Evolution of Ethics in Human Subjects Research

 
Ethics in Research
 
 
PPP No. 7
 
Human Subjects Research (HSR)
or
Human Subjects Use (HSU)
 
Involves:
Use of human subjects
[
participants
]
          As
 Research subjects [
participants
]
 
HSR/HSU
 
 
Important part of medical research
People volunteer:
Clinical trials of med treatment
Basic medical science and biology
Social/behavioral (psychological) research
 
History
 
 
HRS been treated unethically
Hence been put in many places:
Requirements
Guidelines
Processes
at national, academic and scientific
community levels
to ensure similar events not repeated
 
Definitions
 
Respondents
 = any object observed for
purposes of research
 
In survey research/opinion polls
In human-participant research – very
important:
Informed consent
:
Possible consequences
What study is all about
Quit any time without adverse
repercussions.
 
 
Background
 
 
Human experiments and associated ethics
Have evolved over time
Part of atrocities – strict policies in place today
Common subjects:
Prisoners
Slaves
Family members
Self-experimentation – on occasions, doctors
experiment on themselves
 
Past History
 
 
Ancient:
Herophilos of Chalcedon – On prisoners from
Ptolemais kings
Middle Ages:
Systematic experimentation/quantification in
physiology
Avicerna Ibn Sina – an influential Persian Muslim
physician:
Biomedical res
Cl trials
RCTs
Drug tests
On human subjects
 
Past History
 
 
12
th
 Century:
Experiments  human dissections
By Ibn Zuhr, Ibn Tufail, Ibn Jumay
Early Modern Times
An upsurge in HSR experiments:
Vaccine trials in 1700s
Self-experimentation
Slaves – Not informed on dangers associated
with such experiments
 
Past History
 
Outstanding examples:
 
 
Edward Jenner experiments
:
Small pox vaccine – on his son and neighbourhood
children
Johann Jorg
:
Self-experimentation
17 drugs in various doses
To test their properties
Conversely:
Lois Pateur agonised over treating humans
 
Past History
 
Early 20
th
 Century:
 
1900s:
Accelerated progress of med.
Emergence of concept of code of
ethics and science discipline
Changed dramatically
 
 
Past History
 
Early 20
th
 Century:
 
Attitude towards research subjects revolutionarised
Examples: Walter Reeds experiments:
Develop inoculation to Yellow Fever
Experiments carefully scrutinized unlike
earlier trials
 
 
Past History
 
However contraventions still existed:
 
eg. Tuskegee Study of untreated Syphilis in
Negro males (1932-1970)
Conducted on subjects without informed consent
Covertly and under coercion
1930-1940 – British Army:
British and Indian soldiers used as guinea pigs
Mustard gas effects on Indian and British skin
 
Past History
 
2
nd
 World War:
 
Nazi human experiment in German –
Euthenasia
23 Nazi doctors/scientists tried for murder
of concentration inmates (Nuremberg)
15 convicted
Result of these trial proceedings –
Nuremberg Code
 
 
Nuremberg Code
 
Informed consent is essential
Research should be based on prior animal work
Risk should be justified by the anticipated
benefits
Research must be conducted by qualified
scientists
Physical/mental suffering must be avoided
Research where death or disabling injury is
expected should not be conducted
 
Guidelines towards HSR
 
Code of research ethics:
 
 
Nuremberg code/principle of 1944
Declaration of Geneva of 1948:
By General Assembly of the World Medical Association
Physician’s dedication to humanitarian goals of medicine
Declaration of Helsinki of 1964
Beecher Article of 1966
Belmont Report of 1974:
Respect for persons
Beneficence
Justice
Evolution of IRBs
 
 
Research Ethics: Definition
 
Branch of philosophy
Deals with distinction between:
Right and wrong
With moral consequences of human actions
Informed consent
Confidentiality
Respect of human rights
Scientific integrity
 
Ethical guidelines in research
 
Proper scientific merits:
Potential for benefits
Low level of risk
Written protocols – proper planning of studies
Appropriate expertise of investigator
Room to stop study whenever necessary
Ethics committees – ensure standards are met
Informed consent – voluntary participation
Equitable selection of subjects
Compensation for research-related injury.
 
 
Ethical guidelines (contd)
 
Duties of researcher:
Honest
Impartial
Not to distort the truth
Uphold public interest – not narrow sectional
interests
Decline contractual obligations aimed at reaching
particular conclusions
Decline grants/contracts – sponsor retaining
right to edit/suppress results
 
 
 
1998 – Code of practice
 
Researchers should:
Seek truth in good faith
Judge own work and that of others
impartially
Disclose conflicts of interest to ethics
review committees
Publicly acknowledge all res sponsorship
 
 
1998 – Code of practice
 
Researchers should:
Publish research with scientific merit
Refuse requests to withhold results –
change or tone down the content
Ensure sponsors abide with dissemination
of results
Declare sources of funding
 
 
Ethical Principles
 
3 principles on research involving human
subjects (Belmont Report 1974):
1. Respect for persons:
Obtain informed consent from res participants
Protect participants with impaired decision-making
capacity
Maintain confidentiality
 
 
Ethical principles (2)
 
2. Principle of beneficence:
 
Research design be scientifically sound
Risks of research be within acceptable levels–
both physical and psycho-social harm
 
 
Ethical principles (3)
 
Principle of justice:
 
Benefits and burdens of research be
distributed fairly among vulnerable populations
e.g.
Those with poor access to health care
Those with impaired decision-making capacity
Residents of nursing homes etc
 
 
Responsibilities of investigators
 
Scientific misconduct eg doctoring of
data
Conflicts of interest eg financial, dual
roles - these impair research objectivity
Authorship - rush for promotion,
prestige and grants
RCTs – special ethical concerns because
treatment often determined by
chance/randomly
 
 
Responsibilities of investigators
 
Acknowledge use of existing data
 
Genetic research – particular ethical
concern on confidentiality
Payments due to research
participants/assistants to levels not
exceeding compensation for out-of-
pocket expenses, time and effort
 
Reading
 
Fisher, Jill a. (2007). Governing human
subjects research in the USA: Individualized
Ethics and structural inequalities. Science &
Public Policy 34 (2): 117-126.
 
Ledered, Susan: Subjected to science. Human
experimentation in America before the
Second World War Baltimore, Maryland:
Johns Hopkins University press 1995.
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Human Subjects Research (HSR) or Human Subjects Use (HSU) plays a vital role in medical research, with a historical background and strict ethical guidelines in place. From past atrocities to contemporary practices, the use of human subjects has evolved, emphasizing the importance of informed consent and ethical treatment. Key figures and experiments in history have shaped the current ethical standards in research involving human participants.

  • Ethics
  • Human Subjects Research
  • Medical Research
  • Informed Consent
  • History

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  1. Ethics in Research PPP No. 7

  2. Human Subjects Research (HSR) or Human Subjects Use (HSU) Involves: Use of human subjects [participants] As Research subjects [participants]

  3. HSR/HSU Important part of medical research People volunteer: Clinical trials of med treatment Basic medical science and biology Social/behavioral (psychological) research

  4. History HRS been treated unethically Hence been put in many places: Requirements Guidelines Processes at national, academic and scientific community levels to ensure similar events not repeated

  5. Definitions Respondents = any object observed for purposes of research In survey research/opinion polls In human-participant research very important: Informed consent: Possible consequences What study is all about Quit any time without adverse repercussions.

  6. Background Human experiments and associated ethics Have evolved over time Part of atrocities strict policies in place today Common subjects: Prisoners Slaves Family members Self-experimentation on occasions, doctors experiment on themselves

  7. Past History Ancient: Herophilos of Chalcedon On prisoners from Ptolemais kings Middle Ages: Systematic experimentation/quantification in physiology Avicerna Ibn Sina an influential Persian Muslim physician: Biomedical res Cl trials RCTs Drug tests On human subjects

  8. Past History 12th Century: Experiments human dissections By Ibn Zuhr, Ibn Tufail, Ibn Jumay Early Modern Times An upsurge in HSR experiments: Vaccine trials in 1700s Self-experimentation Slaves Not informed on dangers associated with such experiments

  9. Past History Outstanding examples: Edward Jenner experiments: Small pox vaccine on his son and neighbourhood children Johann Jorg: Self-experimentation 17 drugs in various doses To test their properties Conversely: Lois Pateur agonised over treating humans

  10. Past History Early 20th Century: 1900s: Accelerated progress of med. Emergence of concept of code of ethics and science discipline Changed dramatically

  11. Past History Early 20th Century: Attitude towards research subjects revolutionarised Examples: Walter Reeds experiments: Develop inoculation to Yellow Fever Experiments carefully scrutinized unlike earlier trials

  12. Past History However contraventions still existed: eg. Tuskegee Study of untreated Syphilis in Negro males (1932-1970) Conducted on subjects without informed consent Covertly and under coercion 1930-1940 British Army: British and Indian soldiers used as guinea pigs Mustard gas effects on Indian and British skin

  13. Past History 2nd World War: Nazi human experiment in German Euthenasia 23 Nazi doctors/scientists tried for murder of concentration inmates (Nuremberg) 15 convicted Result of these trial proceedings Nuremberg Code

  14. Nuremberg Code Informed consent is essential Research should be based on prior animal work Risk should be justified by the anticipated benefits Research must be conducted by qualified scientists Physical/mental suffering must be avoided Research where death or disabling injury is expected should not be conducted

  15. Guidelines towards HSR Code of research ethics: Nuremberg code/principle of 1944 Declaration of Geneva of 1948: By General Assembly of the World Medical Association Physician s dedication to humanitarian goals of medicine Declaration of Helsinki of 1964 Beecher Article of 1966 Belmont Report of 1974: Respect for persons Beneficence Justice Evolution of IRBs

  16. Research Ethics: Definition Branch of philosophy Deals with distinction between: Right and wrong With moral consequences of human actions Informed consent Confidentiality Respect of human rights Scientific integrity

  17. Ethical guidelines in research Proper scientific merits: Potential for benefits Low level of risk Written protocols proper planning of studies Appropriate expertise of investigator Room to stop study whenever necessary Ethics committees ensure standards are met Informed consent voluntary participation Equitable selection of subjects Compensation for research-related injury.

  18. Ethical guidelines (contd) Duties of researcher: Honest Impartial Not to distort the truth Uphold public interest not narrow sectional interests Decline contractual obligations aimed at reaching particular conclusions Decline grants/contracts sponsor retaining right to edit/suppress results

  19. 1998 Code of practice Researchers should: Seek truth in good faith Judge own work and that of others impartially Disclose conflicts of interest to ethics review committees Publicly acknowledge all res sponsorship

  20. 1998 Code of practice Researchers should: Publish research with scientific merit Refuse requests to withhold results change or tone down the content Ensure sponsors abide with dissemination of results Declare sources of funding

  21. Ethical Principles 3 principles on research involving human subjects (Belmont Report 1974): 1. Respect for persons: Obtain informed consent from res participants Protect participants with impaired decision-making capacity Maintain confidentiality

  22. Ethical principles (2) 2. Principle of beneficence: Research design be scientifically sound Risks of research be within acceptable levels both physical and psycho-social harm

  23. Ethical principles (3) Principle of justice: Benefits and burdens of research be distributed fairly among vulnerable populations e.g. Those with poor access to health care Those with impaired decision-making capacity Residents of nursing homes etc

  24. Responsibilities of investigators Scientific misconduct eg doctoring of data Conflicts of interest eg financial, dual roles - these impair research objectivity Authorship - rush for promotion, prestige and grants RCTs special ethical concerns because treatment often determined by chance/randomly

  25. Responsibilities of investigators Acknowledge use of existing data Genetic research particular ethical concern on confidentiality Payments due to research participants/assistants to levels not exceeding compensation for out-of- pocket expenses, time and effort

  26. Reading Fisher, Jill a. (2007). Governing human subjects research in the USA: Individualized Ethics and structural inequalities. Science & Public Policy 34 (2): 117-126. Ledered, Susan: Subjected to science. Human experimentation in America before the Second World War Baltimore, Maryland: Johns Hopkins University press 1995.

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