Consent Statistic -- Research Methodology

¶ … Consent

Statistic -- Research methodology

Informed consent: Respecting patients' rights

Informed consent: Respecting patients' rights

One aspect of the research process seemingly everyone can agree upon is the need for informed consent upon the part of research subjects. In medical research, "informed consent is the process by which a fully informed patient can participate in choices about her health care. It originates from the legal and ethical right the patient has to direct what happens to her body and from the ethical duty of the physician to involve the patient in her health care" (Edwards 2008). Simply because research can benefit medical science does not mean that the individual abdicates the right to his or her autonomy and decision-making. When making decisions about patient care, informed consent given by the patient under fully transparent circumstances is the ideal -- however, even clinical research often takes place under far from 'ideal' conditions.

Fully informed consent demands more on the part of the researcher than giving a speech to a patient or subject and asking him or her to sign a form. A patient must be able be competent and give consent in a voluntary fashion. Yet "it is easy for coercive situations to arise in medicine. Patients often feel powerless and vulnerable. To encourage voluntariness, the physician can make clear to the patient that he is participating in a decision, not merely signing a form" (Edwards 2008). Even in non-medical forms of research, the subject may not fully understand how his or her data or case study may be used, the implications of its use, or how his or her life may be viewed by outsiders.

When a patient's mental state is compromised due to dementia, mental illness or when the patient is a minor, the issue grows even more problematic. It is vitally necessary to test drugs that deal with medical issues particular to these groups, and to seek out greater understanding on a sociological level of these populations. The question will always arise if the subject's consent was valid under these circumstances. Even for a mentally competent individual with a chronic ailment, there may be concerns about his or her ability to provide consent. A patient facing mortality may not be able to weigh the pros and cons of a potential miracle drug, for example. When evaluating the patient's ability to provide consent, one possible standard is that of the 'reasonable physician' standard: the researcher must ask him or herself, would a reasonable physician consider consent to be adequate (or reasonable psychologist, sociologist, or anthropologist, depending on the nature of research being conducted). Other states, in the case of medical research, mandate that a more stringent standard is applied -- that of the reasonable person standard (Edwards 2008). In other words, would a reasonable person consider the nature of the research ethical and acceptable? This seems fairer -- but is also more intensely subjective. And when conducting research in a different cultural context, it may be difficult for the researcher to evaluate the subject's conception of justice within the subject's own culture.

When research is performed upon minors or patients whose lucidity may vary from day-to-day, a medical surrogate may be legally required or advisable, in terms of giving consent for the use of research. Confidentiality at all times should be respected for minors and adults alike. The patient must, to the maximum of his or her ability, be able to understand his or her situation and the implications of the benefits and the risks of participation, even if his or her identity is kept confidential (Edwards 2008).