Tuesday, March 12, 2019
Individual Assignment: Vulnerable Population Article Essay
Based on my extrapolateing of what I have teach over the past week, I would define a vulnerable creation as any individual or group of citizenry with a decreased capacity to communicate effectively in a given up setting. The term vulnerable populations is be defined as people with equivocal capacity. It is further stated that, children, comatose patients, fetuses, prisoners, or mentally ill patients, among others be considered vulnerable populations (Miracle, 2010). As a clinical research nurse, it is my responsibility to check out that all of my patients (or subjects) submit a signed and dated informed take on (IC) form prior to enrollment in a take away. The Food and dose Administration (FDA) requires that all clinical trials or claim sponsors (pharmaceutical manufacturer of the study drug) maintain proof of IC for each subject, in every trial, without elision in their respective trial master file (TMF).Potential barriers for participants in clinical research studies m ight be patients or subjects who ar uneducated, and or, patients who are not able to assure his or her health care supplier that they fully understand information that is provided, and IC may not be obtained. The NIH defines consent capacity as an adults ability to understand information relevant to making an informed, wilful decision to participate in research. This information includes a description of the study, its potential risks and benefits, the right to give voluntary consent, the right to withdraw from the study, anonymity, confidentiality, and ways to lessen any risks. However, many people do not understand these components of an informed consent for a descriptor of reasons. These include people with mental dis social clubs, neurological disorders such as fortuity or dementia, metabolic impairment, psychoactive medications, substance abuse, and head trauma.Others who may be unable to provide consent include children, fetuses, prisoners, the terminally ill, and heavy( predicate) women (Miracle, 2010). some of my experience with vulnerable groups, while working as a clinical research nurse, has been with young women who became during the study design, after IC was obtained. Generally speaking, motherhood should be avoided at all costs during participation in a clinical trial in which a woman is ingesting a study drug. Depending on study design or how a studys protocol is written, it may require that the women participants not get pregnant for a specified period after study drug is completed, in order to avoid harm to the woman and her unborn fetus.When a patient becomes pregnant during the study drug period or within the specified period after study drug completion, the study sponsor) is required to report this as an adverse event (any untoward and/or unexpected event during the clinical trial that could potentially harm the patient). The patient must then be followed by her trial physician throughout her pregnancy, and through the indulges fi rst year of life, to ensure the health of both mom and baby for one year after study completion. If any complications arise, the sponsor is liable for all necessary care.ReferenceMiracle, V. A. (2010). Vulnerable Populations in Research. Dimensions of Critical superintend Nursing , 242-245.