Assignment: Special Issues Vulnerable Adults
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Assignment: Special Issues With Vulnerable Adults Details:
Develop a PowerPoint presentation of 15-18 slides, addressing clinical issues in the elderly and neglect and abuse of dependent adults and the elderly. Create speaker notes for each of the slides. Include the following in your presentation:
Part 1: Clinical Issues (cognitive decline, depression, anxiety, substance use, etc.)
Part 2: Abuse and Neglect
Common forms of vulnerable adult and elderly neglect.
Warning signs of vulnerable adult and elderly abuse.
Legal and ethical considerations for reporting abuse and/or neglect of vulnerable adults and the elderly.
In addition, include slides for a title, introduction, conclusion, and references (four slides minimum).
Include a minimum of four scholarly references in your presentation.
Include speaker notes below each content-related slide that represent what would be said if giving the presentation in person. Expand upon the information included in the slide and do not simply restate it.
Please ensure the speaker notes include a minimum of 50 words.
While APA style is not required for the body of this assignment, solid academic writing is expected, and in-text citations and references should be presented using APA documentation guidelines, which can be found in the APA Style Guide, located in the Student Success Center.
This assignment uses a rubric. Please review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.
The inherited skepticism of disregard and contempt for human rights from the past has left powerful influences, making autonomy, justice and safety the citadels for current ethical research practices. Civil rights violations from the infamous Nazi and Tuskegee to radiation human experimentations have promoted sustained maturation and augmentation of clinical bioethical research environments. The lack of informed consent (IC), or coercive, guileful, forceful influences and methods that were used to obtain consent from potential participants; this associated with impaired risk-benefit scales, unjustified research population selections have prompted international regulations to stand firm on principles advocating conscientious clinical and ethical research systems. Following marketing approvals, medicinal products are conventionally utilized by pharmaceutical organizations, medical practitioners and allied bodies across a wide range of age groups, genders, special populations, nationalities and races, who unfortunately had not been satisfactorily represented in pertinent clinical studies resulting in deficient evidence-based health care.
There are several definitions available for the term “vulnerable population”, the words simply imply the disadvantaged sub-segment of the community[1] requiring utmost care, specific ancillary considerations and augmented protections in research. The vulnerable individuals’ freedom and capability to protect one-self from intended or inherent risks is variably abbreviated, from decreased freewill to inability to make informed choices. Vulnerable communities need assiduous attention during designing studies with unique recruitment considerations and quality scrutiny measurements of overall safety and efficacy strategies ensuing research. Ethical dilemmas are widely prevalent in research involving these populations with regard to communications, data privacy and therapeutic deliberations. Non-therapeutic research participation is granted if the envisaged risks are minimal[2] and well-being of this community is not compromised. Research with this sub-segment of population is validated if reasonable direct benefits are foreseen, in compliance with local legal regulations.[1,3] The vulnerable populations refers to but not limited to children, minors, pregnant women, fetuses, human in vitro fertilization, prisoners, employees, military persons and students in hierarchical organizations, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized, elderly individuals, visual or hearing impaired, ethnic minorities, refugees, international research, economically and educationally disabled and healthy volunteers.[1,4] Due to their circumstances, the communities may be inclined to participate in a clinical study or be unjustifiably influenced by the expectations of predicted benefits associated with participation.[3]
There is an aggrandized awareness with pressing needs to include potential participants from heterogeneous demographics and variegated vulnerable backgrounds, both from the regulatory and patient groups.[5]
The cornerstones of vulnerable participant safeguard ubiquitously comprises of comprehensive IC process, authorized substitute decision makers, addressing privacy and confidentiality concerns, justified benefit versus risk assessments, equitable justice and methods of subject selection.[2,6]
Changes in benefit to risk ratios, either aggravated risks than those assumed and or a decrease in direct benefits presaged to the vulnerable participant should deter fresh enrolment and stagger or discontinue further participation up till the issue is appropriately corrected. The interim analyses of research may be made available in public domain to apprise the scientific community of the integrity of the study and initiate public trust.
Development of comprehensive safety monitoring plans with Data Safety Monitoring Committee (DSMC) supervision and wherever applicable with Observational Study Monitoring Boards are crucial. Their role may be optimized by involving them in both, early and late trial phases[7] soliciting vulnerable subjects, to contribute recommendations to the scientific caliber, integrity, safety, lucidity, timeliness, and quality of data and documentation. Compliance to advocated norms and sustained monitoring by ethical review boards (ERBs),[8] governmental agencies and independent DSMC is obligatory.
Any form of willful violations to Good Clinical Practices (GCP) with connotations to autonomy, voluntariness, distributive justice, other parameters of safeguards are to be imperatively scrutinized and those involved to be appropriately penalized by applicable authorities.
Protection of rights, well-being, safety with measurements of risk-benefit scales, privacy and confidentiality of vulnerable subjects and ascertaining appended safeguards[4] are prerogatives of ERBs. Infringement of methodologies in data collection and dissemination could bring individuals into disrepute, especially in research involving socially sensitive issues associated with stigma, as with HIV, mental illnesses, genetic[4] or of epidemiological natures. Confidentiality transgressions with unethical usage of personal data may occur endangering the social fabric of this already disadvantaged community. Therefore, establishment of updated security mechanisms of human research data protections is of paramount priority to industry, ERBs and supervising committees.
The trial documents require meeting the expectations of ERBs, especially with reference to vulnerable subjects’ protection.[9] Competent and trained ERBs overseeing sensitive studies should observe full-scheduled reviews[4] and may have representatives from specific populations during deliberations. The concerned ERBs prior to decision making may establish site research conditions, example a prison site[10] with relevance to participant rights, safety and well-being. The ERBs’ standard practices should include continued review for compliance whilst monitoring these trials.
Presently due to disparate factors, there is neither uniformity nor equitable standards in the understanding and grading of risks globally for these populations with relevance to extent of acceptability and evaluation of quantum of risks to establish consistent safeguards in biomedical research aiding stakeholders.
Role of regulatory in biomedical and behavioral research is maximal in providing scientific direction to industry and unambiguous thought-through instructions.[11] Regulatory governance is critical, more so in socially sensitive trials and also contributes to evolving a responsible media. International collaborations of regulatory organizations can establish scientific and regulatory policies to positively impact global safeguards for vulnerable populations.
Stringent reporting guidelines should be followed by industry in maintaining validated databases for safety data dissemination highlighted for this community, with risks being regularly interpreted by expert clinical evaluators, steering committees and timely recommendations shared between stakeholders. There is a continual need to federate and be vigilant to develop strategies for establishing appropriate advancements in monitoring plans according to trends scrutinized from research. Assignment: Special Issues With Vulnerable Adults
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