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PROTECTING HUMAN RESEARCH PARTICIPANTS
1
Protecting Human Research Participants: Role and Significance of Institutional Review
Boards (IRBs)
Student’s Name
Institutional Affiliation
PROTECTING HUMAN RESEARCH PARTICIPANTS
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Abstract
Human research is critical for developing scientific knowledge, but it also raises ethical
concerns about participant protection. This study examines the significance of protecting human
research participants and the critical role that Institutional Review Boards (IRBs) play in
ensuring ethical standards and regulatory compliance. This study explores the roles of IRBs, their
composition, review processes, and the issues they face in combining scientific advances with
participant protection, drawing on ethical principles and legal frameworks.
PROTECTING HUMAN RESEARCH PARTICIPANTS
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Protecting Human Research Participants: Role and Significance of Institutional Review Boards
(IRBs)
Research involves a thorough exploration with the goal of gaining knowledge that can be
applied broadly. The challenging journey to find effective treatments for diseases and various
conditions is complex. Scientific research leads to groundbreaking discoveries that enhance life
quality, extend survival, and can even save lives (Czubaruk, 2019). Human research participants
play a crucial role in this effort. Investigators must ensure they safeguard the rights and lives of
these participants. The significance of this responsibility is rooted in the belief that research
should be conducted ethically, prioritizing the well-being and rights of each subject in a
protective environment. Human-participant research has made substantial contributions to
scientific and medical progress. However, ethical issues have taken precedence in order to
protect the well-being, autonomy, and rights of those engaging in research. The formation of
Institutional Review Boards (IRBs) is a critical step in protecting participants and sustaining
ethical standards in research settings.
Institutional Review Board
The Institutional Review Board (IRB) is a committee required by the government and
managed locally. It has experts with the knowledge and skills to make sure that participants in a
research study are not harmed. The board consists of five members, including both scientific
experts and members of the public, each coming from different backgrounds. One member
cannot be a scientist, and another cannot be associated with the institution conducting the
research. Additionally, each member is trained in their field to oversee research activities
effectively. In safeguarding human research participants, IRBs play a crucial role to prevent
potential harm and exploitation (Grady, 2015). The IRB has the power to approve, request
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changes for approval, or reject research altogether. However, the IRB doesn't solely protect
research participants; they operate within universities, institutions, and organizations like the
Mayo Clinic the Food and Drug Administration.
Ethical Principles and Regulations
An IRB review is commonly used to ensure the ethics of research. Ethical principles in
clinical research are established not only to protect participants but also to maintain the study's
integrity. It is considered unethical to use individuals only as a means to an end. The relationship
between human subjects and investigators is crucial and should be built on respect, trust, and
honesty. Moreover, ethical research should adhere to principles such as respect for potential and
enrolled subjects, independent review, a favorable risk-benefit ratio, fair subject selection,
informed consent, ethical and social value, and scientific validity. As articulated in papers such
as the Belmont Report, the ethical principles guiding research involving human participants
stress respect for humans, beneficence, and fairness (Beauchamp, 2008). These principles serve
as the foundation for building regulatory frameworks, such as the Common Rule in the United
States and equivalent standards around the world that demand research subject protection.
Research and Quality Improvement
Quality improvement (QI) involves organized, data-driven activities aimed at making
immediate enhancements in the delivery of healthcare in specific settings (Spraycar, 2021). It
includes assessing and learning from experiences to determine the impact of practice changes on
outcomes. Quality care prioritizes fairness, effectiveness, efficiency, safety, timeliness, and
patient-centeredness. QI encourages healthcare professionals to think creatively and find
innovative ways to enhance healthcare systems (Hall & Rousell, 2017). Continuous review and
monitoring occur throughout the research study's course. Regular checks ensure the welfare of
PROTECTING HUMAN RESEARCH PARTICIPANTS
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participants, allowing for adjustments in case of unforeseen circumstances, participant decisions,
changes in clinical status, emerging information, and adverse reactions. If errors or issues,
especially involving human subjects, are identified, the study may be paused, corrections made,
treatment provided, or participants removed to improve future outcomes based on the gathered
data.
Types of IRBs
Various types of IRB reviews exist, and the IRB determines which review is necessary
for a study. The three main types are full reviews, expedited reviews, and exempt reviews. Full
reviews are necessary for studies with inherent risks, such as population studies with vulnerable
individuals, those involving sexual behavior, and drug studies. Full reviews are also required for
studies involving individuals with a capacity impairment, data collection about illegal behavior,
prisoners, and children under 18. Expedited reviews apply to studies with minimal risk. Exempt
reviews don't involve human subjects and, therefore, don't pose any risk to them.
Role of the Institutional Review Boards
IRBs evaluate research protocols to verify compliance with ethical standards and
regulatory obligations. IRBs, which are made up of interdisciplinary members, perform rigorous
reviews of research proposals, taking into account risks, benefits, informed consent processes,
and participant anonymity. Their control extends to current trials, which they monitor to ensure
participant safety. It has a mission to protect human participants, safeguard public health, and
uphold ethical research (Grady, 2015). They are responsible for adhering to policies, regulations,
and laws related to studies involving human subjects. In research involving human subjects,
IRBs hold significant control and power, and that is why the decisions made by IRBs carry
significant consequences for the subjects, investigators, and the general public (Lynch, 2018).
PROTECTING HUMAN RESEARCH PARTICIPANTS
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Before any procedures can commence, the IRB must thoroughly assess, evaluate, and approve
the research, considering the risks and benefits for participants. Ensuring the welfare and rights
of human subjects is a key responsibility of the IRB. They closely monitor research to ensure
ongoing compliance with ethical standards. Additionally, the IRB conducts periodic reviews to
address any potential issues or situations that could violate their rights or jeopardize the well-
being of participants.
Challenges and Considerations
People are expressing dissatisfaction with the IRB system due to worries about
inconsistencies in the review process and how federal regulations are applied. Some believe that
the IRB review takes too much time and is burdensome, and there's not enough clear proof that it
effectively safeguards the well-being of human subjects (Grady, 2015). While IRBs act as
custodians of ethical research, they face difficulties in balancing scientific progress with
participant protection. In ethical concerns, complications arise when assessing risks, assuring
informed consent, and managing cultural or contextual variances. Furthermore, developing
technology and procedures necessitate the ongoing modification of ethical principles.
The Belmont Report
The Belmont Report, crafted by the National Commission, aims to establish widely
accepted principles for safeguarding human subjects in research. The three main principles it
relies on are justice, beneficence, and respect for persons (Beauchamp, 2008). Justice, focuses on
ensuring fair treatment for all participants. This includes preventing exploitation, particularly of
those who may be easily influenced or have limited capacity due to their circumstances.
Beneficence, akin to the Hippocratic Oath of "do no harm," involves maximizing benefits and
minimizing risks. Respect for persons involves upholding participant autonomy and ensuring that
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each participant fully understands the benefits and risks of the research. Participants must
provide consent willingly and without pressure.
Conclusion
Human study participants' safety is critical to ethical research techniques. Institutional
Review Boards play an important role in sustaining ethical standards, ensuring regulatory
compliance, and protecting participants' rights and well-being. Maintaining the integrity of
human research requires adhering to recognized ethical norms and encouraging constant
examination and adaptation. In short, the IRB ensures that no sacrifices are made without
consent, without awareness, or under false pretenses.
PROTECTING HUMAN RESEARCH PARTICIPANTS
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References
Beauchamp, T. L. (2008). The belmont report.
The Oxford textbook of clinical research ethics
,
149-155.
Czubaruk, K. (2019, October 17).
The Belmont Report: What is it and how does it relate to
today’s clinical trials?
Cancer Support Community. Retrieved November 21, 2023, from
https://www.cancersupportcommunity.org/blog/2019/10/belmont-report-what-it-and-
how-does-it-relate
Grady, C. (2015). Institutional review boards: Purpose and challenges.
Chest,
148(5), 1148-1155.
Hall, H. R., & Rousell, L. A. (2017). Evidence Based Practice: An Integrative Approach to
Research.
Administration and Practice.(2nd ed.) Burlington: Jones& Bartlett Learning
.
Lynch, H. F. (2018). Opening closed doors: Promoting IRB transparency.
The Journal of Law,
Medicine & Ethics,
46(1), 145-158.
Spraycar, A. (2021). Quality Improvement vs Research. Quality Improvement vs Research |
CHOP Institutional Review Board.
https://irb.research.chop.edu/quality-improvement-
vsresearch
.