovision of medical care, rather than a good initself.

Indeed, the intimate association between medi-cal research and medical practice is perhaps arelatively recent development.8 At the turn of thecentury, a number of medical advances, includingErhlich's discovery of Salvarsan, the first effectivetreatment for syphilis, began to change thepublic's perception ofmedical treatment. Diseaseslike cancer became "medicalised" and peoplecame to invest in science their hopes for progressin the fight against disease.9

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Weijer 33

Thus the connection between improvements inmedical treatment and medical science weresolidified: cancer was seen as "both a loomingthreat to civilization and a disease that brilliantscientists were beginning to conquer".10 But if itwas to be conquered, concerted governmentaction was required." Cancer research waspublicly supported to the end of improvingtreatment for the disease and subsequent fundingmeasures, including the declaration of a "waragainst cancer," have been justified and acceptedon this basis.'2

The distributive logic ofmedical researchIf the distribution of knowledge generated frommedical research is to "recognize and uphold theunderlying equality of membership,"'3 the resultsof medical research must be applicable to thebreadth of community members afflicted with aparticular illness. Clinical trials have a variety ofpurposes. Phase I trials examine toxicity and otherpharmacological properties ofnew drugs. Phase IItrials seek to establish whether a new drug has aneffect in a particular disease. In many cases,though perhaps not all, phase III clinical trials aimto change medical practice, for example bycomparing a new treatment with the best standardtreatment. Just eligibility criteria will further theend of the trial and thus, eligibility criteria mustselect subjects solely in accord with the exigenciesof medical care and science. If an eligibility crite-rion selects (or excludes) subjects because of theirstanding in another sphere, without reference tothe requirements of medical care or science, thecriterion involves boundary crossing and is unjust.

Eligibility criteria are justified by appeal to thepurpose of the clinical trial. Phase I and phase IIclinical trials, by and large, aim to answer narrowbiological questions: how is this drug brokendown in the body, does it have any effect on thisparticular disease? A more restrictive approach tocriteria for trial eligibility is justified in such trials.If, however, phase III clinical trials aiming tochange clinical practice are to be applicable to thecommunity at large (generalisable), then the studypopulation must be representative of patients inclinical practice.A natural tension exists between phase III trials

that are scientifically fastidious and those that arewidely generalisable. (Indeed, North Americantrialists tend towards fastidious studies withrestrictive eligibility criteria, and trialists on theother side of the Atlantic often prefer broadlyinclusive designs.) A fastidious approach is likelyto appeal to clinician-scientists who embrace theethos (and the aesthetic) of the controlled labora-tory experiment.'4 But such narrowly focused

studies produce results that are only applicable toa narrow segment of the patient population. Avariety of other goods may be served by fastidioustrials: investigator prestige and recognition, aca-demic advancement, and even "purer" (thoughless clinically relevant) knowledge. But each ofthese considerations originates from spheresseparate from that of security and welfare. Inphase III trials, eligibility criteria that heed thedistributive rules of the sphere of security andwelfare will minimise restrictions to the studypopulations and will justify necessary restrictionscarefully and in a manner open to scrutiny byresearch ethics committees.

Unjust inclusion and exclusion asdominationThe discussion thus far has focused on the justdistribution of medical knowledge according tothe norms of the sphere of welfare and security.There is another relevant category of justice: jus-tice as the absence of boundary-crossing betweenspheres (domination). Domination occurs whenan eligibility criterion selects or excludes subjectsbecause of their standing in another sphere, with-out reference to the requirements of medical careor science. Medical research is unjust if it selectssubjects solely on the basis of wealth, education,political empowerment, gender, citizenship, em-ployment or religious belief.Well-known examples of unethical research

have included subjects in research on the basis oftheir standing in other spheres, and without refer-ence to the exigencies ofmedical care and science.Notorious experiments conducted by Nazi physi-cians in the second world war preyed on thepolitically disempowered, including political pris-oners, Jews, Gypsies and homosexuals. TheTuskegee syphilis study observed the effects ofuntreated syphilis for decades after penicillinbecame available.'5 The study was unjust in partbecause it exclusively enrolled subjects who werepoor, uneducated and Afro-American.But domination can cut both ways: subjects can

be unjustly included in research, or they can beunjustly excluded. When domination takes theform of unjust inclusion, subjects are exposed tothe risks associated with the research; when domi-nation takes the form of unjust exclusion, otherharms may be incurred. Members of excludedgroups may be exposed to ineffective treatments,unexpected side effects may occur, or a lack ofinformation may lead to delays in the diagnosisand treatment of disease.'6

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34 Selecting subjects for participation in clinical research: one sphere ofjustice

Exclusion ofwomen as dominationUntil recently, women were excluded from early-stage studies of new drugs.'7 The evidence forexclusion of women from late-stage studies isstrongest in cardiology trials.'8 (There is, however,evidence that women have not been excludedfrom cancer trials.19) The exclusion of womenfrom trials of cardiovascular disease may have anegative impact on the health care that womenwith heart disease receive. Despite the fact thatgender is not a factor predictive of heart disease,women undergo fewer major diagnostic andtherapeutic procedures than men.20 By the timewomen actually receive heart surgery, their diseaseis more advanced and they have a higher operativemortality rate.2' Two reasons have been given forthe exclusion of women from phase III trials:female reproductive physiology is a "complicatingfactor" in scientific studies, and concern for toxic-ity of experimental treatments to fetuses.22Walzer recognises that the family is an impor-

tant unit within contemporary society. Particularrules of distributive justice apply in what Walzerinterchangeably calls the sphere of "kinship andlove" and that of "personal relations, domesticlife, reproduction and child rearing". Women havean important role to play within the family, onethat involves carrying a child to term, giving birthto it, and caring for it after birth. While this repro-ductive role has a central place in the family,women have been wrongly excluded from othersocial roles on the basis of this familial role, on thebasis of their standing within the sphere of kinshipand love.23The exclusion of women of reproductive age

and women in general from medical research isbased on the reproductive role that women fulfilwithin the family. Studies have excluded womenbecause of the fact that the reproductive physiol-ogy of women is viewed as a "complicatingfactor". Although men and women share manymore physiological similarities than differences,differences none the less exist. But the reproduc-tive physiology ofwomen is a complication only ifmale physiology is taken to be the norm.24 Thischaracterisation of women - and, importantly,not men - in terms of their reproductive role andtheir exclusion on this basis from scientific studiesis domination.Women of reproductive age have been excluded

from research on the grounds that experimentaldrugs may be harmful to fetuses. When a givendrug is known to be teratogenic, excludingpregnant women from participation in the study isa necessary precaution. But, even in such cases ofclear risk to the fetus, the exclusion of all women of

reproductive age from a study seems to characterisewomen solely on the basis of their reproductiverole.

Patterson and Emanuel describe two studiesinvolving drugs with the potential to harm thedeveloping fetus: 1 3-cis retinoic acid for theprevention of secondary lung cancer in one trial,and finasteride for prostate cancer in the other.25In the 13-cis retinoic acid study, all women ofreproductive age were excluded; in the finasteridestudy, men were merely required to use aneffective contraceptive method. Ifmen are trustedto use effective contraception when there is risk tothe fetus, then why are women not similarlytrusted?26 In both trials it was reasonable to takesteps to protect fetuses from harm. The exclusionof all women of reproductive age in the one trial,however, clearly characterises and excludeswomen on the basis of their reproductive role andis therefore an instance of domination. If theexclusion of all women of reproductive potential isunjust in the case of a clearly teratogenic drugthen, a fortiori, it is unjust when evidence for tera-togenicity is less clear or lacking.

Ifwomen are to receive an allocation of medicalcare which upholds "the underlying equality ofmembership" in the community,27 they must beincluded in adequate numbers in medical re-search. Clinical trialists must provide clear justifi-cations for any exclusion and evidence to supportsuch exclusions ought to be carefully examined.Even in the exceptional case when strong evidenceexists that women may respond differently thanmen to a particular treatment, the equality provi-sion does not seem to allow them to be excluded.Rather, a larger study ought to be mounted toaddress any gender differences that may bepresent.

New areas for ethical attentionInsofar as the unjust inclusion of groups inresearch is driven by widely held beliefs about theworth of members of such groups, the unjustexclusion of other groups is driven by sociallyconstructed notions of deviation from the norm orvulnerability. It may be that groups other thanwomen have been wrongly excluded from clinicaltrials. The elderly have long been excluded fromcancer clinical trials despite the fact that theycarry the heaviest burden of the disease.28 Olderpatients have been excluded from trials on thepresumption that they are more susceptible to thetoxic effects of cancer therapy, yet the assump-tions upon which those policies were based havenot been substantiated by empirical scrutiny.29

Persons with a history of drug or alcohol abuseare often excluded from clinical trials. Such

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Weijer 35

persons are barred from participation becausethey are thought to be unreliable: they are unlikelyto comply with treatments and required follow-upvisits. There is, however, no empirical basis for thisclaim.30 Indeed, in the context of some clinicaltrials compliance may be adequate even inpersons with active drug abuse (let alone in thosewith a mere history of abuse)."

Other groups are also often excluded without aclearly compelling justification. Otherwise healthypersons who carry the Human ImmunodeficiencyVirus (HIV) are often regarded as ineligible forstudy participation. But are they really more likelyto suffer adverse events? Persons with a history ofmental illness are also sometimes excluded. Butare they more likely to be incapable of givinginformed consent? These questions deserve em-pirical attention.

Implications for research ethicscommitteesThe NIH guidelines set an important precedent inthe regulation of clinical research. They identifythe systematic exclusion of women from researchas an important ethical issue and give ethics com-mittees the authority to challenge eligibility crite-ria that restrict the generalisability of studyfindings. But the jurisdiction of these require-ments is limited to studies funded by the NIH. Byexamining the moral basis of clinical researchthrough Walzer's theory of justice, I have estab-lished principles applicable to communities inwhich medical care and research is a communitypriority and is, therefore, provided for commu-nally.A number of implications follow for research

ethics committee review of phase III clinical trialsaiming to change clinical practice.

1. Eligibility criteria must select subjects solely inaccord with the exigencies of medical care andscience. If research ethics committees are toscrutinise criteria, trial designers must providean explicit justification for each eligibilitycriterion within the clinical trial protocol.

2. Research ethics committees must question eli-gibility criteria that seem to select potentialresearch subjects solely on the basis of wealth,education, political empowerment, gender,citizenship, employment or religious belief.

3. Women must be included in adequate num-bers in phase III studies. Research ethics com-mittees must question criteria that exclude,without compelling justification, women fromresearch participation. In a study of a tera-togenic drug, it is reasonable to excludepregnant women from participation and to

require all participants to use adequate birthcontrol measures. The exclusion of all womenof reproductive potential is, however, unjust.Questions of legal liability often loom large insuch cases. Clearly potential subjects must becarefully informed of risks and benefits ofresearch participation. Pharmaceutical compa-nies ought to recognise that the potentialliability associated with releasing a drug ontothe market that is inadequately tested inwomen likely exceeds the legal risk stemmingfrom including women of reproductive poten-tial in clinical trials.32

4. Other groups, perhaps including the elderly,people with a history of alcohol or drug abuse,otherwise health people with HIV, and thosewith a history of mental illness, have beenunjustly excluded from research participation.Research ethics committees ought to ensurethat the exclusion of such groups is carefullyjustified and that these justifications rest onempirically substantiated claims. Efforts toensure that phase III trials that aim to changeclinical practice are broadly inclusive rest onboth an ethical and scientific foundation. Largesimple trials have been advocated as a way ofefficiently and reliably advancing treatment forcommon diseases, including cancer and heartdisease. Pragmatic approaches to trial designrecognise both reliability and clinical relevanceas desirable: the criteria for a good trial arefairly straightforward: ask an important ques-tion and answer it reliably. The importance ofthe question depends to a large extent on itsclinical relevance. It is obvious that the morewidely applicable are the results of a clinicaltrial, the more relevant and valuable are thoseresults.33

More recently, the Cochrane Collaboration hassought to enhance the impact of clinical trials onmedical practice through the dissemination ofsystematic reviews of health care research.34 Theanalysis presented in this paper highlights the rolethe research ethics committee has in promotingclinically relevant trials and, ultimately, the healthof the community.

AcknowledgmentsThe author's work is supported by an OperatingGrant and Scholar Award from the MedicalResearch Council of Canada. The author isgrateful to Professor Karen Lebacqz, the lateProfessor Benjamin Freedman and RobertCrouch for their helpful comments on earlierdrafts of this paper. The author would like tothank the two anonymous reviewers of the

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36 Selecting subjects for participation in clinical research: one sphere ofjustice

J7ournal of Medical Ethics for their insightfulsuggestions.

Charles Weijer, MD, PhD, is Assistanit Professor ofMedicine at Dalhousie Uniiversity, Halifax, NlovaScotia, Canada.

References1 Dresser R. Wanted single, white male for medical research.

Hastings Center Report 1992; 22: 24-9.2 Department of Health and Human Services, National

Institutes of Health. NIH guidelines on the inclusion ofwomenand minorities as subjects in clinical research. Feder^al Register1994; 59: 14508- 13.

3 Sherwin S. Women in clinical studies: a feminist view, andDeBruin DA. Justice and the inclusion of women in clinicalstudies: a conceptual framework. In: Mastroianni AC, Faden R,Federman D, eds. Woiiieni and health research: ethical and legalissues of including wonien in clinical stucdies. Volunie ii: workshop anidconsniissioned papers. Washington, DC: National AcademvPress, 1994: 11-17, 127-50.

4 Walzer M. Spheres us] justice: a dec-ice ol pluralisni andc1 eqiali.New York: Basic Books, 1983.

5 See reference 4: 7.6 See reference 4: 19.7 See reference 4: 88.8 Patterson JT. The dread disease: cailcer and niodern Anierican cidl-

tuire. Cambridge, MA: Harvard University Press, 1987.9 See reference 8: 47.10 See reference 8: 124.11 See reference 8: 78.12 Committee on Labor and Public Welfare, United States

Senate. National prograni for the conquest oj caiicer: report of theniational paiel ofconsuiltants ot the coniquest ol cancer. Washington,DC: US Government Printing Office, 1971: 1.

13 See reference 4: 84.14 Begg CB, Engstrom PF. Eligibilits and extrapolation in cancer

clinical trials. Jo7urnal of Clinical Oncology 1987; 5: 962-98.1 5 Jones JH. Bad blood: the Tuskegee sYphilis experilnent. New York:

Free Press, 1993.16 Mastroianni AC, Faden R, Federman D, eds. Womnen aiid lealth

research: ethical anid legal issues of including zlwomen in clinical stuid-ies. Volunie I. Washington, DC: National Academy Press, 1994:75-83.

1 7 Food and Drug Administration. Genieral coiisideration for theclinical evaluiationt of neuc drlugs. Washington, DC: US Govern-ment Printing Office, 1977. Publication no: HEW (FDA)77-3040.

18 General Accounting Office. Won1ien 's health: FDA nieeds to enisuircniiore stuidy of genider differenices ina prescriptioii druig testin7g. Wash-ington, DC: US Government Printing Office, 1992. Publi-cation no: GAO/HRD-93-17. See also reference 3: 151-73.

19 Ungerleider RS, Friedman MA. Sex, trials, and datatapes.oron-ial (sf the N'atisiial Ca?icci Iiistitute 1991; 83: 6-7.

20 Avanian JZ, Epstein AM. Differences in the use of proceduresbetween women and men hospitalized for coronarv artery dis-ease. Nen- Eniglanld Jouriial C' Mediciuie 1991; 325: 221-5; andSteingart RM, Packer M, Hamm P, Coglianese ME, Gersh B,Geltman EM ct al. Sex differences in the management ofcoronary artery disease. Nea! Fneglanid_uuitrnial sf AIedicis1e 199 1;325:226-30.

21 Council on Ethical and Judicial Affairs, American MedicalAssociation. Gender disparities in clinical decision making.J76oi)ial (sf thi Asiscricais .Nhdical Asssociatlssi 1991; 266: 559-62

22 See reference 16: 108-27, 175-202.23 See reference 4: 240.24 See reference 16: 113.25 Patterson WB, Emanuel EJ. The eligibility of women for clini-

cal research trials. Journlal sl' Clinical Oiicoluogv 1995; 13 :293-9.26 See reference 25: 297.27 See reference 4: 84.28 Trimble EL, Carter CC, Cain D, Freidlin B, Ungerleider RS,

Friedman MA. Representation of older patients in cancertreatments trials. Canicer- 1994; 74 (suppl): 2208-14.

29 Giovanazzi-Bannon S, Rademaker A, Lai G, Benson AB.Treatment tolerance of elderlv cancer patients entered ontophase ii clinical trials: an Illinois cancer center study. Journial sslCliiiical Onicology, 1994; 12: 2447-52; and Christman K, MussHB, Case LD, Stanley V. Chemotherapy of metastatic breastcancer in the elderly: the Piedmont oncology associationexperience. Joisrnial o5f thc Ainicrican Mlcdical Associatsoni 1992;268: 57-62.

30 Hughes JR. Exclusion of "Noncompliant" individuals fIromclinical trials. Conitr-olled Cliical Trials 1993; 14: 176-7.

31 Harrison K, Vlahov D, Jones K, Charron K, Clements MAL.Medical eligibility, comprehension of the consent process, andretention of injection drug users recruited for an HIV vaccinetrial. Joutrnial os Acqlir^ed In)iniune Deficiency Syiidroiiics anidHiuuiaii Retrovirolsogs 1995; 10: 386-90.

32 See reference 16: 128-74.33 Yusuf S, Held P, Teo KK. Selection of patients for randomized

controlled trials: implications of wide or narrow eligibilitVcriteria. Statistics in Medicinie 1990; 9: 73-86.

34 Bero L, Rennie D. The Cochrane Collaboration. Preparing,maintaining, and disseminating systematic reviews of theeffects of health care. Joisirnial (f thlic Ausreticani MVLdicalAssscliati'on 1995; 274: 1935-8.

News and notes

Ethics of Clinical Research in Developing Countries

The Nuffield Council on Bioethics is to hold a two-dayworkshop, February 22-23 1999 on the ethics of clinicalresearch in developing countries. Amongst issuesaddressed will be: the adequacy of existing guidelines;the ethics of externally funded research in developingcountries; the ethical issues highlighted by AIDSvaccine trials; non-therapeutic research and consent,and what happens once research is completed.The workshop will be funded by the Medical

Research Council, the Wellcome Trust and the UK

Government Department for International Develop-ment.For further information please contact: Dr Sandy

Thomas, Director, Nuffield Council on Bioethics: 0171631 0566; Liz Morgan-Lewis/Dawn Duncan, MedicalResearch Council press office: 0171 637 6017/6011;Catherine Nestor/Noorece Ahmed, Wellcome Trustpress office: 0171 611 8846/8540; Lisa Louis, Infor-mation Officer, The Department for InternationalDevelopment: 0171 917 0680.

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