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Medical Research_Important for research in Humans Useful for M.pharm students.

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Medical Research
M.PHARM_SEM-3_RM
RISHITA D PATEL
CONTENT
• History
• Values in medical ethics
• Autonomy, beneficence, non-maleficence, double effect, conflicts between
autonomy and beneficence/non-maleficence, euthanasia
• Informed consent, confidentiality, criticisms of orthodox medical ethics
• Importance of communication, control resolution, guidelines, ethics
committees
• Cultural concerns, truth telling, online business practices, conflicts of
interest, referral, vendor relationships, treatment of family members, sexual
relationships, fatality.
22-11-2023 Rishita Patel_IICP 2
History
• The code of conduct for physicians was well laid out in traditional
Indian systems of medicine and do no harm was the underlying
universal principle besides other principles applicable to the
prevalent culture and the class systems of the society.
• The Indian Council of Medical Research (ICMR) issued the Policy
Statement on Ethical Considerations Involved in Research on
Human Subjects in 1980.
22-11-2023 Rishita Patel_IICP 3
• In the meantime, the Central Drugs Standard Control Organization
(CDSCO) also released the Indian Good Clinical Practice
Guidelines (2001) for clinical trials and revised Schedule Y of the
Drugs and Cosmetics Act, 1940, in the year 2005 with several
amendments in the Rules under Drugs and Cosmetics Act in the
year 2013.
• ICMR and the Department of Biotechnology (DBT) jointly
brought out Guidelines for Stem Cell Research and Therapy in
2007 and a further revision in 2013 which is now revised as
National Guidelines for Stem Cell Research, 2017.
22-11-2023 Rishita Patel_IICP 4
• The Nuremberg Code of 1947 was the first international treatise on
the ethics of research involving human beings and highlighted the
essentiality of obtaining voluntary consent. In 1964, the World
Medical Association formulated guidelines on conducting research
on humans, known as the Declaration of Helsinki. This has
undergone seven revisions with the latest version being issued in
October 2013 at Fortaleza, Brazil.
• In 1979, the Belmont Report released by the National Commission
for the Protection of Human Subjects of Biomedical and
Behavioural Research in the United States of America (USA), for
the first time enunciated the three basic ethical principles for
research involving human subjects: respect for persons,
beneficence and justice.
22-11-2023 Rishita Patel_IICP 5
Values in medical ethics
• STATEMENT OF GENERAL PRINCIPLES SECTION
• Research on human participants pertains to a broad range of scientific
enquiry aimed at developing generalizable knowledge that improves health,
increases understanding of disease and is ethically justified by its social
value.
• Every research has some inherent risks and probabilities of harm or
inconvenience to participants/communities. Therefore, protection of
participants should be built into the design of the study.
22-11-2023 Rishita Patel_IICP 6
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MEDICAL RESEARCH.pptx

  • 2. CONTENT • History • Values in medical ethics • Autonomy, beneficence, non-maleficence, double effect, conflicts between autonomy and beneficence/non-maleficence, euthanasia • Informed consent, confidentiality, criticisms of orthodox medical ethics • Importance of communication, control resolution, guidelines, ethics committees • Cultural concerns, truth telling, online business practices, conflicts of interest, referral, vendor relationships, treatment of family members, sexual relationships, fatality. 22-11-2023 Rishita Patel_IICP 2
  • 3. History • The code of conduct for physicians was well laid out in traditional Indian systems of medicine and do no harm was the underlying universal principle besides other principles applicable to the prevalent culture and the class systems of the society. • The Indian Council of Medical Research (ICMR) issued the Policy Statement on Ethical Considerations Involved in Research on Human Subjects in 1980. 22-11-2023 Rishita Patel_IICP 3
  • 4. • In the meantime, the Central Drugs Standard Control Organization (CDSCO) also released the Indian Good Clinical Practice Guidelines (2001) for clinical trials and revised Schedule Y of the Drugs and Cosmetics Act, 1940, in the year 2005 with several amendments in the Rules under Drugs and Cosmetics Act in the year 2013. • ICMR and the Department of Biotechnology (DBT) jointly brought out Guidelines for Stem Cell Research and Therapy in 2007 and a further revision in 2013 which is now revised as National Guidelines for Stem Cell Research, 2017. 22-11-2023 Rishita Patel_IICP 4
  • 5. • The Nuremberg Code of 1947 was the first international treatise on the ethics of research involving human beings and highlighted the essentiality of obtaining voluntary consent. In 1964, the World Medical Association formulated guidelines on conducting research on humans, known as the Declaration of Helsinki. This has undergone seven revisions with the latest version being issued in October 2013 at Fortaleza, Brazil. • In 1979, the Belmont Report released by the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research in the United States of America (USA), for the first time enunciated the three basic ethical principles for research involving human subjects: respect for persons, beneficence and justice. 22-11-2023 Rishita Patel_IICP 5
  • 6. Values in medical ethics • STATEMENT OF GENERAL PRINCIPLES SECTION • Research on human participants pertains to a broad range of scientific enquiry aimed at developing generalizable knowledge that improves health, increases understanding of disease and is ethically justified by its social value. • Every research has some inherent risks and probabilities of harm or inconvenience to participants/communities. Therefore, protection of participants should be built into the design of the study. 22-11-2023 Rishita Patel_IICP 6
  • 7. • Do no harm (non-maleficence) has been the underlying universal principle guiding health care in all systems of medicine around the world. • While conducting biomedical and health research, the four basic ethical principles namely; respect for persons (autonomy), beneficence, non- maleficence and justice have been enunciated for protecting the dignity, rights, safety and well-being of research participants. • These four basic principles have been expanded into 12 general principles described below, and are to be applied to all biomedical, social and behavioural science research for health involving human participants, their biological material and data. 22-11-2023 Rishita Patel_IICP 7
  • 8. • General Principles • Principle of essentiality whereby after due consideration of all alternatives in the light of existing knowledge, the use of human participants is considered to be essential for the proposed research. This should be duly vetted by an ethics committee (EC) independent of the proposed research. • Principle of voluntariness whereby respect for the right of the participant to agree or not to agree to participate in research, or to withdraw from research at any time, is paramount. The informed consent process ensures that participants’ rights are safeguarded. 22-11-2023 Rishita Patel_IICP 8
  • 9. • Principle of non-exploitation whereby research participants are equitably selected so that the benefits and burdens of the research are distributed fairly and without arbitrariness or discrimination. Sufficient safeguards to protect vulnerable groups should be ensured. • Principle of social responsibility whereby the research is planned and conducted so as to avoid creation or deepening of social and historic divisions or in any way disturb social harmony in community relationships. 22-11-2023 Rishita Patel_IICP 9
  • 10. • Principle of ensuring privacy and confidentiality whereby to maintain privacy of the potential participant, her/his identity and records are kept confidential and access is limited to only those authorized. • However, under certain circumstances (suicidal ideation, homicidal tendency, HIV positive status, when required by court of law etc.) • privacy of the information can be breached in consultation with the EC for valid scientific or legal reasons as the right to life of an individual supersedes the right to privacy of the research participant. 22-11-2023 Rishita Patel_IICP 10
  • 11. • Principle of risk minimization whereby due care is taken by all stakeholders (including but not limited to researchers, ECs, sponsors, regulators) at all stages of the research to ensure that the risks are minimized and appropriate care and compensation is given if any harm occurs. • Principle of professional competence whereby the research is planned, conducted, evaluated and monitored throughout by persons who are competent and have the appropriate and relevant qualification, experience and/or training. 22-11-2023 Rishita Patel_IICP 11
  • 12. • Principle of maximization of benefit whereby due care is taken to design and conduct the research in such a way as to directly or indirectly maximize the benefits to the research participants and/or to the society. • Principle of institutional arrangements whereby institutions where the research is being conducted, have policies for appropriate research governance and take the responsibility to facilitate research by providing required infrastructure, manpower, funds and training opportunities. 22-11-2023 Rishita Patel_IICP 12
  • 13. • Principle of transparency and accountability whereby the research plan and outcomes emanating from the research are brought into the public domain through registries, reports and scientific and other publications while safeguarding the right to privacy of the participants. • Stakeholders involved in research should disclose any existing conflict of interest and manage it appropriately. • The research should be conducted in a fair, honest, impartial and transparent manner to guarantee accountability. • Related records, data and notes should be retained for the required period for possible external scrutiny/ audit. 22-11-2023 Rishita Patel_IICP 13
  • 14. Principle of totality of responsibility whereby all stakeholders involved in research are responsible for their actions. The professional, social and moral responsibilities compliant with ethical guidelines and related regulations are binding on all stakeholders directly or indirectly. Principle of environmental protection whereby researchers are accountable for ensuring protection of the environment and resources at all stages of the research, in compliance with existing guidelines and regulations. 22-11-2023 Rishita Patel_IICP 14
  • 15. The Fundamental Principles of Ethics Autonomy • The philosophical underpinning for autonomy, as interpreted by philosophers Immanuel Kant (1724–1804)and John Stuart Mill (1806–1873), and accepted as an ethical principle, is that all persons have intrinsic and unconditional worth, and therefore, should have the power to make rational decisions and moral choices, and each should be allowed to exercise his or her capacity for self-determination. • This ethical principle was affirmed in a court decision by Justice Cardozo in 1914 with the epigrammatic dictum, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body” • The ability and capacity of a rational individual to make an independently informed decision to volunteer as a research participant. 22-11-2023 Rishita Patel_IICP 15
  • 16. • Beneficence To try to do good or an action which weighs the risks against benefits to prevent, reduce or remove harm for the welfare of the research participant(s) in any type of research. • The principle of beneficence is the obligation of physician to act for the benefit of the patient and supports a number of moral rules to protect and defend the right of others, prevent harm, remove conditions that will cause harm, help persons with disabilities, and rescue persons in danger. • The principle calls for not just avoiding harm, but also to benefit patients and to promote their welfare. 22-11-2023 Rishita Patel_IICP 16
  • 17. • Do no harm (non-maleficence) has been the underlying universal principle guiding health care in all systems of medicine around the world. • While conducting biomedical and health research, the four basic ethical principles namely; • respect for persons (autonomy), • beneficence, • non-maleficence and • justice have been enunciated for protecting the dignity, rights, safety and well- being of research participants. 22-11-2023 Rishita Patel_IICP 17
  • 18. Nonmaleficence • Nonmaleficence is the obligation of a physician not to harm the patient. • This simply stated principle supports several moral rules – do not kill, do not cause pain or suffering, do not incapacitate, do not cause offense, and do not deprive others of the goods of life. • The practical application of nonmaleficence is for the physician to weigh the benefits against burdens of all interventions and treatments, to eschew those that are inappropriately burdensome, and to choose the best course of action for the patient. • This is particularly important and pertinent in difficult end-of-life care decisions. • Goals of ethics education • To appreciate the ethical dimensions of patient care • To understand ethical principles of medical profession 22-11-2023 Rishita Patel_IICP 18
  • 19. • To have competence in core ethical behavioral skills (Obtaining informed consent, assessing decision-making capacity, discussing resuscitation status and use of life sustaining treatments, advanced care planning, breaking bad news and effective communication) • To know the commonly encountered ethical issues in general and in one’s specialty • To have competence in analyzing and resolving ethical problems • To appreciate cultural diversity and its impact on ethics withdrawing life- sustaining treatment, medically administered nutrition and hydration, and in pain and other symptom control. 22-11-2023 Rishita Patel_IICP 19
  • 20. • Principle of non-maleficence – • Maximum efforts should be made to minimize harm done to individuals and others, such as the community, especially while collecting data and its subsequent disclosure. • Harm could be in the form of stigma, poverty, and discrimination that affect persons living with diseases like HIV, STD, TB, mental illnesses, etc. • Safeguards to maintain confidentiality should be established as there could also be indirect harm to the individual/community/ relationships and loss of benefit. 22-11-2023 Rishita Patel_IICP 20
  • 21. • According to the principle of double effect, sometimes it is permissible to cause a harm as an unintended and merely foreseen side effect (or “double effect”) of bringing about a good result even though it would not be permissible to cause such a harm as a means to bringing about the same good end. 22-11-2023 Rishita Patel_IICP 21
  • 22. Conflicts between autonomy and beneficence/non- maleficence • Each one of the 4 principles of ethics is to be taken as a prima facie (commonly understood) obligation that must be fulfilled, unless it conflicts, in a specific instance, with another principle. • When faced with such a conflict, the physician has to determine the actual obligation to the patient by examining the respective weights of the competing prima facie obligations based on both content and context. • Consider an example of a conflict that has an easy resolution: a patient in shock treated with urgent fluid-resuscitation and the placement of an indwelling intravenous catheter caused pain and swelling. • Here the principle of beneficence overrides that of nonmaleficence. Many of the conflicts that physicians face, however, are much more complex and difficult. • Consider a competent patient’s refusal of a potentially life-saving intervention (e.g., instituting mechanical ventilation) or request for a potentially life-ending action (e.g., withdrawing mechanical ventilation). 22-11-2023 Rishita Patel_IICP 22
  • 23. • Nowhere in the arena of ethical decision-making is conflict as pronounced as when the principles of beneficence and autonomy collide. • Beneficence has enjoyed a historical role in the traditional practice of medicine. • However, giving it primacy greater importance over patient autonomy is paternalism that makes a physician-patient relationship analogous to that of a father/ mother to a child. • A father/mother may refuse a child’s wishes, may influence a child by a variety of ways – nondisclosure, manipulation, deception, coercion (compulsion)etc., consistent with his/her thinking of what is best for the child. Paternalism can be further divided into soft and hard. 22-11-2023 Rishita Patel_IICP 23
  • 24. • In soft paternalism, the physician acts on grounds of beneficence (and, at times, nonmaleficence) when the patient is nonautonomous or substantially nonautonomous (e.g., cognitive dysfunction due to severe illness, depression, or drug addiction). • Soft paternalism is complicated because of the difficulty in determining whether the patient was nonautonomous at the time of decision-making but is ethically defensible as long as the action is in concordance with what the physician believes to be the patient’s values. • Hard paternalism is action by a physician, intended to benefit a patient, but contrary to the voluntary decision of an autonomous patient who is fully informed and competent, and is ethically indefensible. 22-11-2023 Rishita Patel_IICP 24
  • 25. • On the other end of the scale of hard paternalism is consumerism, a rare and extreme form of patient autonomy, that holds the view that the physician’s role is limited to providing all the medical information and the available choices for interventions and treatments while the fully informed patient selects from the available choices. • કઠોર પિતૃવાદના માિદંડના બીજા છેડે ઉિભોક્તાવાદ છે, જે દદીની સ્વાયત્તતાનં એક દર્લભ અને આત્યંપતક સ્વરૂિ છે, જે માને છે કે પિપકત્સકની ભૂપમકા તમામ તબીબી માપિતી અને િસ્તક્ષેિ અને સારવાર માટે ઉિર્બ્ધ િસંદગીઓ િૂરી િાડવા સધી મયાલપદત છે જ્યારે સંિૂર્લ માપિતગાર દદી ઉિર્બ્ધ િસંદગીઓમાંથી િસંદ કરે છે. • In this model, the physician’s role is constrained, and does not permit the full use of his/her knowledge and skills to benefit the patient, and is tantamount to a form of patient abandonment and therefore is ethically indefensible. • આ મોડેર્માં, પિપકત્સકની ભૂપમકા મયાલપદત છે, અને તે દદીના ર્ાભ માટે તેના/તેર્ીના જ્ઞાન અને કૌશલ્યોનો સંિૂર્લ ઉિયોગ કરવાની મંજૂરી આિતં નથી, અને તે દદીના ત્યાગના સ્વરૂિ સમાન છે અને તેથી તે નૈપતક રીતે અસરપક્ષત છે. 22-11-2023 Rishita Patel_IICP 25
  • 26. • Faced with the contrasting paradigms of beneficence and respect for autonomy and the need to reconcile these to find a common ground, Pellegrino and Thomasma argue that beneficence can be inclusive of patient autonomy as “the best interests of the patients are intimately linked with their preferences” from which “are derived our primary duties to them.” • સ્વાયત્તતા માટે ર્ાભ અને આદરના પવરોધાભાસી દૃષ્ાંતોનો સામનો કરવો અને એક સામાન્ય ગ્રાઉન્ડ શોધવા માટે આમાં સમાધાન કરવાની જરૂપરયાતનો સામનો કરવો, િેર્ેપગ્રનો અને થોમાસ્મા દર્ીર્ કરે છે કે ર્ાભ એ દદીની સ્વાયત્તતાનો સમાવેશ કરી શકે છે કારર્ કે "દદીઓના શ્રેષ્ઠ પિત તેમની િસંદગીઓ સાથે ગાઢ રીતે જોડાયેર્ા છે" જેમાંથી "તેમના પ્રત્યેની અમારી પ્રાથપમક ફરજો ર્ેવામાં આવે છે." 22-11-2023 Rishita Patel_IICP 26
  • 29. Euthanasia • What is euthanasia? • Euthanasia is the practice of ending the life of a patient to limit the patient’s suffering. • The patient in question would typically be terminally ill or experiencing great pain and suffering. • The word “euthanasia” itself comes from the Greek words “eu” (good) and “thanatos” (death). • The idea is that instead of condemning someone to a slow, painful, or undignified death, euthanasia would allow the patient to experience a relatively “good death.” • પવિાર એ છે કે કોઈને ધીમી, િીડાદાયક અથવા અિમાનજનક મૃત્ય માટે પનંદા કરવાને બદર્ે, ઈચ્છામૃત્ય દદીને પ્રમાર્માં "સારા મૃત્ય" નો અનભવ કરવાની મંજૂરી આિશે. 22-11-2023 Rishita Patel_IICP 29
  • 30. • Types of euthanasia Different practices fall under the label “euthanasia.” Here are some distinctions demarcating different versions. Active euthanasia: killing a patient by active means, for example, injecting a patient with a lethal dose of a drug. Sometimes called “aggressive”euthanasia. Passive euthanasia: intentionally letting a patient die by withholding artificial life support such as a ventilator or feeding tube. Some ethicists distinguish between withholding life support and withdrawing life support (the patient is on life support but then removed from it). 22-11-2023 Rishita Patel_IICP 30
  • 31. Voluntary euthanasia: with the consent of the patient. Involuntary euthanasia: without the consent of the patient, for example, if the patient is unconscious and his or her wishes are unknown. Some ethicists distinguish between “involuntary” (against the patient’s wishes) and “nonvoluntary” (without the patient’s consent but wishes are unknown) forms. Self-administered euthanasia: the patient administers the means of death. Other-administered euthanasia: a person other than the patient administers the means of death. દદી પસવાયની વ્યપક્ત મૃત્યના માધ્યમનં સંિાર્ન કરે છે. 22-11-2023 Rishita Patel_IICP 31
  • 32. • Assisted: the patient administers the means of death but with the assistance of another person, such as a physician. • There are many possible combinations of the above types, and many types of euthanasia are morally controversial. Some types of euthanasia, such as assisted voluntary forms, are legal in some countries. • Mercy-killing: The term “mercy-killing” usually refers to active, involuntary or nonvoluntary, other-administered euthanasia. In other words, someone kills a patient without their explicit consent to end the patient’s suffering. • Physician-assisted suicide: The phrase “physician-assisted suicide” refers to active, voluntary, assisted euthanasia where a physician assists the patient. A physician provides the patient with a means, such as sufficient medication, for the patient to kill him or herself. 22-11-2023 Rishita Patel_IICP 32
  • 33. • Privacy and confidentiality • Privacy and confidentiality of research participants should be considered while selecting sites for data collection, choosing sensitive research areas, specific contexts and settings. • In some circumstances participants become more vulnerable in research because of heightened psychological, social, physical or legal risks. • Breach of confidentiality in these types of research may cause serious harm to vulnerable participants. • It is important to protect study participants from potential future risks and harm by establishing culturally sensitive and context specific safeguards 22-11-2023 Rishita Patel_IICP 33
  • 34. • Some key aspects related to maintaining confidentiality and privacy of donors of biological materials and/or data: 1. The procedure of anonymization minimizes the connection between the identifiers and the stored sample or medical data by delinking the person from her/his biological material. અનામીકરર્ની પ્રપિયા ઓળખકતાલઓ અને સંગ્રપિત નમૂના અથવા તબીબી ડેટા વચ્િેના જોડાર્ને વ્યપક્તની/તેની જૈપવક સામગ્રીમાંથી પડપર્ંક કરીને ઘટાડે છે. 2. Maintaining confidentiality of data and respecting ethnic identity is of prime importance, especially in population based genetic studies. 3. More precautions should be sought when the research pertains to stigmatizing diseases. 4. When data pertains to epidemiological and public health practice or research. 22-11-2023 Rishita Patel_IICP 34
  • 35. Measures to ensure privacy and confidentiality of individuals • Ensure physical safety and security of the involved devices and computer servers. • Take data security measures such as password protection. • Provide differential and role-based controlled access to data elements for members of the research team. • Ensure use of data encryption when data is transferred from one location/device to another. • Ensure benefit sharing with owners and related legal issues since, unlike some other countries, India does not have a data protection act as yet. 22-11-2023 Rishita Patel_IICP 35
  • 36. • CRITICISMS OF ORTHODOX MEDICAL ETHICS • ઓર્થોડોક્સ મેડડકલ એડર્થક્સની ટીકા • It has been argued that mainstream medical ethics is biased by the assumption of a framework in which individuals are not simply free to contract with one another to provide whatever medical treatment is demanded, subject to the ability to pay. • એવી દર્ીર્ કરવામાં આવી છે કે મખ્ય પ્રવાિની તબીબી નીપતશાસ્ત્ર એક માળખાની ધારર્ા દ્વારા િક્ષિાતી છે જેમાં વ્યપક્તઓ િૂકવર્ી કરવાની ક્ષમતાને આધીન, કોઈિર્ તબીબી સારવારની માંગર્ી િૂરી િાડવા માટે એકબીજા સાથે કરાર કરવા માટે મક્ત નથી. • Because a high proportion of medical care is typically provided via the welfare state (ie. Medicare), and because there are legal restrictions on what treatment may be provided and by whom, an automatic divergence may exist between the wishes of patients and the preferences of medical practitioners and other parties. 22-11-2023 Rishita Patel_IICP 36
  • 37. • CONTROL RESOLUTION • ડનયંત્રણ ઠરાવ • To ensure that appropriate ethical values are being applied within hospitals, effective hospital accreditation requires that ethical considerations are taken into account, for example with respect to physician integrity, conflicts of interest, research ethics and organ transplantation ethics. • RESOLUTION STRATEGY Sets out the key elements of the proposed approach to resolution. Scope Conditions for entry into resolution Activation of the operational resolution plan Funding arrangements Key options resolving the failing firm Protects critical functions, government funds and systemic stability Achieves relevant resolution objectives. 22-11-2023 Rishita Patel_IICP 37

Editor's Notes

  1. unselfish
  2. Prima facie is a Latin term that is commonly understood to mean “on the first appearance” or “based on the first impression.