Medical Research and Litigation Effects Research Paper

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Litigation, broadly defined, is the process where two parties attempt to settle a dispute by court action. The general objective is to obtain a judicial decision about which party’s claim is legally stronger. This research paper considers how litigation has affected medical research. It highlights the concerns of researchers and research subjects about court decisions regarding their rights and liabilities, and how this may have affected their approach to research. The main regions in focus are the USA, Europe, and the Commonwealth countries. One general area of concern is the nature of dispute resolution in the courts. The ability of parties to argue fairly in an atmosphere that is competitive, stressful, and expensive and the efficacy of legal norms about justice and truth have been widely discussed in critical legal studies literature as well as in media reports.

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There is a common view that litigation better suits the strategies of powerful, well-resourced parties, and hence has a tendency to determine justice according to their interests. These issues are not addressed in detail in this research paper as they are not peculiar to the research relationship. This research paper examines, from a sociolegal perspective, the content of court decisions about medical research and the way that judges have developed legal rules that govern, and hence shape, the experience of research. It considers the claims that judges’ decisions have led to legal defensiveness in research and participants’ unwillingness to volunteer. A significant point to note is that there is no clarity about the effect that litigation has had on medical research. On the one hand it is claimed that while court decisions have been aimed at justice, the law in practice has led medical researchers to be anxious and disillusioned, and consequently have limited their innovativeness and medical progress. On the other hand, it is claimed that research subjects are concerned about the strength of their legal rights and this makes them reluctant to participate in medical research. There is little empirical data to support either the view that the quality of medical research has diminished, nor whether the effect is due to direct or indirect courtimposed constraints on innovativeness or participants’ rights. Thus the competing accounts of the effects of litigation on medical research are inconclusive. Nevertheless, it is informative to consider the main areas of law that are reported as being structural evidence for litigation’s impact on the relationship between researcher and subject.

1. Compensation for Harm Caused by Medical Research

Medical research inevitably results in some injuries and harm to research subjects irrespective of the care and caution taken. It is a natural consequence of the search for new knowledge. Some researchers have insurance cover, and funding bodies occasionally have a policy of offering limited payment for injuries that were caused by the research, but this is far from universal. However, to receive large sums of compensation, research participants have needed to litigate in the courts.

The compensation cases are usually based on product liability laws, the law of negligence, or insurance contracts. To win their case, the injured person has to prove as a bare minimum that their injury was ‘caused’ by the medical research and not due to any alternative causal agent like environmental pollutants or underlying disease. ‘Causation’ has a technical meaning in the law. Suffice to say that it can be difficult to prove legal causation because the typical side effects complained of can be caused by many things and, in therapeutic research, patients are ill to begin with.

Research participants feel that courts require them to prove too much in order to get compensation. They think that their altruism in being a research subject entitles them to easier access to compensation. Researchers feel that they carry the burden of legal liability and that it should instead be spread across the whole community through health insurance or nofault compensation schemes since medical progress benefits everyone, not just the researcher. They are also alarmed by the variety of legal rules through which they can be called to account, and would prefer more integration and certainty.

This sort of experience could naturally be expected to cause a degree of tension in the research relationship. For example, researchers might be increasingly defensive in their work, and volunteers reluctant to participate. However, the extent to which compensation cases have affected medical research is open to doubt. In the USA, there have been a substantial number of compensation cases about innovative treatment (Siegler et al. 1987), and widespread calls for reform of this area of law. However, there is little evidence of an actual impact on the quality of research, medical progress, or the relationship between research and subject. Furthermore, while liability for compensation has been a significant topic of debate in the USA, it has had a much lower profile in most other countries, which have seen far fewer compensation cases.

2. Informed Consent

A shared concern for researchers around the world is the courts’ interpretation of ‘informed consent.’ All research guidelines emphasize the need to obtain prior informed consent from research subjects. Additionally researchers are anxious to avoid liability for assault or bodily trespass for failing to have legally valid consent prior to research involving internal or external body contact.

Court decisions have caused researchers considerable concern because of the demanding levels of communication that they require. A participant must not only be provided with information about the material risks, but steps must also be taken to ensure that they understand that information. Furthermore, consent must be sought without any coercion or inducement, otherwise it will not satisfy the legal requirements of a decision made by free will. The courts have justified these standards on the basis of the importance of individual autonomy. In medical law cases the court has noted that the community expects a less paternalistic relationship with medical professionals than existed in the past.

The medical and research professions complain that this interpretation stifles medical research by imposing impractical and unrealistic standards of consent, and by failing to recognize the utilitarian justifications that exist in the context of medical research. Put briefly, in some cases research participants do not have sufficient scientific understanding to understand the risks, regardless of how much information is provided to them. In other situations, research will inherently have an element of inducement because the mere fact of participating in the study will mean that the patient will receive medical attention that they would not have otherwise had (e.g., where the research methodology involves frequent monitoring or is set in Third World countries).

Researchers are concerned that the effect of court decisions is to rest a heavy burden of potential liability on them. Despite obtaining apparent consent from participants, they may not have met the strict tests of the law. Furthermore, researchers argue that there are certain research studies where obtaining consent would skew research results (e.g., in population studies, or in behavioral studies where subjects’ lack of awareness of the research is a critical factor). Therefore, certain exceptions to the consent requirement should be recognized. The exceptions recognized in ethical guidelines are not necessarily recognized by the law.

It is said that the risks of liability for failing to obtain legally valid consent threaten the continuation of research in these areas, albeit they are important research projects with potential benefits for many more people than just the research subjects themselves. Two points should be noted. First, what is a consent burden on researchers is a consent protection for research participants. Thus the effect of litigation about consent cannot be easily categorized as negative or positive. Secondly, there have been very few cases decided where the facts related to medical research rather than consent to treatment (cf. the Canadian case of Halushka s. Uni ersity of Saskatchewan (1965) 53 DLR (2d) 436). Thus the law relating to consent in medical research is unclear. Researchers could be anxious about a form of liability that the courts will not enforce in view of the public interest in research. This points, though, to one of the general difficulties of court-made law, namely that prior to a binding precedent being set, the law is often ambiguous and uncertain.

3. Confidentiality and Pri acy

For many years, laws about confidentiality have been largely established by court decisions, as there was very little legislation on this topic. It is clear that legal obligations of confidentiality apply to the doctor– patient and researcher–participant relationship. Researchers have been particularly concerned about the effect of these laws for research that evaluates personal information in medical records. Frequently, a researcher will wish to use information that has already been collected from individuals for a purpose other than research (e.g., during a general medical consultation). Consent to disclose the information for research purposes will not have been obtained at the time the information was collected. It can be very impractical, sometimes impossible, to work within the courts’ interpretation of confidentiality and contact the individuals for their consent to use their record in the research project. For a start the researcher must locate records that belong to a doctor who is willing to spend time identifying and contacting relevant patients, because this process involves looking through confidential details and may not be carried out by an external researcher. Secondly, the contact details will often be long out of date. To proceed without the individuals’ express consent leaves the researcher open to liability that is said to be sufficient to deter many.

Research participants, on the other hand, have been getting increasingly concerned that the courts are too lenient about privacy rights beyond nondisclosure. For example, they argue that there ought to be additional standards about data security and aggregation of data held in databanks. In recent years, the privacy movement has successfully motivated governments to enact statutes and protocols with standards for the collection, use, disclosure, security, personal access, and linkage of personal health information. There are limited concessions for medical research in these rules. In many jurisdictions privacy commissioners or data protection commissioners have been established.

4. Property Rights and Patents

Court decisions have also had a major impact on the way in which researchers collect tissues and organs for research. One of the most influential cases that has been discussed extensively across the world was Moore s. Regents of the Uni ersity of California 793 P. 2d 479 (Cal SC1990). In this case a doctor at a university hospital developed a cell line from cells he took from his patient’s spleen during an operation. Although the patient had consented to the spleen operation, he had not consented to the use of his cells in research. The cell line was patented and the patient claimed a right to the profits. The court rejected the argument that the patient owned his own body cells. This aspect of the court judgment reinforced the legal norm that patients have no claim to the profits of research despite the fact that they ‘invest’ their bodies in research. Only those who invest money or professional skill have a claim. This case highlighted the commercial tensions that exist between researchers and participants and dispelled any myths of pure altruistic motivation on the part of either.

The case also had an impact on the relationship between a research subject and a researcher who is also that subject’s treating doctor. Although the court said that Mr. Moore did not have property rights in the medical invention, he was nevertheless awarded compensation. The court held that if a doctor treating a patient simultaneously pursues his or her own research for economic gain, the doctor breaches the special legal duties that doctors owe their patients (called ‘fiduciary duties’). This decision thus put ‘doctorresearchers’ on notice that they have a particularly strong obligation to obtain the consent of their patients prior to research, not only to permit interference with their bodies and use of their personal information, but also to keep control of subsequent intellectual property rights and to avoid a serious breach of their professional standards.

The Human Genome Project, which aims to map human genes, has heralded a new wave of controversy about social distribution of biomedical research profits. There have been many court challenges about patents that have been granted by patent offices for human gene sequences. The decisions of US courts have had a global impact. Courts in the USA have upheld the validity of these patents, notwithstanding technical legal arguments about novelty and inventiveness, and submissions that the practice was unethical. This has put considerable economic pressure on other countries to follow suit.

A significant question is whether research participants ought also to profit from a patent that is based on the participant’s body but which relies on the researcher’s skills and ingenuity. The orthodox position is that research subjects are instruments of research that have rights to human dignity but not to financial profits. It is argued that to change this would radically change the incentives to invest in research to the point of threatening its continuation. Others claim that legal protection of property rights over gene sequences stymies research because new knowledge is disseminated more slowly and small firms are priced out of the market since they cannot afford to license patented knowledge. The empirical evidence is entirely inconclusive.

These landmark court decisions about property rights in human tissue continue to have major reverberations. There have been several recent and highly controversial inquiries in the UK to investigate reports that hospitals have been routinely compiling banks of human tissue and organs from deceased patients (including babies) without the consent of the patients’ families and using these for research purposes. The public’s shock at the prevalence of this practice has had significant implications for the community’s trust in the medical and research professions.

5. Subpoenas

Further areas where litigation has generated concern is the ability of parties who are suing or defending a claim to issue subpoenas for oral and documentary evidence to be given by researchers (Fischer 1994). Not uncommonly the effect of the subpoena is to coerce the researcher to disclose confidential research to a party whose motivation for seeking the information may be questionable. Not only is crossexamination in the courtroom a harrowing experience, but compelled disclosure under subpoena also affects the researcher’s ability to release ‘fresh’ results for publication or intellectual property rights. Some believe that the strategic use of subpoenas to compel release of research has the potential to discourage research in economically or politically sensitive areas. This has been a concern reported in US literature, but less so in other countries despite the similarity of laws on subpoenas.

6. Putting the Concerns in Perspective

The discussion above has highlighted the main ways in which it is claimed that court interpretations of the law have affected the practice of medical research. It is important, however, not to form an exaggerated view of the effect of litigation.

There are in fact relatively few court cases about medical research. One US study that systematically reviewed the incidents of medical research litigation in medical faculties and academic medical centers found only 43 cases in 41 years in all US state and federal courts (Helms and Helms 1993). Also the frequency of medical research cases would seem to be considerably less in other countries. Books and articles about legal issues in medical research rarely refer to more than a handful of court decisions.

As noted in the introduction, there is little empirical evidence to sustain the view that the court decisions are actually stifling medical research. The concerns of researchers and patients about the effects of litigation reported above are generally based on anecdotal experience. Naturally, to reinforce their concerns, researchers and patients argue that there is, or is likely to be, a causal link between their concern and the future progress of medical research. However, this has not been established.

Litigation is, in fact, only one part of the regulatory framework for medical research, and its impact cannot be assessed without considering it relative to other forms of regulation. The reality is that medical research is regulated mainly through a system of selfregulation largely controlled by the medical profession with very little involvement by the courts (Moran 1993). The principal avenue of regulation is the process of review by a research ethics committee (sometimes called an institutional review board or human subject committee). This local level of regulation has the most direct and frequent impact on medical research. It determines which projects proceed, which types of patients are recruited, and how the recruitment and research takes place.

The courts are rarely involved for several reasons. The ethics committees are nonstatutory and owe no statutory duties. While they are arguably required to follow rules of administrative law, these relate mostly to procedural breaches rather than substantive rights. Information to establish court cases is also scarce because the committee proceedings are generally held in private. The ethical guidelines enforced by the ethics committees are generally policy documents of professional associations, regulatory agencies, or central government and are not generally reproduced in legislation. Therefore, they too fail to sustain any substantive legal rights and obligations that might be litigated in a court. There are few, if any, sanctions in legislation for breaching the guidelines. Instead, non-compliance is deterred, because it might cause funding to be cut, journals to refuse publication, or give rise to a finding of professional misconduct. However, having noted the limited court involvement in enforcement, it would be an oversight to fail to note the profound influence of one court in propagating the ethical guidelines, namely the Nuremberg Military Tribunal whose decision in the Nuremberg war crime trials in 1946 was transposed into the international treaty on medical research known as the Declaration of Helsinki (adopted by the 18th World Medical Assembly, Helsinki, in 1964 and revised by the Declaration of Tokyo, adopted by the 29th World Medical Assembly, Tokyo in 1975), and subsequently into many self-regulatory research guidelines (Kennedy and Grubb 2000).

The self-regulatory system of medical research has been frequently criticized and may explain (any) disillusionment in medical research more than the effects of litigation. For example, it would seem that the committee review is often cursory and rarely extends beyond examining issues of informed consent because the committees are underresourced. The process rarely requires researchers to submit regular follow-up reports to confirm compliance with the approved research protocol. It is not uncommon for the committees to have too many members, too few, or a pattern of representation that does not accord with government guidelines. The enforcement mechanisms are weak and have limited application to research whose success does not depend on state funding or publication. There can also be an extraordinary degree of bureaucracy for research involving a broad geographical ambit, if the researcher must approach several local ethics committees (Nicholson 1997, Jamrozik 2000).

Although there are frequently calls for reform of the primarily administrative review of research, the proposed alternatives do not include greater court involvement. Most propose a stronger form of selfregulation with legislation, policy guidelines, the backing of state agencies, and more accountable research review committees. This has also been the case with privacy and confidentiality in medical research (see Sect. 3).

7. Conclusion

In summary there are many reasons to consider that litigation may have had a significant impact on medical research and altered the approach of both researchers and research subjects. This research paper has explored the principal court decisions that underpin the view that litigation has had such an effect. However, it has also noted that courts are involved in just a few pockets of the mainly self-regulatory framework of research, and have had more particular impact in North America. Further empirical field research is necessary before the claims that litigation is stifling research could be substantiated. In fact this work may well support the contrary view that recourse to litigation is an important safety net for the protection of fundamental human rights and enhances the experience of medical research.


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