Miami Regional University Ethical Conduct in Research Presentation

User Generated

PehmEA64

Other

Miami Regional University

Description

Topic: Ethical Conduct of Research.

1.- Select a healthcare related research study.

2.- Identify the sample population.

3- Analyze and critique the study to identify if sampling method reflects ethical principles including consent, conditions of the participants, study approved by IRB.

4- 15-Pages Minimminum.

5- Make a Power Point to present it.


RUBRIC

• Minimum 20 pages excluding title and reference page.

• APA format, paper will be submitted through TURNIT in™. Papers MAY NOT show evidence of similarity beyond 20% excluding reference pages! Papers that reflect over 20% SIMILARITIES will be assigned a ZERO. There is NO opportunity for late or re-submitted work!

User generated content is uploaded by users for the purposes of learning and should be used following Studypool's honor code & terms of service.

Explanation & Answer

Attached.

Running head: ETHICS IN RESEARCH

1

Ethical Conduct of Research
Student Name:
Course Name:
Professor Name:
Date:

ETHICS IN RESEARCH

2

Introduction
Ethical conduct is an expression of how we should behave not only as individuals but also
as a society. The moral foundations of ethics apply to particular situations that help individuals
make proper decisions and also guide behavior. Research ethics provide guidelines on responsible
conduct by educating and monitoring researchers to ensure high ethical conduct. The history of
ethical conduct in the field of research has been built on the disastrous and egregious breaches of
human ethical values. For example, the Tuskegee Syphilis Study provided a great revolution
towards the development of ethics in research. These ethics govern the standards of conducts
scientists. Ideally, it is important to adhere to the ethical value to protect the rights, dignity, and
the welfare of the research participants. Research involving human beings are often reviewed by
the ethics committee to ensure that scientists are upholding the appropriate ethical standards. In
addition, all researchers are required to be up to date with the knowledge about the policies and
procedures that are crafted to ensure the safety of research participants. Ethical conduct is also
designed to avoid irresponsible research. This paper provides an analysis and critique of ethical
principles in health care research.
Selected Research Study
Pelletier, Bacon, Arsenault, Dupuis, Laurin, Blais & Lavoie, (2015) conducted a study to
assess whether anxiety and depression increase the major adverse cardiovascular events and risk
of mortality. This study focused on patients with and without coronary artery disease (CAD). The
primary prediction of the study was that depression and anxiety cause major adverse
cardiovascular events and also increases the risk of mortality. One of the key findings of the
research is that patients with depression have an increased risk of mortality, whereas those with

ETHICS IN RESEARCH

3

anxiety are not associated with the risk of mortality. With a focus on the CAD status, depression
increases the risk of mortality among patients without CAD while those with CAD presented no
correlation with an increased rate of mortality. Based on the results, the study was able to provide
an understanding of the role of anxiety and depression among patients with or without CAD.
Population Sample
The patients approached for this study were from the Montreal Heart Institute (MHI).
Besides, the scope of the sample population comprises of patients referred for a single-photon
emission CT (SPECT) that have undertaken a stress test between September 1998 and June 2002.
These tests were completed in the Department of Nuclear Medicine. The study comprises of a total
of 2,460 patients. In addition, the age eligibility of subjects to participate in the study were between
the age of 18 and 75. The subjects were also excluded in case the tests presented a higher chance
of greater mortality or morbidity of CAD.
Analysis and Critique of the Study
Consent
The current foundation of the informed consent in research has its roots with both legal and
ethical theory. The provision for informed consent on research is primarily found in the concept
of autonomy and the right of an autonomous participant to make decisions based on his or her own
reasoning (Katz, Webb, & Bioethics, 2016). In a health care set-up, informed consent entails;
disclosing information to patients and their care providers and obtaining consent or authority
before undertaking any form of experiment or intervention. The emergence of the concept of
informed consent emerged following the shift in the United States Medical practice from
paternalism to respect an of individual’s autonomy (Katz, Webb, & Bioethics, 2016). Various

ETHICS IN RESEARCH

4

events shaped this shift during the 20th century such as widespread public awareness concerning
ethical violations, lack of trust of the medical profession following the Nuremberg trial of Nazi
doctors, the rise of civil rights and the women rights movement. Informed consent is a legal and
ethical requirement in research involving human subjects. The foundation of consent entails a
process in which participants are informed about all the aspects of the research. This information
is vital for the participant. Ideally, he or she would be able to make an informed decision after
reading after studying all aspects relating to the research experiment. As such, the participant
would be able to confirm his or her voluntary willingness in participating in the research study
(Spatz, Krumholz, & Moulton, 2016).
Information Disclosure
Informed consent is not only essential before enrolling a human subject but is also
considered an ongoing process after the subjects have been enrolled. In addition, informed consent
must be obtained for all human participants, including therapeutic, diagnostic, interventional,
behavioral and social studies, or even researches conducted internationally or locally. This
principle involves informing the human subjects regarding the purpose of the study, the procedures
that are part of the study , the potential consequences, and also the benefits of the study. Besides,
the researchers are required to accurately and sufficiently communicate the research information
using appropriate languages and methodologies. The participants should also be allowed to ask
questions regarding the proposed research.

The study conducted Pelletier, Bacon, Arsenault,

Dupuis, Laurin, Blais & Lavoie, (2015) did not offer specification on whether the selected human
subjects were offered all the information regarding the study before the initiation of the
experiment. Upon completion of the SPECT imaging tests, the research assistant conducted a oneon-one interview regarding the medical history of the patients. While this is not specified in the

ETHICS IN RESEARCH

5

research, it is possible that the researchers complied with the element of disclosure of information
to ensure informed consent.
Voluntarism
In addition to the element of information disclosure, informed consent in research also
relies on the concept of voluntarism. The subjects should not be forced into participating but
instead given an opportunity to decide whether or not to agree into being part of the human subjects
of the study (Spatz, Krumholz, & Moulton, 2016). Besides, the legal rights of the participants may
not be waived (Cini, 2018). The principle of informed consent lays down the various circumstances
in which the voluntarism may be waived. Ideally, informed consent may be waived in case of
minimal risk, when the resulting waiver does not affect the welfare and rights of the human
subjects in the study, when the waiver is required for the enhancement and practicality of the
research study and when any additional information is provided to the people involved in carrying
out the research (Cini, 2018). Upon achievement of approval from the independent committee or
the institutional review board (IRB), the researcher must obtain informed consent from each
participant. The study conducted Pelletier, Bacon, Arsenault, Dupuis, Laurin, Blais & Lavoie,
(2015) complied with the component of voluntarism. Ideally, written informed consent was
obtained from all the participants in the study.
Competency
Besides voluntarism, competency is another essential component of informed consent in
research. Before involving human subjects in a study, researchers are required to develop a proper
evaluation and ensure that the approach potential participants are able to understand and can make
a rational decision. In this case, researchers are expected to exclude individuals believed to be

ETHICS IN RESEARCH

6

unable to offer a valid consent and contribute to the development of the research. Some human
subjects, on the other hand, may understand the simple instructions in the procedure hence
increasing the capability of providing valid consent. In some occasions, subjects with severe health
problems such as mental illness may be included in the research as they provide informed consent.
The vulnerable groups such as prisoners, pregnant women, the elderly and the young children
should be given extra protection to ensure that the researchers do not take advantage. Children, for
example, may not be able to provide informed consent. As such, these groups can be guided
through the consent process or can be excluded to avoid the risk of invalidating the research
process. For example, children involved as human subjects can either be eliminated in a research
study or their parents or guardians can be involved to ensure that informed consent is provided.
Pelletier, Bacon, Arsenault, Dupuis, Laurin, Blais & Lavoie, (2015), in their study, was
able to comply with the component of competency in informed consent. The study involved human
subjects between the age of 18 and 75. The research also indicated that the selected human subjects
should be able to speak English or French. This scope indicates that children, a vulnerable group,
were excluded from the experiment. Also, this study complied with the component of competence
by excluding patients with a medical condition that conferred a greater chance of mortality or
morbidity. The scope of the health care research also excluded patients who had a report of a recent
cardiac arrest, precisely within the past six weeks. The foundation of the scope of competency was
to ensure that a valid research report would be obtained.

ETHICS IN RESEARCH

7

Conditions of Participants
Participants in Health Care Research
A research participant in health care research is the person or the subject involved in the
research activity. The term subject has been discouraged because it appears to dehumanize human
participants. In health research, a participant is that person or institution that has been involved in
the collection an analysis of data. One of the leading participants in heath research can be a patient.
Patient can either be out patient or inpatients. An outpatient is the one who has not been admitted
in the hospital. Patients are a group of people who suffers from a particular health issue being
investigated. For example, health research on cancer will have cancer patients as participants.
Public members can also be participants in research and especially research on a health policy that
is going to affect their livelihood. Another participant in health research can be physicians. These
are professionals who have been trained in several health disciplines and are valuable for
interviews. Research that deals with the effectiveness of health management will have the
physicians as the participants. All the participants in the health research have peculiar rights that
the researcher must be cognizant of. They have the right to privacy and data can only be collected
from them and shared if they have given voluntary consent. They also have the right to dignity and
to be treated with respect and not as a research object. They must also be informed so that they can
have informed consent.
Importance of Including Participants in a Research
Participants are essential in research because they help in getting raw data, which is more
reliable than secondary data. Therefore, this makes the research outcome to be more authentic and
reliable (Preston, Farquhar, Walshe, & Todd, 2016). Participants are also important in research

ETHICS IN RESEARCH

8

because they facilitate the research process by aiding the researcher to confirm his or her
hypothesis. The democratic principle of inclusion can also be only achieved by engaging the
participants in a research program because there will be lack of relevance and quality if research
over a specific problem is evaluated without hearing from the people affected or likely to be
affected by the problem. It is also important to include participants in research because most of the
research funders are likely to support researches that are inclusive and are useful to society. It is
an ethical research issue to have public participation so that the findings of the research done can
attain legitimacy (Preston, Farquhar, Walshe, & Todd, 2016).
Procedures Used in the Selection of Participants
Selection of participants is often made through sampling. Sampling is an economical way
of identifying what is affecting a larger community (Preston, Farquhar, Walshe, & Todd, 2016).
Unlike government researches such as census which deals with the whole population, the
procedure in health research is always done in a sampling technique. There are several procedures
of sampling that can be used in research. The main two procedures are probability and nonprobability sampling (Elfil & Negida, 2017).

The probability sampling also has several

procedures, which include random, systematic, stratified, and cluster sampling. Simple random
sampling is a procedure where the probability of selecting one person from a population is equal.
There are no criteria in the selection of a participant because they are picked randomly from a
targeted population.
The second type of probability sampling is systematic sampling. It is quite different from
random sampling but can be described as an improved random sampling. A list is made for the
selection process, and selection is made sequentially from the list of groups. For example, groups

ETHICS IN RESEARCH

9

of ten patients each can be formed, and the six-person in each group is then selected for
participation method. Thirdly, stratified sampling is a procedure where the population of the study
is divided into several hierarchies and then participants dare selected from each class. For example,
in a hospital place, if doctors were to be interviewed as participants, then a stratified procedure
would have involved categorizing the doctors to the most experienced, moderate and the least
experienced classes then pick randomly from each class (Elfil & Negida, 2017). Lastly, probability
sampling is a procedure called cluster sampling. It is used when there is no conclusive data of the
population to be studied. For example, if there were no full list of nurses in a place, then selection
could have been done by cluster sampling method which allows one to select a participant from
each agency (Elfil & Negida, 2017).
On the other hand, there is also a nonprobability sampling method which includes the quota
sampling, referral sampl...


Anonymous
Great! 10/10 would recommend using Studypool to help you study.

Studypool
4.7
Trustpilot
4.5
Sitejabber
4.4

Similar Content

Related Tags