There are several definition of informed consent. According to LeMone and Burke, informed consent is a legal document required for certain diagnostic procedures or therapeutics measures, including surgeries. (LeMone & Burke, 2004). According to Taber’s Cyclopedic Medical Dictionary, informed consent is a voluntary agreement made by a well-advice and mentally competent patient to be treated or randomized into a research study.(Venes & Taber, 2005).
According to The Research Ethics Guidebooks, consent is the central act in research ethics, as set out in the 1947 Nuremberg Code. (Consent. n.d.) According to Bulger, the Nuremberg Code was establish in 1949, for the purpose of having a standard by which to judge the Nazi scientist and physicians during the Nuremberg Trials. It consist of 10 basic principles that to be followed by everyone conducting research with human participants.
It also states that all those who are participating in an experiment are required to give voluntary consent not under influence such as coercion, fraud, duress or deceit. Ever since then, the scientific community has continued to revise the principle in order to ensure the ethical treatment of participants. The declaration of Helsinki and Belmont Report also confirm to the ongoing need to refine the rules and regulations behind the informed consent process. The key components of informed consent defined by the 1979 Belmont Report are respect for persons, beneficence and justice.
For respect for persons, participants should be treated as autonomous agents and no pressure should be used or implied to encourage participation. they should be given the opportunity to decide whether to continue or stop from participation at any time, without prejudice or threat. Participants should be given the opportunity to ask questions about the research.
As for beneficence, every action must be taken to protect them from harm and ensure that they experience the possible benefit from participating in the research to secure the well-being of all research participants. By mean harm,other than physical injury, it may include feeling of stress and embarrassment. The last components is justice.
Every effort should be made to distribute the risks and benefits fairly and without bias, therefore the decision about whom to include or exclude in a research activity is sensitive. Equal opportunity for participation should be provided, independent of race, socioeconomic status, or education, unless it is justified by the objectives of the research activity.The effort should be made to ensure that participants who are willing to bear the potential risks also receive the benefits.