Essential Elements of Informed Consent
The first step towards ensuring subjects protection in research perhaps lies in the most basic requirement of all, obtaining informed consent from them. Here, getting an informed consent does not necessarily mean directing the subject where to sign. Neither does it mean superficially going through the elements of the consent form and asking for a signature, especially among the special populations. Instead, the clinical research coordinator or RN has to be thorough in informing the client what the research entails including the potential side effects and satisfactorily settle any queries or hesitations the subject has before signing the form. The RN Klein embodies these sentiments when she refuses to brush over the elements of the consent form and takes it upon herself to thoroughly explain what the study is about in detail to the satisfaction of Mrs. Casper, even when she shows little interest -“Hold on, I want to make sure you are getting this Mrs. Casper, would you mind repeating to me what the purpose of the study is in your own words?”(Garrity et al., 2017).
According to the definition by Manti and Licari (2018), informed consent is the process by which a participant in a study voluntarily ascertains his or her willingness to take part in particular research following being informed of all the aspects of the trial relevant to the subject’s decision to participate. The form should be in written form and signed with the correct dates. Without which, the authors assert that complications may arise during the research process putting the researchers in an ethical dilemma that could lead to litigations, especially when vulnerable populations are involved. As such, based on its implications and overbearing tenets, informed consent is legally binding and should be fulfilled without coercion, deceit, fraud, or duress.
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Special Populations
Special populations in research refer to participants or subjects with diminished autonomy such as the elderly, the economically and educationally disadvantaged, pregnant women, children, or disabled subjects, subjects with Alzheimer’s, dementia, or those with hearing impairment. When dealing with this special group, the form should as well be provided when the research plans to use or collect human genetic material, personal data, and biological samples as a way of respecting their dignity and privacy. Also, prisoners under the HHS Code of Federal Regulations are protected as part of special populations whereby not only should consent be sought and provided in understandable language but the IRB should also ensure that the research is beneficial with minimum risks. If a subject is not of consensual age like a child or is not in the right state of mind due to illness or another form of disability, to protect them, consent should be provided by a representative such as a relative or a legal one.
Nurses Role in Research Situations
Indeed, in the protection of research participants, all individuals, including officials and researchers, need to be actively involved. These include the PI, the CRC, RA, the RN, as well as all the supervisors including the IRB. The IRB such as that led by Rosenberg in the video has to give permission or authorization for research like the melanoma trial involving human subjects to be conducted. This authorization is, however, only granted after the IRB has determined that all the ethical considerations have been fulfilled and that the research itself satisfies the ethical standards of any research involving human subjects. This is evidenced in the Research Clinic Video when Klein, the RN tells the PI, doctor sowers to await approval of their study protocol by the IRB instead of overlooking it and going straight to trials, (Garrity et al., 2017). In essence, the IRB in liaison with the supervisors and the CRC has to oversee the study, ensuring that no ethical standards are violated as elaborated by the video.
On a more subjective scale, however, the active participants such as the RNs and RAs need to ensure that the three ethical principles as stipulated in the Belmont Report are adhered to. These principles include respect for persons, beneficence, and justice. Respect for persons according to the report as defined by Yip, Han, & Sng (2016), refers to the requirement to acknowledge autonomy and protect those with diminished autonomy or otherwise vulnerable populations. Beneficence, on the other hand, means doing no harm and maximizing possible benefits while minimizing potential harm. This is possible after risk and benefit assessment of the research. Ultimately, justice means that both individual and societal rights to privacy and safety are protected at all times and levels of the research process.
In other words, based on the three core principles above, the Belmont Report aims to seek out positive solutions to research, which informs the areas of application it specifies. These include informed consent, assessment of risks and benefits, as well as the selection of subjects. It is based on these concepts that Klein, the RN and CRC question doctor Sowers’ selection criteria stating that all the selected participants in the folders were ineligible for the melanoma trials and proceeding would do more harm than good for some of the participants chosen, (Garrity et al., 2017).
By defining the above areas, confined within the auspices of the three core principles, the report protects against ethical risks such as mistreatment or subjects, failure to adhere to approved protocol, lack of or incompetent informed consent, exposure of participants to psychological or physical harm, fraud, deception, and failure to maintain confidentiality. Here, the nurses, together with the CRC, take active advocacy roles to ensure that those risks are mitigated and the participants are safe.
References
Garrity, S. R., Tarzian, A.J., Lehmann, K., Greene, K.L., Browning, S., Dauses, … Zimmet, S. The Office of Research Integrity and The Office for Human Research Protection. (2017). The research clinic [Video file]. Retrieved from http://ori.hhs.gov/TheResearchClinicVideo/
Manti, S., & Licari, A. (2018). How to obtain informed consent for research. Breathe , 14 (2), 145-152. Doi: 10.1183/20734735.001918
Yip, C., Han, N. L. R., & Sng, B. L. (2016). Legal and ethical issues in research. Indian Journal of Anesthesia , 60 (9), 684. Doi: 10.4103/0019-5049.190627
