The document discusses the evolution of research ethics, highlighting historical events that led to ethical codes, including the Tuskegee Study and Nazi human experimentation. It details principles established by the Nuremberg Code and the Declaration of Helsinki, emphasizing voluntary consent, risk-benefit assessments, and the protection of research subjects. The importance of ethics in research is underscored, noting the necessity for honesty, fairness, transparency, and the humane treatment of participants.

1. ETHICAL ISSUES IN
RESEARCH
Presented by
S.M GHARIB NAWAZ JAN

2. ETHICS:
• Moral principles that govern a person’s behavior
or the conducting of an activity.
• Ethics is the branch of philosophy that deals with morality.
It is concerned with distinguishing between good and evil
in the world, between right and wrong human actions, and
between virtuous and non virtuous characteristics of
people-The American Dictionary of Cultural Literacy
(2005).

3. How did research ethics evolve?

4. HISTORICAL EVENTS AND
DEVELOPMENT OF CODE OF ETHICS

5. Tuskegee Study ( Alabama) 1932 -1972:
• 399 poor and mostly illiterate Negro males suffering from
Syphilis were studied to observe the natural progression of the
disease.
• The subjects were not told they had syphilis and consequently
they went into infecting many of their wives, which resulted in 19
of their children being born with congenital syphilis.
• By 1947 penicillin had become the standard treatment for
syphilis. However, the treatment was withheld.
• Plenty of papers were published from this study. Eventually the
study was leaked to the press and the program was terminated.

6. Nazi human experimentation early 1940’s:
• Experiments carried out on large numbers of
prisoners in concentrated camps by the German.
Nazi regime during World War II:
They were forced into participating,
Typically, the experiments resulted in death,
disfigurement or permanent disability of the
subjects

7. Nazi human experimentations:
• Malaria experiments (1942-1945) – conducted on over 1200 prisoners to
test for immunization and treatment of malaria. Prisoners were infected by
mosquitoes or by injections of extracts of the mucous glands of female
mosquitoes. About a half died of the disease and subsequent complications.
• Mustard gas experiments (1939-1945) - subjects were deliberately
exposed to mustard gas which inflicted severe chemical burns . Then they were
tested to find the most effective treatment for the mustard gas burns.
• Sulfonamide experiments (1942-1943) – Wounds inflicted on the
subjects were infected with bacteria, such as Streptococcus, gas gangrene and
tetanus. Blood circulation to these wounds was interrupted to create a
condition similar to that of a battlefield wound. Infection was aggravated by
forcing wood shavings and ground glass into the wounds. The infection was
treated with sulfonamide and other drugs to determine their effectiveness.

8. Aftermath of the experimentations:
• Many of the subjects died, many others were murdered after
the tests were completed to carryout a post mortem. Those
who survived were often left mutilated, suffering permanent
disability, weakened bodies, and mental duress.
• On August 19, 1947, the doctors captured by Allied forces
were put on trial in USA – Doctor’s trial. At the trial, several
of the doctors argued in their defense that there was no
international law regarding medical experimentation.
• This led to the development of the Nuremberg Code of
medical ethics.

9. Nuremberg Code – 1949:
The code calls for standards such as,
• Voluntary consent of human subjects
• To recognize that the risks must out
weigh the expected benefit, and that
unnecessary pain and suffering must
be avoided.
• Doctors should avoid actions that injure
human patients.

10. DECLARATION OF HELSINKI (1964):
• Greater care can be exercised
to protect subjects from harm.
• Strong, independent
justification for exposing a
healthy volunteer to
substantial risk of harm.
• Investigators must protect life
and health of research
subjects.

11. The Importance of Research Ethics:
• They promote the aims of research, such as expanding knowledge.
• 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.
• 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.
• They ensure that the public can trust research. For people to support
and fund research, they have to be confident in it.

12. Codes of Ethics:
• Government agencies who fund or commission research often publish
codes of conduct for researchers, or codes of ethics.
• For example, the US National Institutes of Health (NIH) and Food and
Drug Administration (FDA) both publish ethical codes. Some ethical
codes may have the force of law behind them, while others may
simply be advisable.
• Be aware that even if you do nothing illegal, doing something
unethical may end your research career.
• Many or even most ethical codes cover the following areas:

13. Honesty and Integrity:
• This means that you need to report your research honestly, and that
this applies to your methods (what you did), your data, your results,
and whether you have previously published any of it.
• You should not make up any data, including extrapolating
unreasonably from some of your results, or do anything which could
be seen as trying to mislead anyone. It is better to undersell than over-
exaggerate your findings.
• When working with others, you should always keep to any
agreements, and act sincerely.

14. Fairness:
• You should aim to avoid bias in any aspect of your research, including
design, data analysis, interpretation, and peer review.
• For example, you should never recommend as a peer reviewer
someone you know, or who you have worked with, and you should try
to ensure that no groups are unintentionally excluded from your
research.
• This also means that you need to disclose any personal or financial
interests that may affect your research.

15. Carefulness:
• Take care in carrying out your research to avoid careless mistakes.
• You should also review your work carefully and critically to ensure
that your results are credible.
• It is also important to keep full records of your research.
• If you are asked to act as a peer reviewer, you should take the time to
do the job effectively and fully.

16. Openness:
• You should always be prepared to share your data and results, along
with any new tools that you have developed, when you publish your
findings, as this helps to further knowledge and advance science.
• You should also be open to criticism and new ideas.

17. Respect for Intellectual Property:
• You should never plagiarize, 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 acknowledge
contributions to your research. If in doubt, acknowledge, to avoid any
risk of plagiarism.
• Intellectual property refers to creations of the mind: inventions; literary and
artistic works; and symbols, names and images used in commerce
• Plagiarism is an act or instance of using or closely imitating the language and
thoughts of another author without authorization and the representation of that
author's work as one's own, as by not crediting the original author

18. Confidentiality:
• You should respect anything that has been provided in confidence. You
should also follow guidelines on protection of sensitive information
such as patient records.
Responsible Publication:
• You should publish to advance the state of research and knowledge,
and not just to advance your career. This means, in essence, that you
should not publish anything that is not new, or that duplicates someone
else’s work.
Legality:
• You should always be aware of laws and regulations that govern your
work, and be sure that you conform to them.

19. Animal Care:
• If you are using animals in your research, you should always be sure that your
experiments are both necessary and well-designed. You should also show respect
for the animals you are using, and make sure that they are properly cared for.
Human Subjects Protection:
• If your research involves people, you should make sure that you reduce any
possible harm to the minimum, and maximize the benefits both to participants and
other people.
• This means, for example, that you should not expose people to more tests than are
strictly necessary to fulfil your research aims. You should always respect human
rights, including the right to privacy and autonomy. You may need to take
particular care with vulnerable groups, which include, but are not limited to,
children, older people, and those with learning difficulties.

20. The Role of the Ethics Committee:
• Most universities have an ethics committee. This is required to
scrutinize all research proposals, to ensure that they do not raise any
ethical issues.
• This will generally include research for master’s and undergraduate
degrees and Ph.D. studies.

21. Guidance on Ethical Treatment of Research
Participants (Human and Animal):
• The ethical treatment of research participants (human and animal) requires
informed consent for human participants, humane treatment of animals,
nondiscriminatory practices, and confidentiality.
Informed Consent:
• When conducting clinical research, the obtaining of informed consent is
required. Informed consent is a procedure through which a competent
subject, after having received and understood all the research-related
information, can voluntarily provide his or her willingness to participate in
a clinical trial.Failure to obtain written consent from individuals
participating in research, or from the parents/guardians of individuals
participating in research, represents an ethical violation of Principles and
Rules of ethics.