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Protecting Human Research Participants
Student’s Name
School of Business, Liberty University
BUSI 418: Research and Evidence Based Practice in Healthcare
Professor’s Name
Put the due date here. Spell out the month, followed by the day and year.
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Protecting Human Research Participants
Type an introduction explaining a brief overview of the topic here. It should only be one
paragraph, typically less than one half to one page. The introductory paragraph is to include a
comprehensive explanation of protecting human participants in research. The information should
be engaging and offer a clear purpose of the importance of protecting human participants in
research. Do not use the word, “introduction” in this section. For this paper, do not include an
abstract. Paragraphs all have the first line indented 0.5 inches. Everything is double spaced with
no extra spaces between paragraphs. For APA 7th ed., there is to be only ONE space after a
period or punctuation mark at the end of a sentence before the next sentence begins. This paper is
to be at least four pages, but no more than eight pages. This does not include the title page or the
reference page(s). The references should be in alphabetical order according by the first author’s
last name. You need to include at least five peer-reviewed articles published within the past 10
years and at least one citation for the textbook directly related to the topic of protecting human
research participants. You are to include a biblical integration at any point that is appropriate in
the paper or in the conclusion. Remember that biblical integration is more than just quoting
Scripture. For each topic in this paper, once you have read the instructions, erase them and put
your discussion of each topic in place of these instructions. Do not add extra spaces between
headings and paragraphs.
Institutional Review Board and Purpose
Define the Institutional Review Board (IRB) in this first section. Explain the purpose of
the IRB. Note in the first sentence in this paragraph how I spelled out word(s) that I want to
abbreviate and followed with the abbreviation in parentheses. After this point, I can now use just
the abbreviation IRB alone in the rest of the paper.
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Ethical Principles
In this paragraph, identify ethical principles that are foundational to the IRB process.
Research and Quality Improvement
In this paragraph, describe and discuss the link between research and quality
improvement (QI) as they relate to the IRB process. You can find this information in the
textbook and possibly in peer-reviewed journal articles.
Types of IRBs
In this paragraph, describe the types of IRB reviews. You can find this information in the
textbook.
The Belmont Report
In this paragraph, explain and discuss the Belmont Report. What are the three primary
principles on which the Belmont Report is based? Describe each. You can find this information
in the textbook. You may want to include examples or explanations of experiments involving
human participants that did not protect the subjects. You might find more on these experiments
in peer-reviewed journal articles.
Conclusion
In the conclusion, give a summary of the main points that is clearly articulated. A clear
and relevant description is to be offered regarding the importance of protecting human research
participants and why. If you have not included a Christian world view or biblical integration
elsewhere in the paper, you could include it here. Remember, if you quote Scripture, you must
explain how it is integrated into the topic.
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References
Buckner, E. B., Hall, H. R., Roussel, L. A., & Jones, C. T. (2017). Navigating the institutional
review board. In H. R. Hall, & L. A. Roussel (Eds.), Evidence-based practice: An
integrative approach to research, administration, and practice (2nd ed.) (pp. 99-124).
Jones & Bartlett.
Include all references here in current APA formatting and in alphabetical order, including a
reference for the version of the Bible used. Delete this instruction from the reference list.
BUSI 418
PROTECTING HUMAN RESEARCH PARTICIPANTS ASSIGNMENT INSTRUCTIONS
OVERVIEW
Write a scholarly paper discussing the topic of Protecting Human Research Participants and the
Institutional Review Board (IRB). A template in APA format is provided for you. This template
provides you with headings of the topics to be discussed. It must be submitted on this template
and must be submitted as a word document. Do not change the format to a pdf or any other
format when saving it and submitting it.
INSTRUCTIONS
The paper should include the following:
The entire paper will be set up with current APA formatting of page numbers, title page,
body of paper, bolded headings, and reference list. Using the template provided will help
ensure the paper is formatted correctly.
Introductory paragraph (with the heading being the title of the paper in bold font). The
introductory paragraph includes a comprehensive explanation of protecting human
participants in research. The information is engaging and offers a clear purpose of the
importance of protecting human participants in research.
In the content, there is a clear explanation of the IRB, including the purpose, ethical
principles, research and quality improvement, types of IRBs, and the Belmont Report are
comprehensively discussed.
Christian World View or Biblical Integration is present, is appropriate to the topic, and
includes an explanation of how it is related to the study.
A conclusion will include a summary of the main points that is clearly articulated. A clear
and relevant description is offered regarding the importance of protecting human research
participants and why.
A minimum of 4 pages but no more than 8 pages, not including the title page and the
references
Do NOT include an abstract
At least 1 citation/reference from the textbook
At least 5 peer-reviewed journal articles as sources. (The peer-reviewed journal articles
for this assignment may be up to 10 years old.)
A Christian world view and/or Biblical integration.
References start on a separate page. The template is formatted with a page break so this
will happen automatically if you do not change the template.
References are all to be in current APA format, hanging indents, and double-space, like
the rest of the paper, with no extra spaces between any of them.
References must be alphabetical order by the last name of the first author listed in each
article.
Note: Your assignments will be checked for originality via the Turnitin plagiarism tool. The tool
is a starting point for instructors to check overall Academic Integrity and higher scores generally
indicate a higher probability of Academic Misconduct. The higher a score the higher the
probability that there are too high a percentage of quotations included in the narrative, and/or
there are passages that have not been properly cited.
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Protecting Human Participants in Research
Author
Institution
Course
Tutor
Date due
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Protecting Human Participants in Research
Human protection is critical in ensuring the safety of participants in research. Various
laws and policies have been established by authorities to ensure humans are safe at all costs
when conducting research (White, 2020). Some studies have shown that dilemmas can occasion
research entailing humans. When determining or understanding some diseases and how to
prevent their occurrence, investigators use humans because the outcome of the investigation is
equally important to protect the entire human race, apart from the sampled participants (White,
2020). Using human subjects presents an ethical dilemma because studies sometimes subject
participants to risks. For example, in controlled studies, participants might be subjected to
potential risks with no benefits. To ensure that human subjects are safe, the Institutional review
boards (IRBs) were established by the federal government and assigned with the mandate to
review research involving human participants (White, 2020). It makes sure the studies implement
the use of all protocols that meet the ethical guidelines before enrolling human subjects in the
study. Human protection has evolved over time since the 17th century. For example, in 1717, the
wife of a British ambassador to Turkey, Mary Wortley became an advocate of variolation after
learning about Constantinople (White, 2020). It is through her return to England that she initiated
a human protection policy. This research paper shall discuss what Institutional Review Board
(IRB) is, its mandate, the ethical principles involved in human subjects studies, research and
quality improvements, and brief analysis of the Belmont report. The information will be essential
in helping the audience understand the importance of human subject protection and the various
agencies or boards established to protect them.
Institutional Review Board and Purpose
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The Institutional review board is a group under the Food and Drug Administration (FDA)
regulations designated to review and monitor biomedical research involving human participants.
According to FDA regulations, Institutional Review Board has the power to approve, require
modifications, or disapprove research if it does not meet the human protection requirements
(FDA, 2019). According to (Grady, 2015), Institutional Review Boards (IRBs) is also known as
research ethics committee that provides core protection to all human subjects through advanced
and periodic independent review of the ethical acceptability of human-involved research
proposals. The primary purpose of IRBs review is “to assure, both in advance and by periodic
review, that appropriate steps are taken to protect the rights and welfare of humans participating
as subjects in the research” (Grady, 2015).
Ethical Principles
Three ethical principles form the foundation of the IRB process. The three principles
include respect of persons, beneficence, and justice. The principle of respect for persons
incorporates at least two ethical convictions (HHS.gov, n.d.). The first one requires that
participants be treated as autonomous agents while the second requires that diminished persons
be accorded protection. The concept of autonomous persons are individuals capable of
understanding personal goals and acting in a provided direction (HHS.gov, n.d.). Respecting
autonomy is providing autonomous individuals a space to air their opinions and choices while
refraining from obstructing their actions.
The beneficence principle requires the human subjects to be treated with ethics,
respecting their decisions and protecting them from any potential harm (HHS.gov, n.d.). It also
requires researchers to secure the well-being of participants. Therefore, this principle protects
human subjects from any potential harm. It provides researchers with the moral responsibility of
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protecting human subjects at all costs; whether physical or psychological. The last principle of
ethics is justice. The Justice principle requires all participants to receive all the benefits of
research (HHS.gov, n.d.). It provides room for fairness and equal distribution. It is an injustice if
the benefits entitled to an individual participating in the research are denied without good reason.
In the event of providing unequal benefits, one needs to explain to all participants of their
decision. There are several formulations established to ensure fairness and equal distribution of
benefits.
Research and quality improvement
Research is a “systematic investigation designed to contribute to a generalized
knowledge” (Foster, 2013). The research findings are not intended for immediate clinical use but
for future evaluations and upgrades of clinical practices. On the other hand, quality improvement
is improving services or products to provide quality and effective ones (Foster, 2013). It is
defined as a systematic framework of data collection with the purpose of immediate
improvement or achievement of a particular desired goal. For instance, in a healthcare setup,
quality improvement brings changes immediately. Researchers have tried to establish methods
that will breach the gap between research and quality improvement (Foster, 2013). However,
before the actualization of quality improvement, research needs to be conducted to establish its
effectiveness in healthcare. It is through research that most interventions and processes are
evaluated to be effective. After the research findings, a decision is then taken for quality
improvement. The link between quality improvement and research is that they both aim at
improving services or products (CHOP Institutional Review Board, 2019). In general, both
research and quality improvement are systematic investigations involving human subjects.
Although they have similarities, they also have differences in terms of their design and benefits.
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Before quality improvements are approved, IRBs need to evaluate them. Approval by
IRB is required when the involved activities seek to develop new knowledge or validation of
new treatments than assessing the existing knowledge (CHOP Institutional Review Board, 2019).
In case there is a delay in the implementation of results, IRB has to be involved. Therefore, there
are many areas of quality improvement activities that need approval from IRBs.
Types of IRBs
There are different types of IRBs, namely; exempt, expedited, and full board review. The
exemption review consists of self-determination and limited review. Self-determination is where
the principal investigator is allowed to issue a system-generated exemption determination letter
based on the responses to questions asked within the qualifying human subjects exemption
category. It is important to note that the IRBs do not review self-determined projects, but the
investigator chooses to submit a study to the IRB for exemption determination (The College of
New Jersey, 2020). On the other hand, limited IRB reviews are an expedited review process. It
ensures that privacy protections are in place with exempt research when collecting or using
sensitive data. The exempt review has eight categories.
Expedited review is where studies involving minimal risks and do not meet ny of the
exempt category criteria are incorporated. Minimal risk is the probability and magnitude of harm
anticipated when conducting research. The expedited review involves collecting data from video,
audio or images made for research purposes, researching individuals, group characteristics, and
behavior by following established methodologies and having minor changes (The College of
New Jersey, 2020).
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A full board review is used when research involves more than minimal risks to human
participants (The College of New Jersey, 2020). Regardless of the risks, the IRB will require a
full board to review the research involved to establish the vulnerable populations, sensitive
topics, research involved, and research design. All these components are checked to ensure
human subjects are safe.
The Belmont Report
The Belmont report provides a summary of the basic ethical principles established by the
Commission when conducting research. The report was documented after discussions were held
by the Smithsonian Institution’s Belmont Conference Center in 1976 (HHS.gov, n.d.). The report
states that some of the ethical principles required to be implemented when conducting research
include respect of persons, beneficence, and justice (HHS.gov, n.d.). Before it details the
principles, the report defines the boundaries between practice and research. It is important to
distinguish between behavioral research and biomedical research so as to understand the kind of
review to implement. The report describes that research is a formal protocol with objectives and
procedures.
Respect for persons ethical principles requires researchers to respect and treat individuals
as expected (HHS.gov, n.d.). Participants can be either autonomous agents or categorized as
diminished people with autonomy entitled to protection. Beneficence is a principle where the
participants have to be provided with al benefits associated with the study equally. Researchers
are prohibited from conducting the study unfairly or distributing benefits in unequal propositions
to human subjects (HHS.gov, n.d.). Lastly, justice involves how issues are solved in the event
one gets injured while in the research.
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There are multiple examples where unethical research has been conducted globally. For
example, the Nazi medical experimentation in the 1930s and the Willowbrook State School
research in the 1950s conducted unethical research (Barrow et al., 2021). Participants were
exposed to diseases or subjected to unproven treatments in these studies. Therefore, there was a
need for policies to be established to guide how human subjects are to be treated when
conducting research.
Conclusion
Protecting humans is key to implementation of ethical principles stipulated in the
Belmont report. Although human subjects in a research are key to understanding and establishing
disease prevention measures, they need to be protected to ensure their future lives is guaranteed.
To safeguard the human participants in research, the Food and Drug Administration established
IRBs to review all research conducted involving human subjects. There are three types of IRBs:
exempt, expedited and full board review.
Christian World View or Biblical Integration
Similarly, the biblica context is also applied effectively in dictating the values and
processes of the human research participations. For instance, the biblical perspective has been
used effectively to provide a deeper knowledge of when, how and why the research is applied in
the behavioral studies structures. The more specific Christian world views in the human research
related concepts can be well applied in establishing a proper integration where Christianity and
research has described the concept that every method, step and type to the research results to a
closer truth that can be applicable in effectuating the posituive changes to the mankind while also
envouraging respect, willingness and discipline to please the lord in different pursuit (Ewest,
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2019). The biblical perspective thus is much applicable in dictating the behavioral essence in the
research processes that builds the feeling of ambiguity towards the relevane mainly in everydays
life scope. The biblical views are much applicable mainly in dictating the values of human
existence and their need in participating in the research practices in general since the bible
considers human research as a key progress in improving human health since the findings
accumulated through the research can be applied in other different life aspects.
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References
Barrow, J. M., Brannan, G. D., & Khandhar, P. B. (2021). Research Ethics. StatPearls.
https://www.ncbi.nlm.nih.gov/books/NBK459281/
Ewest, T. (Ed.). (2018). Faith and work: Christian perspectives, research and insights into the
movement. IAP.
CHOP Institutional Review Board. (2019). Quality Improvement vs Research. CHOP
Institutional Review Board. https://irb.research.chop.edu/quality-improvement-vs-research
FDA. (2019). Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical
Trials | FDA. FDA. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-
cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials
Foster, J. (2013). Differentiating quality improvement and research activities. Clinical Nurse
Specialist, 27(1), 10–13. https://doi.org/10.1097/NUR.0B013E3182776DB5
Grady, C. (2015). Institutional Review Boards: Purpose and Challenges. Chest, 148(5), 1148.
https://doi.org/10.1378/CHEST.15-0706
HHS.gov. (n.d.). Read the Belmont Report. HHS.Gov. Retrieved September 12, 2022, from
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-
report/index.html
The College of New Jersey. (2020). Institutional Review Board: Types of IRB Review . The
College of New Jersey. https://irb.tcnj.edu/types-of-irb-review/
White, M. G. (2020). Why Human Subjects Research Protection Is Important. The Ochsner
Journal, 20(1), 16. https://doi.org/10.31486/TOJ.20.5012
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