MEETING REPORT.........................................................................................................................

Fraud and misconduct in biomedicalresearch – 15 January 2002*Hugh Boardman

Boardman Clarke, 6 Stanton Road, London SW20 8RL

Introduction

This excellent meeting, held at the Institute of Biology inLondon, was organized by the Society of PharmaceuticalMedicine and chaired by Shaun Kilminster of Guildford ClinicalPharmacology, UK. The agenda was designed to address allaspects of research misconduct, culminating in a workshop inwhich the delegates took part in a role play around an imaginarycase of research fraud. The speakers all had good credentialsbeing contributors to the third edition of Fraud and Misconductin Biomedical Research (BMJ Books 2001) and having strongconnections with MedicoLegal Investigations Ltd, UK (MLI).The delegates were almost all senior pharmaceutical physicians(medical directors and heads of clinical research), suggestingthat the pharmaceutical industry has finally realized thatresearch misconduct is an important aspect of audit. Investiga-tors sometimes need investigating.

Research fraud: a USA perspective

The first talk was given by Arthur Horowitz, an expert onresearch misconduct in the USA. Thanks to the Food and DrugsAdministration (FDA), the USA has been setting the pace inrecognizing and tackling research misconduct; it was the firstcountry to take the problem of research misconduct seriously.This is not surprising since the Americans take researchmisconduct to mean failure to comply with good clinicalpractice (GCP), or to be more precise, with the FDA’s visionof GCP under the International Conference on Harmonization(ICH).

Failure to comply with GCP is increasingly likely to occurbecause commercial and regulatory pressures mean that morestudies with more sites and more inexperienced investigators arebeing run by more companies, and more contract researchorganizations (CROs) in more countries under more investiga-tional new drug (IND) applications. Furthermore, investigatorsare delegating more of their duties to an expanding range ofresearch nurses and trial co-ordinators. Thus there are moreopportunities to make mistakes, genuine or disingenuous.

Clinical research has broken out of thehospital setting in the USA

Most trial patients in the USA are now recruited in privatepractice settings. This is a result of the demand for subjectsoutstripping the numbers available in the managed care andVeterans Administration settings. The same forces have drivenclinical research abroad and the FDA now finds itself auditingan increasing number of overseas investigators taking part inpivotal studies. In the time window 1995 to 1999, over 14 000overseas investigators contributed to USA pivotal studies. Atthe same time studies are becoming larger and more compli-cated. As a result more people are doing more research in moreplaces under more stringent time lines, and more commercialpressure. In such circumstances cutting corners for good or badreasons is likely to occur, and greedy or arrogant investigatorsmay see opportunities to exploit the situation and not getcaught.

In recent years the FDA has been finding serious problems ina small proportion (3%) of its ‘not for cause’ audits and in overa quarter (26%) of its ‘for cause’ audits. Not all of these seriousproblems are cases of fraud. Research misconduct, in the senseof non-compliance with the FDA version of GCP, is difficult toavoid in some cases because of cultural and legal issues in thenon-USA countries where the clinical trials have taken place.These have included shortcomings of ethics committees in LatinAmerica and China, inadequate consent procedures in Russiaand language problems with consent forms in South Africa. Alltoo often there is inadequate awareness of GCP amonginvestigators in the second world countries now used as sourcesof treatment-naı̈ve patients.

The system for auditing clinical trials isoverloaded

It is clear that the system for auditing clinical trials is having tocope with the increasing demands of an increasing workload,but this has now been compounded by litigation. The Americanpublic has woken up to the issue and is complaining andlitigating over malpractice in clinical trials. As a result, moreresearch misconduct and fraud has been discovered. In a third ofcases, the problem is identified by anonymous callers and in athird of cases by whistle blowers working at the study site. Less

*An earlier journalistic version of this meeting report appeared inPharmaceutical Physician.

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than 20% of cases are spotted by ethics committees orsponsoring companies. In 60% of cases investigated recentlyby the FDA the target was the investigator rather than thepharmaceutical company.

The American media have now taken up the issue. Thenotorious case of Robert Fiddes, the Florida physician whoran a research institute that fabricated data, was the catalystfor the rise in media interest. Because he exploited patients ina shameful way he was eventually sent to prison, and laterdeported to Canada. More respectable institutions, such asthe Fred Hutchinson Cancer Research Institute and theUniversity of Pennsylvania, have also been in the newsbecause of complaints of misconduct by researchers. Thesecentred on procedures for obtaining consent from patientswho subsequently died. The ethics committees came in forcriticism in these cases because they have a duty to overseeresearch.

The American government has responded to the problem bytightening up the system and developing an anti-fraudprogramme in clinical research. There have been congressionalhearings and FDA meetings on the subject. A key problem thatneeds to be solved in the wake of all the negative media interestin research malpractice is how to restore public confidence inclinical research. After all, clinical research is necessary for thelong-term public good.

Research fraud: a British and Europeanperspective

The second talk was given by Frank Wells (MLI) who outlinedthe situation in Europe and the United Kingdom. In Europewe are less suspicious and more trusting than our UScolleagues. We believe that the conduct of most clinicalresearch is honest and honourable. Occasionally the sponsorof a clinical research project may be faced with data that aresuspect, but that may be due to sloppiness on the part of theinvestigator or unreasonable expectations on the part of thesponsor. There may be instances of research misconduct butthe suspect data are not necessarily fraudulent. Misconductmay be major or minor, but it only becomes fraud when therehas been a deliberate intention to deceive. Of course, in anideal world fraud would not occur. But we do not live in anideal world, even in Europe.

Standards for clinical research

Because we do not live in an ideal world standards have to be setfor clinical research. Once standards have been introduced allinterested parties have to be made aware of them as aprerequisite for conducting clinical research. From the view-point of the pharmaceutical industry, the standards are those setout in the International Conference on Harmonization Guide-lines on Good Clinical Practice (ICH GCP) which are now beingwritten into European Union (EU) law as a result of the EUDirective on Clinical Trials. Furthermore clinical research inEurope is already regulated by several other directives,particularly 75/318/EEC, 911507/EEC and 2001/20/EC. Thelast of these was published in May 2001 and, in effect,incorporates all of ICH into EU law. Furthermore, the UKhas the Medicines Act of 1968 that regulates the behaviour ofthe British research-based pharmaceutical industry.

The nature of clinical research fraud

All this legislation has its place, but laws are not written inplain language that ordinary researchers can understand.When it comes to research misconduct Dr Wells took theview that clinical research fraud is best defined as ‘thegeneration of false data with the intent to deceive’. TheJoint Consensus Conference on Misconduct in BiomedicalResearch (Edinburgh, October 1999) put it differently:‘behaviour by a researcher, intentional or not, that fallsshort of good ethical and scientific standards’. In Francefraud is defined as ‘Un acte de mauvaise foi et de tromperieaccomplie en vue de nuire au droit d’autrui’ (an insincere actof deception achieved in order to harm the right of others).But no matter how it is viewed, fraud is an intentional actaimed at misleading for personal advantage – it is the samethe whole world over.

The frequency of fraud

It would be wrong to believe that fraud is rife, but it probablyoccurs throughout Europe. Its very existence is a cause forserious concern: serious research misconduct may affect morethan 1% of all clinical research. If this is true, it suggests thatat any one time there will be at least 30 fraudulentinvestigators active in the UK. How many are active elsewherein the world is more difficult to quantify because ideas aboutresearch fraud are not so well developed. For example, inFrance the notion of fraud only exists as a general legalconcept and is a subject for the civil and criminal law ratherthan for self regulation in the scientific community. Untilrecently it was the same in Germany: there were no specialrules regarding misconduct in science so no information wasavailable about how much misconduct was going on. RecentlyGermany appointed an Ombudsman for Science, an importantstep forwards. Elsewhere in northern Europe there are nowsystems for dealing with research misconduct, although thesmall volume of drug company research conducted theremeans that the problem is not a big one. In southern Europethere are, as yet, no official systems for dealing with researchfraud.

Pharma-political aspects of fraud

In the past the greatest concerns of pharmaceutical companieson discovering that they had uncovered cases of researchmisconduct or fraud were the predictable ones: they wereconcerned about the risks of recrimination, of adverse publicityand loss of favour, support and prescriptions if they prosecutedthe perpetrators. However, patient safety and the prevention ofexploitation of the vulnerable are now moving to the top of thepharma-political agenda. Companies are now anxious touncover fraud with minimal delay and some even want to beseen to be taking action. There is also an informal mechanismin the UK for sharing information about questionableinvestigators in a way that protects the public withoutinfringing their legal rights. This is a good thing since itprotects patients from being exploited by questionable inves-tigators. Nevertheless, it is better to prevent fraud in the firstplace. Drug companies can do this if they follow a few simplerules.

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Avoiding inappropriate investigators

Some doctors choose to become investigators for the wrongreasons. They may be responding to the pressure to publish tofurther their careers or they may have turned to clinical trials as away of relieving the tedium of routine clinical practice. They maybe greedy or over ambitious, they may be vain, arrogant or justplain bad. Sensible companies avoid potential investigators whoare too busy, too arrogant, too tired, too frustrated by bureau-cracy, too lazy, too greedy or too careless. Sensible companiesalso reject any investigators who have ‘underperformed’ in thepast. This may be difficult where the investigator is a ‘key opinionleader’ or a good friend of the marketing department, but shouldbe easy when the funding arrangements are disclosed to the localresearch ethics committee.

Investigating inappropriate investigators

Fraud is most often detected by trial monitors. These are thejunior drug company staff who actually visit the site and lookat the case report forms and diary cards. The detection offraud can be difficult, but if a clinical trial monitor has theslightest concern that something is wrong it is essential thatthis is flagged and raised at a more senior level, usually byreporting the matter to the medical director. Causes forconcern may include the use by the investigator of only onetype of pen for a study involving patients from differentcentres over a prolonged period or the fact that several‘patients’ have marked visual analogue scales in the sameidiosyncratic way. Materials may have been returned in anunlikely pristine state or data may be too perfect, orcompliance with treatment too exemplary. Dedication toresearch may even stretch to seeing patients in special clinicsrun on bank holidays. Recently the commonest type of fraudhas involved forged consent forms and diary cards. Once aninvestigator has been shown beyond all reasonable doubt tohave submitted fraudulent data, a pharmaceutical company orCRO must act at once in the interests of the public, theprofession and the industry.

Actions to take on suspecting research fraud

In the United Kingdom the options are: to do nothing, to referthe case to the General Medical Council (GMC), to refer thecase to the police for further investigation of the criminaloffence of deception, or to bring a civil action. In the futurethere may be a National Panel on Research Integrity or anOffice for Research Integrity. In the USA the matter can bereferred to the Office for Human Research Protection, the Officeof Research Integrity, or the Food and Drugs Administration.In the Nordic countries there are Committees on ScientificDishonesty, in Germany there is the Ombudsman for Science,but in the rest of Europe there are no official bodies designed todeal with research misconduct or fraud.

In the last 10 years in Britain 22 cases of research misconducthave been referred to the GMC. In 21 of the cases the complaintwas upheld and the doctor found guilty of serious professionalmisconduct. In 12 of the cases the doctor was struck off themedical register and in five of the cases the doctor wassuspended from the medical register. It is clear that the GMCtakes the matter as seriously as the drug industry does.

Standards of practice for dealing with researchfraud

In order to help companies manage cases of suspected fraudstandard operating procedures (SOPs) are necessary. Wellssuggested that all pharmaceutical companies should have SOPSthat cover: (i) the company policy on what to do about suspectdata; (ii) referral of the matter to a company physician at thehighest level (e.g. medical director); (iii) guidelines on how toproceed when investigating suspected fraud; (iv) guidance onhow to deal with aggrieved suspects (e.g. right of appeal); and(v) advice on how to screen data routinely for statistical cluespointing to fraud.

A case history – first hand account

A very interesting case study was presented by Roberta Coss,Head, Global Study Audit Management, Bayer Medical QualityManagement, Bayer, UK. She described the events she becameinvolved in when Bayer discovered research misconduct in ahypertension study. The study was a multinational, double-blind, comparator-controlled study of a new formulation of anantihypertensive drug. It involved each patient making 16 studyvisits over a three-year period. The investigator in question wasa London general practitioner (GP) who recruited 37 patientsduring 14 months in the mid-1990s. In October 1996 themonitoring staff alerted the audit group at Bayer about concernsthey had regarding the quality of the data from this centre. InOctober 1996 Bayer carried out an audit in which study fileswere compared with patient records. It was noted that the sameelectrocardiogram (ECG) tracing had been used for severaldifferent patients, indeed 25% of the ECG tracings had markedsimilarities but all had had the patient identifiers cut off and thepatient name written on by hand. It was also noted that some ofthe patient signatures on consent forms appeared to be in rathersimilar handwriting.

Bayer therefore took the available study documents in houseand alerted the Association of British Pharmaceutical Industry(ABPI) and MLI. MLI approached the Area Health Authorityand was allowed to make contact with the patients. Of the 15patients interviewed none was aware of the study. A forensicgraphologist was engaged to report on the handwriting of the‘patient’ signatures. He found similarities with the doctor’shandwriting in 15 out of the 37 subjects ‘enrolled’ in the study.None of the patients interviewed had received or taken studymedication and one did not even have hypertension. The casewent to the GMC and was heard in November 1998. The doctorwas found guilty of serious professional misconduct and wasstruck off the medical register with immediate effect.

What can be learnt from this case?

Clinical trials rely on the honesty and integrity of doctors,nurses and other paramedics. Taking action against a fraudulentinvestigator helps to maintain the integrity of the caringprofessions and the pharmaceutical industry. Evidence frompatients was central to the case. Patient safety and theprotection of their rights is a major concern for the pharma-ceutical industry. For these reasons it is very important to havea procedure in place to handle the reporting of suspicious data.Procedures were in place at both Bayer and the ABPI but the

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same is not always true of Health Authorities or EthicsCommittees. The procedures should protect both the reporter(assuming he or she is acting in good faith) and the accused untilhe or she is shown to be guilty.

Happily the attitude of the medical profession to cases suchas this has improved and there was no local backlash againstBayer as a result of investigating a fraudulent GP.

The role of research ethics committees

Jennifer Blunt, past Chairman of the Multicentre ResearchEthics Committee (MREC) North West, UK, gave an interest-ing talk explaining how research ethics committees can helpprevent research misconduct and even perhaps detect it. Shethought that rigorous ethical review could assist in preventingresearch misconduct, promoting a culture of good qualitybiomedical research and discouraging practices in whichresearch misconduct can flourish. The ethical environment forresearch is now being regulated more appropriately due to therecent changes in the regulation of research that have beentaking place in Europe and the UK. These changes areencapsulated in Internet-based documents such as ‘2001120/EC’, Research Governance Framework for Health and SocialCare (RGF), Governance Arrangements for NHS ResearchEthics Committees, and the EU Draft Protocol on HumanRights and Biomedicine on Biomedical Research (see furtherreading below).

Research Governance Framework for Health and SocialCare aims to improve research quality and protect the public bypromoting good practice. It plans to do this by enhancingethical and scientific quality, promoting good practice, reducingadverse incidents, ensuring lessons are learned, preventing poorperformance and preventing misconduct. The key elements ofthis strategy are all designed to produce a quality researchculture in which there is respect for the participants, in whichdiversity is valued, in which all express personal and scientificintegrity, leadership, honesty, accountability, and openness,facilitated by clear and supportive management.

As a result the role of the research ethics committee will be toprovide independent advice on each research proposal so as toensure the dignity, rights, safety and well-being of theparticipants. It will also help to protect participants fromunethical risks and invasion of privacy, to facilitate researchtowards new and better treatments and to review any significantdeviations from the original protocol as the research progresses.As a result, research ethics committees will act as gatekeepersfor research. Thus prior research ethics committee approval willbe required in the UK’s National Health Service (NHS) for anyand all research projects that involve human participants, theirorgans, tissues or data. Furthermore prior research ethicscommittee approval will be required by sponsors and researchfunders, research and development (R&D) management, aca-demic boards, and medical and scientific journals.

Process of ethical review

The process of ethical review will address the validity of theresearch by asking questions like: how important is the researchquestion and can the research provide an answer to the questionasked? The welfare of the research participant will be ensured byasking: what will participating in the research involve and arethe risks necessary and acceptable? The dignity of the research

participant will be protected by asking: will consent be sought,will confidentiality be respected?

To help with this process a new common NHS research ethicscommittee form is being developed:

. Part A will collect details of the research project, theprincipal researcher, the funder and the sponsor of theresearch, as well as details of the research itself.

. Part B will focus on ethical issues such as the design andscientific conduct of the research, the methods used forpatient recruitment, obtaining consent, the care andprotection of research participants, the use of tissue andother bodily materials, any community issues, any use ofpersonal data, and will end with a declaration. Annex 1to part B will cover the use of medicinal products andmedical devices, Annex 2 the use of ionizing radiation,and Annex 3 the use of existing (retained) stored samples.

. Part C will address locality issues such as contact details,arrangements for the care and protection of researchparticipants, financial matters, including use of resources,relevant authorizations, declarations from the lead localresearcher, local R&D management at the organizationhosting the research, and details of the local research ethicscommittee (LREC) considering locality issues.

More emphasis will also be placed on design aspects such asstudy type and primary purpose, scientific justification (includ-ing evidence from a systematic review), scientific quality andcritique, registration of any randomized controlled trials(RCTs), principal researcher access to raw data, and rules fordissemination of results.

More data will also be collected on the principal researcheror the lead local researcher (curriculum vitae, number of projectsundertaken in the last 12 months), who will take responsibilityfor continuing patient care, adequacy of local facilities, localfinance implications, support and data protection issues.

Working example

The illustrative case used to support the points made in thispresentation concerned an investigator who submitted 18 studiesto his LREC over a period of two and a half years. The projectsinvolved 14 pharmaceutical companies or CROs and a widerange of indications (respiratory disorders, hypertension,arthritis, migraine, digestive disorders and major depression).The per capita payments to be paid ranged from £200 to £2000per completed patient. Quite by chance the ethics committeechairman discovered that the doctor was doing more studiesthan this, having forged LREC letters of approval for threeadditional projects.

Would this forger have been detected earlier if the newproposed ethical safeguards had been in place (MREC review,LREC consideration of locality issues such as number ofconcurrent studies, R&D responsibilities via primary caretrusts, financial arrangements and the larger number ofauthorizations before research could start)? It is difficult toknow. The extra paperwork might even have prompted moreforgery.

Nevertheless, it is to be hoped that rigorous ethical review byresearch ethics committee will act as a preventive measure intackling research misconduct, will encourage a culture of goodquality research, will discourage mediocre research, will protectpatients from harm by research and researchers, but will still

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somehow facilitate attempts to identify new and better treat-ments. If not we will have to continue investigating fraud casesby whatever means are available.

MedicoLegal Investigation

Peter Jay, former detective and former investigating officer tothe GMC’s solicitors, gave a lively talk describing howinvestigations into cases of research misconduct and fraudare carried out. He started by describing the variableworkload fraud presents as evidenced by the variable numberof studies under investigation at any one time. Suchinvestigations may be instigated by a pharmaceutical companyor CRO as a result of issues that come to light by followingmonitoring procedures, or as a result of the intervention of awhistleblower. Often the investigations require LREC supportand assistance.

The approach adopted by MLI is simplicity itself: to checkand double check the integrity of the information that suggeststhat misconduct may have occurred. If a whistleblower isinvolved, it is also necessary to assess his or her motivation andcredibility. As in all investigations, the goal is to gather andevaluate the evidence.

Evidence is often obtained by liaising with HealthAuthorities to obtain their cooperation in contacting patients.Once permission has been granted patients are visited tointerview them and obtain written evidence from them in theform of signed statements. The ultimate goal is to collectappropriate evidence of a quality necessary to present a casebefore the GMC. The process depends upon a number offactors including: the quality of the evidence available fromthe pharmaceutical company or CRO; the reliability of thewhistleblower as a witness; and the willingness of patients tobreak confidentiality. Key questions which need to be kept inmind include: what if everything goes wrong and theinvestigation reveals only sloppiness, and whose career is intatters as a result?

Any approach to patients by MLI is done with HealthAuthority approval. A letter is always sent before a visit. Patientresponses are often mixed. Many patients feel a sense of loyaltyto their doctors and are reluctant to accept that he or she mayhave been misleading them for fraudulent purposes. Many arereluctant to become involved, at least at first. However, oncethey have been presented with the facts they are often shockedand disgusted by the way their trust has been abused. As a resultthey are only too willing to cooperate regardless of their regionalor social affiliations, and regardless of their financial orprofessional circumstances. Almost all patients are subsequentlyvery grateful for the trouble the pharmaceutical industry hastaken to right the wrongs done to them.

The investigation process

MLI investigations have two parts to them. The first part,which leads to the preparation of a case to set before theGMC’s Preliminary Proceedings Committee, is funded by thepharmaceutical company involved in the case. If there is acase to answer the cost of working up the evidence forpresentation to the Professional Conduct Committee is fundedby the GMC itself. The end result of the process is ajudgment or determination handed down by the GMC. Thepunishments available to the GMC include: referring the

doctor to the Health Committee, admonishing him or her,suspending him or her for up to 12 months, erasing his or hername from the medical register, attaching conditions to his orher registration, or perhaps acquitting him or her. Thechairman sums up the hearing and delivers the determinationrather like a judge does in the High Court. Such determina-tions make sober reading.

Extracts from a determination

‘Dr Fairhurst, trust lies at the heart of the practice of medicine.Patients must be able to trust doctors with their lives andwellbeing. That trust must not be abused. Medical research isfundamental to the advance of medical practice and must alwaysbe conducted with scrupulous honesty and integrity.

‘Where doctors intend to involve patients in clinical trials,it is essential that they first give those patients a properexplanation. Patients have the right to know what isinvolved, and to understand the implications for them,before they are invited to take part. No such trial shouldever be carried out without the consent of the patient. Thetrust of the patients is maintained through such under-standing and consent.

‘The facts proved against you in the charge demonstrate thatyou have repeatedly behaved dishonestly and have betrayed thetrust placed in you by your patients, in particular by involvingthem in pharmaceutical trials without their knowledge orconsent.

‘You have also abused the trust of your medical colleaguesand those with whom you were collaborating in pharmaceuticaltrials. In doing so, you have undermined the reputation of themedical profession, and damaged the confidence of the public inthe integrity of scientific research. Your behaviour has not onlybeen dishonourable in itself, but has also placed the welfare ofpatients at risk.

‘In your case, the committee’s concern is the greater becauseof the position you have held as a member of a Research EthicsCommittee. The committee have judged you to have beenguilty of serious professional misconduct in relation to the factsproved against you in the charge and have directed theRegistrar to erase your name from the register. The effect ofthe foregoing direction is that unless you exercise your right ofappeal, your name will be erased from the register 28 daysfrom today.

‘Finally the committee wish me to add the followingstatement. All doctors are reminded of their duty to take actionwhere they have good reason, as in this case, to believe that acolleague may be acting contrary to the standards of practice setout in the council’s guidance. Only in this way can the Counciluphold the integrity of the profession.’

From theory to practice

The last session of the meeting involved audience participation.Dr Wells led the delegates through a lively role play in which afictional fraud case was discovered, investigated and sent beforethe GMC. This was a good way to reinforce the lessons learntearlier in the day. If there was a fault with the role play, it wasthe surprising zeal with which even the most naturally cautiouspharmaceutical physicians were willing to suspect foul play andfraud. Once, it seems, one has fraud on the mind one sees iteverywhere.

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Further readingFurther reading

Directive on the approximation of the laws, regulations and administrative provisions ofthe member states relating to the implementation of good clinical practice in the conductof clinical trials on medicinal products for human use (May 2001) EU Directive 2001/120/EC.

DH Research Governance Framework for Health and Social Care (March 2001) http://www.doh.gov.uk/research/rd3/nhsrandd/researchgovernance/govhome.htm

DH Governance arrangements for NHS Research Ethics Committees (July 2001) http://www.doh.gov.uk/research/rd1/researchgovernance/corec.htm

EC Draft additional protocol to the Convention on Human Rights and Biomedicine, onBiomedical Research. Consultation document Strasbourg (July 2001).

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