Guide Writing Clinical Research Protocols: Ethical Considerations

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Contents:
  1. Protocol Ethics
  2. Stanford Libraries
  3. Bestselling in Clinical Trial
  4. Writing a Protocol
  5. WHO | Recommended format for a 'research protocol'

Protocol Ethics

Yet investment in such infrastructure can bring essential professional training, clinical resources and medical treatment to developing countries and localities, and their institutions and patients. The clear benefit of investment must be balanced against key challenges to the design and conduct of global clinical trials in emerging economies. The expansion of trials from high resource regions to developing countries has faced rigorous ethical scrutiny. The specter of exploitation underpins many ethical concerns of trials in developing countries.

Should or do cultural norms influence the design and conduct of clinical trials? Can patients in low-resource countries undertake the risks involved in testing new medications and advancing medical science if, despite the availability of the medicine, the community is unlikely to benefit widely for reasons of access or cost thereafter? The doctrines for ethical conduct of medical research involving human subjects embodied in the Belmont Report, 5 the Declaration of Helsinki, 6 the Council for International Organizations of Medical Sciences CIOMS 7 and others 8 form the ethical foundation upon which human subjects research can be appropriately conducted.

More recently, Emmanuel et al 9 posited seven key requirements that must be met for clinical research to be considered ethical including: 1 scientific or social value; 2 scientific validity; 3 fair subject selection; 4 favorable risk-benefit ratio; 5 independent review; 6 informed consent; and 7 respect for potential and enrolled subjects of multi-regional clinical trials. These principles are universal, broad, and generally self-evident, and do not depend on sponsor, country, study population or site. It is the application of these principles, however, in the nuanced and specific clinical research situations that requires open discussion and for which many questions remain unanswered.

It is only with open dialogue that sponsors, health care providers, government regulators and — most importantly— trial participants and the public will become comfortable that clinical trials are not exploitative but fair, necessary, and often beneficial. Transparency in that debate and dialogue is critical. However aside from this standard declaration, the ethical underpinnings of clinical trials are almost never directly addressed in the clinical trial protocol — the process document that determines how a study will be conducted.

The ethical questions and approaches to answer those questions may be embedded in the study design but are rarely explicit or discussed in any written document. Whether the appropriate and focused ethical questions have been addressed at all is therefore often unclear. The problem is aggravated by the fact that members of the clinical research team—,whether industry, non-profit, or academic members serve as the protocol writing team—often lack specific training and guidance to recognize and address relevant ethical issues.

Stanford Libraries

This can result in protocols with insufficient ethical analysis. Appropriate training and guidance of reviewers is also, at best, uneven. The pervasive use of protocol templates in many organizations results in the inclusion of vague references to international ethics statements without specific plans and justifications for how ethical issues have been addressed and will be managed in this particular protocol.

The Multi-Regional Clinical Trials Center at Harvard University MRCT Center 10 is a collaborative effort to improve standards for the design, conduct and oversight of multi-regional clinical trials, with a particular focus on trials sited in the developing world. The MRCT Center ensures that all stakeholders—including patients and patient advocates, academia, industry, clinical research organizations, and regulators—are engaged in the analysis of any problem and creation of practical solutions such as training materials, guidance documents, and tools to enable sponsors of clinical trials industry, government, non-profits and others to meet many of these ethical requirements.

The MRCT Center, alarmed by the absence of explicit ethical reasoning in many protocols, has sought to address this deficiency. In this context, the MRCT Center convened a multi-stakeholder workgroup to develop tools and guidelines to assist protocol writers in recognizing and addressing common ethical challenges in clinical trials as well as raising the overall quality of clinical trial protocols.

This toolkit includes detailed points-to-consider in user-friendly worksheets as well as useful examples that guide users towards drafting a standardized ethics section. The toolkit is not prescriptive; rather, it illuminates central questions, gives examples and considerations, and encourages analytic discourse.

Bestselling in Clinical Trial

Recently, in collaboration with the Global Health Network at Oxford University, this Essential Ethics Toolkit has been transformed into an e-learning resource 12 and has launched as a modular course that is geared toward users in developing countries. The Ethics Tool Kit is also intended to assist ethics committee members who may lack sufficient time or breadth of experience in reviewing complex protocols to analyze clinical trial protocols in a more efficient, comprehensive manner. These resources recommend that protocol writers address ethical issues through a dedicated ethics section incorporated into all study protocols.

This ethics section would address the ethical concerns for a study in every geographic region proposed for siting the study and would require study teams to think through and address ethical considerations prior to ethics committee review. Others have added that disclosure of any potential conflicts of interest by investigators or clinicians is important and that the procedure should never be used for political, social or law-enforcement purposes Merkel et al.

Implementation of various safeguarding guidelines will be challenging; however, if employed sensibly they will only enhance the contribution of this exciting new field.

Writing a Protocol

Such designer medications target specific neurobiological processes that control cognition and emotions and may be used for purposes of spiritual experience, shyness, alertness, low self-esteem, confidence, memory and other similar cognitive enhancements e. Stein, While this is not a new phenomenon, today much of their use is evidence-based.


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However, many questions of an ethical nature are raised including what level of adverse effects is acceptable. It should be borne in mind that many other day-to-day practices continue to proliferate despite some element of danger, e. Since physicians are ultimately the gatekeepers of the proliferation of these medications, several ethical issues need to be addressed.

When should attempts be made to limit their use, if at all? Is it ethically permissible to investigate long-term use of enhancers in healthy individuals? One of the most commonly used substances of relevance includes methylphenidate whose use in various school districts and on college campuses far exceeds the highest estimate of the prevalence of attention deficit hyperactivity disorder Diller, Following their widespread use, employers and educators may prefer those who are enhanced over those who are not enhanced, or vice versa.

Farah and colleagues have defined four broad areas of ethical relevance with the use of neurocognitive enhancement. These include factors of safety unanticipated complications resulting from the complex process of neurocognitive enhancement , coercion potential pressure on the individual to enhance cognitive function by employers, educational facilities, family , distributive justice unfair allocation due to cost or social inequality and personhood issues conflict with who we are and what it is to value a meaningful life and its responsibilities and imperfections. A central ethical dilemma is the conflict between improving one's productivity and function via medication administration vs.

Does this demand policy development and legislation or should this be left to the decision of the psychopharmacologist? This would include full informed consent, including knowledge of the medication's dependence potential, and acknowledging that not all details about potential risks are known both in the healthy and ill. You would expect different cultures to develop different sorts of ethics and obviously they have; that doesn't mean that you can't think of overarching ethical principles you would want people to follow in all kinds of places.

An issue that has taken centre stage in the past few years is the relationship between psychopharmacologists, both clinical and research, and the pharmaceutical industry. Interestingly it is the media who, following several celebrated episodes of alleged conflicts of interest by psychopharmacology practitioners, have led the way by forcing the issue to the front stage of the ethical debate.

The issue is complex since a relationship with the industry is unavoidable, given the nature of required research and information distribution following product approval. At each stage in this interaction, however, various precautions are demanded and become critical for the ethical practice of psychopharmacology.

Resources and Services

From the public's perspective, there are conflicting reports on whether relationships with industry affect medical care. One prominent study among patients enrolled in cancer research trials indicated that most were not concerned about financial ties between researchers, medical centres and drug companies Hampson et al. They indicated that such knowledge would not necessarily have affected study enrolment. A more recent study, however, showed that patients believe that financial ties, including recruitment incentives, do indeed influence professional behaviour and impair study quality and therefore should be disclosed.

Such financial ties may even influence interest in study participation Licurse et al. The consensus appears to be in step with the later study, bearing in mind that the former study investigated patients with cancer, an illness with which patients will often pursue all available new treatment opportunities, given that in many cases little long-term hope is offered. While the problem of conflicts of interest exists in all fields of medicine, many claim that the problem is especially prevalent in psychiatry, given the psychopharmacology focus of many pharmaceutical companies Insel, Since differences in efficacy between medications are becoming slight, the role of marketing and influence of decision-makers and perceived field-leaders over other physicians and the public are becoming increasingly important.

WHO | Recommended format for a 'research protocol'

Public trust in psychiatrists has been affected by serious accusations of conflicts of interest arising from failure to report such conflicts. In a review of published reports of clinical trials in four psychiatric journals, Perlis et al. Furthermore, it was noted that articles with industry support are approximately five times more likely to report positive results.

While a relationship with industry in a speaking capacity is not unethical per se , it becomes unethical not to report such an association. None of these relationships were disclosed Cosgrove et al. While dialogue between clinical and research scientists is critical, it is important to ensure that the association remains ethical and free of conflicts of interest. The stakes are too high and the demands for progress too vital to waste the potential symbiotic relationship. Constant awareness of these dangers at all levels is necessary and psychiatrists need to ensure transparency by means of disclosure of these interactions with industry, both with respect to financial compensation received and any other associated conflict of interest Mitchell, Other more subtle but nevertheless profound influences include the phenomenon of gift-giving to psychopharmacologists Stokamer, The practice is endemic to the profession.

It is always fascinating to record how many times a name of a commercial medication product or company appears in a doctor's office. The existence of these subtle, almost subliminal forms of advertising is widespread.

Along these lines, psychopharmacologists need to beware of the overuse of medications when there are no good indications and when non-pharmacological measures might be just as effective, as in mild depression Fournier et al. Although there are problems with the relationship with the pharmaceutical industry, completely ignoring studies with commercial support would also be ethically questionable since it may benefit patients.

Thus, careful discrimination between poor and well-designed studies is demanded, along with attempts by academic publications to include a range of studies, including those with negative results. These guidelines are comprehensive and greatly assist the clinical and research psychopharmacologist in managing interaction with the pharmaceutical industry.

Any research that is not carried out by the most rigid of ethical principles and guidelines is simply not worthy and definitely not suitable for publication. The medical profession has learned its lesson from the Nazi-physician experience. The vast majority of research by national-socialist physicians during the Nazi era was pseudoscience and without any value, with research carried out under the most wicked of conditions and no attention paid to informed consent and patient safety Lifton, The medical profession has learned from this, and there has been a substantive change in what is considered ethically acceptable in research and practice.

The first official response came with the Nuremberg Code in , followed in the mids by the World Health Organization's more extensive Helsinki Declaration and the Belmont Report in Finally, the WPA Declaration of Madrid in August implemented a comprehensive code of professional behaviour for psychiatrists with relevance to clinical psychopharmacology. Participation in research still remains an option for those without decisionary capacity on condition that proper informed consent is obtained from the relevant legal guardian and that the relevant stipulations of the institutional review board IRB are met Byerly, It is crucial that patients know the difference between clinical care and research protocol participation.

Optimal informed consent includes the need for an informed psychiatrist, non-technical presentation, patient familiarity, involvement of other potential informants, information repetition and ensuring that the patient is as free as possible to make the choice without any unreasonable pressure Appelbaum, ; Taylor, Several unresolved issues regarding informed consent remain.

For example, is there a difference in the level of competence required for informed consent between blood testing for a biomarker and blood testing for pharmacogenetics? Furthermore, there are some instances where no informed consent from the patient is obtained, such as in the case of post-mortem brain analysis. Is it acceptable in such cases to obtain informed consent from the family?

There are several special problems in research of psychiatric disorders. While decisionary capacity is one well known ethical issue, as mentioned above, others include the place of challenge paradigms Benjamin, , what precisely may be considered risk in research Young, and the ethics of offering financial compensation to mentally ill patients who may be unfairly coerced into study participation based on economic need Marson et al. Legal requirements for informed consent may differ between countries.

However, requirements that are stricter than the law allows may be considered in various situations where ethical principles may preclude certain practices, e. Others have argued that those administered a placebo, particularly in cases of psychosis or depression, would be adversely affected by not receiving a known efficacious compound Baldwin et al. While this argument is cogent, it has been called into question by many maintaining that these risks are exaggerated, as well as several reports of increased risk for suicidality with some antidepressants, and finally the need to prove that the study compound is better than the placebo.

Sample numbers needed of patient participants are also smaller. The use of placebos in research trials may also vary between disorders and between levels of severity. For example, in randomized controlled trials of antidepressant medications, since there is sufficient evidence of their efficacy in severe depression, the use of placebo controls may only be ethically admissible in mild to moderate depression Fournier et al.

While placebos are often required by regulatory bodies for optimal research, their use is not always in the best interest for the well-being of the patient and needs to be carefully considered prior to inclusion in research protocols. A further ethical consideration in such clinical trials is the concept of clinical equipoise which is satisfied if there is genuine uncertainty over whether the treatment in a randomized clinical trial involving patients assigned to different treatment arms will be beneficial Freedman, An important theme that runs through all ethical issues related to psychopharmacological research is the preoccupation with the best interest of patients and protection of the rights and well-being of participating subjects.