Protection of Human Subject Participants in Nursing Research

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Just as ethical responsibilities are essential in clinical settings, it is also necessary when conducting nursing and other types of research. One ethical principle that needs to be determined before starting a research project is if informed consent is required. “Studies that measure the effect of an intervention or practice or that challenge a “policy” or established practice standard require informed consent” (Quatrara & Shaw, 2018, p. 244). Informed consent is required when the research involves health volunteers, children, patients, incompetent/incapacitated people, immigrants, or others such as prisoners. It is also needed when biological samples, personal data, and human genetic material are used or collected by the research. (Manti & Licar, 2018). Obtaining informed consent is not just as simple as signing a piece of paper. Participants are given consent voluntarily. Participants should be competent to sign the consent and understand the expectations of their role in the research project. The participant has to be given a thorough explanation of the research, and they also have to have the ability to comprehend the information (Arifin, 2018). The duration of the study and the risks and benefits is also explained to potential participants. After the researcher has addressed the participant’s concerns and questions and has voluntarily agreed to be in the study,  the researcher or other assigned member can obtain a written, signed, and dated consent (Nusbaum et al., 2017).

A researcher could maintain anonymity in the study by not using names in the data results and keeping the consent in a secure place, whether electronic or paper version, as we do for all other HIPPA  (Health Insurance Portability and Accountability Act) documents and records (Nusbaum et al., 2017).

 

References

Arifin, S. R. (2018). Ethical considerations in qualitative study. International Journal of Care Scholars1(2), 3033.

Manti, S., & Licari, A. (2018). How to obtain informed consent for research. Breathe14(2), 145152. 

Nusbaum, L., Douglas, B., Damus, K., Paasche-Orlow, M., & Estrella-Luna, N. (2017). Communicating risks and benefits in informed consent for research: A qualitative study. Global Qualitative Nursing Research4, . 

Quatrara, B., & Shaw, D. (2018). The advanced practice nurse and research. In L. Joel (Ed.), Advanced practice nursing: Essentials for role development (4th ed., pp. 240250). F.A. Davis Company


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