In-depth Analysis of Ethical Issues in Human Pharmacological Research

This report delves into the ethical considerations surrounding human drug trials, examining the pros and cons of pharmacological research, with a focus on ethical, integrity, safety, and risk issues. It highlights the importance of human consent, monitoring responsibilities, and data safety, while also addressing the vulnerabilities of clients participating in experiments. The report proposes response plans and solutions to mitigate these ethical concerns, including privacy rules, obtaining informed consent, protecting client rights, regulating researcher training, and establishing adverse medical reporting frameworks, ultimately aiming to ensure the safety and ethical treatment of human subjects in drug trials. The document is contributed by a student and available on Desklib.

Running head: Introduction to Research 1
INTRODUCTION TO RESEARCH
Student Name
Institution

Introduction to Research 2
Table of Contents
1. Introduction.........................................................................................................................................2
2. Background of the research.................................................................................................................2
3. Pros and cons of research....................................................................................................................3
3.1 Pros of human clinical trials research................................................................................................3
3.2 Cons of pharmacological research.....................................................................................................3
4. Ethical issues in human drug research.................................................................................................4
4.1 Ethical issues.....................................................................................................................................4
4.2 Integrity issues...................................................................................................................................5
4.3 Safety issues......................................................................................................................................5
4.4 Risk issues.........................................................................................................................................6
5. Response plan and solution to the issues and risks..............................................................................6
6. Conclusion...........................................................................................................................................8
7. References.........................................................................................................................................10

Introduction to Research 3
1. Introduction
Human drug trials have been an issue of concern for a time in history with many arguing
for or against the research. The bottom line is the ethical issues that are tied to the practice since
the research uses a human being as the subject for the experiments. The purpose of this research
is to explore human drug trials (pharmacological research) in ethics. Some of the expected
results include pros and cons of the research, ethical issues, risk issues, safety issues and integrity
issues. The research also seeks to presents response action on these issues with the solution to
these issues as the final aspect of the research. Therefore the research in totality looks into ethical
issues within the pharmacological research involving human subject.
2. Background of the research
Ethics is a broad area that affects nearly every aspect of daily life as it defines the moral
and acceptable code or standard of practice in the particular field. Pharmacological research
forms an important step in the clinical investigation leading to the production of a drug that treats
a specific disease or clinical situation. The research uses the human subject for trials and this
may involve taking of drugs, surgery or organ donation. Clinical trials that involve human
subject require high caution and ethical considerations. The research may also include data
collection and analysis before reporting on the result of the trial. For instance, in Australia,
various drug trials have been conducted according to Australian Clinical Trial (2016). Cancer
trials, for example, take more than 10years, one such trial is ALTTO (a study comparing
Trastuzumab and Lapatinib (a new drug)). The research in ethics that investigate human drug
trials serve the purpose of highlighting the pros and cons of pharmacological research, ethical
issues, integrity issues, risk issues and response action coupled with a solution to such issues.

Introduction to Research 4
The expected results include various ethical issues in pharmacological research and the expected
solutions to such issues (Nardini 2014, pp 387).
3. Pros and cons of research
3.1 Pros of human clinical trials research
There are many different advantages or benefits of human drug trial research as this gives
rise to a new treatment or improve existing treatment. Firstly, the research helps others to get
treatment for a particular disease (Howick 2011, pp 18–31). The drug trials though have ethical
issues, has a high potential for treatment for the specific clinical condition under investigation.
Pharmacological research is helpful for getting treatment for clinical situations that has not be
treated or those conditions that need improved treatment. Secondly, the pharmacological
research helps in improvement of future treatment for the specific disease. Some biomedical
research needs further improvement and this can be done through continuous research. Elements
of treatment such as organs that are used in pharmacological research are critical for future
research and medical improvement. Thirdly, pharmacological research has the potential of
improving prevention and cure of some deadly diseases (Maitland & Schilsky 2011, pp 365-81).
3.2 Cons of pharmacological research
Pharmacological research may be associated with some disadvantages that need serious
improvement. Firstly, the research may not lead to actual treatment as this is just an experiment
that is still progressive. Some trials may produce a result that is not as expected and therefore
discarded as treatment may also not better than the previous treatment (Deng, Hanna, Dalakas &
Merkies 2012, pp 348-52). In such case, the client may feel used up without any advantage of

Introduction to Research 5
treatment. Secondly, the pharmacological research may have side effect or risk that are
connected to the experiment. Pharmacological research though of high-risk management strategy
may have some negative implication on human life as the risk not always assured. Moreover, the
investigators need to prevent such unprecedented events that may also result from body reaction
to new drugs or allergic reactions to treatment. Thirdly, the drug may not work as the normal
drugs hence wastage of time spend on research. Human experimentation may result in result
whose integrity is questioned and therefore not useful (Wistuba, Gelovani, Jacoby, Davis &
Herbst 2011, pp 135-41).
4. Ethical issues in human drug research
4.1 Ethical issues
There are many different issues that touch on the ethics in human drug trials and these
issues need proper considerations.
Firstly, human consent is an issue as many research shows that there is need to first seek
personal consent before involving human in drug trials. The basis of the human concern is to
ensure that those under experimentation are aware and accepted to take part in the
pharmacological research (Teira & Reiss 2013, pp. 207–24). Secondly, monitoring of the
overlapping responsibility ensures that personal. There are many parties that need to show
responsibility in monitoring research and these include institution where the trial takes place, an
individual taking the research and the researcher that need to monitor the experiment or data.
Thirdly, safety concerns of an individual and data safety in human drug research are another
important ethical concern. Finally, researcher’s training plays an important role in a human drug

Introduction to Research 6
trial that raises many concerns. The research that are conducting trials needs to be well trained to
ensure there is no error that may lead to complications (Teira 2011, pp 255–297).
4.2 Integrity issues
The integrity of parties involved in the experiment has been a matter of debate since
human drug trials need an extra care. One of the reasons for integrity concern is the safety of the
data that is obtained in the experiment as there is need to monitor data collection and
experimentation in general. This is also touching on the integrity of the client used in the
experiment as some may opt out of the experiment before completion of the trials. This is
detrimental not only to the client but also to the researcher. Patient willing to participate in trials
is good as it improves the integrity of the data obtained from the research. Lastly, the integrity of
the data obtained is important as it determines the usefulness of the data and any future
improvement of the clinical condition under experimentation (Sharma & Schilsky 2012, pp 208–
14).
4.3 Safety issues
The safety issue is another ethical issue that has been shaping human drug trials. One of
the areas that present safety concerns are the safety of human data gained from the experiment as
people fear risk associated with their health data being in the hand of an unsafe person.
Moreover, the data need monitoring responsibility to ensure that people used in a drug
experiment does not lose data due to negligence and misused. This makes those people that
participate in pharmacological research feel used for the wrong purpose when their data fall on
the hand of wrong persons. In addition, some other safety issues are based on the ability of

Introduction to Research 7
researchers to carry out experiment without error that may interfere with the human body and
normal physiological functioning (Fleck 2010, pp16–18).
4.4 Risk issues
Another ethical issue in a human drug trial is a risk that the human is subject to. There
has been a critical concern about the risk that may be associated with human experimentation
that may occur during pharmacological research. The central concern has been the venerability
of clients as a human is subjected to conditions that may be dangerous to human life. about, there
are concerned about the health insurance as the risk may surpass the cost of insurance allocated
for a human subject. Some speculation indicates that human being may be subjected to
conditions that may be detrimental to their life in future. This risk needs serious protection
depending on the right of a human being used in the experiment. Risk issues determine the
willingness of people to take part in clinical trials leading to many people refusing to take part in
the experiment (Cartwright & Eileen 2010, pp 260–266).
5. Response plan and solution to the issues and risks
There are some measures that have been put in place to deal with safety and risk issues.
Firstly, privacy rule is one safety standard put in place to deal with safety concerns that may arise
from client’s data safety. There is medical privacy requirement that is observed before human
experimentation as this is important to reduce any error that may be associated with the trial.
One of the requirements of this plan indicates that there must be written permission that allows
the researcher to use any part of the body or data in research. In addition, the researcher needs to
keep personal data and information of clients used in the experiment as safe as possible. The

Introduction to Research 8
information may be informed of protected health information and this is key to ensure patient’s
right are protected at all cost (Ioannidis & Khoury 2013, pp 32).
Secondly, obtaining the consent of those concerned in the experimentation is an
important response plan to deal with the issue in a human drug trial. There are many elements of
consent requirement that include an explanation of the research, research purpose, the risk
associated with research, the possibility of compensation and contact person in case of any
complication that is associated with research. There is also an institutional requirement that is
also connected to the consent and should be complied with before conducting an experiment.
Researchers are expected to provide the compliance form to the client that is used in an
experiment detailing all the issues that may result in objection of participation in the trial (Petrini
2014, pp 61-3).
Thirdly, client right and client protection is another responses plan that enables a deal
with the issues of concerns. Clients have right to information and provide the consent before
taking part in drug trials. To protect the patient from any harm, exploitation or their privacy data
used for medical research, the researcher is expected to adhere to the set-out legislation that deals
with human experimentation. There are also ethical codes of practice when conducting
experiments with human subject and this must be observed before any experimentation. One of
the requirements is the assurances of protection for human subjects that uphold human rights for
those used in the experiment (Giordano 2010, pp 98–603).
Fourthly, regulation of researcher training is another important response plan put in place
to help in a drug trial. One of the most important aspects of drug trials includes researchers

Introduction to Research 9
training that focuses on the qualification of the researcher that enable them to conduct an
experiment in the most competence manner. There are strategies put in place to assess the
training that researchers have and specific training available to help those involved in the design
and conducting the experiment. This implies that under this requirement, personnel must undergo
specific training before allowed to conduct experiments with a human subject. Moreover, those
directly involved in drug trials must comply with certain requirement before approving
experiment to run. This also includes institutional requirement where the experiment is likely to
take place. The overall objective of this response plan is to reduce any negligence associated
with lack of training (Carpenter 2010).
Adverse medical reporting framework is another response requires that the organization
must comply with before conducting human drug trial. This involves reporting any adverse event
that may arise from the medical research before escalation. Biomedical research requirement
includes compliance with research policies and this includes reporting of medical errors. This
adverse event reporting technique should protect the human subject used in an experiment in
compliance with privacy rules. Various aspects of research are reported by the researcher, not
from any other source as this may complicate the integrity of the data collected an monitoring
strategy (Golan, Milella, Ackerstein & Berger 2017, pp 192).
6. Conclusion
In conclusion, pharmacological research in ethics particularly presents various issues that
may require an ethical response. The research reveals that pros of pharmacological research
include improvement of treatment, finding treatment, and offer material that is used for future
biomedical research. Cons of the research include failure to get treatment, the risk associated

Introduction to Research 10
with the research and result may be no different from normal treatment. Some of the ethical
issues that have been concerns are investigator’s training, client right and safety, the integrity of
parties involved, obtaining client’s consent and client’s privacy. Response actions and solution
for the issues presented include compliance with the right of the client, mandatory investigator
training, adverse event reporting framework, compliance with medical privacy requirement and
obtain client consent before involving them in trials.

Introduction to Research 11
7. References
Carpenter, DP 2010, Reputation, and power: Organizational image and pharmaceutical
regulation at the FDA. Princeton: Princeton University Press. Viewed at
http://scholar.google.com/scholar_lookup?title=Robust%20action%20and%20the%20strategic
%20use%20of%20ambiguity%20in%20a%20bureaucratic%20cohort%3A%20FDA
%20scientists%20and%20the%20investigational%20new%20drug%20regulations%20of
%201963&author=D.%20Carpenter&author=C.%20Moore&pages=340-
362&publication_year=2007
Cartwright, N & Eileen M 2010, The limitations of randomized controlled trials in predicting
effectiveness. Journal of Evaluation in Clinical Practice, vol.16, no.2, pp 260–266. Viewed at
doi.org/10.1111/j.1365-2753.2010.01382.x
Deng, C, Hanna, K, Dalakas, MC & Merkies, IS 2012, Challenges of clinical trial design when
there is lack of clinical equipoise: use of a response-conditional crossover design. Journal of
Neurology, vol.259, no.2, pp 348-52. doi: 10.1007/s00415-011-6200-0.
Giordano, S 2010, The 2008 Declaration of Helsinki: some reflections. Journal of Medical
Ethics, vol.36, pp 98–603. doi: 10.1136/jme.2009.034132.
Golan, T, Milella, M, Ackerstein, A, Berger, R 2017, The changing face of clinical trials in the
personalized medicine and immuno-oncology era: report from the international congress on
clinical trials in Oncology & Hemato-Oncology (ICTO 2017). Journal of Experimental &
Clinical Cancer Research, vo.36, no.1, pp 192. doi: 10.1186/s13046-017-0668-0.

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Howick, JH, 2011, The Philosophy of Evidence-Based Medicine. London: Wiley-Blackwell.
DOI:10.1002/9781444342673
Ioannidis, JPA & Khoury, MJ 2013, Are randomized trials obsolete or more important than ever
in the genomic era? Genome Medicine, vol.5, pp 32. doi: 10.1186/gm436.
Fleck, LM, 2010, Personalized medicine’s ragged edge. Hastings Cent Rep., vol.40, no.5, pp16–
18. doi: 10.1353/hcr.2010.0005.
Karin, A 2016, Breast Cancer clinical trial participant: Australian Clinical Trials, St. John of
God – Bunbury. Viewed at https://www.australianclinicaltrials.gov.au/consumers/real-stories/
karin-ashman-breast-cancer-clinical-trial-participant-st-john-god-bunbury
Maitland, ML, & Schilsky RL, 2011, Clinical trials in the era of personalized oncology. CA
Cancer Journal for Clinicians, vol.61, no.6, pp 365-81. doi: 10.3322/caac.20135.
Nardini, C 2014, The ethics of clinical trials. Ecancer Medical Science, vol.8, pp 387. doi:
10.3332/ecancer.2014.387
Petrini, C. (2014) Ethics and law in research with human biological samples: a new approach.
Drug Metabolic Drug Interact, vol.29, no.1, pp 61-3, viewed 23 December 2015
https://www.ncbi.nlm.nih.gov/pubmed/24317784
Sharma, MR & Schilsky, RL 2012, Role of randomized phase III trials in an era of effective
targeted therapies. National Rev Clinical Oncology, vol.9, no.4, pp 208–14. doi:
10.1038/nrclinonc.2011.190.

Introduction to Research 13
Teira, D 2011, Frequentist versus Bayesian clinical trials. In Philosophy of medicine, ed. Fred
Gifford, pp 255–297. Amsterdam: Elsevier. Viewed at doi.org/10.1016/B978-0-444-51787-
6.50010-6
Teira, D & Reiss, J 2013, In: Causality, Impartiality and Evidence-Based Policy Mechanism and
Causality in Biology and Economics. Chao H-K, Cheng S-T, Millstein RL, editors. the
Netherlands: Springer; 2013. pp. 207–24. Viewed at
https://link.springer.com/chapter/10.1007%2F978-94-007-2454-9_11
Wistuba, II, Gelovani, JG, Jacoby, JJ, Davis, SE, & Herbst, RS, 2011, Methodological and
practical challenges for personalized cancer therapies. Nat Rev Clinical Oncology, vol.8, no.3, pp
135-41. doi: 10.1038/nrclinonc.2011.2.