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Ethical issues in Medical Research. Dr. Anjum Susan John , MD 10/3/2009. Objectives. Trace the development of ethical codes by discussing some of the unethical studies documented in literature What are ethics ? Discuss the 3 features of research ethics

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ethical issues in medical research

Ethical issues in Medical Research

Dr. Anjum Susan John , MD

10/3/2009

Medical Research Center , HMC, Doha , Qatar

objectives
Objectives
  • Trace the development of ethical codes by discussing some of the unethical studies documented in literature
  • What are ethics ?
  • Discuss the 3 features of research ethics
  • Focus of research ethics over the decades
  • 21st century focus of research ethics
  • Critique the ethical aspects of a study

Medical Research Center, Doha, Qatar

objective 1 first part
Objective 1 – first part

To trace the development of ethical codes

Hippocrates

Medical Research Center, Doha, Qatar

hypothermia studies in the 1940s
Hypothermia studies in the 1940s
  • Research subjects were immersed in bath temperatures of 2-12°C.
  • A sub group of them were immersed in ice water tanks
  • They were then made to stand outside , some with and some without clothes , and their body’s reactions to cold observed and measured

Medical Research Center, Doha, Qatar

what did researchers want to determine in this instance
What did researchers want to determine in this instance ?
  • How long does it take for body parts to freeze when people are kept naked outdoors in sub freezing temperatures ?
  • What signs & symptoms are seen when people are kept in tanks of ice water for 3 hours ?

Medical Research Center, Doha, Qatar

medical experiments 1933 1945
Medical Experiments - 1933 -1945

On prisoners by exposing them to high altitudes, malaria, poisons, typhus, untested drugs and operations( without anesthesia)

Medical Research Center, Doha, Qatar

why did these researchers conduct these experiments
Why did these researchers conduct these experiments ?

Who were the people on whom these experiments were conducted ?

Medical Research Center, Doha, Qatar

what happens to the healthy human body when
What happens to the healthy human body when ………….?
  • It is inoculated with live germ causing bacteria (disguised like vaccinations )like typhoid or paratyphoid ?
  • Clothes from plague victims were dropped on it ?
  • When wounds were infected with spores of tetanus ?
  • The subjects for these experiments were civilian and military people from China, Korea, Mongolia and Russia , held as prisoners .
  • Experiments by Dr. Shiro Ishii in Japan – The truth about unit 731)

Medical Research Center, Doha, Qatar

what do you think
What do you think …….
  • were the issues in these cases ?

Medical Research Center, Doha, Qatar

objective 1 second part
Objective 1- second part
  • Discuss some of the unethical studies documented in literature

Medical Research Center, Doha, Qatar

handouts
Handouts

Research on prediction of skeletal size in Germany

Research on human endurance to pain in Japan

Tuskegee case in the USA

Case of Edward Jenner and the small pox vaccine

Willow brook case

Medical Research Center, Doha, Qatar

skeletal size experiments
Skeletal size experiments
  • What are the issues ?

Medical Research Center, Doha, Qatar

atrocities committed in japan
Atrocities committed In Japan
  • What were the issues ?

Medical Research Center, Doha, Qatar

tuskegee syphilis study
Tuskegee syphilis study
  • Issues ?
  • Where were the government and health care systems that should have stopped this unethical study from continuing for 40 years ?

Medical Research Center, Doha, Qatar

edward jenner
Edward Jenner
  • Deliberately exposed an 8 year old boy to cowpox to try out his new vaccine for smallpox
  • Issues ?

Medical Research Center, Doha, Qatar

willow brook study 1950s to 1970s
Willow brook study(1950s to 1970s)

Issues ?

Researchers stressed the benefits the children would receive- cleaner environment, better supervision and a higher nurse /patient ratio on the research ward

Medical Research Center, Doha, Qatar

nuremberg trials
Nuremberg trials

Medical Research Center, Doha, Qatar

development of ethical codes
Development of Ethical Codes
  • Nuremberg code, 1947(http://en.wikipedia.org/wiki/Nuremberg_code )
  • Helsinki Declaration 1965, rewritten 1975-WHO(http://www.wma.net/e/ethicsunit/helsinki.htm )
  • Belmont report of the national commission for the protection of human subjects of biomedical and behavioral research , 1979(http://www.bop.gov/news/BelmontReport.jsp )
  • CIOMS guidelines ,Council for international organizations of medical sciences 2002(http://www.cioms.ch/frame_guidelines_nov_2002.htm )

Medical Research Center, Doha, Qatar

slide19

Nuremberg code, 1947

Helsinki declaration(1964)

Informed

consent

Benefit Vs

Risk

assessment

Subject

interest >Society

interest

IRB approval

Result

accuracy

Medical Research Center, Doha, Qatar

nuremberg code helsinki declaration
Voluntary consent

Withdrawal of subjects

Balance of risks and benefits

Differentiated between therapeutic and non therapeutic research

Nuremberg Code & Helsinki Declaration

Medical Research Center, Doha, Qatar

belmont report of 1979
Belmont Report of 1979
  • Was developed in response to the Tuskegee and Willow brook controversies

Medical Research Center, Doha, Qatar

objective 2
Objective 2
  • What are ethics ?

Medical Research Center, Doha, Qatar

what are ethics
What are ethics ?
  • These include all the rules and principles that determine which actions are right and which are wrong.

Medical Research Center, Doha, Qatar

objective 4
Objective 4
  • Discuss the 3 features of research ethics

Medical Research Center, Doha, Qatar

slide25

Ethical principles guiding researchers (National Commission for the protection of human subjects of biomedical and behavioral research-1978)

  • Respect for human dignity
  • Beneficence
  • Justice
  • ( Belmont Report )
  • Ethical approval of a project depends on the degree to which the researcher plans to protects the rights of the patients.

Medical Research Center, Doha, Qatar

1 respect for human dignity
# 1 :Respect for human dignity
  • Element 1: Right to full disclosure
  • Informed consent
  • Element 2: Right to self determination

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violation of right to self determination
Violation of right to self determination ????
  • Coercion
  • Inclusion in studies without subject knowledge of participation
  • Deception

Medical Research Center, Doha, Qatar

special case situations
Special case situations
  • Individuals with diminished autonomy

Medical Research Center, Doha, Qatar

2 principle of beneficence
#2 Principle of beneficence
  • Element 1: Freedom from harm
  • Element 2 : Freedom from exploitation

Medical Research Center, Doha, Qatar

3 principle of justice
# 3: Principle of justice
  • Element 1 : Right to fair treatment
  • Element 2 : Right to privacy
  • Anonymity
  • Confidentiality

Medical Research Center, Doha, Qatar

objective 41
Objective 4
  • Changing focus of research ethics over the decades

Medical Research Center, Doha, Qatar

changing focus of research ethics
Changing focus of research ethics
  • In the 1970s and 1980s, research ethics guidelines focused on the protection of rights of vulnerable populations like children
  • In the 1990s and the 2000s, the focus is on promoting research participation of all subjects’, including vulnerable subjects’.

Medical Research Center, Doha, Qatar

objective 5
Objective 5
  • Where does research ethics stand in the 21st century?

Medical Research Center, Doha, Qatar

ethical issues in modern day research
The use of control arms (placebo)

‘Standard of care’

Informed consent process

Community consultation

Individual and community access to research

The role & responsibility of ethics committees (ECs)

Compensation for trial injury

Patient/Participant Confidentiality and Privacy

Locating phase I, II, and III trials

Medical treatment during the course of research

Product availability

Sponsorship

Liability & Insurance

Tissues

Stem Cell Research

Gene Transfer

Data Protection

Monitoring (DSMBs)

Publication issues

Data Ownership

Proprietary Information/Knowledge

Botanical/Traditional Medicines

Ethical issues in modern day research

Medical Research Center, Doha, Qatar

21 st century ethical issues
21st century ethical issues

Human guinea pigs ???

Medical Research Center, Doha, Qatar

slide36

Cloning and ethics ???

Cloning ????

Medical Research Center, Doha, Qatar

objective 6
Objective 6
  • How to critique the ethical aspects of a research ?

Medical Research Center, Doha, Qatar

critiquing ethical aspects of a study
Critiquing ethical aspects of a study
  • IRB approval ?
  • Respect for human dignity :
  • Autonomous decision 2. full disclosure 3. informed consent
  • Beneficence :
  • Any harm 2. exploitation/coercion 3. benefit > risk
  • Justice

1. Fair treatment 2. right to privacy /confidentiality / anonymity

Medical Research Center, Doha, Qatar

summary
Summary
  • How and why were ethical codes developed ?
  • What are the principles of research ethics ?
  • Critically appraise ethical aspects of a study

Medical Research Center, Doha, Qatar

the best approach
The best approach ……

… is to prevent ethical problems from arising in the first place.

-Tom Regan, North Carolina State University

Medical Research Center, Doha, Qatar

slide42

Thank you

Medical Research Center, Doha, Qatar