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A Population of Addiction

Scientific research is proud of the many fresh, contemporary


medical discoveries made possible by pharmacological, surgical, and
therapeutic methods. But the abuse of currently available prescriptions,
rather than the creation of new, life-saving drugs, is one of the most
important problems facing today's population. Healthcare has advanced to
the point where doctors are compelled to overprescribe drugs, particularly
potent opioids and pain relievers. America is also feeling the effects of an
increase in patient addiction situations. Unfortunately, little prior study
has been done on the most effective method of treatment for these
suffering patients because the outbreak is so recent. Additionally, it is
unknown how people who are dependent on such harmful drugs may
respond to clinical trials intended to study their disease. The ethical
ramifications of using research participants who are actively using mind-
altering substances at the time of study consent and throughout
participation will be examined in this essay. I think that working with
drug-dependent people is permissible as long as the consent procedures
are thorough, the patient is completely aware of what he or she is
consenting to, and the investigator and participant have an open,
reciprocal relationship.

Regarding participant consent, the Belmont Report, which outlines


the fundamental ethical guidelines for conducting a research study, states
that "Respect for persons requires that subjects, to the extent that they are
capable, be given the opportunity to choose what shall or shall not happen
to them" (Ryan et al., 6). The fundamental premise of upholding the
rights of human subjects is addressed by respect for persons. In research
with participants who are addicted, it is crucial to place focus on the
participant's capacity for consent. If the patient makes numerous other
life-related judgments while under the influence of drugs, it can be
inferred that this is their regular condition of function. The researcher
must keep the subject as at ease and informed as feasible about the
progress of the study, according to the report. The paper emphasizes the
need to "adjust the information presentation to the subject's capacities. It
is the responsibility of the investigators to determine whether the subject
has understood the material (Ryan et al., 7). Therefore, it is the
researcher's responsibility to modify its consent policy to be most helpful
and informative to the participant in these situations if the subject is under
the influence of drugs. Researchers "found evidence for previously
reported therapeutic misunderstanding components, as well as for two
key notions that differently influence comprehension of informed consent
information for the drug users in our investigation," as is clear from
earlier studies with addicted participants (Fisher, et al., 2). In this study,
patients' knowledge of research was compared between those who were
drug addicts and those who were sober. It implores research to offer
further protections against potential misunderstandings. A comprehension
test at the end of a consent package to ensure the participant knows all the
important information is one example of how to improve this initial stage.
To ensure that the subject has not overlooked any significant dangers or
benefits of the study procedure, another approach can involve having
them sign a continuous consent form that needs to be updated once a
month. In addition to making the patient feel more at ease and informed,
these procedures also make it possible for the researcher to move through
with the study without having to worry about violating any ethical
standards.

The Belmont Report makes particular observations regarding


participants with poor comprehension as well. A third party has been
suggested to be involved in consent for patients with significant
limitations: "Respect for persons also demands requesting the approval of
other parties in order to protect the subjects from harm. Thus, such people
are honored by accepting their own wishes and using third parties to keep
them safe (Ryan et al., 7). For people with considerable restrictions, this
argument is valid, but it doesn't seem to apply to participants who are
under the effect of opiates. A third party would not be required to sign
supplementary consent if the participants are still able to live freely while
taking the medication. Additionally, these research could not have a risk
that was significant enough for a third party to be involved because IRB
regulations forbid it.

The susceptibility of the participants in a study looking at drug


addiction is the main problem. They can participate in the project because
they are dependent on a harmful drug or medication. Given the urgency
of the issue, any benefit or reward can become more valuable if it is
provided quickly and effectively. As a result, volunteers may accept to
trials without fully considering the hazards because they believe it to be
their only alternative. "Inducements that would generally be permissible
may become undue influences if the individual is exceptionally
vulnerable," the Belmont Report cautions (Ryan et al., 8). With this
knowledge, researchers should make sure to inform patients about all
possible treatment options and point them in the direction of additional
support services if they decline a trial.
Additionally, there needs to be a good and encouraging rapport
between the researcher and the subject. There are varying degrees of trust
for drug users because many Americans who use medicines like opioids
might not be purchasing them legitimately. The patient might start buying
legally and progress quickly to other forms of use and harsher drugs like
heroin. Participants are not in a secure study environment if the
researcher publicly shames them or considers suing them. The techniques
of consent and the relationships between the subjects and the teams
should be courteous and trustworthy if thorough consideration of the
subjects is ensured from the outset.

The data on drug use show that a wide variety of people are
impacted by this pandemic. Despite these patterns, no one racial group,
social class, or gender accounts for all addicts. As stated in Do Drug
Users Have a Different Moral Voice? Addiction Research Ethics and the
Belmont Principles? "The life circumstances of people who regularly use
illegal drugs together with the socio-ecological setting in which addiction
science is done frequently present particular and unanticipated tensions
between diverse ethical precepts" (Fisher). Each patient who enrolls in
the research will have a unique experience. While maintaining the
integrity of a standardized study, it is crucial to show participants respect
and make an effort to cater to them specifically.

The aforementioned cases demonstrate that, despite the fact that


studies with opioid addicts can be very successful, there should be a
careful set of safeguards integrated into study standards for this subject
group's benefit. The consent process should be as transparent as possible
for the participants, and they should have an open line of communication
with the research team in the event that they have any questions or
concerns. Previous studies have shown that this population is vulnerable.
Therefore, while the general public learns more about this epidemic and
the people who battle addiction every day, further ethical research is
advised.
References

Fisher, C. B. (2011). Addiction research ethics and the Belmont


principles:
Do drug users have a different moral voice?. Substance Use &
Misuse, 46(6), 728-741.

Fisher, C. B., Oransky, M., Mahadevan, M., Singer, M., Mirhej, G., &
Hodge, D. (2008). Marginalized populations and drug addiction
research: realism, mistrust, and misconception. IRB, 30(3), 1.

Fry, C., & Dwyer, R. (2001). For love or money? An exploratory study of
why injecting drug users participate in research. Addiction, 96(9),
1319-1325.

Hall, W., Carter, L., & Morley, K. (2003). Addiction, neuroscience and
ethics [editorial]. Addiction (2003) 98: 867-870 doi:
10.1046. Addiction, 98, 867-870.

Israel, M. (2014). Research ethics and integrity for social scientists:


Beyond regulatory compliance. London, : SAGE Publications.

The National Commission for the Protection of Human Subjects of


Biomedical and Behavioral Research. (1979). The Belmont Report.
Ethical principles and guidelines for the protection of human
subjects of research. 1-10.

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