Informed Consent and Confidentiality

Informed Consent and Confidentiality

Tanisha Smith

University of Phoenix

Informed Consent and Confidentiality

        Having respect for a patient to make an informed decision is the foundation of ethical research. There are many definitions as to what informed consent actually is. According to International Conference on Harmonisation,  ‘Informed Consent’ is “a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate” (1996). Another defines informed consent as “the process of agreeing to take part in a study based on access to all relevant and easily digestible information about what participation means, in particular, in terms of harms and benefits” (Parahoo, 2006). With both of these definitions it is summed up that informed consent simply put is informing clients/participants about all that is taking place within the research and their rights. Jayne Hardicre believes there are three levels to having valid informed consent, which is adequate information, voluntariness, and competence. She defines these three levels as follows:

‘Adequate information: full information about the research so that the patients know exactly what they are consenting to. Voluntariness: an understanding that they are under no obligation to agree to take part and if they do decide to take part they are free to withdraw at any time. Competence: that the patient is capable of understanding what participation entails and has the capacity to make a free and informed choice’ (Hardicre, 2014).

Not only does having informed consent allow for ethical research, by giving the participants the respect of knowing what they are truly participating in. The process of informed consent can be tedious ensuring that it is done at beginning and throughout trials but it is needed as well as a way to make sure that the participants are always aware of what they are participating in and that at any point in time they are free to withdraw consent. It also is put into place not only to protect the participants but also ensuring the safety of the researcher from any implications that may occur. Although this is set in place to protect the participant and the researcher this is only one ethical principal set in place, another very crucial one to research is confidentiality.

        Confidentiality according to Gillian M. Lockwood, the Medical Director of Midland Fertility Services, states that a “good medical practice depends on establishing a relationship of honesty and trust between doctor and patient” (2007). By definition confidential, a Latin word meaning “having another’s trust or confidence; entrusted with secrets or private affairs” (Dictionary.com). Confidentiality has been stated and outlined in many well-known codes of professional ethics such as the Hippocratic Oath. Which states that “What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself, holding such things shameful to be spoken about” (Edelstein, 1943). This is set in place to protect clients and/or participants ensuring that whatever is being entrusted to them will stay with them even after death. But even with this it is not absolute, there are some limits to confidentiality as there is for informed consent as well.

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