Human Experimental and Ethics Committees

Introduction 

The most obvious challenge in biomedical and health research involving human subjects is striking a balance between exposures of the subjects to risk involved and finding a justification for the actions. The ethics of these kinds of research revolve around the risk exposure and the benefit of advancing scientific studies. In essence, biomedical research lays emphasis on knowledge advancement for the overall benefit of the society and future generations as opposed to the direct benefit of the individuals who willingly agree to be used as subjects in the research. 1 Implying that even in situations such as those involving therapeutic trials where the human subjects are set to benefit when the experiments are successful, the situation often directly benefits future generations since the time it takes for the results to be fully developed is often long. The ethics of health research should involve the identification of areas of disconnect between the researchers and the subjects. As such, ethical conflicts between the two groups are avoided while conducting research. 

Ethical Principles Pertaining to Experimental Treatment and Research 

Ethical principles pertaining to research on human subjects are part of the American Medical Association ethics. The health researcher is bound by these ethics to recognize their responsibility to the subjects and conduct the research with respect for human dignity and rights. 2 the participants take part in the research must provide voluntary consent either individually or through their legal representatives in situations where the participants lack the capacity to provide consent. Responsibility for the ethical conduct is shared between the physician and the institution that conducts the research. In that regard, the institution oversees the design, then the conduct and the way the research is disseminated to guarantee that ethical standards are adhered to throughout the processes. Although voluntary consent is a necessity is these forms of research, sometimes the research can only be conducted on a particular population that is not capable of providing this form of consent, for instance, children or mentally ill adults. In such situations, the research is ethically biased if it does not pose any risks to the subjects. Disagreements often emanate from the risks that the study poses on the individuals, regardless of whether the subject was in a position to provide voluntary consent or not. Finding a universal position on the matter is quite challenging but approaching the issue with a focus on the four ethical principles of patient autonomy, beneficence, non-maleficence, and justice promises to shed more light on the situation. 

Patient Autonomy 

Patient autonomy grants individuals the right to determine their involvement in any a particular form of research or to be excluded. Coercive influences diminish patient autonomy and deny the patient the chance to provide consent based on their own judgment. Full autonomy for the patient emanates from the ability of the patients to fully understand the implications of the particular researcher that they are asked to participate in, make judgments with reason on their involvement in the research and avoid any influence either from the researchers or other parties. The fundamental principle of informed consent in medical research protects patient autonomy and supports judgments based on reason. The researcher has a duty to provide full disclosure to the patient about the risks involved and the potential for any form of harm to the individual, the benefits of the exercise and the particular alternatives presented to the patient. The patients must also be granted the opportunity to ask questions concerning the research and be provided with the rightful answers. 

Impaired cognition in individuals diminishes patient autonomy such that obtaining informed consent directly from them is virtually impossible. These include children or mentally ill adults. Circumstances may also reduce the patient’s autonomy in cases where the person is seriously ill or facing a prison sentence. Challenges in patient autonomy work to complicate the already contentious issue of ethics in human subjects’ medical research. Patient autonomy has its underpinning on the choice of adults to decide on the activities that they will be involved in and those that they will reject. 4 The individuals as mentioned above whose cognitive abilities are reduced cannot fully exercise their own autonomy in these situations. Consequently, legal means are provided for obtaining their consent while conducting research. However, this step only seems appropriate where the research poses no risk or harm to the individual. On the contrary, where there are chances of harm, consent should not be provided. Dynamism in biomedical research has introduced the concept of additional consent where the individual has to provide extra consent when new research is undertaken. 3 This is particularly true in situations where samples are kept for use in different experiments. 

Beneficence 

The ethical principle of beneficence advocates for maximization of benefits to the subjects and the society while at the same time reducing the risk involved in carrying out the biomedical research. Potential benefits to the future generations must surpass the risk involved in carrying out the research. The process of risk minimization should account for the probability and severity of the risk. 5 The probability for a particular risk occurring is measured through the chances presented for the risk to occur. Highly risky experiments involving human subjects should rarely be pursued or should only be pursued in situations where the researchers are certain that the threat has been significantly reduced. A risk-benefit calculation measures the anticipated risks and a decision is made on the techniques to reduce the risk and protect the human subjects from harm. The severity of the risk occurring, and in some situations, the discomfort of the research to the subjects should be a matter that needs pursuance. While researchers and institutions mainly major on the direct risk and harm that is likely to occur on the patient, the discomfort is majorly ignored. 5 By mitigating or eliminating the factors that may result in discomfort for the participants, both psychological and physical pain are reduced. 

The principle of beneficence is not implicitly directed to the participants taking part in the study. The benefits of the research must be reflected through gains in the society and future generations who are the main beneficiaries of any form of biomedical research. More importantly, the benefit must outweigh the risk that particular research poses to the participants. In cases where the certainty of the research benefiting the society is in doubt, the principle of beneficence is not fulfilled hence such a study has no merit. 6 

Non-maleficence 

The traditional principle of non-maleficence directs the avoidance of harm to subjects of research. This ethical principle presents the problem of avoiding harm while pursuing the purpose of research. Harm due to processes and procedures of biomedical research varies in degree and ability to be avoided. While it is impossible to avoid harm in some situation, the aspect of avoidable harm is more realistic. For instance, while conducting cancer research, researchers have to take samples which sometimes increase the pain or suffering of the patients. This presents a challenge to the physicians involved as they strive to avoid harm to the individuals while at the same time increasing the benefits of the study. 

Addressing non-maleficence in tandem with beneficence provides a more realistic approach to the ethical principles. 7 Avoidable harm, in this case, assists in reducing the risk that the patient is exposed to while increasing the benefit of the whole research process. The principle of non-maleficence is particularly antagonized in situations where the researchers are unaware of the harm that process may present to the patients or the benefits may lead to other forms of harm. For example, when testing HIV prevention medication such as PrEP, use of the drugs may expose the subjects to different forms of STI. In such cases, the beneficence principle is applicable where the benefits of the medicines surpass the harm that the drug exposes the patient to when in use. 8 

Justice 

Justice in biomedical research ethics stipulates that researchers should avoid populations that are vulnerable or are likely to be unfairly coerced to take part in the study. The researcher must engage in the equitable selection of participants such that those who take part in the study are ones most likely to benefit. Vulnerable populations are mostly avoided in under this ethical principle. These populations include children and incarcerated persons. One of the most rampant violations of this principle is the exportation of clinical trials in developing nations. Pursuing the trials in these countries does not guarantee the benefits to the same people since successful trials mainly benefit populations in the developed world. Justice requires that those who undertake the burdens fully enjoy the benefits for the research. 

Vulnerable populations are not exhaustively defined by researchers and the institutions which monitor the research. Certain parts of the population may be categorized as vulnerable but present the only viable group to be used for research. 9 In such cases, the population is the most likely to benefit from the research and their use in research does not go against the ethical principle of justice. Ethical practice in biomedical research also demands avoidance as a form of justice to the human subjects. Coercion poses the risk of withdrawal of participants while the research is in the process which can potentially jeopardize the outcomes of the study. 10 

Relation to the AMA Code of Medical Ethics 

The AMA code of medical ethics binds medical professionals to the ethics of practice for the benefit of the patient. 1 The ethical statements outlined in the code are a guideline for physicians to handle patients with utmost dignity. Honesty is a critical aspect of the AMA code of ethics particularly in relation to the pursuance of issues relating to biomedical research. All the four ethical principles of research involving human subjects necessitate honesty in guiding the participants to make informed decisions on their participation in the research. Importantly, dynamism in the medical field is transforming the approach to issues relating to biomedical research. 11T he ethics are drafted to be timeless although period updates have been carried out in the past to keep up with trends. Sharing information through the internet is part of these trends are transforming the ethical demands of biomedical research. 12 The AMA code of ethics demands respect for the rights of patients in advancing knowledge on particular matters. Hence, the ethical principles are tied to these codes. 

Conclusion 

In essence, carrying out biomedical research involving human subjects presents a lot of benefits to society through the advancement of knowledge on healthcare and disease control and treatment. Arriving at a consensus on the use of human subjects in research is virtually impossible. However, adherence to the four ethical principles of patient autonomy, beneficence, non-maleficence, and justice avoid the conflict related to the issue and ensures the intended benefits are achieved. 

References 

AMA. AMA Code of Medical Ethics . 2011 

Opinions on Research and Innovations. AMA Principles of Medical Ethics . n.d 

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Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.  Hsings Ctr Rpt . 2013; 43 (s1): S16-S27. 

Denecke K, Bamidis P, Bond C, et al. Ethical issues of social media usage in healthcare.  Yrbk Med InfCs . 2015; 24 (01): 137-147.