February 4, 2013
Sheila De Vaughn
Week 1 Individual Assignment: Vulnerable Population Article
Based on my understanding of what I have read over the past week, I would define a vulnerable population as any individual or group of people with a decreased capacity to communicate effectively in a given setting. The term vulnerable populations is be defined as “people with questionable capacity.” It is further stated that, “children, comatose patients, fetuses, prisoners, or mentally ill patients, among others” are considered vulnerable populations (Miracle, 2010). As a clinical research nurse, it is my responsibility to ensure that all of my patients (or subjects) submit a signed and dated informed consent (IC) form prior to enrollment in a study. The Food and Drug Administration (FDA) requires that all clinical trials or study sponsors (pharmaceutical manufacturer of the study drug) maintain proof of IC for each subject, in every trial, without exception in their respective trial master file (TMF). Potential barriers for participants in clinical research studies might be patients or subjects who are uneducated, and or, patients who are not able to assure his or her health care provider that they fully understand information that is provided, and IC may not be obtained. The NIH defines consent capacity as an "adult's ability to understand information relevant to making an informed, voluntary 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 variety of reasons. These include people with "mental disorders, neurological disorders such as stroke or dementia, metabolic impairment,...