This document discusses medical research in clinical settings, with a focus on euthanasia, informed consent, and confidentiality. It outlines the ethical arguments for and against euthanasia, describes the process and methods of euthanizing animals, and emphasizes the importance of informed consent and confidentiality in research. Additionally, it highlights potential conflicts of interest and the measures researchers should take to protect participant data.

1. MEDICAL RESEARCH-
EUTHANASIA, COI,
CONFIDENTIALITY
Presented by: Prachi Pandey, Rahul Pal
M. PHARM (PHARMACEUTICS), IIIRD Sem,
“Research Methodology and Biostatistics- Unit 3”
DEPARTMENT OF PHARMACEUTICS, NIMS INSTITUTE OF PHARMACY,
NIMS UNIVERSITY, JAIPUR, RAJASTHAN, 303121, India.

2. INTRODUCTION
• Medical research in clinical settings is the study of human health and disease
in people. It is the primary way that researchers determine if a new form of
treatment or prevention, such as a new drug, diet, or medical device, is safe
and effective in people.
• A clinical trial is designed to learn if a new treatment is more effective or has
less harmful side effects than existing treatments.
• Clinical trail is basically have 4 phases: Phase I, Phase II, Phase III, Phase IV

3. PHASES OF CLINICAL TRAIL

4. EUTHANASIA
• Euthanasia, also known as assisted dying or mercy killing, is the practice of
intentionally ending a life to relieve pain and suffering. It is a controversial topic
with strong opinions on both sides for animals as well as for human being.
• There are two main types of euthanasia:
• Active euthanasia, in which the person administering the lethal substance is the one who
initiates the death process.
• Passive euthanasia, in which the person administering the lethal substance is not the one
who initiates the death process. Instead, they allow the patient to die by withholding or
withdrawing medical treatment.

5. EUTHANASIA TYPES

6. ETHICALARGUMENTS
• Arguments in favor of euthanasia:
• Autonomy: Patients have the right to make decisions about their own care, including the decision to
end their life.
• Compassion: Euthanasia can be a compassionate way to end the suffering of patients who are
terminally ill or severely disabled.
• Quality of life: Euthanasia can allow patients to die with dignity and avoid further suffering.

7. ETHICALARGUMENTS
• Arguments against euthanasia:
• Sanctity of life: Some people believe that all human life is sacred and that it is wrong to intentionally
end a life.
• Slippery slope: Some people worry that if euthanasia is legalized for terminally ill patients, it will
eventually be legalized for other groups of people, such as the elderly or the disabled.
• Potential for abuse: Some people worry that euthanasia could be used to kill people without their
consent, such as in the case of elderly people who are neglected or abused by their families.

8. EUTHANASIA
• Euthanasia is currently legal in a handful of countries, including the
Netherlands, Belgium, Luxembourg, Switzerland, and Canada. It is also legal
in some US states, such as Oregon, Washington, California, and Colorado.
• Euthenasia is also conducted for animals that take part in clinical trails.

9. EUTHANASIA
• Animal euthanasia is the practice of intentionally ending the life of an animal to relieve pain
and suffering. It is a common procedure in veterinary medicine, and it is used for a variety of
reasons, including:
• Terminal illness
• Severe injury
• Untreatable pain
• Behavior problems
• Lack of resources to care for the animal

10. EUTHANASIA
• Euthanasia should only be performed by a qualified veterinarian. Veterinarians use a variety
of methods to euthanize animals, including:
• Injectable drugs: These drugs are typically sedatives or anesthetics that are injected into the animal's
bloodstream. The drugs cause the animal to lose consciousness and then die peacefully.
• Carbon dioxide gas: This method is often used to euthanize small animals, such as rodents and
rabbits. The animal is placed in a chamber filled with carbon dioxide gas, which displaces the
oxygen in the animal's lungs and causes it to lose consciousness and die.
• Gunshot: This method is typically used to euthanize large animals, such as horses and cattle. A
veterinarian will shoot the animal in the brain, which causes immediate unconsciousness and death.

11. EUTHANASIA
• Veterinarians will choose the euthanasia method that is most appropriate for the animal's species, age,
health condition, and temperament. They will also consider the owner's preferences.
• The decision to euthanize an animal is a difficult one, but it is sometimes the best way to relieve the
animal's suffering. If you are considering euthanasia for your pet, talk to your veterinarian about your
options.
• It is important to note that euthanasia is a humane and painless way to end an animal's life. Animals do
not feel pain or distress during the euthanasia procedure.

12. INFORMED CONSENT
• An informed consent form is a document that describes a research study and the risks and benefits of
participation. It is important for potential participants to understand the information in the form before they
decide whether or not to participate in the study. It is important to obtain informed consent because it:
• Respects the individual's autonomy: Individuals have the right to make their own decisions about their
bodies and their care. Informed consent allows individuals to make decisions about whether or not to
participate in a medical procedure or research study based on their own values and preferences.
• Protects individuals from harm: Informed consent helps to protect individuals from being harmed by
medical procedures or research studies. By providing individuals with information about the risks and
benefits of a procedure or study, healthcare providers and researchers can help individuals to make
informed decisions about whether or not to participate.

13. ADVANTAGES OF IOC
• There are a number of advantages to obtaining informed consent, including:
• Improved patient satisfaction: When individuals are involved in the decision-making process, they
are more likely to be satisfied with their care.
• Enhanced patient-provider communication: Informed consent provides an opportunity for
individuals to communicate with their healthcare providers about their concerns and expectations.
• Increased public trust: Informed consent helps to build public trust in the medical and research
communities.
• Reduced risk of malpractice lawsuits: Obtaining informed consent can help to reduce the risk of
malpractice lawsuits, as it shows that the healthcare provider has taken the time to explain the risks
and benefits of a procedure to the patient and that the patient has consented to the procedure.

14. DISADVANTAGES OF IOC
• There are also a few potential disadvantages to obtaining informed consent,
including:
• Increased time and costs: Obtaining informed consent can be time-consuming and costly, especially
for complex medical procedures or research studies.
• Potential for misunderstanding: It is possible for individuals to misunderstand the information that
is provided to them during the informed consent process.
• Potential for withdrawal: Individuals have the right to withdraw from a medical procedure or
research study at any time, even after they have given informed consent. This can be disruptive for
healthcare providers and researchers.

15. INFORM CONSENT FORM
• These are the detailed description of the details that need to be filled in an informed consent
form.
• General Information
• Study title: This should be the official title of the research study.
• Principal investigator: This is the lead researcher who is responsible for conducting the study.
• Contact information for the principal investigator and other study staff: This should include the phone
number, email address, and mailing address of the principal investigator and other study staff who
participants can contact if they have questions or concerns.
• Statement that the study is research and that participation is voluntary: This statement should make it
clear to participants that the study is research and that they are not obligated to participate.

16. INFORM CONSENT FORM
• Explanation of the purpose of the study: This section should explain what the study is trying to learn and
why it is important.
• Description of the study procedures: This section should describe in detail what participants will be asked
to do as part of the study. This may include things like filling out questionnaires, providing blood or urine
samples, or participating in medical procedures.
• Explanation of any risks or discomforts associated with participation: This section should explain any
potential risks or discomforts that participants may experience as a result of participating in the study. This
may include things like physical pain, emotional distress, or the risk of side effects from medical
interventions.
• Explanation of any potential benefits of participation: This section should explain any potential benefits
that participants may experience as a result of participating in the study. This may include things like
access to new treatments or the opportunity to contribute to the advancement of medical knowledge.

17. INFORM CONSENT FORM
• Alternatives to participation in the study: This section should explain any other options that
participants have besides participating in the study. For example, if the study is testing a new drug,
the participant may have the option to receive the standard of care instead.
• Statement that participants may withdraw from the study at any time without penalty: This statement
should make it clear to participants that they have the right to withdraw from the study at any time,
for any reason, without penalty.
• Signature of the participant and date: This section should include the participant's signature and the
date that they signed the informed consent form.

18. CONFLICTS OF INTEREST
• The potential conflict of interest has been identified, there are a number of things
that can be done to manage it, such as:
• Disclosure: The person should disclose the conflict of interest to others who may be affected by it.
• Recusal: The person should recuse themselves from making decisions or taking actions that could
be influenced by the conflict of interest.
• Mitigation: The person can take steps to mitigate the risk of bias, such as by seeking input from
others or by using objective decision-making criteria.

19. 6 P’S OF CONFLICTS OF INTEREST
• Personal interests: This includes any personal interests that may influence a person's judgment or actions, such as financial interests,
relationships, or reputation.
• Professional interests: This includes any professional interests that may influence a person's judgment or actions, such as their job, career,
or professional goals.
• Perceptions: This includes how others may perceive a person's potential for bias, even if there is no actual conflict of interest.
• Powers and responsibilities: This includes the power and responsibility that a person has to make decisions or take actions that could affect
others.
• Public interest: This includes the public interest that a person is supposed to serve, such as the interests of their clients, customers, or
students.
• Pressures: This includes any pressures that may influence a person's judgment or actions, such as pressure from peers, superiors, or
subordinates.

21. CONFIDENTIALITY
• Confidentiality in medical research is the protection of participants' personal information and health data
from unauthorized access or disclosure. It is an essential ethical principle in medical research, and it is
important to maintain confidentiality in order to protect participants from harm and to ensure the
trustworthiness of research results.
• There are a number of reasons why confidentiality is important in medical research. First, participants may
be reluctant to participate in research studies if they are concerned about their confidentiality. This could lead
to under-representation of certain groups in research studies, which could bias the results. Second, a breach
of confidentiality could harm participants by damaging their reputation, their relationships, or their
employment prospects. Third, a breach of confidentiality could jeopardize the trustworthiness of research
results by making it impossible to verify the identity of participants or to protect their data from
manipulation.

22. CONFIDENTIALITY
• Researchers take a number of steps to protect the confidentiality of research participants.
These steps may include:
• Obtaining informed consent from participants before collecting any data.
• Using pseudonyms or codes to identify participants in research records.
• Storing data in a secure manner.
• Limiting access to data to only those who need it to conduct the research.
• Destroying data after it is no longer needed.

23. CONFIDENTIALITY
• Obtaining informed consent from participants: Informed consent should include information about how participants' data
will be collected, stored, and used. It should also explain the risks of confidentiality breaches and how participants can
withdraw from the study at any time.
• Using de-identified data: Whenever possible, researchers should use de-identified data, which is data that has been stripped
of all personal identifiers. This makes it impossible to identify individual participants from the data.
• Storing data securely: Researchers should store participants' data in a secure manner, such as in encrypted files or on
password-protected servers.
• Limiting access to data: Researchers should only grant access to data to authorized personnel. This may involve using
access control lists or other security measures.
• Training personnel on confidentiality: All personnel involved in medical research should be trained on confidentiality
procedures. This training should cover the importance of confidentiality, the risks of breaches, and how to protect
participants' data.

24. REFERENCES
1) Guraya, S. Y., London, N. J. M., & Guraya, S. S. (2014). Ethics in medical
research. Journal of Microscopy and Ultrastructure, 2(3), 121-126.
2) Hoeyer, K., & Hogle, L. F. (2014). Informed consent: The politics of intent and practice in
medical research ethics. Annual Review of Anthropology, 43, 347-362.