Introduction To Research Flashcards
What are ethics ?
Norms of right and wrong behavior
What is law?
Rules govern and enforce behavior
Ethical standards are?
Disciplines specific e.g Medicine, Law, Business, Engineering
Why is it important to have ethical norms in research
Promote aim of research
Promotes values essential to collaborative work
Ensure researchers held accountable
Held build public support
Promote moral and social values
Name the 5 historical development of the development of research ethics
Nazi atrocities and Nuremberg code
Thalidomide tragedy
Declaration of Helsinki
Tuskegee syphilis study and Belmont report
Good clinical practice
Mini describe what happened during Nazi atrocities-Nuremberg trial
Nuremberg trials (1946) Doctors case
Nazi medical research conducted in concentration camps
Cruel and often lethal experiments on human subjects (including children)
What is Nuremberg code?
Defendants’ lawyers: experimentation commonplace & no legal
restrictions
o Judges appointed medical advisors: “permissible medical
experimentation”
o The Nuremberg Code (1947): 10 ethical principles on what medical
experiments are permissible in humans
Nuremberg code: 10 principles
Informed consent
o Social value & no other means
o Prior animal studies
o Avoid suffering & injury
o Death or disability not expected
o Risk vs benefit
o Protect subjects – injury, disability, death
o Scientifically qualified researchers
o Subjects can end participation
o Researchers can end study if injury, death, disability likely
What is Truskegee syphilis study
1932 US Public Health services
“Tuskegee Study of Untreated Syphilis in the Negro Male”
o 600 black men in Tuskegee, Alabama
o 400 had syphilis - not told had syphilis, sexually transmitted, study
participants
o 1950’s Penicillin withheld (despite availability & mandatory)
o 1973: Public outrage – study closed
What happened in Guatemalan syphilis study
696 Guatemalans deliberately infected with syphilis (1946 – 1948)
o Aim of study: establish whether penicillin administered directly after sex could
prevent STDs, especially syphilis
o Study subjects included female sex workers, prisoners, soldiers, mentally ill -
none consented
o 2010 – President Obama apologised to Guatemalan president on behalf of US
government & researchers
What happened in the Belmont report
Tuskegee resulted in National Research Act in US (1974)
o National Commission for the Protection of Human Subjects of
Biomedical and Behavioural Research, which produced the Belmont
Report in 1979.
o 3 basic principles of ethical research on humans
Belmont 3 princeples
Respect for Persons (informed consent)
o Beneficence (risk-benefit assessment)
o Justice (fair selection of subjects)
What happened Thalidomide Tragedy
1950’S: Thalidomide (sedative) approved in Europe
o US: not FDA approved – manufacturer provided samples to doctors
to trial on patients
o Used off-label for nausea in pregnant women
o Linked to severe birth defects - Phocomelia
What is the declaration of Helsinki 1964
Following Nuremberg Code – Declaration of Geneva 1948
(physician’s ethical duties)
o Other research atrocities like Thalidomide tragedy
o World Medical Association adopted the Declaration of Helsinki in
1964 : Guidelines for ethical conduct of research
o SAMA is a member of WMA – SA researchers required by Research
Ethics Committees to adhere (2013 update)
Helsinki highlights
Use of placebos
o Post-trial obligations
o Use of unproven intervention
o Participants compensation for harm and guaranteed access to
discovered treatments
What happened during Good clinical practice (GCP)
1970’s and 1980’s : US FDA developed various regulations and
guidelines on research – GCP
o Globalisation of pharmaceutical companies – need for international
standard
o 1990’s: International Conference on Harmonisation (ICH)
What is GCP?
Good Clinical Research Practice (GCP) is a process that
incorporates established ethical and scientific quality standards
for the design, conduct, recording and reporting of clinical
research involving the participation of human subjects.”
[WHO, 2002]
Name 4 South African GCP guidelines
o 3
rd Edition, 2020 (DOH & SAHPRA)
o Compliance mandatory: legal status
o National Health Act, Act No. 61 of 2003
o Medicines and related substances act, Act No. 101 of 1965
List 6 minimum standards for conducting clinical trials outlined in principles
o Protection of participants
o Responsibilities of investigators & sponsors
o Quality assurance
o Data management
o Ethics committees
o Multi-centre studies
What makes clinical research ethical
Relevance and value (social, scientific and clinic)
o Scientific validity
o Fair subject selection
o Risk-benefit ratio
o Independent review
o Informed consent
o Respect for participants
o Action (policy and publication)
Name two important values in research publication and scientific writing
Truth
Honesty
International inaccuracies is?
Scientific misconduct
Problems of scientific misconduct
Morally wrong
o Resources wasted
o Potentially harmful
o Public trust eroded
o Scientific independence threatened
Types of scientific misconduct
Fabrication / Falsification / Plagiarism
o Authorship improprieties / Misappropriation of ideas
o Violation of research practices
o Failure to comply with legal and regulatory requirements
o Inappropriate behaviour (deviance from accepted ethical standards)
Are the following statements true or false
1. Clinical evidence must be scientifically sound and based on ethical
research
2. Research ethics do not protects individual subjects and researchers, as
well as society as a whole
3. Ultimate aim of research ethics is to enhance clinical practice and
promote health
- True
- False
- True
