Evidence-Based Practice week 4dq2

Topic 4 DQ 2 Conducting research projects while ensuring the protection of human subjects is necessary. What are some methods to protect personal rights of someone in one of the groups that is labeled as vulnerable? Justify your rationale. example below 4 posts Re:Topic 4 DQ 2 There are several definitions available for the term “vulnerable population”; the words simply imply the disadvantaged sub-segment of the community 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. The vulnerable populations refer 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. 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 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. Development of comprehensive safety monitoring plans with Data Safety Monitoring Committee (DSMC) supervision and wherever applicable with Observational Study Monitoring Boards are crucial. Involving them in both early and late trial phases soliciting vulnerable subjects to contribute recommendations to the scientific caliber, integrity, safety, lucidity, timeliness, and quality of data and documentation may optimize their role. Compliance to advocated norms and sustained monitoring by ethical review boards (ERBs). 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. Awareness through continued education of stakeholders including media and public would result in better attitudes and approach to this form of sensitive research. Watchdog panels overseeing vulnerable participant protection should remain in an open ongoing dialogue with stakeholders, monitoring compliancy to advocated precautions and norms. Enhancing the interaction between the ERBs and investigators may expand their ability to comprehend the trends involved and engage in greater understanding of ongoing safeguards of these populations. Compassionate use of therapeutic interventions may be made available to vulnerable subjects following completion of research. Comprehensive mandatory pharmacovigilance and targeted risk management plans during post marketing are cardinal. Reference: Shivayogi, P. (2013). Vulnerable population and methods for their safeguard. Retrieved on May 31, 2016 from http://www(dot)ncbi(dot)nlm(dot)nih(dot)gov/pmc/articles/PMC3601707/ Re:Topic 4 DQ 2 The protection of human subjects is critical to the safety and efficacy of a trail. There are many methods to protect the rights, welfare, and wellbeing especially of vulnerable populations. Vulnerable populations can include children, pregnant women, prisoners, students, the mentally and physically fragile, and employees of a company. These populations are considered vulnerable as these groups' ability to protect themselves could be absent or diminished. They could be more disposed to both deliberate and unintentional harm (Schwenzer, 2008). A written consent for treatment is one of the first important steps in protection. These consent forms must adhere to strict regulatory and ethical requirements. For venerable populations such as children, the principal investigator is charged with obtaining parental consent to have their child partake in any type of research. The investigator must also have the child agree to participate as well. If, while in the study a child reveals abuse or whose actions lead to a suspicion of or neglect, the investigator must report this through the proper channels (Schwenzer, 2008). The Common Rule which is also known as the “Human Subjects Regulations” is a federal regulation that governs all studies involving human beings that are supported or conducted federal departments or organizations. It covers procedure requirements such as the review by an independent review board (IRB) and continuing review requirements and the baseline criteria of and IRB composition and approval processes (Presidential Commission for the Study of Bioethical Issues, 2014). Before any study commences, the researchers of the study must propose their project to an Institutional Review Board (IRB). This committee screens and appraisals biomedical and behavioral research regarding humans and its position is to determine if the study is both safe and ethical (U.S. Department of Health and Humans Services, n.d.). References: Presidential Commission for the Study of Bioethical Issues. (2014). Vulnerable Populations: Background. Retrieved from http://bioethics(dot)gov/sites/default/files/VP%20Bkgrnd%20CLEAN%20with%20Timeline%20updated%202.12.14.pdf Schwenzer, K. J. (2008). Protecting vulnerable sub from http://rtjournalonline(dot)com/10.08.1342.pdf effects in clinical research: Children, pregnant women, prisoners, and employees. Respiratory Care, 53(10). Retrieved Respiratory Care, 53(10). Retrieved from http://rtjournalonline(dot)com/10.08.1342.pdf U.S. Department of Health and Humans Services. (n.d.). Institutional review boards (IRBs). Retrieved from http://www(dot)hhs(dot)gov/ohrp/assurances/irb/index.html