Free Biomedical, Behavioural And Social Science Research Has Become Increasingly Complex In Terms Of Ethics Essay Example

Introduction

Highly emotional regulatory reactions to research abuses result in over-compensating regulations
Regulatory framework has also become complex and inhibitive even to legitimate research
It is important to strike a balance between human rights protection and legitimate research
Background
Tuskegee Syphilis Study
Inoculation Sexually Transmitted Diseases Studies
Huron-Wendat: Studying Old Bones
Deception of subjects about the purpose of the study and nature of the research procedures
Withholding of treatment and preventing subjects from accessing treatment elsewhere
Exposure of third parties to further infections
Violation of cultural values/dignity
Deliberate infection of subjects with STDs
Overly emotional reactions to abuses coloured regulatory responses
How Institutional Review Boards (IRB) should enforce laws/regulations
IRBs exist to protect human subjects as against hindering legitimate research
Main responsibility lies in the protection of vulnerable populations
The Belmont Report Principles and their derivative regulations are the most important benchmarks for both the researchers and regulators
Harm reduction
Exposure to reasonable risk
Minimization of risk
Reporting of unanticipated risks that pose risks to subjects and/or third parties
This should only be strictly read in the context of vulnerable populations
Invulnerable populations must be trusted to make decisions to participate in research as long as they are properly informed in making their decisions
IRBs should be satisfied with the inexistence of vulnerabilities, before allowing researchers and consenting subjects to choose their involvement in research freely

Sources of vulnerabilities include information asymmetries and susceptibility to coercion, and undue persuasion should be checked to prevent

Justice principle
Equitable, fair treatment e.g. in the recruitment of samples to avoid racism, class and cultural discrimination

Beneficence principle

Ensure value for public resources
IRBs must invest more resources monitoring data and other aspects of research in order to arrest possible ethical violations
Mandatory informed, written consent
Greater flexibility by IRB is necessary to avoid undue hindrance to legitimate studies
Customised IRB approval requirements for different studies
Biomedical research
Behavioural and social research
Records-based research
Genetic research in humans
Research involving different vulnerable populations
Role of IRBs needs to be redefined and minimized in cases federal and other agencies including the Food and Drug Administration
Observance of other regulatory frameworks at the local, state and federal level to the extent that they do not unduly hinder legitimate research efforts
U.S.Department of Health and Human Services (HHS) at 45 CFR 46
U.S.Food and Drug Administration (FDA) Regulations

Conclusion

There is a thin line between regulation and hindrance of legitimate research
Differentiation of ethical standards and processes
Expansion of monitoring and oversight IRB role as against boardroom review and approval
Expansion of subject autonomy in order to allow researchers greater flexibility in conducting their own studies
Op-ed Article
The increasing complexity of human subjects research and the applicable regulatory frameworks have rendered it difficult to conduct such studies, especially since there is little distinction between biomedical and behavioral/social science research. With the emergence of complex research areas such as embryonic stem cell research, human cloning, and genetic engineering, the procedural and other ethical requirements are certain to inhibit as against ensure ethical research practices. This is perhaps best illustrated by the fact that the tight regulations are a consequence of over-compensating and highly emotional responses to egregious ethical violations in past researches. It is imperative that human research regulatory frameworks strike a balance between institutional power and research hubris on one hand, and the protection of fundamental human rights. The structural factors (including the false sense of urgency and importance) that create abusive research contexts must be actively checked to the best extent practicable, but protection of human subjects must never translate to the near complete restriction of human research.
It is critical to understand the highly emotional approach to regulation, which has resulted in Institutional Review Board (IRB) decisions that have had the consequence of crippling even the most harmless human research. The Tuskegee Syphilis Study (1932-72), and the Inoculation Sexually Transmitted Diseases Studies conducted among Guatemalan subjects (1946-48) initiated by the United States Public Health Service are perhaps best illustrative of the two extremes of abuse and resultant regulation. In the Tuskegee Study, subjects were knowingly deceived about the study’s procedures, kept from treatment and possibly allowed to expose other people to the risk of infection. Similarly, in Guatemalan case, subjects (mainly vulnerable) were not allowed an informed consent, were deceived and were deliberately infected with STDs, with the express or implicit permission by government agencies. Similar difficulties are evident in the Huron-Wendat study. While not ignoring the obvious ethical violations and lessons from these abuses, it is just as important to realize that millions of people today are denied care for lack of insurance, spiritual convictions and deliberate withholding of benefits, but this has not aroused similar emotions. Even more are exposed to hazardous environmental conditions that lead to diseases such as radioactive material leakages and pollution. However, these incidents are not characterized by as much emotion as the abuses by researchers. Such emotions have proven to the detriment of the flexibility of researchers in designing and conducting their studies, as well as whether they can conduct them at all.
IRBs exist to protect human subjects in research against abuse and even most importantly, prevent research activities that hardly yield any benefits to humanity. These institutions’ main responsibility lies in the protection of vulnerable populations, including approval or waiver of informed consents as it relates to such populations. The Belmont Report Principles, as embodied in the criteria for IRB approval, are perhaps the most important benchmarks for both the researchers and regulators. The respect for people’s autonomy should, however, only be strictly read in the context of vulnerable populations, but consenting invulnerable populations must be trusted to make decisions to participate in research. Once IRBs are satisfied with the inexistence of vulnerabilities (including information asymmetries and susceptibility to coercion and undue persuasion), then researchers and consenting subjects should freely choose their involvement in research.
Further, IRBs must ensure beneficence and justice principles are adhered, by preventing unfair treatment of populations and promotion of the public good where public resources fund studies. Instead of preventing questionable research, these boards must invest more resources in monitoring data and other aspects of research in order to arrest possible ethical violations. While this requires a massive commitment of resources, it is more important than boardroom reviews and approvals, especially since past violations occurred with the full knowledge of government agencies (regulators). Greater flexibility by IRB is necessary to avoid undue hindrance to studies that should not be subject to strict approval processes. This requires the enactment of different IRB approval requirements for different studies including biomedical research, behavioral and social research, records-based research, genetic research in humans, and research involving different vulnerable populations. Further, the role of IRBs needs to be redefined and minimized in cases federal and other agencies including the Food and Drug Administration Agency already regulates the study to avert undue procedural impediments.
There is a thin line between protecting human subjects and hindering legitimate research, especially where non-experimental studies are treated simillarly as experimental research studies. Other than differentiation of ethical standards and processes, it is important for IRBs to weight ethical considerations against the potential good that research promises. To this end, IRBs must invest more resources in monitoring and research oversight as against just reviewing and approving proposals. Further, researchers and subjects’ autonomy must be expanded to include the ability to provide informed consent that can override the thresholds expected by IRBs.