MEDICAL RESEARCH: UNIT_III_ EUTHANASIA, COI, CONFIDENTIALITY RESEARCH METHODOLOGY AND BIOSTATISTICS

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

1. MEDICAL RESEARCH- Euthanasia, COI, Confidentiality Presented by: Prachi Pandey, Rahul Pal M . PHARM (PHARMACEUTICS), III rd 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. ETHICAL ARGUMENTS 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. ETHICAL ARGUMENTS 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 .

20. 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.

21. 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.

22. 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 .

23. REFERENCES Guraya , S. Y., London, N. J. M., & Guraya , S. S. (2014). Ethics in medical research.  Journal of Microscopy and Ultrastructure ,  2 (3), 121-126. 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.