Research Ethics Flashcards
What factors are used to decide whether an animal experiment should be performed ?
– Benefits – Model (what is the model used ?) – Sentience (of the animal) – Value – Moral agency (of the researchers + of the animals) – Spiritual/religious potential – Human achievement
Identify the main arguments in favor of the use of animals in research.
- Animal research has enabled the development of vaccines, medical devices, and medications
- Physiologically, humans and animals often quite similar (so results can generally be applied to humans)
- Animals are really only used where there is no other alternative not involving an animal + when it is necessary, the living conditions have been made better (3Rs)
Identify the main arguments against the use of animals in research.
- Speciesism (“If experimenters are not prepared to use orphaned humans with severe and irreversible brain damage, their readiness to use nonhuman animals seems to discriminate on the basis of species alone, since apes, monkeys, dogs, cats and even mice and rats are more intelligent, more aware of what is happening to them, more sensitive to pain, and so on, than many brain-damaged humans barely surviving in hospital wards and other institutions”)
- “Causes suffering to animals
- Benefits to human beings are not proven
- Benefits to human beings that animal testing does provide could be produced in other ways”
Explain the three principles governing the use of animals in research (from the Home Office policy).
• Replacement:
– e.g. alternative technologies (in vitro, biochemical, mathematical & computer models); use lower organisms
• Reduction:
– e.g. better study design to allow use of fewer animals; better storage of data
• Refinement:
– e.g. improve housing; minimise pain; improve welfare
Outline the regulatory role of the Home Office in animal research.
• Home Office- advised by Animal Procedures Inspectorate.
Determines whether and on what basis to grant a project license, by weighing the likely adverse effects on the animals concerned against the benefit likely to accrue as a result of the programme to be specified in the license (hence, no cosmetics, toiletries ingredients, tobacco or alcohol)
• Each local arena- animal ethics committee (here in St Andrews, AWEC) – review & monitor all eligible research, using ASPA & Home Office guidelines
• Licenses are granted:
– Site licence
– Personal license
– Project license
• Concordat on Openness (set of commitments for UK-based life science organisations to enhance their animal research communications)
Outline the regulatory role of National Research Ethics Service (NRES) & local ethics committees in human research.
• If the research involves NHS staff, patients or premises: National Research Ethics Service (NRES)
– Local level: NHS Research Ethics Committee (NREC)
• If the research does not involve NHS, then:
–Local level: Research Ethics Committee( REC) E.g. here at St Andrews, UTREC
These local medical ethics research committees are UK Wide National Service Accredited committees whose aim is to safeguard the rights, safety, dignity and well being of research participants.
What is considered human research ?
Any experiment involving participants, data, tissue
Identify the different “flags” of RECs and what each is responsible for.
- REC A Scotland – Phase 1 trials in healthy volunteers, Gene Therapy, Adults with Incapacity, IRB Registered (i.e. can approve projects with USA participants)
- EoSRES Rec 1 - Research Tissue Banks, Qualitative research
- EoSRES REC 2 – CTIMPs, Research involving children, IRB Registered
Explain the structure of RECs.
• REC consists of up to 15 members
– Expert & Lay & Lay+ members (at least 1/3 of committee)
– Also recommended that the researcher attend the REC meeting
Lay members are people who have never been involved in a healthcare profession
Lay + members are people who used to be involved in healthcare but not anymore
Explain what exactly RECs do in their meetings.
- Undertake Full Review (60 days) or Proportionate Review (14 days), to review full applications and amendments
- RECs then give their opinion
- Unfavorable
- Provisional
- Favorable with conditions
- Favorable
Describe the Declaration of Helsinki and explain its importance in the context of research ethics.
• Declaration of Helsinki (latest version 2013)
“The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.” Especially addresses issues of:
– Consent (also be aware of coercion)
– Confidentiality (including resulting data)
– Risks and burdens
– Post-trial provision
– Publication (number of trials with nothing published afterward)
Identify some of the guidance provided by the Declaration of Helsinki on consent.
- Subject must voluntarily consent to being included in medical research
- Subject must be informed of the aim, methods, sources of funding, possible conflicts of interests, anticipated benefits and possible risks
- Subject must be informed of right to refuse to participate and to withdraw consent at any point
- Consent must be given in writing
- No coercion
- If deemed incompetent, ask legally authorized representative for consent
Identify the different ethical issues raised by Edward Jenner’s smallpox experiment.
- The situation: Jenner vaccinated James Phipps, the eight- year-old son of his gardener, with material obtained from a milkmaid who had cowpox. A few weeks later he deliberately infected Phipps with smallpox to see if he would develop the disease.
- The problems: Consent/assent and coercion + poor design (only one subject)
Identify the different ethical issues raised by the Tuskegee Syphilis trial.
-The situation: a study to record the natural history of syphilis in hopes of justifying
treatment programs for blacks. Examined regularly but not treated for the disease, even after penicillin became drug of choice in 1947 (* note: nor were they allowed to be treated in clinics/hospitals in area), incentivized by free medical exams, free meals, and burial insurance
-The problems: No informed consent for the 40 years of the experiment (participants told they were being treated for “bad blood”, not given diagnosis, nor effective treatment)
Identify the different ethical issues raised by the British Chemical and Biological Weapons experiments.
-The situation: a total of 11,000 servicemen were exposed to mustard and nerve gas (tabun, sarin and soman) at Porton Down
+ Gruinard Island, Scotland, was dangerously deliberately contaminated with anthrax during a trial
+ the MRE carried out trials in Lyme Bay, Dorset, in which live bacteria (e Coli and Bacillus globigii) were sprayed from a ship to be carried ashore by the wind to simulate an anthrax attack.
+ Porton Down was also investigated for injecting anthrax, smallpox, polio and bubonic plague into unsuspecting volunteers.
-The problems: No consent was sought (the men did not know what was being done to them) + harm was done to many subjects (disabled and deaths)
