Research and

Bioethics
 Ethics is concerned with the conduct of a human being. All scientific
activities, including those by social scientists, are conducted with the
participation of human beings or have an impact on human beings
and on the wider society and environment.
In making an ethical judgment, the researcher relies upon various
standards of ethics, which could be universal or specific to the
cultures or localities.

INTRODUCTION : A researcher should have deep concern for human welfare and
sensitivity for the rights of the research subjects. Sometimes, the
ethical responsibility to safeguard the subject’s rights conflicts with
the efficiency with which one progresses with the research; it may
affect the ultimate quality of the results .
History,evaluation,principles and players of bioethics its
importance why it is prerequisite to follow ,how to resolve a
dilemma which arise during a research and to make considerations
in such dilemma
 HISTORY OF ETHICAL CONCERN IN RESEARCH

The period during the origin of ethical research is known as the dark ages of ethics.\

Slaves, prisoners, criminals, children and poor people were forcibly used as samples or
experimentation subjects for the research activities. They were treated like animals and there was
no consideration for their rights, consent, wishes, or values.

Between 1932 and 1972, there was a drastic and contagious spread of a sexually transmitted
disease called syphilis. This disease was studied by researchers as a kind of retrospective cohort
study to know the natural history of the disease, which has pre-pathogenesis, pathogenesis,
recovery from acute disease or chronic existence of disease leading to terminal illness with
disability or death.

The research study titled “The Tuskegee Study of Untreated Syphilis in Negro Male” done in
Macon County, Alabama, used 400 Black males as subjects.
The main aim of the study was to determine the damage caused in the patients affected
by syphilis if it was left untreated.

The spirochete treponema palladium, which caused the disease, was injected into the
subjects without their consent and they were left untreated.

They were not given any information regarding the disease and were left to die or
experience the course of illness, even though a proven cure was available for the
disease.
There were other ethical issues during the Second World War period.
Many prisoners in the German concentration camps were forced to
participate in research studies, in which most of the subjects died or were
permanently crippled.
It included deliberate breaking of bones until no healing was possible,
sterilization of women without anaesthesia, and, in case of twin children,
using one child as control while the other was used as a sample for the
medical experiments..
The research study should get the approval of an ethical team or
organization before conducting the research.
The American Psychological Association (APA) and the U.S. Department of Health and
Human Services have established standard guidelines that should be followed in all
kinds of research in the USA.

The Nuremberg trials in 1947 helped bring forth many hidden details regarding the
ethical issues in the Second World War and paved way for the establishment of the
Nuremberg Code. It became the foundation for future ethical guidelines regarding the
use of human samples in the research study.
The American Psychological Association (APA) and the U.S. Department of Health and
Human Services have established standard guidelines that should be followed in all
kinds of research in the USA.

The Nuremberg trials in 1947 helped bring forth many hidden details regarding the
ethical issues in the Second World War and paved way for the establishment of the
Nuremberg Code.

It became the foundation for future ethical guidelines regarding the use of human
samples in the research study.
 3 PRINCIPLES OF ETHICAL ISSUES AND CONCERNS IN RESEARCH

The following are the principles of ethical issues and concerns in research:

Following accurate ethical norms helps to promote the research objectives, that is, both horizontal
and vertical widening of broad and in-depth knowledge.
1. The ethical norms to be followed include adopting truth and honesty in conducting the research
as per the principles and avoiding mistakes and errors, for example, copying the thesis of others
without conducting actual research and misinterpreting research data.
2. An important task in research activity is collaboration and coordination, which can be achieved
only by strictly adopting the ethical principles such as accountability, trust, mutual respect and
fairness, because they favor unity. Coordination and combined efforts are needed to achieve the
objectives of any research activity.
For example, a researcher should go through the guidelines
for authorship while reviewing the quality of a book, and if any
copyright is needed, the required formalities must be
completed properly.
When information is taken from published books and journals,
permission needs to be obtained from the concerned authors.
Confidentiality must be maintained while doing the literature
review.
Such measures will protect the researcher from legal problems
while doing any research activity.
3. Ethical norms also help the public. They ensure that the research is done in a safe manner.
The norms are formed in such a way that the researcher is made answerable and accountable
for any of his/her research activity towards public. The activities are legalized, licensed and
securitized; the financial resources used for research work should be transparent and should
be used fruitfully for the benefit of the study, which should ultimately give good outcomes to the
public.
4.The scientific knowledge and educational background of the people today is so wide and
deep that there is a lot of awareness about health. Any new research activity creates curiosity
among the public and is generally supported by the public because they anticipate good
outcomes, which depend upon the quality and integrity of the research activity. Innovations
through research for health problems and their benefits through evidence-based practice will
be supported by the people, provided the research work binds to ethical norms.
5.Ethical norms help to protect the public from any kind of harm because of fake results
published, since the norms framed are so strong that they give importance to moral and social
values, such as social responsibilities, basic human rights, animal welfare, compliance with
law, health, and safety. The data that is obtained through the research should be collected
ethically, relevantly, and accurately. Strictly following the research methodology and openly
agreeing to the limitations will help to promote the health of the people.
Nurses are always present with patients and are under
pressure to deal with all kinds of problems and issues
during patient care. There is a need for each nurse to be
well acquainted with the ethical principles and norms, so
that they act as a shield and protect him/her from all the
legal and ethical issues concerning patient care.
Therefore, the nurse should update his/her knowledge
about the new technology as well as the ethical issues
affecting it.
The ethical considerations safeguarding the subject’s
rights must always be given the highest priority. Among
human subjects, the rights that must be taken into
consideration are as follows:
4. The right to be informed of any potential risk or harm that might be incurred as a result
of participating in the research
5.The right for privacy, dignity and confidentiality
6. The right to be informed about the results of the research

ETHICAL ISSUES IN RESEARCH PROCESS

Ethical and legal issues play an important role throughout the process of research activity, right from
the selection of the problem until its application. Always the boundaries rotate from input,
throughput and output, and throughout the entire research process, the legal and ethical issues will
be kept hidden. Similar to the weapon used by the stone sculptors to carve the statue from the
stone, the ethical principles in research process must remove the unwanted ethical issues and
ensure a safe and harmless research process. The sculpting process is done in the following areas:
1. Identification and selection of the research problems and conceptual models
2. Determination of the research methodology and data collection
3. Publication of the research reports
4. Application of the research outcomes
Selection of Research Problems and Conceptual Models:  This is a crucial period during the research
process. Initially, it is not possible for the researcher to accurately estimate the expense for the research
process when selecting a research statement. He/she should select a problem that is free from ethical
issues, is affordable, is reasonable, has widely implementable outcomes and has more benefits to the
public. Adequate time and expert guidance are needed to select the conceptual model for the research.

Ethical Research Concerning Research Methodology:  There should be truth, honesty, and sincerity in
collecting the data for the research process. Faking or fabricating the data is against ethical principles and
becomes an ethical issue. The researcher should be evaluated at each step by the guide and co-guide.
Duplicating the results may help the researcher to complete the project easily, but if the research data is
found to be fabricated, it will ruin his/her future. Methodology means the design of research. The core of
research should be clear, the methods should be enjoyable, and the subjects as well as the investigator
should have full interest in the research.

Ethical Issues in Publishing Research Reports:  The reports should be original, clear, and verified by the
experts. The report should be relevant to the research statement and should be made known to the public.

Ethical Issues in Application of Research Outcomes:  It should be possible to apply the findings of a
research project in practice. For example, it was proved with evidence that changing the position of an
unconscious or bedridden patient every two hours reduces the incidence of pressure sores. Thus, the
finding should be constructive, creative, innovative, and useful. It should benefit the patient and be widely
implementable. It should be ensured that the findings published in the report are not fake or duplicate,
because implementing fake findings in nursing care may prove harmful.
 THE NUREMBERG CODE (1947)

It is a code of research-related principles for doing human experimentation, which has been framed based on the
Nuremberg trials that happened subsequent to the Second World War. This code is framed to protect the humans
from being forcibly used as experimental subjects and to prevent them from being harmed or injured through human
experimental research.
16.6.1 Origin of Nuremberg Code

In December 1946, an American military tribunal opened criminal proceedings against 23 German physicians and
administrators who participated in war crimes and crimes against humanity. They had conducted experiments on
thousands of prisoners without their consent and most of the subjects died due to the human experimentation. As a
result of the trial, the Nuremberg Code was established in 1947, which stated that voluntary consent of the human
subject used for experimentation is absolutely essential. All the participants in the research have to be informed
about the advantages and disadvantages before participating in the study. The medical experiments conducted
under the disguise of scientific research by the German doctors fall under the following categories:
1. Medico-military research
2. Ad hoc experiments
3. Racially motivated experiments

The Nuremberg code is the first international document that advocated voluntary participation and informed consent
and was framed based on the transcript given in the Doctor’s trial. It has acted has a guide to ethical issues in
research over the past seven decades.
 Nuremberg Trials

After the Second World War, an international military tribunal was set up with judges from different countries
such as United States, Britain, France and former Soviet Union, with a view to solving the emerging issues in
human experimentation. Subsequent to this trial, the following three important physicians were involved in
framing the medical ethics:
Leo Alexander, an American neuropsychiatrist
Werner Leibbrand, a German psychiatrist and medical historian
Andrew Ivy, an American physiologist

Contribution of Leo Alexander

Leo Alexander, an American physician who was born in Vienna, worked in the US Army Medical Corps in
1942. He worked for an intelligence organization called Combined Intelligence Objectives Subcommittee. It
sent him to gather the evidence needed for the Nuremberg trials. He submitted a report titled “Ethical and
Non-Ethical Experimentation on Human Beings” in which he postulated three important ethical, legal, and
scientific requirements for conducting human experimentation. They are as follows:
To give the subject the right to get informed consent and the right to participate or refuse
Not to injure the subjects or to conduct research that might harm humans, based on the Hippocratic Oath
To follow good research practices
 Contribution of Werner Leibbrand

In January 1947, Werner Leibbrand, a German psychiatrist and medical historian, explained to the
court that German physicians had adopted biological thinking and treated patients as objects and
not as humans. German doctors had no morality and respect for human life. He strongly
condemned doctors who conducted experiments on patients without getting their consent.
Contribution of Andrew Ivy

Andrew Ivy presented three important research principles on research practices in his document
titled “Principles of Ethics Concerning Experimentation with Human Beings”, which was adopted by
the American Medical Association House of Delegates in December 1946. They are as follows:
The consent of the subject should be obtained with full explanation about problems. Small
rewards in various forms have been provided as a rule.
Before performing on human subjects, the experiment should be first done on animals, with
the knowledge of the natural history of the disease. It must be so designed that the anticipated
results will justify the performance of the experiments, which will be for the good of the society.
 The Ten Points of Nuremberg Code

The ten points of the code (all from United States National Institutes of Health) are as follows:

1. Voluntary Informed Consent:  The voluntary consent of the human subject is absolutely

essential. This means that the participant should give consent wholeheartedly to participate in
the study, and not by force or compulsion. The researcher should give complete details about
the research to be conducted, such as the nature, duration, purpose, advantages, and problems
that participants may have to face in the research.

2. Beneficial Results:  The research should yield results that benefit the society and should not
be random or uncertain in nature. The researcher should anticipate the benefits and ensure that
the experiment does not harm the humans or society.

3. Prior Experimentation on Animals and Prior Knowledge of Problem:  The experiments

should not be performed on humans without tests to determine their safety on animals, and the
researchers should determine from prior knowledge the likely effects of the experiment. Thus,
the problem under the study will justify the conduct of the experiment on humans.
1. Avoidance of Physical and Mental Harm:  The experiment conducted on humans
should ensure that it does not harm or injure them physically or psychologically. The
researcher should justify and prove that the subjects are not made to suffer any harm,
injury or insult during the research study.

2. Avoidance of Lethal or Disabling Experiments:  Experiments should not be

performed if there is an a priori reason to believe that death or disabling injury will
occur. The exception to this rule is if the physicians performing the experiment also
serve as subjects.
 The Ten Points of Nuremberg Code

6.Limitation of Risk in Study:  There should no increase in the degree of risk mentioned. The degree of
risk should not be more than the benefits caused by solving the problem through the research.

7.Protection and Facilities for the Subjects Involved in Research:  Adequate physical facilities should be
provided for each participant to safeguard him/her from any possible injury, disability or death.

8.Performance of Experiment by Qualified and Experienced Persons:  It is important that the research
is conducted by a qualified as well as experienced researcher with good skill and knowledge about the
research study through all the phases of the research process.
9.Freedom or Liberty for the Subjects to Withdraw:  The participants of the study
must have the freedom to withdraw from the study at any time if they feel physically or
mentally unable to continue. This allows the subjects to choose what happens to them
and to protect their rights.

10.Termination of Study at any Stage:  During the course of the experimentation, the

researcher must be prepared to terminate the study if there is a cause to believe, after
careful judgement, that the continuation of the experiment might cause injury, disability,
or death to the subjects.
 ETHICAL PRINCIPLES CONCERNED WITH RESEARCH

The code of conduct and the ethical principles for research as published by the APA 1992 are as
follows:

Planning Research in Use of Humans as Research Subjects:

Step 1:  The entire blueprint of the research process should be planned in advance under expert
guidance; it must be cleared without any harmful drawbacks.

Step 2:  The researcher should submit the synopsis of the study and the possible ethical
issues/problems and benefits arising out of it to the members of an ethical review board/committee
and should get a clearance and approval to conduct the study.

Step 3:  Human rights, values, respect and dignity of participants should be ensured.
Confidentiality must be maintained throughout the research process.
Responsibility:  The entire research content should be thoroughly analysed by the
guide, co-guide and psychologist; the investigator has to get their full guidance.

The psychologist has to scrutinize the tool used and determine whether it will harm the
subjects physically, socially, or psychologically, which might affect their self-esteem and
dignity.

The psychologist should also ensure that the values and rights of the participants are
respected throughout the research process and should anticipate any potential harm
and guide the researcher accordingly.

State and Federal Law:  All members involved in the research to be conducted such as
the investigator, supportive researcher, the guide, co-guide, and psychologist should be
familiar with the state and federal law and regulations.

For example, if a research is conducted using any sedative drugs that cannot be
experimented on children or old people as the state law prohibits it, the researcher and
his/her team should follow and abide by the rules.
Provision of Any Benefit or Money to the Subjects:  Even if the participants are provided any
reward such as money for participating in the study, they should not be ill-treated. Irrespective of the
provision of benefit, the participants must be ensured security and safety and must be given full
information about the subject and its benefits and risks.

No Plagiarism in Reporting the Results of the Research:  If the results of the research are
erroneous, it will be the researcher’s responsibility to correct it and publish the correct results. He/she
should not fail to credit the citations for the work of other authors and should not resort to plagiarism.

Approval from the Institutional Ethics Review Board (IERB):  A person involved in conducting
research for a doctoral degree in an institution or for any other purpose should present a research
proposal to the IERB. This organization has experts from all the areas such as medicine, surgery,
pharmacology, pathology, microbiology, nursing, psychology and psychiatry, and specialized doctors
from the field of obstetrics, orthopaedics, neurology and neurosurgery, nephrology, dermatology, ENT,
ophthalmology, etc. They will assess the entire proposal. The researcher has to present the ethical
issues present in the research and the ways to solve them. The proposal should have a format of the
informed consent and its details should be present. Once the IERB approval is obtained, the
researcher can start the study ensuring that the subjects involved in the study are free from all injuries
and risks and that their safety, values, dignity and human rights are respected and valued.
Use of Informed Consent in Research:  The informed consent is a legal document. All
participants are clearly informed about their role in the research and any potential harm/injury if
present.

They are assured of safety and confidentiality throughout the research process and are free to
withdraw from the study whenever they want.

The participants must also be allowed to view the results of the study. Many researchers do not
give complete details to the participants as they are afraid of not getting samples.

They just get the signature, take videograph, and give some money to the subjects so that
they silently accept to participate.

Nowadays, the informed consent form is available in the e-format in the World Wide Web. The
subjects can click on the accept button and proceed to participate in the study or can click on
the default button to withdraw from the study.
 LIMITATIONS IN APPLYING ETHICS AND ETHICAL PRINCIPLES IN NURSING RESEARCH

The following are the disadvantages of ethics in research:

If the participants of the research are the workers of an institution, there are chances of them
being psychologically harmed by the management when it comes to know about their
performance through the results of the research.
All activities regarding the work might be revealed through the research on the work
performance and a worker may lose job or promotion if he/she is found to indulge in
malpractice or negligence through the research study.
Certain projects may reveal the sexual orientation of the subject, which is supposed to be kept
confidential during the study. The researcher may disclose the sexual orientation of the subject
and violate the principle of ethics.
Wrong information can be given by the participants if they are afraid of the management.
All ethical principles cannot be followed by all hospitals. Nursing care must always be
practiced with ethical principles but the policies of all hospitals are not the same, which will
hinder following certain ethical principles.
The researcher may provide money to the subject to cooperate in the study, if the
research is conducted among people of high status.
The respect and safety during the research will be followed by the researcher in
such cases because the money and status is valued. However, if people of low
status or poor people who are admitted in government hospital are involved, the
researcher may violate the ethical principles of non-maleficence, accountability and
responsibility.
There is no money offered by the researcher to such patients and the experiment is
conducted for free on them as a part of treatment.
Case analysis
 CONCLUSION

Research is searching something that is unknown.

Nursing research is the stepping stone for quality care. Following ethical principles and gaining
knowledge about ethical issues in the nursing research are essential and will ensure that the
outcome of the research is good and valid.

This chapter deals with the many ethical issues in research that have been observed until now. It
is the responsibility of a nurse to follow ethics in research and apply the relevant principles
wherever needed, so that he/she is able to bring out an excellent nursing research activity, which
leads to quality care.