Institutional Review Boards

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Institutional Review Boards There have been several incidences of unethical research across the globe, which has tainted people's perception of these studies, especially when human subjects are involved.

Multiple examples, such as medical experiments by Nazi and Willow Brook Research at State School, depict the need for research protocol in conducting human subject research. Unethical studies have shown to have dire impacts. In some instances, human subjects were exposed to untested treatments that exposed them to diseases without their consent. In this study, I review the Institutional Review Boards and the policies of respect, justice, non-maleficence, and beneficence.

The research process involves data collection by professionals entailing privately held information. Despite this being an integral part of the medical and scientific fields, it's critical to ensure measures are taken to protect the study participants' rights. Various reports like Belmont and requirements as stipulated by the Department of Health and Human Services and Food and Drug Administration are certified by an Institution Review Board (Chiong et al., 2018). The aim to verify human rights are taken into consideration during the research process.

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The Institutional Review Board As an administrative body, the IRB is constituted to safeguard the rights of research participants. It reviews the research process to ensure vulnerable participant's rights are met.

Before the research begins, IRB reviews the intended participant's recruitment process, informed consent documentation, confidentiality, risk/benefits assessment, and collected data during and after research (Johansen et al., 2008). The review ensures the rights of the participants are given priority before any study commences. In the process, the participant gets a chance to be chosen relatively, and their consent sort before participating. The data storage and safety are also safeguarded to ensure confidentiality is maintained. Agreeing with the fact that human participation in medical research is essential in guaranteeing medical advancements. However, participants' rights should not be compromised (Kennelly, 2011).

The IRB aims to protect the abuse of vulnerable participants in research by ensuring research standards are followed. There is a need to have regulations guiding clinical research with clearly established human subject protective factors (Weisleder, 2020). Among these are the ethical principles of respect of persons, justice, non-maleficence, and beneficence. Moreover, human-based subjects' defensive application entails seeking informed consent, risk/benefit evaluation, and participant selection (Chiong et al., 2018).

Policy of Respect The Belmont Report in 1978 stipulated the protective principle of respect referred to human dignity (Johansen et al., 2008). It dictates protecting the independence of research participants in the study by disclosing all information surrounding the research. The autonomy of participants should be prioritized in that they understand the study's benefits and potential harms.

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Independence is achieved when an individual is allowed to deliberate about one's personal goals and that his/her actions are based on these deliberations (Johansen et al., 2008).

In ensuring the participants' autonomous rights are met and achieves desired selfdetermination, the researcher is obligated to ensure participation is involuntarily cases. The participants need to be informed of their rights and that the decision taken will not deter access to care currently receiving or in the future. The participants should be able to ask questions about the study and be in apposition to understand their role with ease from the researcher. The researcher is expected to inform the participants that they can stop being part of the study at any particular stage without fear of any consequences (Johansen et al., 2008).

The Belmont report noted that some individuals lack autonomous capacity regarding research participation. It is observed due to disability/illness or the level of individual development. There is a need to have superior protection for these persons and be excluded from research activities that can potentially harm them. Alternatively, the appointment of a third party guardian can be instigated in cases vulnerable participants are involved (Kennelly, 2011) Research should not be carried out with participants that are coerced into agreeing to be part of the study. The researcher should ensure participants are not threatened with a penalty if they decline to join or drop-out at any research stage. It also unethical to reward participants significantly so that they agree to join the study (Warner, 2013). The reward provides an enticement that some participants feel they cannot turn down at the moment, while its lack of they would not have given their consent. It's evident that the researcher uses varying incentives while conducting studies; it needs to be considered a form of coercion (Johansen et al., 2008).

Additionally, the policy of respect aims to establish self-determination among participants through full disclosure of study information and the nature of voluntary participation

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expected (Sims, 2010). It explicitly targets to lay bare participants' rights with possible benefits and risks associated with being part of the study. It is arguable if full disclosure is not done, participants are denied the opportunity to make a genuinely informed decision (Chiong et al., 2018). Some researchers have found this aspect a bit tricky in some instances, considering research designs and questions. The reactivity biases is associated with study participants who are aware of the research purpose and questions. In some instances, masking of critical study information has been employed to avoid reactivity biases by researchers. Pharmaceutical trials have also been carried out using placebos to avoid affecting study outcomes. However, it's viewed that masking and concealing of data collected in some ways fail to respect the participant's rights to self-determination in the process. In these instances, IRB needs to be informed of the intent to conceal data collected for oversight purposes and letting participants in clinical trials know of random assignment of medication or placebo. It's the role of IRB to determine if the study warrant masking methods as its research design (Weisleder, 2020).

Principle of Beneficence Beneficence denotes acting in a manner that is beneficial to others by promoting their safety and welfare (Chiong et al., 2018). Beneficence is in line with the principle of nonmaleficence of not doing any harm. The beneficence principle can be looked at in two perspectives of enhancing participant's right to freedom from discomfort or harm, and rights to be protected against exploitation (Johansen, et al., 2008) IRB approval for conducting a study requires a researcher to analyze possible risks to the participants and research benefits. Potential risks include loss of privacy, physical or mental harm, unprecedented side effects, embarrassment or distress, loss of time, monetary costs, and physical discomfort (WMA Declaration of Helsinki, 2017). Likely benefits consist of enhanced

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understanding of medical conditions, possible valuable intervention, and chances of being resourceful to others suffering similar ailments (Kennelly, 2011). In light of this, the study should have risks and benefits explicitly appearing in a written document for seeking informed consent. There should be implementations of specific protection to mitigate harm or discomfort as set by the beneficence principle. It also stipulates that participants should be protected from exploitation by the researcher. Besides, participants' information received through participation in the study should be safeguarded (Weisleder, 2020).

Principle of Justice The principle of justice entails ensuring participant's right to privacy, and fair treatment is advocated. The participant's selections for the research should be led by the research questions' needs to all groups a chance and reflect the population's representation. It's essential for the study and IRB to scrutinize participants' selection to ensure the group is systematically identified rather than ease of access or due to their vulnerability. The principle of justice anticipates the fair treatment of participants who decline to part of the study in an appropriate manner devoid of any prejudice (Chiong et al., 2018).

The principle of justice encompasses the right to privacy. The shared information should be kept in strict confidence by the researcher. Safeguarding participant's privacy involves enacting procedures that ensure confidentiality and anonymity (Ivan & Velicanu, 2015). There is a need for the researcher not to connect data to a specific participant to achieve complete anonymity. Every researcher should assure confidentiality to the participant by ensuring the participant's data identification is locked. Names should be substituted with codes possessing

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correlation identifiers only to offer safety in emergency cases while restricting direct match to researchers (Miracle, 2016) Principle of Non-maleficence The principle states that researchers in clinical trials should not harm the patient. It is important to discuss the possible side effects that the research process could have. The complications anticipated should be discussed with the participants before consent is sought.

IRB is an external reviewer mandated to safeguards the rights of the participants in various researches. The research proposal is reviewed, entailing all documentation depending on the nature of the study's risks. The IRB approves before the researcher can begin contacting participants for data collection. In some cases, multi-site studies are evaluated by various IRBs with varying review process (Miracle, 2016).

IRB is concerned with research using vulnerable groups as participants. These are individuals without the capacity to grant informed consent or one at high risk of unintended side effects. Vulnerable groups include young children, pregnant women, and mentally or emotionally challenged participants. Minor does not have the capability to comprehend most researches; thus, extra care should be taken as stipulated by the principle of beneficence (Johansen, et al., 2008).

Conclusion Research ethics is key to modern clinical research. It's critical to ensure measures are taken to protect the rights of the participants in the study. The IRB plays a crucial role in advocating for participants' rights, especially from the vulnerable group. The IRB comprises experts drawn from various disciplines with the capacity to build consensus on varying research studies and thus safeguard the rights of research participants.

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References Chiong, W., Leonard, K., & Chang, F. (2018). Neurosurgical Patients as Human Research Subjects: Ethical Considerations in Intracranial Electrophysiology Research Neurosurgery, 83(1), 29-37.

Ivan, M., & Velicanu, M. (2015). Healthcare industry improvement with business intelligence.

Informatica Economica, 19(2), 81–89.

Johansen, V., Aagaard-Hansen, J., & Riis, P. (2008). Benefit--a neglected aspect of health research ethics. Dan Med Bull., 55(4), 216-8.

Johansen, J. (2011). Medical ethics: Four principles, two decisions, two roles and no reasons. J Prim Health Care 3, 170–4.

Miracle, A. (2016). The Belmont Report: The Triple Crown of Research Ethics. Dimens Crit Care Nurs. 35(4), 223-8.

Sims, M. (2010). A brief review of the Belmont report. Dimens Crit Care Nurs. 29(4), 173-4.

Warner, D. (2013). IG 101: Developing clinical business intelligence. Journal of AHIMA. Weisleder, P. (2020). Helping Them Decide: A Scoping Review of Interventions Used to Help Minors Understand the Concept and Process of Assent. Front Pediatr, 2(20), 8:25 WMA Declaration of Helsinki. (2017). Ethical Principles for Medical Research Involving Human Subjects. Available from: http://www.wma.net/en/30publications/10policies/b3/