unregulated research with human subjects

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  • This article was downloaded by: [University of Auckland Library]On: 06 December 2014, At: 15:33Publisher: Taylor & FrancisInforma Ltd Registered in England and Wales Registered Number:1072954 Registered office: Mortimer House, 37-41 Mortimer Street,London W1T 3JH, UK

    Accountability in Research:Policies and QualityAssurancePublication details, including instructions forauthors and subscription information:http://www.tandfonline.com/loi/gacr20

    Unregulated research withhuman subjectsAdil E. Shamoo aa University of Maryland , School of Medicine ,108 N. Greene Street, Baltimore, Maryland,21201, USAPublished online: 11 Jun 2008.

    To cite this article: Adil E. Shamoo (1999) Unregulated research with humansubjects, Accountability in Research: Policies and Quality Assurance, 6:3, 205-214

    To link to this article: http://dx.doi.org/10.1080/08989629908573928

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    http://www.tandfonline.com/loi/gacr20http://dx.doi.org/10.1080/08989629908573928

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    http://www.tandfonline.com/page/terms-and-conditionshttp://www.tandfonline.com/page/terms-and-conditions

  • Accountability in Research, Vol. 6, pp. 205-214 1999 OPA (Overseas Publishers Association) N.V.Reprints available directly from the publisher Published by license underPhotocopying permitted by license only the Gordon and Breach Science

    Publishers imprint.Printed in Malaysia.

    Unregulated Research with HumanSubjectsAdiI E. ShamooUniversity of Maryland, School of Medicine, 108 N. Greene Street,Baltimore, Maryland 21201, USA

    The hearings of the National Bioethics Advisory Commission (NBAC)during 1997 on the use of human subjects in research have revealedand emphasized many interesting and disturbing facets of the use ofhuman subjects in research. Among the problems that has not caughtyet the attention it deserves from the public and federal officials isthe use of human subjects in research that is not Federally funded(private funding). This is a sink hole no one knows accurately itsdepth, size, and magnitude except from case reports (i.e. anecdotes).Federally funded research, almost entirely is covered by the CommonRules of 1991 signed by sixteen federal departments and agencies(ACHRE, 1995, p. 675). Therefore, all privately funded research byresearch foundations, industry, and individuals is not regulated. Anexception is that clinical drug trials for new drugs are covered byFDA rules. In contrast, the use of animals in research regardless of thesource of funding Federal or private is covered by the Animal WelfareAct since 1966 (AWA, 1966). It is remarkable that human subjects inresearch to date are not given protection parity to animals.

    The Advisory Committee on Human Radiation Experiments(ACHRE) (1995) compiled an excellent accounting of all laws pro-tecting human subjects in research. ACHRE compilation highlightedthe serious gap in the protection of human subjects in research.Eventhough, ACHRE's charge was to deal with the Federally fundedresearch, it recommended (recommendation #13, section 2, p. 826):

    "Extension of human subject protections to nonfederally funded research."

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  • 206 A.E. Shamoo

    However, the committee did not recommend any specific solution.The lack of protection for human subjects in research was also

    strikingly recognized by the New York Supreme Court, appellate-Division decision (T.D. vs NYSOMH, 1996, p. 52) when it stated that:

    "It is evident that, given the motivation to test these medications andquickly bring them to market, industry-sponsored studies, which will notrely on Federal funds and therefore will not be strictly subject to Federalguidelines and oversight, will proliferate. These developments serve tohighlight the importance of safeguarding the rights of incapable adults andminors, who may be potential subjects of greater than minimal risk studiesinvolving psychiatric medications, through constitutionally acceptableprotocols and guidelines promulgated by the appropriate agency."

    On October 3,1995, President Clinton through an executive order(US, Federal Register, 1995) created the "National Bioethics AdvisoryCommission" (NBAC) to provide advise on:

    "bioethical issues arising from research on human biology and behavior,and the applications, including the clinical application, of that research."

    One of the two primary declared goals of the commission is the

    "protection of the rights and welfare of human research subjects" (Gibbons,1996).

    Therefore, NBAC to its credit has been holding extensive informa-tion gathering activities and hearings on the subject. However,NBAC does not have the authority and is not investigating abusesof human subjects in research that have come to their attention.

    Numerous groups, professionals, government officials, and advo-cates have testified in front of or sent written testimonies to NBAC.We have testified in front of NBAC by invitation and twice inpublic sessions (Shamoo and Sharav, 1997; Shamoo, 1997) on the"unethical use of persons with mental illness in high risk research experi-ments." In all of our testimonies, our top recommendation was to:Enact a National Human Subject Welfare Act for all research onhuman subjectsits scope not to be limited to the source of fundingFederal or private. We asked that humans be afforded the sameFederal legal protection as are already provided to animals under theNational Animal Welfare Act. More importantly, on September 18,1997 about a dozen families and patients testified (NBAC, 1997)alleging horrific abuses of patients when enrolled as researchsubjects in various research protocols.

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  • Unregulated Research with Human Subjects 207

    We have chosen the following two testimonies from NBACproceedings that highlights what parents perceive was researchprotocol masquerading as treatment. The first testimony is of acourageous mother Ms. Arlis Neason who paid travel expenses ofher entire family to share her experience of her son Jeffrey Neasonwith NBAC (Neason, 1997). Ms. Neason testified that:

    "At age 8, his medical records discussed the possibility of Crohn's disease.Because of his chronic diarrhea with associated weakness and failure tothrive, my husband and I bought Jeffrey to UCLA seeking medical treat-ment. His first appointment was during January 1992, at which time hewas evaluated for three days. We all returned to UCLA during February1992, so that Jeffrey could be further evaluated. After several more days oftesting, an accusation of suspected child abuse was made by Jeffrey's pedi-atric gastroenterologist. We were accused of "poisoning" Jeffrey with laxa-tives. Precisely at the same time the false allegation of child abuse wasmade, Crohn's disease was also diagnosed by the same doctor. Jeffrey wastaken immediately from us and admitted to the pediatric intensive careunit on February 26, 1992. He was labeled a victim of MunchausenSyndrome by Proxy (MSBP). While we were at Jeffrey's bedside at UCLA,our Nevada residence was searched for laxative, but none were found.More than 3 years passed before Jeffrey was finally reunited with his familyon May 1, 1995. A University of Chicago pediatric gastroenterologist andfour Mayo Clinic physicians, a pediatric gastroenterologist, toxicologist,endocrinologist, and a geneticist all refuted UCLA's child abuse allega-tions. We were triumphant at trial!

    Jeffrey remained hospitalized at UCLA for over seven months, until hewas discharged to an Illinois foster home on October 4, 1992. Throughouthis hospitalization, our visits were monitored. Therefore, we felt it wasnecessary to also have our own witnesses to observe the visits. Duringthose seven months, he was admitted to the Neuropsychiatric Institute(NPI) on April 21,1992 due to the false diagnosis that Jeffrey was a victimof MSBP. Teaching funds were approved to support him during his NPIhospitalization.

    Despite relentless diarrhea, Jeffrey remain in the NPI. His health deterio-rated so severely, that an emergenc

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