Vulnerable Population Article Homework

Vulnerable Population Article Homework

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, psychoactive medications, substance abuse, and head trauma.”

Others who may be unable to provide consent include children, fetuses, prisoners, the terminally ill, and pregnant women (Miracle, 2010). Most of my experience with vulnerable groups, while working as a clinical research nurse, has been with young women who became during the study period, after IC was obtained. Generally speaking, pregnancy 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 study’s 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 baby’s first 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 responsible for all necessary care.


Miracle, V. A. (2010). Vulnerable Populations in Research. Dimensions of Critical Care Nursing , 242-245.

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