Ethics in clinical research is of paramount importance to protect the rights, safety, and well-being of human participants involved in studies. However, there are several challenges that researchers and regulatory bodies face in ensuring ethical practices. Let's discuss some of these challenges and potential solutions

1. Welcome
ETHICS IN CLINICAL RESEARCH:
CHALLENGES AND SOLUTIONS
KUSUMA T
PHARM.D
062/042023
04/10/2023
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2. Clinical Research:
Clinical research is the study of health and illness in people.
Clinical research helps in finding new and better ways to detect, diagnose, treat, and prevent diseases.
Types include (i) clinical trials – which test new treatments for a disease
(ii) natural history studies – which collect health information to understand how a disease develops and
progress over time.
Reasons for doing a clinical study:
- To explore the cause of a disease or set of symptoms
- To test if a treatment will help with
a symptom or condition
- To learn how a certain behavior affects people’s health
- Improving or validating diagnostic or treatment
methods in medicine
- Improving or validating the effectiveness of methods for
preventing injury or illness
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3. ETHICS IN CLINICAL RESEARCH:
Ethical strategies not only ensure the integrity of the research results, but also protect the safety of patients
who volunteer to participate in the clinical trials.
The ethical parameters helps to prevent the participants from being exploited (or) treated unfairly by the
research team.
GOAL OF CLINICAL ETHICS: Identify, understand and resolve the ethical issues that arise in patient care
by helping to clarify why certain actions are right (or) wrong.
IMPORTANCE OF ETHICS IN CLINICAL RESEARCH :
- Ethics is important in clinical research because it keeps the researcher from committing errors while
seeking knowledge and truth.
- It promotes essential values that helps researchers working on a topic to have a common understanding
of how things should go about.
- Since research may involve experts coming from different fields of expertise, ethics binds them together
by considering the important values such as accountability, mutual respect and fairness among others.
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4. HISTORY OF ETHICS:
During the past centuries many researchers have performed a number of experiments on humans to test the
new drugs, vaccines and the devices invented to save the human life and to prevent the progress of the
disease.
But there were many tragedies throughout the history of research involving the human subjects for clinical
research.
Many physicians had pursued research as it was found interesting. Consequently, exploitation of human
subjects occurred in clinical research by placing some people at risk for the good of others.
Therefore, ethical requirement for clinical research is aim at to minimize the possibility of exploitation by
ensuring the subjects are not merely used but are treated with respect while they contribute to social good.
The use of ethical theories several rules and regulations have been justified involving a few principles and
guidelines to be followed while conducting the clinical research.
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5. Scandals and tragedies during clinical research in the history:
History of early clinical research: The 1st record of clinical research had begun on eighteen century. Scurvy
was a threatened disease at that time and tolled the life of British sailors abroad. In 1740 James Lind, a
surgeon in the royal navy of Salisbury conducted randomized clinical trials on some sailors who were
suffering with scurvy disease. He noted a dramatic treatment effect from citrus, although his findings were
largely ignored for decade leading to unaccounted deaths. After 50 years(1795), Royal Navy adopted rationing
citrus fruits to their sailors at which point, Scurvy disappeared from Royal Navy. Scurvy study tragically
highlights as an important challenge of disseminating the research result.
In 19th century’s clinical research: There are many researches that violate right and dignity of human subject
and in some cases cost their health or even lives. Some of them are below;
Case-1 : Coley(1892) injected patients with cancer cells to induce artificial erysipelas. He described how he
begun treatment with a patient who had sarcoma.
Case-2 : In 1896-1897, a control clinical trial was conducted by the Johannes Fibiger from Denmark to see the
effectiveness of his invented anti-diptherial serum. All hospitalized patients received standard treatment or
diptheria serum with standard treatment. After 1 year 8 died of 239 patients in the serum group vs 30 died of
245 patients in the diptheria serum with the standard treatment group.
Case-3 : Guiseppe Sanarelli (1897), an Italian bacteriologist announced that he isolated bacillus of yellow
fever. To prove his claim, he injected with his isolate and produced yellow fever in them. In 1898, William
Osler, prof. of John Hopkins and Oxford University condemns Sanarelli for deliberately injecting poison of
known high degree of virulence into a human being without his consent.
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6. Cont…
In 20th century’s Clinical Research : In 20th century, the most barbaric experiments were done by Nazi doctors.
Some of them are below -
Experiment-1 : Prisoners were put into low pressure tank to see how long they could survive with little oxygen.
Many of them died.
Experiment-2 : High altitude experiments: Prisoners were hanging to see how long they could survive in high
altitude. Many of them died then autopsied. Those who did not die immediately were put under water till they died
and autopsy followed.
Experiment-3 : Cold experiment: Prisoners were forced to remain outdoors during winter of -20 degrees
temperature with cloth for 9 to 14 hours or force to remain in bath of freezing water till death to see how long a
man can bear cold or what are the consequences of cold till death.
Experiment- 6 : Malarial Experiment: Dr. Klaus Kari Schilling , an eminent malaria expert, infected more then
1000 prisoners with malaria at Dachau and treated with his anti-malarial drug. More than 400 died from
complications of treatment with experimental malaria drugs.
Experiment-7 : Twins Experiment: Where, one baby was exposed to a pathogen and killed and then autopsied to
determine the natural progression of disease. The other control twin was then sacrificed to see what the differences
were. It may constitute o very interesting comparision for a scientific perspective but such an experiment was not
only unethical but also inhumane.
Experiment-9 : hundred of prisoners were killed for accumulation of skeletons for anthropological investigation.
Those killed were considered prototype of what the Nazi called characteristic sub human.
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7. Members- roles/responsibilities of ethics committee :
Members of Ethics committee :
1. Chairperson
2. 1-2 basic medical scientists
3. 1-2 clinicians from various institutes
4. One legal expert or retired judge
5. One social scientist / representative of non-governmental voluntary agency
6. One philosopher / ethicist / theologian
7. One lay person from the community
8. Member – secretary
Roles/Responsibilities :
- Review of all ethical aspects of project proposals
- Advice to researchers on all aspects of welfare and safety of all the participants
- Protect rights, dignity and well being of participants
- Subject recruitment procedures
- Information about payments and compensations available to the subjects
- Other documentation evidencing the qualifications of the investigators
- Informed consent forms and consent forms updates
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8. Principles and guidelines of ethics in clinical research:
CORE PRINCIPLES :
There are three basic principles involved in clinical research
1. Respect for privacy and confidentiality
2. Respect for the subjects involved in the clinical research studies
3. Respect for vulnerable persons
4. Respect for justice and inclusiveness
5. Respect for free and informed consent
6. Beneficence and non-malaficence
(i)minimize the risks, harms and wrongs
(ii) maximize the benefits
(iii)do no harm
ETHICS GUIDELINES:
Every clinical trial program should be reviewed by an Ethical committee
- Initial review of proposed research protocols
- Regular monitoring of compliance to ethics guidelines
- Can be constituted by the institute where the research Is done
- Independent
- Multi-disciplinary
- Multi-sectorial
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9. Challenges and solutions:
Ethics in clinical research is a critical area of concern because research studies involving the human
subjects have the potential to cause physical, emotional, psychological harm to the participants. Therefore,
it is essential to identify and address the challenges associated with conducting ethical research.
Here are some common challenges in ethics in clinical research and potential solutions to address them.
1. Informed consent form : obtaining an informed consent form from the participants can be a challenge
because some participant may not fully understand the risks and benefits of participating in the study.
- Solutions to this challenge include – providing clear and concise information about the study, ensuring
that participants have adequate time to consider their decision, and using non-technical language to
explain the study.
2. Conflicts of interest : Researchers may face conflicts of interest, such as financial gain or pressure
from the sponsors, which may affects the study’s design or results.
- Solutions to this challenge include ensuring that the study is designed with impartiality, transparency in
reporting the results and disclosing any potential conflicts of interest.
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10. Cont…
3. Protection of vulnerable population : Certain populations such as children, pregnant women and
mentally incapacitated individuals, require special protection during the research studies.
- Solutions to this challenge include obtaining consent from parents or guardians ensuring that
vulnerable populations are not unduly coerced into participating in the study, and providing protections
such as monitoring and oversight.
4. Privacy and confidentiality : Researchers must ensure that participant’s personal information remains
confidential and that their privacy is maintained during the study.
- Solution to this challenge includes obtaining informed consent, storing data securely and using de-
identification techniques when necessary.
5. Data management : Managing the data collected during the clinical trial can be significant and the
accuracy and completeness of date are very crucial for ethical research.
- Solutions for this challenge include employing rigorous data management practices, ensuring that data
are accurately and efficiently and training research staff are on proper data collection techniques.
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11. Cont…
Other challenges that arises in clinical
research are as follows –
They might be internal and external challenges ;
Internal challenges:
1. Knowledge
2. Experience
3. Status
4. Structure
5. Internal fear
External challenges:
1. Funding
2. Ethics
3. Insurance
4. Monitoring
5. Agreements
6. Culture
7. Pharmaceutical interventions
8. The world around you
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12. Thank You!
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