The document discusses bioethics and research ethics. It begins with definitions of ethics, biomedical research, and clinical research. It then outlines the history of international ethical guidelines, including the Nuremberg Code, Declaration of Helsinki, and others. The document defines types of research involving human participants and discusses the importance of research ethics in promoting values like honesty, accountability, and minimizing harm. It concludes by outlining several codes for research ethics regarding topics like informed consent, confidentiality, and protecting human subjects.

1. BIOETHICS (RESEARCH ETHICS)
BY-SANJUSAH
ST. XAVIER’S COLLEGE, MAITIGHAR
DEPARTMENTOF MICROBIOLOGY

2. Introduction
• The word ethics is derived from the Greek
word “ethos” which means ‘character’,
‘disposition’ or ‘a fundamental outlook
influencing behavior related to customs and
moral values of the people’.

3. • It deals with the process of determining
correctness of an activity.
• It is guided by the concept o human rights,
social and professional responsibility.
• Ethics concerns primarily with safeguarding
the interests of research participants and aims
to promote their right and dignity.

4. History
• First international document on ethics: Nuremberg code,
• promulgate in 1947 as the consequences of the trial of
physician who had conducted terrible experiments on
unconsenting prisoners and detainees
• This code then:
1. Protect the integrity of the research subject
2. Set out conditions for the ethical conduct of research
involving human and non human subjects.
3. Emphasize the human subject “voluntary consent” to
research.

5. • Similarly Article 7 of Universal Declaration of
Human Right adopted by United Nation
Assembly in 1948 states that “No one shall be
subjected without his free consent to medical
or scientific experimentation.

6. • The Declaration of Geneva of the World
Medicine Association bind the physician with
the word: The health of my patient will be my
first consideration.
• International code of medical ethics declare
that “A physician shall act only in the patient’s
interest when providing medical care which
might have the effect of weakening the
physical and mental conditions of the
patients”.

7. • The Declaration of Helsinki, promulgated in 1964
by World Medical Association is the prominent
document in the field of ethics in biomedical
research.
• It set out the ethical guidelines for physician
engaged in both clinical and nonclinical
biomedical research.
• “The well-being of the subject should take
precedence over the interests of science and
society”

8. • The Nepalese national ethical guidelines for
health research is cognizant of these
declarations, code and guidelines and has
followed the spirit in which they are written.

9. Research
• Definitions: set of activities designed to
develop or to contribute to generalizable
knowledge consisting of theories, principles,
relationships or the accumulation of
information which they are based, that can be
corroborated by accepted scientific methods
of observation and inference.

10. • Health research includes medical and
behavioural studies related to human health.
• Biomedical research refers to research
related, directly or indirectly, to the
advancement of medicine.
• Clinical research refers to any study of which
one or more components is diagnostic,
prophylactic or therapeutic in nature and is
applied to human participants.

11. • Research ethics concerns the responsibility of
researchers to be honest and respectful to all
individuals who are affected by their research
studies or their reports of the studies’ results.

12. Research involving human participants
1. Studies of physiological, biochemical or pathological
processes.
2. Studies of responses to physical , chemical, genetic,
psychological or social interventions.
3. Controlled trials of diagnostic, preventive or
therapeutic methods or measures in persons
designed to demonstrate a specific generalized
response to these measures against a background of
individual biological variation.

13. 4.Studies designed to determine the
consequences for Individuals and
communities of specific preventive or
therapeutic measures.
5.Studies concerning human health related
behaviour in a variety of circumstances and
environments

14. 6. Studies in which environmental factors are
manipulated in a way that could affect
incidentally exposed individuals;
• for example, exposure to toxic chemicals,
radiation, or pathogenic organisms or agents

15. 7. Epidemiological or observational studies
aimed at exploring the distribution and
determinants or risk factors or health related
events or problems in a specified population
and geographic area in order to prevent,
control, and or manage health problems and
or promote healthy or environment friendly
behavior.

16. Importance of Research Ethics
1. They promote the aims of research, such as expanding
knowledge.
2. They support the values required for collaborative work, such as
mutual respect and fairness. This is essential because scientific
research depends on collaboration between researchers and
groups.
3. They mean that researchers can be held accountable for their
actions. Many researchers are supported by public money, and
regulations on conflicts of interest, misconduct, and research
involving humans or animals are necessary to ensure that money
is spent appropriately.
4. They ensure that the public can trust research. For people to
support and fund research, they have to be confident in it.
5. They support important social and moral values, such as the
principle of doing no harm to others.

17. Codes for Research Ethics
• Many different professional associations,
government agencies, and universities have
adopted specific codes, rules, and policies
relating to research ethics.
• Researcher must be aware that even if you do
nothing illegal, doing something unethical may
end their research career.
• Hence, the ethical codes must address the
following area:

18. Honesty and Integrity
• Strive honesty in all scientific communications.
• Honestly report data, results, methods and
procedures, and publication status.
• Do not fabricate, falsify, or misrepresent data.
• Do not deceive colleagues, research sponsors, or the
public. When working with others, researcher should
always keep to any agreements and promises, and
act with sincerity; strive for consistency of thought
and action

19. Objectivity
• Strive to avoid bias in experimental design, data
analysis, data interpretation, peer review, personnel
decisions, grant writing, expert testimony, and other
aspects of research where objectivity is expected or
required.
• For example, researcher should never recommend as a
peer reviewer someone they know, or who they have
worked with, and they should try to ensure that no
groups are inadvertently excluded from their research..

20. Carefulness
• Avoid careless errors and negligence; carefully and critically
examine your own work and the work of your peers.
• Research work should be review carefully and critically to
ensure that results are credible.
• This can be done by keeping good records of research
activities, such as data collection, research design, and
correspondence with agencies or journals.
• If you are asked to act as a peer reviewer, you should take
the time to do the job effectively and fully

21. Openness
• Researcher should always be prepared to
share their data and results, along with any
new tools that they have developed and their
findings as this helps to further broaden
knowledge in advance science.
• Similarly, they should also be open to criticism
and new ideas.

22. Respect for Intellectual Property
• Never plagiarise, or copy, other people’s work and try to pass it
off as your own.
• You should always ask for permission before using other
people’s tools or methods, unpublished data or results.
• Not doing so is plagiarism.
• Obviously, you need to respect copyrights and patents,
together with other forms of intellectual property, and always
give proper acknowledgement or credit for all contributions to
research

23. Confidentiality
• Respect anything that has been provided in
confidence.
• Follow guidelines on protection of sensitive
information such as papers or grants submitted
for publication, personnel records, patient
records.

24. Responsible Publication
• Publish to advance to state of research and
knowledge, and not just to advance career.
• Do not publish anything that is not new, or
that duplicates someone else’s work.

25. Responsible Mentoring
• Help to educate, mentor, and advise students.
• Promote their welfare and allow them to
make their own decisions

26. Legality
• always be aware of laws and regulations that
govern your work, and be sure that you
conform to them.

27. Animal Care
• While using animals in research, researcher
should be sure that their experiments are both
necessary and well-designed.
• They should also show respect for the animals
and make sure that they are properly cared for.

28. Human Subjects Protection
• When conducting research on human subjects, minimize harms
and risks and maximize benefits both to participants and other
people.
For example:
• do not expose people to more tests than are strictly necessary
to fulfill your research aims.
• respect human dignity, privacy, and autonomy;
• take special precautions with vulnerable populations;
• strive to distribute the benefits and burdens of research fairly.

29. Salient points of the
international ethical guideline

30. 1. All proposals to conduct research involving
human subjects must be submitted for review
and approval to one or more independent
ethical and scientific review committees. The
investigator must obtain such approval of the
proposal to conduct research before research
is begun.

31. 2. For all biomedical research involving human
subjects, the investigator must obtain the
informed consent of the prospective subjects or,
in the case of an individual who is not capable
of giving informed consent, the proxy consent of
a properly authorized representative.

32. 3. Before requesting the individual’s consent to participants in research,
the investigator must provide the individual with the following
information, in language that he/she is capable of understanding:
a. That each individual is invited to participate as a subject in
research, and the aims and methods of the research.
b. The expected duration of the subject participation
c. The benefits that might reasonably be expected as an outcome of
the research
d. Any foreseeable risk or discomfort to the subject associated with
participation in the research
e. Any alternative procedures or courses of treatment that might be
as advantageous to the subject as the procedures or treatment
being tested
f. The extent to which confidentiality of records in which the subject
is identified will be maintained.

33. g. The extent of the investigator’s responsibility, if any,
to provide medical services to the subjects
h. That therapy will be provided free of charge for
special types of research related injury.
i. Whether the subject, the subject’s family or
dependents will be compensated for disability or
death resulting form such injury; and
j. The freedom to refuse to participate and the
freedom to withdraw from the research at any time
without penalty or loss of benefits to which he/she
would otherwise be entitled.

34. 4. The investigator must obtain from each
prospective subjects a signed form as evidence
of informed consent; and review the informed
consent of each subject if there are material
changes in the conditions or procedures of
research.

35. 5. The subject may be inconvenient and spend valuable time, and
should be reimbursed for expenses incurred in connection
with their participance in research; they may also receive free
medical services. However the payment should not be so
large or medical services so extensive as to induce
prospective subjects to consent to participate in the research
against their better judgment. All payments reimbursement
and medical services to be provided to research subjects
should be approved by ad ethical review committee.

36. 6. For several types of epidemiological research individually
informed consent is either impracticable or inadvisable. In
such case an ethical review committee should determine
whether it is ethically acceptable to proceed without an
individual’s informed consent and whether the
investigator’s plan to protect the safety and respect the
privacy of research subjects and to maintain the
confidentiality of the data are adequate.

37. 7. Research subject who suffer physical injury as a
result of their participation are entitled to such
financial or other assistance as would
compensate them equitably for any temporary
or permanent impairment or disability. In the
case of death, their dependents are entitled to
material compensation.