lOMoARcPSD|22517024
BUSI 418 Protecting Human Research Participants
Paper
International Business (Liberty University)
lOMoARcPSD|22517024
1
Protecting Human Research Participants
School of Business, Liberty University
BUSI 418: Research and Evidence-Based Practice in Healthcare
lOMoARcPSD|22517024
2
Protecting Human Research Participants
Everyone in research is responsible for human subjects. After many years of cruel
experiments, people began to talk, and the media did the talking for them. When the
publicity started, and more thought was given to protecting human research subjects,
congressional meetings began to happen. After many years of going back and forth, laws and
regulations were passed to oversee human subjects' protection; this is when the Institutional
Review Board (IRB) was formed. When starting clinical trials, patients tend to acquaint
themselves for many reasons. Some do it to better the future of healthcare and others
participate because they think their health will improve. While there are many reasons one
engages in clinical research, human subjects are given privacy, with no harm done and
treated fairly. It is the researchers' responsibility to get a signed consent form from the
patient even if it’s just an interview.
Institutional Review Board
Under FDA regulations, IRB is a group of individuals designated to review and monitor
the research proposals involving human subjects. The group must consist of at least five
members. "The IRB is a committee composed of at least five members who have sufficient
experience, expertise, and diversity to make an informed decision on whether the research is
ethical, informed consent is sufficient, and appropriate safeguards have been provided"
(Westlake, Taja, 2012, p.66). These members have varying backgrounds of one who has
professional experience to provide a scientific and ethical review. They must complete basic
training through the National Institutes of Health (NIH) or the Collaborative Institutional
Training Initiative regarding human subjects' protection. The committee should consist of men
and women and at least one community member who is a scientist and nonscientific concerns.
lOMoARcPSD|22517024
3
“In 1991, the Federal Policy for the Protection of Human Subjects, or “Common Rule,” was
codified as 45 CFR part 46, subpart A and required the establishment of IRBs to review all
research in agencies receiving any federal funding” (Hall, Roussel, p.99). The common rule also
states the need for overly increased protection for the more vulnerable population, such as
children, pregnant women, and prisoners. The IRB has a complete say to review, approve,
require modifications for, or disapprove of a study. “Independent review of clinical research by
an IRB is required for US studies funded by the Department of Health and Human Services
(DHHS) and other US federal agencies, as well as for research testing interventions such as
drugs, biologics, and devices that are under the jurisdiction of the US Food and Drug
Administration” (Grady, 2015, p.1148). Not all institutions or research labs have their own IRB
committee, but they should seek one to be responsible for initial and continuing review of
studies. Researchers are to have their projects and informed consents reviewed regularly to
ensure that they follow the correct protocols, policies, and procedures.
Ethical Principles
The ethics of research are usually ensured through an IRB review. IRB are to safeguard
the morals and govern the behavior of the researchers and their projects. According to Sontag
(2012), “Moral constraints function quietly in the background, shaping the projects that
researchers choose to pursue, the questions asked, and the theories that result from that research.
Theories rise and fall with shifting standards in research ethics” (p.78). Researchers have many
protocols to follow before, during, and after all, research and failure to disclose new findings will
result in IRB's willingness to consent to a study. “Lack of clarity regarding such key terms as
‘‘risk,’’ ‘‘harm,’’ and ‘‘research’’ has led naturally risk-averse IRBs to interpret these notions
very broadly” (Sontag, 2012, p.76). Any new findings are the investigator's responsibility to
relay to
lOMoARcPSD|22517024
4
that participant, which could affect their willingness to continue. Participants must be informed
of alternative treatments that they may consider in their decision.
Ethics also deals with privacy. Privacy relates to how the researcher approaches the
potential participant and does not make them feel that they stand out in the crowd or have
particular characteristics. Privacy is the right of the participant to have control of what other
people know about them. Another part of ethics falls under informed consent. Informed consent
shows that the participants have voluntarily chosen to disclose certain information with the
investigators. At this point, its best the investigator applies for a certificate of confidentiality to
protect the participants' privacy and against any compulsory legal demands, such as court orders.
Research and Quality Improvement
Quality improvement is a significant contributor to the acceleration of evidence-based
practice. QI can also be the most significant factor that a trial can fail through presentations. Still,
after asking many questions, one can gain lots of general knowledge to meet the review criteria.
QI projects within a healthcare system are developed to test the efficiency and effectiveness of
improving the healthcare system. “Using the implementation science framework focusing on the
participatory implementation process, many clinicians are working alongside their academic
partners engaging in quality improvement activities to improve healthcare processes and patient
outcomes" (Patel, Stevens, Puga, 2013, p.1). Investigators conducting a QI project must know
the definition of research and why they should submit their proposal to IRB for review to prevent
errors and ensure that care standards are being met.
Types of IRBs
While protecting human participants' rights, the investigator must know what type of
review the research falls under. Research projects can fall under three structured levels of a full
lOMoARcPSD|22517024
5
board review, expedited or exempt. The first, full review applications are studies greater than
minimal risks, such as topics that include vulnerable populations or drug studies. The studies do
not qualify for exempt or expedited categories. The full committee must read, consider, question,
and vote to approve, modify, or disapprove the protocol. Second, expedited review. Expedited
means that it can be done by a single qualified member if IBR, with minimal risk subjects.
Minimal risk is known as just living everyday life as you would typically with no harm or
accident. And lastly, the exempt review. Exempt means the research does not involve human
participants, and no one is at risk, and subject identifiers must be protected. "Exemption is
determined by the IRB, not the investigator” (Heflin, DeMeo, Nagler, Hockenberry, 2016,
p.56).
Purpose of the Institutional Review Board
The IRB’s primary purpose is to regulate research protocols, protect patients from harm
within a clinical trial, and ensure that measures are taken to reduce risks. “The committee
determines that the risks to subjects are balanced by the potential benefits to society, and that the
subject selection process represents an equitable distribution of risks and benefits to eligible
subjects” (Westlake, Taja, 2012, p.66). More reason that the IBR exists is that many individuals
have been harmed in the process. No research such as interviews, screenings, and even
procedures cannot begin until IBR has evaluated, examined, and approved the research. When
the research process does begin, IBR stays in the process until the end. They will assess the
study once a year until done. The investigator is responsible for all consents and doing no harm.
Suppose the investigator decides to make changes during the trial, IRB must be notified
immediately, and they must approve first before the study continues. IRB has federal regulations
and rules to follow for federally funded research, and at any point, the research does not meet the
lOMoARcPSD|22517024
6
standards of approval, IBR has the power to defer or completely withdraw all permission for
investigation.
The Belmont Report
The Belmont Report serves as a guide for every research plan and provides important
distinctions between research and practice. “The Belmont Report serves as the guiding ethical
document to protect the rights of human subjects and participants involved in research and may
be applicable in many areas of health care, not only research” (Miracle, 2016, p.223). Three
principles must be taken in to consideration that involve, beneficence or nonmaleficence, respect
of persons, and justice or equality of burden.
The first principle of the Belmont Report is beneficence. Beneficence ensures that the
study does no harm, and although there may be some risks, it says that it should decrease
possible adverse while not increasing potential benefits. People that agree to the research should
be made aware of all possible adverse events if known. This information must be known so that
participants can make an informed decision about the treatment, if any. The second principle of
the Belmont Report is respect for persons. Respect for persons is just ensuring that one has
voluntarily agreed to be a part of the research based upon an informed consent including the
risks, benefits, the right to withdraw and that they are not a suffer if they decide not to be a part
of the clinical trials anymore. Humans have the right to make their own decisions and choices to
determine if they want to participate in the research. Since the Belmont report also serves in
other healthcare areas, this has been used when patients have the right to choose which
treatments and medications they use prescribed by their physician. Also, under respect for
persons, are the vulnerable. The vulnerable are persons who need more protection, such as
children or the mentally disabled. When given all information, an autonomous person, given
lOMoARcPSD|22517024
7
their choice, must be honored and respected. The third principle of the Belmont Report is justice.
Justice is reflected in all persons to be treated fairly and equally. This is especially true in
healthcare where no single group or vulnerable population is discriminated upon. When
participants A receives a medication, so should participant B without any special treatment.
When participants agree to a research trial, they must know that they can stop treatment and still
be treated fairly. They are not to be misled in thinking that participation will guarantee a cure
even though the informed consent does not completely state this belief.
One unethical approach was that of a Tuskegee Study. It conducted a study in African
American men in Alabama to determine the course or progression of syphilis without their
consent. All subjects with syphilis were never told of their diagnosis, nor informed of the
experiment, and were not offered treatment. “Other unethical studies included using mentally
disabled children in a hepatitis trial, and another involved injecting live cancer cells into patients
with chronic diseases” (Miracle, 2016, p.224). The doctors of this study were only looking out
for there own interest. The Bible tells us in Philippians 2:4 Let each of you look not only to his
own interests, but also to the interests of others. I’m sure these doctors would not have wanted
this done to them.
Conclusion
IRBs have an essential role in protecting human research participants from possible harm.
There will always be controversy over the best methods and ways to handle the protection of
human participants. In many cases, if the research weren't protected or given the risks, no one
would want to participate. With the right people in place under the IRB and following the
Belmont Report, approvals will continue to happen when the proper protocols in place when
addressing human subjects or denials when a researcher is unsure of the right steps or using
lOMoARcPSD|22517024
8
unethical ways. “Knowledge is power, and comprehension of the necessity of IRB and ethical
review can only strengthen our multidisciplinary healthcare environments” (Hall, Roussel,
p.116). Evolving healthcare is the key to the future and must be done in a respectful way other
than using the vulnerable without know consent. QI projects still must be done promptly to
facilitate innovation that comes from it. IBR has evolved, and overall, research subjects appear
better protected than ever. We must treat others the way we expect to be treated.
lOMoARcPSD|22517024
9
References
Grady, C. (2015). Institutional Review Boards. Chest. 148 (5). 1148-1155
Hall, H. R., & Roussel, L. A. (Eds.). (2017). Evidence-based practice: An integrative approach
to research, administration, and practice (2nd ed.). Burlington, MA: Jones & Bartlett.
Heflin, M. T., DeMeo, S., Nagler, A., & Hockenberry, M. J. (2016). Health Professions
Education Research and the Institutional review Board. Nurse Educator. 41 (2). 55-59.
Miracle, V.A. (2016). The Belmont Report: The triple Crown of Research ethics. Dimensions of
Critical Care nursing. 35(4). 223-228.
Patel, D.I., Stevens, K. R., 7 Puga, F. (2013). Variations in institutional review board approval in
the implementation of an improvement research study. Nursing Research and Practice.
2013(548591),1-6.
Sontag, M. (2012). Research Ethics and institutional review boards. Polictics and the Life
Sciencies. 31(1-2). 67-69
Westlake, C., taha, A.A. (2012). The institutional review board: Purpose and process. Clinical
Nurse Specialist.26 (2). 66-70.
