Consent Who Does it Apply

¶ … consent "who does it apply to and what should it contain

The term "informed consent" applies to any human participants asked to join in a research project. The researcher is obligated to inform the human potential participant about the scope and context of the research as well as all pertinent details. This is particularly important if the research may carry some element of risk to the human involved.

The participant too, is given the choice of refraining from the study whenever he so wishes to do so.

The details of the study are delineated to the potential participants, usually they are supplemented on paper, and the individual is asked to sign his consent in agreeing to be part of the study.

The concept of "informed consent" has various rules some of which are the following:

all details of the study must be thoroughly explained to the person -- at least those that are pertinent to him

This must be done in his language

It must be done on his level so that he can comprehend it

The researcher must make sure that he comprehends all details and has no further questions before the study commences.

In some situations where research or involvement of the participant is necessary (such as in some counseling situations or for some crucial medical research that involves the individual) and the participant may be unable to provide his informed consent (due to his being a minor or severely mentally incapacitated), a guardian or parent may take the place again on the grounds that certain conditions are met in this case too. Waiver of informed consent is also permitted in situations where no foreseeable harm will devolve from the study. The IRB is the Board that decides whether or not this is the case.

In a similar way, waiver of consent is also applied to the military where, according to 10 USC 980, the United States Code for the Armed Forces, Limitations on the Use of Humans as Experimental Subjects, the Secretary of Defense may grant advanced waiver of consent if the study will:

1. Directly benefit subjects.

2. Advance the development of a medical product necessary to the military.

3. Be carried out under all laws and regulations (i.e., Emergency Research Consent Waiver) including those pertinent to the FDA (McManus, et al. 2005)

The necessity of meeting the conditions of 'informed consent' is crucial since grave ethical ramifications can ensure if this condition were violated. Possibilities of this occurring are anticipated and prevented by an ethics committee or Institutional Review Board.

For informed consent to be legitimate, three are needed: disclosure, capacity and voluntariness (Faden & Beauchamp, 1986).

1. disclosure, - the first is that the researchers disclose all necessary information in a comprehensible and comprehensive way without any undue pressure not from researcher or from anyone else

2. Capacity - The potential participant has the capacity to both understand the given information and follow through making a reasoned decision. His cognitive abilities are up to the situation

3. Voluntariness -- there is no coercion, manipulation, or undue influence involved. The person feels utterly free to make his own decision.