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.In doing research, there are five main ethical principles that must be followed by researcher. A researcher need to: 1) minimize the risk of harm to participants; 2) attain informed consent from participants; 3) protect participant’s anonymity and confidentially; 4) avoid using deceptive practices; and 5) provide participants the right to withdraw from research. The core of these ethical principles emphasizes on do good and give benefit while avoiding harm and maleficent. These ethical requirements in research are important not only for ethical reasons, but also practical ones, since a failure to meet such basic principles may lead to the research being criticised and rejected by Ethics Committee, costing valuable time. Principle one stress on how a dissertation research should not harm participants by considering all aspects and types that could bring harm such as physical harm, psychological distress and discomfort, social disadvantage, financial status or an invasion of participant’s privacy and anonymity. Non-maleficence requires a high level of sensitivity from the researcher about what constitutes “harm” (Ford L., 2009).
According to Burns and Grove “discomfort and harm can be physiological, emotional, social and economic in nature”. By acknowledging these risk aspects, interventions to avoid or minimizing the risk of harm could be taken by researcher. The idea of informed consent is one of the foundations of research. Informed consent means the knowing consent of a person without undue inducement or any element of force, extortion, duress or any other form of constraint or coercion. It is the researcher’s responsibility to provide sufficient information in understandable language on the benefits and possible risks prior to their involvement in the research, so that participant can make an informed judgment about participation.
Informed consent is a process, not a form, when it was done appropriately, the process assures that participants are willingly participating in the research with full knowledge and information of relevant risks and benefits. Those people with diminished autonomy such as young children, very ill people or mentally disable should be protected. They could only be included in research under specific circumstances, as they not able to make fully informed decisions on their own. Another practical component of research ethics is by protecting the anonymity and confidentiality of research participants. Protecting anonymity of information collected from participants means that either the researcher does not collect personal information of participants such as name, address, email address, job title, length of services or the researcher does not link individual responses with participants’ identities. Unless it is necessarily essential to the study protocol, participant’s personal details should be keep ‘anonymous’ to protect the participant identity. Nonetheless, permission should be obtained before any confidential information is disclosed.
Another principle of research ethics is a dissertation research should avoid any kinds of deceptive practices. Deceptive may not be seen as an issue if an informed consent has been performed, however the question is, how can the participants know what the research requires of them if they are being deceived? this question makes the use of deceptive practices controversial. Therefore, dissertation research should avert any types of deceptive practices. However, deception is sometimes needed in covert research where the identity of the observer and the purpose of the research is not known to participants. This is most likely to be the case where a research requires an observation rather than direct contact with participants, for example; observing what customers are doing in an internet chat room.Lastly, providing the right of participants to withdraw is one of the principles of research ethics that should be followed by researcher.
Participants should have the right to withdraw from the research process at any stage and when the decision to withdraw was made, the participant should not be pressured or coerced in any way in order to stop them from withdrawing. According to Good Clinical Practice (GCP) guidelines, an individual can withdraw from research at any point of time and it is no binding of the participant to reveal the reason of discontinuation.
