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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

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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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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 subjects—its 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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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 emergency admission back into the MedicalCenter was necessary. A court order was granted to accomplish the transferon July 30, 1992. It is what happened to Jeffrey, after he was transferredback into the Medical Center, that is the focus of this report. BeginningJuly 30, 1992, cyclosporine was started intravenously. Cyclosporine is amedicine, which in 1983 has received FDA approval with specific labels foruse. It is used to prevent organ transplant rejection. The cyclosporine waseventually administered orally throughout the remainder of his UCLA hos-pitalization. The foster parents continued to give Jeffrey cyclosporine untilNovember 1993. During April 1993, Jeffrey was rushed by ambulance toa local hospital, accompanied by his foster mother. He was admitted to theemergency room suffering from explosive diarrhea, dehydration, and lowpotassium.

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Questions come to mind as to why Jeffrey would become so seriouslyill, while hospitalized at a major medical center. The first encounter withserious illness at UCLA occurred shortly after his admission. He suffered anelectrolyte imbalance, after his regular medications were stopped and hisprevious gastroenterologist's orders to avoid dairy products were ignored.

His second encounter with serious illness was during his hospitalizationin the NPI. Although he was taking numerous medications for his boweldisease, a psychiatrist was his primary physician. Did his "treatment" playa role in his declining health? Was Jeffrey "at risk" the moment ourparental rights to make informed decisions regard his health care, weretemporally taken from us? Did that legal situation open the door for theaccusing physicians' to benefit from research, related to the "treatment" ofJeffrey's unique and challenging medical problems?

At this time, I will begin to focus on the decision to use cyclosporine inJeffrey's treatment. On the surface, the use of cyclosporine appears to be fortreatment. But was it used solely for treatment or was it used part forresearch? Do medical articles written in 1994 by the accusing physician andanother treating physician, discussing the use of cyclosporine for theirpediatric patients afflicted with Crohn's disease, prove that their intent inusing this drug, was at least partly for research?

Since cyclosporine's initial FDA approval in 1983, it has still not beenapproved for the treatment of inflammatory bowel disease. The literature isfilled with medical articles that discuss the serious risk factors associatedwith its' use. Significant toxicity including renal dysfunction and superinfection can result from the use of cyclosporine.

The accusing doctor and another pediatric gastroenterologist treatingphysician, state in an article published in 1994, that cyclosporine benefitsless than 25% of cases of ulcerative colitis or Crohn's disease. Many studiesconclude that cyclosporine does not appear to be effective in maintainingremission in the majority of Crohn's disease patients. The literature statesthat physicians need to gain experience with this drug, to learn how toavoid significant toxicity. Further studies are necessary to determine theoptimal dose of cyclosporine when it is given intravenously.

Today, Jeffrey carries three diagnoses. The University of Chicago diag-nosed Crohn's disease during November 1996. Although UCLA initiallydiagnosed Crohn's disease during February 1992, by the latter part ofJeffrey's seven month hospitalization, his physicians committed only to hissymptoms being "consistent" with Crohn's disease.

Jeffrey also has asthma. The University of Chicago diagnosed and istreating his asthma condition. A Mayo Clinic geneticist diagnosed Jeffreywith a rare genetic condition, which is described as a variant of theJohanson-Blizzard syndrome. Given Jeffrey's unique and complex medicalstatus, was enough known in 1992, about how cyclosporine would affectJeffrey's future, to warrant its' use? Was Jeffrey really a victim of research,which was masqueraded as "treatment"? In trying to answer that question,only more questions come to mind. Why was Jeffrey's NPI hospitalizationwhich lasted for over three months, covered by teaching funds? But mostpuzzling is why didn't UCLA provide Jeffrey's insurance carrier with com-plete medical records, so that their physicians could review his medical

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records? Almost the entire claim for Jeffrey's seven month hospitalizationat UCLA, was denied in October 1992 because the insurance carrier wasnot given the requested medical records. To this day the claim remainsdenied.

In legal situations where parental rights have been temporally takenaway, is research disguised as treatment, being conducted on innocent, pre-cious children?"

The second testimony came from a heart broken father withcourage and determination, Arun K. Guha, Ph.D. (1997). He statedthat:

"My son died in the UCLA Neuropsychiatric Hospital (NPH) in November1993 at age 26. ...

He was on a business trip in Southeast Asia in November 1993 when hefelt indisposed. He saw a clinic inside the hotel where he sought medicaladvice and was given five medications. He reacted to one of them. I under-stood nothing of the medical aspects at the time as I do now. The drug hereacted to is a gastro-intestinal medication to control nausea. For the psy-chiatrists in the audience, let me add that it is metoclopramide, a dopamineblocker equipotent with chlorpramazine. The medical literature has dozensof articles on reactions to metoclopramide, including Neuroleptic MalignantSyndrome leading to sudden death, and akathisia of various degrees ofseverity. My son had blisters on his feet presumably from walking aroundunder the effect of akathisia, and there are witness accounts of his walking.He also had severe cognitive akathisia that lay people like myself wronglyassume to be psychosis.

Unfortunately for my son, it was the Thanksgiving day when he presentedhimself to the UCLA Emergency Medical Center. The person who calledhimself a psychiatrist and put him on involuntary hold to admit him inthe hospital was an untrained first year resident without a license topractice medicine, and who had no supervision. With proper diagnosis, myson could have been cured of his symptoms in a matter of hours by theadministration of large doses of an anticholinergic such as Cogentin. ...

My son died on Monday after Thanksgiving under strange circum-stances. He did not have to die; he was driven to his death by various actsof omission and commission by the hospital medical personnel. The act ofomission was the failure to provide even minimal standard of caring dur-ing his stay. The act of commission was to subject him to clandestinehuman experimentation. Finally, the hospital has followed this up by falsi-fying information, and compromising the investigation of various agenciesinto the case. ...

On Thanksgiving day 1993, the untrained resident admitted my sonunder the diagnosis of Major Depression. The DSM-III-R diagnostic logicdoes not justify that diagnosis. The next day, I found my son to be terrifiedcalling his room a torture chamber. He complained that someone came intohis room at night every so often, shone a flashlight on his face till he wasforced to open his eyes, and then left. I found the account hard to believe.

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However, in the evening, the second most senior nurse explained to us thatit was policy. I protested for the next four days to residents and nursesagainst what I considered a bizarre practice in psychiatric clinical practice.The medical record has a quote I used to describe it as "primitive and bar-baric." After death, when we met with Dr. the unit director and thedirector of adult psychiatry, he seemed to be in a state of shock himself. Heresponded to our questions like a person in a trance. We asked him severalquestions, including: "Did you know he was awakened every 15 minutes?"his answer: "Yes, standard procedure. Eye contact was made, flashlightwas shown in front of eyes." Dr. was the first person to use the specif-ic phrase "eye contact." He also acknowledged that he made the policies ofthat department. He had several family members and friends in the group,and we carefully documented the main statements verbatim.

... the medical board of California wrote, "you state that your son wasawakened every 15 minutes during the night, that a flashlight was showninto his eyes and he was forced to open his eyes each time. The Consultantagrees that what your son was describing was cruel and inhumane, andknows of no psychiatric facility which practices this procedure. We askedUCLA for the protocol for night checks. The written protocol for the staff atUCLA NPI states that a flashlight is to be pointed at the ceiling just longenough to allow observation of the patient's body, the continued presenceof breathing, and no unusual changes in the room such as overturned fur-niture, etc." During the discovery process in our litigation, we also receivedUCLA NPH policies and procedures verifying the above statement; theredoes not exist any approved clinical policy that authorizes the "standardprocedure" so graphically described by Dr. However, our conclusionwas different from that of the medical board. The board made the faultyassumption that UCLA NPH followed the written policy for clinical care.We knew that several residents and nurses had acknowledged that nightawakening had taken place, the attending physician had written it downin the chart, and Dr. himself had acknowledged it in an interview.We concluded that the evidence indicated that Sujon was the victim ofa clandestine experimental protocol. Further inquiry has confirmed thatconclusion.

We intend to prove in trial that Dr. had instituted a clandestineresearch program to study night awakening for depressed patients, some-thing that psychiatrists had been studying for several decades but typicallyunder controlled conditions and with adequate safeguards. The untrainedresident expected to get a pat on the back from his boss by finding anothersubject for research. Had competent psychiatrists been around, his errorwould have been discovered in time to save my son's life; but it was theThanksgiving weekend, and consistent with their negligent ways, the hos-pital did not have coverage and no one reviewed the situation in time tointervene. The attending physician and the senior resident were back onMonday but did not find time to examine a new admission who hadalready been ignored for four days. People who are knowledgeable havetold me that even if you took a perfectly healthy subject and kept himawake for four nights, there is no telling what the man would do onthe fifth day. My son was tired from long travel, had a bout of some viral

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infection, was suffering from akathisia, and above all was terrified at theunexpected and unexplainable things that were happening to him. Fournights of night awakening was devastating for him. On the fifth day, in theafternoon of Monday 11/29/93, when the attending physician, Dr.did not find time to examine him, he begged the admitting resident aboutthe night awakening, "I can not take it any more. Please make me an out-paient. I promise to come in for my treatments." The untrained unlicensedunsupervised resident did not budge.

While I can not go into the details of all our findings, the following factsare on public record, and you or the media should be able to ask Dr.or Dr. the questions I suggest below. As the administrator/personalrepresentative of my son's estate, I have the legal authority to waive med-ical confidentiality that may prohibit the good doctors from answeringyour questions, and I am doing so....

Since I have taken the position that you would not know the true dimen-sions of the problem unless you dig deep, I provide a few selected exam-ples to demonstrate the extent to which this institution has carried its effortto suppress information. We intend to prove in trial that the reason for thiscover-up is that my son died on 11/29/93 at about 4:30 p.m. in a mannerthat was so embarrassing to the hospital that they faked a sham discoveryof the body at 6:15 p.m. claiming that he was seen alive until 6:00 p.m.

Mistakes do happen. There is an honest professional way to handle suchproblems. Two best know examples are the Johnson & Johnson response tothe Tylenol case, and the Dana Farber hospital situation. I like to believethat my son's case is atypical, a frightening example of inappropriate andwantonly unlawful response to the situation. However, since such thingshappen, this commission should not take anything for granted if it wantsto make a serious effort to address the issues. It must understand the truedimensions of the problem."

NBAC's Human Subjects Subcommittee is led by ethicist Dr.James F. Childress. Dr. Gary Ellis is the Director of Office forProtection from Research Risks (OPRR). Dr. Ellis has made severalappearances before the subcommittee on behalf of his Federalagency. Members of the Human Subjects Subcommittee have maderepeated inquires about research with human subjects to Dr. Ellis.Dr. Ellis in a remarkably candid letter for a Federal official onApril 10, 1997 addressed to Dr. Childress, discusses this issue andcites 19 cases that came to his office's attention. We obtained a copyof the letter from Dr. Ellis under the Freedom of Information Act.The letter states:

"I am writing to respond to questions raised by some members of yourSubcommittee regarding the nature and extent of human-subjects researchtaking place beyond the boundaries of existing protections. Subcommitteemembers have made repeated reference to human subjects involved insuch activities as the "most vulnerable" of all human subjects.

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In my October 4, 1996 remarks to the National Bioethics AdvisoryCommission, I noted that human subjects involved in research outside theperimeter of the existing protections are protected only by occasional stateor local law or regulation, or at the discretion of the individuals or institu-tions undertaking the research. In other words, I am referring to humansubjects research that is: 1) not conducted or supported by any of 17Federal Departments or Agencies that adhere to the Federal Policy for theProtection of Human Subjects; 2) not regulated by the Food and DrugAdministration (FDA); and 3) not voluntarily pledged to the Departmentof Health and Human Services' regulations at 45 CFR Part 46.

The Office for Protection from Research Risks (OPRR) receives a numberof inquiries involving human subjects research over which it has no juris-diction. Most are informal inquiries received over the telephone and arenever pursued by OPRR. Each year, however, OPRR is presented with sev-eral formal, written complaints that can be reviewed in sufficient depth toconfirm OPRR's lack of jurisdiction.

For example, parents of a young child who underwent experimentalbone marrow transplantation alleged that they were not adequatelyinformed about the procedure's reasonably foreseeable risks, including thesevere brain damage which their child suffered. In a second example, itwas alleged that women who had experienced multiple miscarriages weremisled about the substantial financial cost of participating in research toenhance pregnancy. A third example involved a mid-level state university,where there was a considerable controversy about appropriate confiden-tiality protections for subjects involved in a study of adult literacy, as wellas charges of conflict of interest among members of the university'sInstitutional Review Board (IRB). In a fourth example, a woman who hadbeen treated for breast cancer alleged that identifiable private informationfrom her medical record had been placed in a registry and made availableto research investigators without her consent.

In each of these examples, OPRR was unable to pursue the allegations,because it was formally determined that the research was neither supportedby the Federal government nor voluntarily covered under an institutionalAssurance of Compliance submitted to OPRR.

OPRR also receives many less-formal inquires and complaints involvingindividuals or institutions for which OPRR's lack of oversight authority isreadily apparent.

For example, it is frequently alleged that patients have been subjected to"experimental" treatment procedures without appropriate informed con-sent and without IRB review. OPRR has received specific inquiries aboutthe use of "experimental" techniques in gall bladder surgery; "experimen-tal" psychotherapy techniques, and surgery research that was not subjectedto IRB oversight, allegedly because the investigator generated a great dealof revenue for the hospital involved.

Other examples involve breach of confidentiality in research. In oneinstance, it was alleged that confidential, identifiable responses of nursesinvolved in research about lapses in patient care were made availableto the nurses' employers. In another instance, it was alleged that an investi-gator utilized sensitive, identifiable drug abuse treatment information for

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research without informed consent or IRB review. In a third instance, it wasalleged that several physicians provide a research investigator with confi-dential patient identity and medical record information without patientinformation permission or IRB review.

The use of deception in research has also generated inquires to OPRR.For example, one complainant described "team management" research inwhich unsuspecting individuals were subjected to a sham robbery, result-ing in significant stress, fear, and anxiety. Another complainant described"fright response" research in which participants were subjected to un-expected and disturbing visual stimuli.

OPRR was also unable to pursue complaints alleging 1) a coercive struc-ture of payment for participation in weight loss research which made itextremely unlikely that subjects would discontinue participation prior tocompletion of the research; 2) failure to characterize adequately the severityof reasonably foreseeable risks associated with a research comparison oftwo FDA-approved drugs; and 3) lack of parental consent and IRB reviewfor survey research in which children were asked sensitive questions abouttheir own behavior and that of their parents and friends.

From time to time, OPRR is also made aware of media reports describingquestionable involvement of human subjects in research. A November 9,1995 University news release describes private-foundation funding of adentist's study of removal and replacement of mercury amalgam from thedental fillings of approximately 30 patients. On October 10,1994, the NewYork Times reported that a Manhattan gynecologist had successfullyinduced abortions in 121 of 126 patients with two FDA-approved drugs inan attempt "to show the medical community that there is a safe, simple,effective, legal technique of terminating pregnancies that is private andinexpensive." In another New York Times story (August 15, 1994), gradeschools in North Carolina are described as permitting industry-sponsoredsurvey of the height of children, so that short children could be identifiedfor referral for potential treatment with genetically engineered humangrowth hormone. On June 13, 1996, the San Diego Tribune reportedthat "four African-American children were singled out for a race-relatedsurvey" by a local graduate student without the permission of their parentsor of the school system.

The information contained in these 19 examples drawn from OPRR filesmay seem fragmentary. That is by necessity. With current authority, it isneither proper nor possible for OPRR to pursue these incidents and manyother like incidents, and to fully described and understand what is happen-ing to the participants that are involved.

I hope that the details provided herein will put to rest any uncertaintyamong Subcommittee members as to the existence of a substantial prob-lem: That is, the unwitting participation—with attendant possibility forphysical or dignitary harm—of some of our fellow Americans in research.OPRR's experience indicates that there exists in 1997 a substantial reservoirof such research activity.

The National needs to tools necessary to insure that human subjects areprotected by 1) initial and continuing IRB review, and 2) legally effectiveinformed consent. As the Subcommittee proceeds with its consideration of

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protecting the rights and welfare of human subjects, please do not advancebeyond what I would call Square One without articulating a meaningfulstandard of protection for all individuals who may be research subjects."

From these above referenced case reports and the fact that pri-vately-funded research is not regulated by any process, it is clearthat our nation need to regulate all research with human subjectsregardless of the source of funding.

REFERENCES

Animal Welfare Act (1966). (PL 89-544) as amended in 1970 (PL 91-579) and amendedin 1976 (PL 94-279).

Advisory Committee on Human Radiation Experiments (ACHRE) (1995). FinalReport, U.S. Government Printing Office, Washington, D.C. 20402, Stock Number061-000-00-848-9.

Ellis, G. (1997). A text of a letter addressed to James F. Childress, Ph.D., Chairman,Human Subjects Subcommittee, April 10, 1997, pp. 1-3.

Gibbons, John H. (Assistant to the President for Science and Technology) (1996).A text of the "National Bioethics Advisory Commission Charter," dated July26, 1996.

Guha, A.K., Ph.D. (1997). "Submission to the National Bioethics AdvisoryCommission, Testimony, September 18, 1997, pp. 1-25, plus 11 attachments.

Neason, A. (1997). Testimony to the National Bioethics Advisory Commission,September 18, 1997, pp. 1-6.

Shamoo, A.E. and Sharav, V.H. (1997). "The Unethical Use of Persons with MentalIllness in High Risk Research Experiments," Testimony to the National BioethicsCommission on January 9, 1997.

Shamoo, A.E. (1997). 'The Unethical Use of Persons with Mental Illness in High RiskResearch Experiments," Testimony to the National Bioethics AdvisoryCommission on July 15, 1997.

T.D. et al. vs New York State Office of Mental Health et al, (1996) N.Y./APP. Div.Lexis 12293.

U.S. Federal Register (1995). Presidential document Title 3—Executive order 12975 ofOctober 3, 1995, "Protection of Human Research Subjects and Creation of NationalBioethics Advisory Commission, Vol. 60, No. 193: 52063-52065.

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