IRB: Safeguarding Human Research Subjects' Rights - Essay Sample

Ethics is critically essential in any research, particularly those involving human subjects. Independent bodies review the approaches, processes and methods applied to ensure adherence to ethical standards. One of such independent body is the institutional review board (IRB) popularly known as the ethical review board. It refers to the administrative entity established to safeguard and protect individual rights and welfares of people serving as human research subjects in the numerous research and studies conducted by institutions affiliated to the body. The IRB has overall responsibility and duty of reviewing all the information relating to the research involving human subject participants. As such, the body ensures that it protects the welfare, rights and freedom and privacy concerns of persons serving as the human participant subjects. Due to the vital roles of IRB, understanding its operational framework, responsibilities and priorities as well as examining an example of an organization that works with human research subjects is critically essential and the focus of the research paper.

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The primary responsibility and function of the IRB are safeguarding the rights and welfares of the human subjects. The body achieves this by ensuring that it puts measures in place that would see that the research acquire essential training on research ethics (Enfield & Truwit, 2008). It installs best practices measures and reviews all the research proposals to affirm that researchers follow the established regulatory frameworks. Balancing the risks that come with the research on human subjects against its benefits to society is another key role of the IRB (Enfield & Truwit, 2008). Therefore, the body reviews all the research protocols to get an insight into the study and determine if it is worth taking the risk. In most cases, confusion arises in the definition of the risks and attractive benefits of the research. Thus, the IRB steps in to describe the risks in terms of the possibilities of harmful effects and the beneficial facts from the study.

Besides safeguarding the rights of human research subjects, the body has a responsibility of providing the necessary administrative support and assurances primarily through internal auditing and keeping the records of scientific studies. The recording keeping and auditing is the critical role of the IRB as it ensures that the body foresees the implementation of its policies and procedures. Therefore, the IRB is in a better position to identify and rectify any arising issues in the research process. It is a requirement by the federal law that the body maintains and hold sufficient documentation of research activities. The documentation may include IRB procedures, all the registered members, all critical research proposals that the body has reviewed, the IRB minutes, and a record of the activities and researches under review and the correspondence of the IRB and analysts, among others (Enfield & Truwit, 2008) In addition to that, the IRB has the mandate to approve, authorize, disapprove, regulate and monitor, and request for the modifications in the parts of the research activities that do not meet its established specification. However, the IRB can only operate under its jurisdiction based on the specifications of the federal rules and regulations, and policies of the sovereign institutions.

Pfizer Inc is one of the global pharmaceutical companies accredited with the capacity to conduct human research studies. The organization conducts studies on human research subjects that involve the at-risk populations such as children, women, selected minority groups and cognitively impaired subjects. The organization conducts studies as per the requirements and regulations of the IRB. The Pfizer Human Research Protection Program (HRPP) stipulates the principles, guidelines and procedures essential for the organization’s interventional studies. The specific guidelines entail the Pfizer’s responsiveness to the healthcare environment in the regions where the company conduct the human study researches. Pfizer, through HRPP, focuses on the sensitivities of the social and cultural considerations of minority groups and cognitively impaired subjects by establishing and promoting vital infrastructure in the regions where these services are lacking. The organization has policies in place that safeguards protection for the rights of human subjects. It also safeguards the privacy concerns and welfare of both women, children and minority groups that serve as study participants in the research conducted by the organization. Informed consent is a critical factor for human research subjects. The organization has clearly stipulated policies regarding informed consent (Goodwin, 2016). The policy and guidelines specifically apply to the children taking part in the research study. Other essential policies in the organization include the benefit and risk assessment from human subjects’ point of view, the examination of the qualification of the study team, including analyzing informed consent, among others. Additionally, the organization ensures that the study participant selected for the research conforms to the guidelines and policies stipulated by CIOMS and ICH (Goodwin, 2016).

In a nutshell, the institution review board is responsible for safeguarding and protecting the rights and welfares of individuals or groups taking part in research as human study participants. The organization is responsible for ensuring that the companies conducting the research respect the human participants’ rights, welfares and freedom. It also weighs the potential risks and benefits of the research at societal and individual levels. Additionally, the IRB maintains essential documentation for the many research conducted by its affiliate organizations. An example of such an organization is Pfizer. The organization is a pharmaceutical company that researches human participants in developing interventional curative measures. The company has established guidelines and policies that protect the rights, privacy and needs of the human research participants.

References

Enfield, K. B., & Truwit, J. D. (2008). The purpose, composition, and function of an institutional review board: balancing priorities. Respiratory care, 53(10), 1330-1336. Retrieved on August 15, 2020, from http://rc.rcjournal.com/content/respcare/53/10/1330.full.pdf

Goodwin, M. (2016). Vulnerable subjects: why does informed consent matter? The Journal of Law, Medicine & Ethics, 44(3), 371-380.

Myers, C. (April 3, 2009). Pfizer Becomes the First Pharmaceutical Company to be Accredited for the Protection of Human Rights in Clinical Research. Fierce Biotech. Retrieved on August 15, 2020, from https://www.fiercebiotech.com/biotech/pfizer-becomes-first-pharmaceutical-company-to-be-accredited-for-protection-of-human-0#:~:text=AAHRPP%2C%20through%20accredited%20research%20programs,are%20protected%20from%20unnecessary%20harm.&text=Founded%20in%201849%2C%20Pfizer%20is,new%20approaches%20to%20better%20health.