Healthcare research involves using human subjects to investigate various aspects of physiology, disease mechanisms, patients’ behavior, and the effectiveness of treatment regimens. Such research may pose risks to individuals participating in the study; hence, adequate measures must be initiated by the relevant parties to mitigate them. For instance, the use of human beings in Nazi Germany during the World War involved cruelty, leading to the need to create international standards when conducting such research. This culminated with the development of the Nuremberg code to guide the participation and involvement of human subjects (Miracle, 2016). Consequently, the protection of human research participants ensures that they are respected, benefit from the research, and do not suffer any injustices while voluntarily participating in the studies.
Institutional Review Boards
An Institutional Review Board (IRB) is an administrative body whose mandate lies in protecting the welfare and rights of human participants under the different researches they may be involved in. Institutions or individuals planning to conduct studies using human trials must thus present their proposals in advance to an IRB for review. As a result, the board approves, rejects, monitors, and may modify activities under the research based on existing regulations and protocols of such activities (Qiao, 2018). The IRB thus plays an essential role in protecting human research participants by analyzing scientific, legal, and institutional frameworks.
As an oversight authority on medical research involving human subjects, IRBs ensure that institutions adhere to ethical standards. In this case, they protect investigators from any potential conflicts of interest during the research that may pose a significant risk to the participants. For instance, human subjects must get protection during such studies by giving informed consent before its onset. Each participant must expressly state their desire to partake in the research after receiving full disclosure on the risk and benefits associated with it (Resnik, 2018). This means that each individual must understand the aims, objectives, and purpose of the study to enable them to determine its feasibility before agreeing to join (Taraban, 2016). In some instances, subjects may participate due to pressure or lack of adequate knowledge on the research, thus increasing the possibility of regret at a later stage. Therefore, informed consent protects the participants and outlines all the risks, potential benefits, and ultimate outcomes of the study
The issue of ethics also arises from a Christian point of view when dealing with human beings and treasuring their lives. The Bible explains that any individual that sheds the blood of man shall also shed his own since God made man in his image (Genesis 9:6 New International Version). From this scripture, human life holds great value meaning that no person should destroy another’s for their benefit. This provides the basis for ethical decision making in research involving human participants through the analysis of potential risks before subjecting them to the study.
Research and Quality Improvement
An analysis of the research to be undertaken provides an understanding of the magnitude and probability of success of the procedures and methods recommended for use. The examination of the risks must analyze the risk to the study’s potential benefits both to the participant and the medical field. Additionally, the model used must be justifiable and necessary by comparing any possible alternatives that would provide minimal inconveniences to the subjects. In most cases, non-invasive procedures, fewer participants, and the use of other alternative species are preferred to reduce the risk to human beings (Grady, 2015). The type of research used must possess a higher quality improvement (QI) ratio when assessed with the potential risks. Such studies must only be carried out if they prove beyond doubt that they would add value to the healthcare industry and the human population.
Types of IRB Reviews
There are three types of reviews undertaken by IRBs, which include exempt, expedited, and full. Exempt reviews involve studies that pose minimal risks to the human participants, thus become exempted from the regulatory requirements and protocols. Such research mainly involves non-invasive methods that do not require extensive analysis by the board. On the other hand, expedited reviews apply to studies with a very low probability of discomfort or harm to the participants as would be experienced in standard routine examinations. Therefore, research undertaken without using vulnerable populations such as the elderly or children can qualify for this type of review from the IRB. Lastly, research that includes high-risk procedures and methods requires a full review from the IRB due to the potential dangers that they may pose to participants (Whitney, 2015). This ensures that the individuals’ lives are protecting by analyzing the associated risks and the possible dangers to the participants as a priority.
Purpose of the Institutional Review Board
Human research must follow all available protocols and regulations set out by authorities by passing through Institutional Review Boards. This means that requisite approvals must be acquired to ensure compliance with the applicable laws and protocols. For researchers, this promotes responsible conduct since it involves issues of maintenance of records, documentation and reporting mechanisms (Grady, 2015). Additionally, they also ensure that risks to the participants are minimized since the researchers are proven to be ethical and adequately trained to perform the research. By adhering to such rules and standards, the studies can be deemed professionally acceptable and beneficial for the medical fraternity.
The Belmont Report
The Belmont Report outlines the codes that may guide both reviewers and investigators of research activities. The report offers guidelines that help reduce potential conflicts in the processes and ensure the protection of human subjects. The three primary principles on which the Belmont Report is based include beneficence, respect for persons, and justice. Beneficence refers to protecting participants from undue harm and assuring the security of their wellbeing (Miracle, 2016). In such cases, the research must yield the maximum benefits to the subject as opposed to the risk. Apart from that, the principle of respect for persons denote the need to equally treat patients despite their mental capacity to make informed decisions. As a result, all efforts must be implemented to prevent any form of discrimination against them caused by their involvement in such activities (Miracle, 2016). Finally, justice refers to fairness, where burdens and benefits must be shared equally among all participants and stakeholders of the research (Miracle, 2016). For instance, the selection of participants must be based on appropriate criteria to ensure that racial and ethnic minorities are not selected due to their background but rather objectively.
Human research subjects provide essential services in the evolution of the medical field by participating in research. To prevent any potential risks and maximize the benefits of such studies, the participants must be protected by law and professional practice. IRBs exist to protect human research participants by reviewing the proposals prior to their start and constantly monitoring them. The Belmont Report outlines the guidelines to be used in the selection and the processes used under these types of research. The three main principles recommended by the report include justice, beneficence and respect for persons. The value of human life cannot be quantified, thus, there is the need to preserve and maintain it at all costs. Therefore, the measures put in place guarantee these protections by providing the guidelines to assist professionals, investigators and the participants in the research progression.
Grady, C. (2015). Institutional review boards: Purpose and challenges. Chest, 148(5), 1148-1155. Web.
Miracle, V. A. (2016). The Belmont report: The triple crown of research ethics. Dimensions of Critical Care Nursing, 35(4), 223-228. Web.
Qiao, H. (2018). A brief introduction to institutional review boards in the United States. Pediatric Investigation, 2(1), 46-51. Web.
Resnik, D. B. (2018). The ethics of research with human subjects: Protecting people, advancing science, promoting trust. Springer.
Taraban, B. (2016). Institutional review board review of clinical research. The Southwest Respiratory and Critical Care Chronicles, 4(15), 89-93. Web.
Whitney, S. N. (2015). Balanced ethics review: A guide for institutional review board members. Springer.