Background information on the Principle of Consent

Informed Consent

Informed consent refers to permission given with full awareness of the individual implications, particularly in medical contexts where a patient receives treatment from a doctor or physicist with full knowledge of the possible advantages and hazards of the process (Mazur, 2011).

According to Padmanabhan (2013), all rules of ethics pertaining to human subjects research affirm or rather advocate for the importance of the informed consent principle.

The principle of informed concept sprang from revulsion at the horrors committed by German scientists and physicians during Adolf Hitler’s rule (Mazur, 2011).

During this regime, thousands of prisoners from the concentration camp were used in experiments, as human Guinea pigs, against their will (Mazur, 2015).

These experiments were typically excruciatingly painful whereby they resulted to permanent disfigurement or led to death (Padmanabhan, 2013).

Out of these, the Nazi Doctors found it absolutely, essential for voluntary consent of the human subjects (Mazur, 2015).

In research, informed concept deals with the willingness and understanding of an individual to partake in research as opposed to signing a form.

A researcher has legal obligations to inform the prospective participants on the potential benefits and risks of their involvement as well as the procedures, and the purpose of the research such that they can have an alternative of either participating or failing to participate in the process.

Justification of the Principle of Informed Consent

Scholars have given only two types of reason as a justification that the status of informed consent is a fundamental principle of the ethical researches that involve the human beings as subjects.

These are the consequential reasons and the non-consequential reasons.

Notions of Informed Consent

There are two notions of the informed consent.

These are the first sense, otherwise referred to as the moral sense and the second sense which is referred to as the socio-legal sense (Mazur, 2011).

The first sense gives the definition of informed consent as the autonomous participation of an individual in a study while the second sense defines the informed consent as the institutionally or legally effective authorization (Padmanabhan, 2013).

Elements of Informed Consent

There are four elements of an informed consent, and these are information, understanding, voluntariness, and the decision-making capacity.

Information is the fundamental element of all, and it comprises of relevance, professional practice, a reasonable person standard, and a subjective standard.

Relevance element is the cornerstone of the informed consent and it demands that all the potential subjects have a right to be fully informed will all the available information deemed relevant to the individuals’ decision regarding participation (Padmanabhan, 2013).

The professional practice requires that the information which professional typically provide is disclosed while a reasonable person standard requires that any information that can be considered, by a thoughtful layperson, relevant to such a decision (Padmanabhan, 2013).

On the other hand, a subjective standard requires that information that is considerably materialism in the decision making of a potential subject must be disclosed (Mazur, 2011).

Understanding is essential because it is not simply enough to receive the information but rather understand it.

Voluntariness has it that a genuinely autonomous authorization is whereby a person is freely given, that is his or her decision is the decision and not of another.

Lastly, the person must be in the right capacity to make a decision.

Informed Consent is not Always Necessary

Examples are experiments without human as the subjects, the human subject research that is exempted from complying with the federal regulations and lastly the research with non-exempt human subject (Mellado, 2016).

Troublesome Issue in Informed Consent

One of the most troublesome issues in the informed concept is that of the deception or concealment.

Researchers can have some very good reasons to refuse to give or hold back information from the potential participants and thereby influencing their decisions.

In the ACA code of ethics (2013), section G, 2.b states that counselors should not carry out a study that involves deception “unless alternative procedures are not feasible and the prospective value of the research justifies the decisions.”

In a situation whereby deception has been used, it is the obligation of the researcher to give the subjects of the research an explanation and this ought to be as soon as possible.

Conclusion

In summary, in spite of these exceptions to the requirement of securing the informed consent. The informed consent in both moral and socio-legal senses is an indispensable constituent of research that has been ethically conducted.

Perhaps, more than anything, the principle and practice of the researcher reflect the researcher attitude towards the experimental subject that is inextricably interconnected to the scientific enterprise itself.

References

ACA Code of Ethics. (2013). ACA Code of Ethics. Journal of Counseling & Development, 84(2), 235-254.

Mazur, G. (2011). The Major Current Interpretations of the Principle of Free and Informed Consent. Philosophy and Medicine, 49-80.

Mazur, G. (2015). The Historical Development of the Principle of Free and Informed Consent. Philosophy and Medicine, 1-12.

Mellado, J. (2016). Autonomy, consent and responsibility. Part 1: Limitations of the principle of autonomy as a foundation of informed consent. Radiología (English Edition), 58(5), 343-351.

Padmanabhan, V. M. (2013). The Human Rights Consent Principle. SSRN Electronic Journal.