Legislative acts protecting research ethics
International & National Professional Guidelines:
Nuremberg Code, Declaration of Helsinki, BMA, GMC.
Legislation:
Data Protection Act 1998.
Mental Capacity Act 2005.
Medicines for Human Use (Clinical Trials) Regulations
2004.
Human Tissue Act 2004.
Criminal law:
Cannot administer “noxious substance” unless this
part of a “properly approved research” with proper
consent.
Common law:
Negligence.
What are the key research ethics principles
- Scientific Validity
- Consent
- Confidentiality / Data Protection
- Balance of risks v benefits
- Equipoise (& Placebo)
- Reciprocity
Components of scientific validity
- Is the question asked important and relevant?
- Is the methodology appropriate and adequate?
- Can the answer be obtained within a reasonable period
of time? - Unduly repetitive of earlier work can be said to be
“unethical”? - Is the research justifiable?
- All researchers should ask themselves the “so what”.
Components of consent
Consent must be voluntary, informed and made by a
capacitous individual if it is to be valid.
- A signed consent form is not sufficient
- Consent is not always necessary
Threats to voluntariness
- Payments.
- Vulnerable groups:
- Patients (esp. those with terminal illness).
- “Therapeutic misconception”.
- Gratefulness / Sense of duty.
- Fear of rejection or the withdrawal of care. - Medical students.
What is equipoise?
In order for research (esp. interventional research) to
be justified it is often argued that there must be
genuine uncertainty over whether or not the treatment
will be beneficial. This is known as equipoise.
Once there is sufficient evidence the research is usually
stopped since clinical equipoise is not met.
When is the use of a placebo ethical
no alternative treatment available,
if the research is non-therapeutic (e.g.
phase 1 trial).
What do research ethics committees take into account
The relevance of the trial.
The risk/benefit ratio.
The protocol.
Quality of facilitates.
Adequacy of procedures for obtaining consent (e.g.
adequacy of written information sheet).
Provision for indemnity/compensation.
What are the 3 ‘R’s’ of ethical research?
- Replacement: Non-animal methods to be used
where possible. - Reduction: The number of animals used should be
kept to a minimum. - Refinement: The smallest amount of pain &
distress should be caused to animals & should be
caused only for a justifiable purpose.
What are the main points of the Animals (Scientific Procedures) Act 1986
- Regulates the use of all “protected” laboratory
animals where the research procedures might cause
“pain, suffering, distress or lasting harm”. - Provides for special protection for primates, cats,
dogs and horses. - Requires that there be an ethics committee in
institutions. - Created the Animal Procedures Committee which
advises the government on policy and practice. - Requires researchers to obtain two licences and
one certificate. - Enables officials from the Home Office can inspect
at any time.
What are the requirements of the project licence with regards to animals
Are the experiments well designed?
Are the experiments to be performed for
justifiable reasons.
What is the level of distress likely to be caused
to the animal(s).
How invasive are the proposed experiments/
procedures?
Licences granted on the basis of cost-benefit
analysis…
Requirements of applicants
- Understanding of ethical debate.
- Working knowledge of law.
- Understanding of health and safety.
- Understanding of minor/common surgical
procedures, anaesthesia, analgesia and humane
euthanasia. - Practical knowledge of animal handling.
Purpose of the certificate of designation
The place where regulated procedures are
carried out is controlled by the granting of a
certificate of designation.
The certificate of designation ensures that the
institution where the research will take place
has adequate facilities to:
Perform high quality research.
To protect the welfare of animals.
