Nursing Research: Informed Consent in Vulnerable Groups

This report examines the ethical concept of informed consent within the context of nursing research. It defines informed consent as a prerequisite for research participation, emphasizing the importance of voluntary agreement and participant awareness of research aspects, risks, and rights. The report highlights ethical responsibilities, including protecting vulnerable populations like children and pregnant women. It discusses challenges such as language barriers, religious influences, and low literacy levels, which can hinder comprehension of the informed consent process. The report references several studies that support the need for enhanced communication techniques and collaboration to improve research literacy and trust among vulnerable groups, ensuring that ethical standards are maintained and that research findings are not skewed due to underrepresentation of specific populations. The report concludes by emphasizing the ongoing debate about achieving informed consent in vulnerable groups and the need for standardized approaches to foster comprehension and improve the overall ethical conduct of research.

Running head: NURSING RESEARCH
Nursing research
Name of the student:
Name of the University:
Author’s note

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Research ethics are the moral principles that give guideline for responsible conduct of
research and distributing benefits and burdens in a fair manner. Informed consent is one
important ethical responsibility in research. Taking informed consent is a prerequisite before
taking any participants in research (Kadam, 2017). It is the process of voluntary agreement to
the research and the informed consent process makes research subjects aware about all
aspects of the research and the risk associated with it. Informed consent form used during the
recruitment process mainly informs the study subjects about their rights, the aim of research,
the procedures to be undertaken, confidentiality considerations and potential risk and benefits
of research. Informed consent process must also ensure take extra protection for vulnerable
population groups like children, pregnant women, prisoners (Nijhawan et al., 2013).
Various research papers enlightens about the advantages and challenges associated
with informed consent process. Nijhawan et al. (2013) explains about many requirements for
obtaining informed consent process. For example, the investigator or the person designated
by the research must obtain informed consent and it should be obtained before screening
procedures. However, certain factors impose challenges in obtaining informed consent. For
example, language barriers result in misunderstandings and due to this reason; many subjects
withdraw from the study at later stage of the research. Other challenges occur because of
religious influence, false expectation, conducting research with children and vulnerable
groups. Many subjects deny receiving a treatment because of religious values and many
people refuse to sign the form because of historical evidence of clinical trial fraud and
misconducts. Heerman, White and Barkin (2015) supported too that participant’s language,
education levels and low literacy lead to poor comprehension of the informed consent
process. However, this evidence also demonstrated how such barriers could be removed. For
example, the researcher combined the traditional informed consent process with enhanced

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communication techniques such as use of visual aids and graphics to promote understanding
and address dissenting behaviours of vulnerable groups.
In biomedical research related to health disparities, there is a need to recruit many
traditionally underrepresented minorities in research. However, as understanding and consent
standard is very difficult for young children, there is a need for more work and research in
this area. This will help to ensure that the ethical responsibility of obtaining informed consent
takes place smoothly and without any interruptions (Kadam, 2017). Due to issues in informed
consent process, many vulnerable population groups are underrepresented in this research.
Such developments can make the reasons skewed towards people with higher socioeconomic
status and there is high likelihood of achieving erroneous results. Thus, the feasibility of
achieving informed consent in vulnerable group is a highly debatable topic. One major
drawback is that no standard approach has been consistently applied to foster the
comprehensibility of the informed consent for vulnerable groups. There is a need for better
collaboration between cross disciplinary science team and the community so that research
literacy and trust among vulnerable population group is enhanced (Gehlert & Mozersky,
2018).

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References:
Gehlert, S., & Mozersky, J. (2018). Seeing beyond the margins: Challenges to informed
inclusion of vulnerable populations in research. The Journal of Law, Medicine &
Ethics, 46(1), 30-43.
Heerman, W. J., White, R. O., & Barkin, S. L. (2015). Advancing informed consent for
vulnerable populations. Pediatrics, 135(3), e562-e564.
Kadam, R. A. (2017). Informed consent process: A step further towards making it
meaningful!. Perspectives in clinical research, 8(3), 107.
Nijhawan, L. P., Janodia, M. D., Muddukrishna, B. S., Bhat, K. M., Bairy, K. L., Udupa, N.,
& Musmade, P. B. (2013). Informed consent: Issues and challenges. Journal of
advanced pharmaceutical technology & research, 4(3), 134.