Informed Consent for Research Participation
The need to take the necessary precautions when dealing with human beings as subjects in any research has attracted controversial debates. Such issues as have remained relevant to this debate include the physical, emotional, ethical and legal effects of certain risks on the participants. Scholars have therefore emphasized on the need to obtain the participant’s consent before a researcher involves him/her in any research. The argument is that the participant should be made aware of all the possible risks he/she is likely to encounter during the research process to enable them to make informed decisions prior to the actual research activities. This write up, therefore, discusses the issues related to the risk assessment of informed consent and how leaders can best assess risks to enable their participants to make an informed consent before taking part in a research process.
According to Robson & Toscano (2007), risk assessment is careful examination of what could possibly cause harm to an individual in particular undertaking or activity. On the other hand, Glahn (2007) states that the informed consent is communication leading to agreement between the researchers and people they wish to take part in the research. This communication is important since it helps to obtain an informed consent from the targeted participants. In order to obtain legally effective consent from an individual subject for a research procedure, there are requirements to be fulfilled. These requirements are based on the principle of respect for an individual’s rights. This means that for leaders to address the risk assessment of informed consent, they should also address the dangers of assuming any risk.
There is a wide variety of risks which are likely to be incurred by individual participants in any given research. They can be categorized as psychological, physiological or spiritual. Therefore, a proper assessment of the risks involved should be done so as to make known the various risks involved to the research subjects for their informed judgments. For this to be possible, the communication leading to the judgment on whether to assent to the risks involved should be very clear and understandable to both the research parties. To enhance clarity, the potential participants should also be allowed to ask questions in the course of communication (Glahn, 2007).
Clarke (2007) also notes that it is prudent that the researcher and the research institution’s identities be disclosed to the research subject so that one can perfectly know whom he or she is getting involved with. The researchers should also note that it is important to mention the rights of the research subjects. These may include the freedom to refuse or withdraw from the research. The duration and the purpose of the research should also be made clear to the research subject. All this information helps the participants to have better understanding of all the risks involved and thus making them participate effectively in the research decision making process.
In trying to approach a potential research subject, consideration should be put on his or her cultural norms and practices. This will enable the researcher to gain favor with participants making it easier for him/her to obtain an informed consent. Additionally, enhancing cooperation for an informed consent would require that the researcher uses a wide range of media items such as video tapes, newsletters and brochures. The tools have been proved to be more effective than the formal consent forms which could be confusing (Clarke, 2007).
However, in case an already signed consent puts the subject’s life at risk, then it should be weighed. Additionally, in any situation where it is necessary to have the written consents, the subject is allowed to state whether he or she is comfortable. However, in cases where such consent is risk involving, a verbal consent can be done in presence of a trusted colleague as a witness. That is, the verbal consent by the subjects should not be recorded. To further facilitate the consenting process, the community leaders of the potential subjects should also be informed so as to erase any suspicion (Clarke, 2007).
Even though detailed information should be given to the potential subjects, some circumstances may allow for only a partial detail disclosure. However, there should be a lot of care taken so as not to expose the individual subject to any risk. Finally, it is important to note that for the person who is not capable to make legally informed consent, appropriate permission from other people who are legally authorized can be obtained (Glahn, 2007).
In conclusion, it is therefore clear that it is necessary to give full information to the targeted participants, especially as regard to all the risks involved in any particular research undertaking. This is the only way in which the participants can find it possible to either control the effects of such risks or to avoid them.