INFORMED CONSENT .

1. INFORMED CONSENT. Dr. Nick Neave (Chair of PSS Ethics Committee) nick.neave@northumbria.ac.uk

2. Some Background... • The Hippocratic Oath. • Hippocrates, often described as the ‘father of medicine’ is famous for the ‘Hippocratic Oath’ – a set of laws for defining good medical practice and morals. • It set out the duty of the doctor to respect life and to do the best for one’s patients. • Most modern medical schools use a modernised version written by Dr Louis Lasagna. • Currently there is no such oath for scientists! Hippocrates of Kos (ca 460 BC–ca 370 BC)

3. Nazi Human Medical Experiments • In the concentration camps Nazi doctors conducted horrific experiments on inmates for ‘medical science’. • These included deliberate exposure to nerve gases and biological agents . • Notorious ‘research’ involved immersing inmates into icy water wearing flying uniforms to mimic a crash landing at sea. • The inmates were forced to stay in the water until they froze to death or drowned – the data was then used to improve Luftwaffe pilot survival. A cold water immersion test at Dachau

4. The Nuremberg Trials. • The ‘Nuremberg trials’ were held between 1946-49 in order to bring to justice Nazi war criminals. • One of the trials was called ‘The Doctors Trial’ where 20 doctors and 3 Nazi officials were accused of being involved in human experimentation in the concentration camps, and in conducting euthanasia programmes in hospitals and nursing homes. • In their defence the doctors argued that there was currently no international law dealing with medical experimentation. • As a result Leo Alexander and Andrew Conway Ivy drafted the ‘Nuremberg Code’ a 10-point list calling for voluntary consent, avoidance of unnecessary pain and suffering etc

5. Tuskegee Syphilis Experiment. • Between 1932-1972 , the US Public Health Service conducted a study on syphilis in African-American males in Tuskegee Alabama. • They recruited 399 impoverished males who had the disease, to study the effects of various treatments. • In 1940 a cure for syphilis was found (penicillin) and by 1947 this was the standard treatment. • The researchers continued with the study and withheld treatment in order to study the effects of the disease. • In 1966 Peter Buxtun, a disease investigator, raised his concerns as to the ethics and morality of the Tuskegee study, but the Center for Disease Control successfully argued for the study to continue until all the ‘volunteer’s had died. • Buxtun went to the press and the scandal broke in 1972, there were 5 survivors.

6. ‘Declaration of Helsinki’. • The ‘Declaration of Helsinki’ was adopted in 1964 by the World Medical Association as a set of ethical principles covering human experimentation. • It was the first key attempt by the medical community to regulate research activities and was based on the ‘Nuremberg code’ established in 1947 in light of Nazi and Japanese medical experimentation. • It has undergone several revisions and clarifications, the most recent revision took place in 2008. • It is widely regarded as the cornerstone document of human research ethics.

7. Key Articles from the ‘Declaration of Helsinki’. • The fundamental principles are: • ‘Respect for the individual’ (Article 8). • ‘The right to self-determination’ and the right to make ‘informed decisions’ (Articles 20-22). • The duty of the researcher is towards the patient or the volunteer (Articles 2,3,10,16,18). • The welfare of the participant must take precedence over the research (Article 9). • Individuals or groups who are deemed to be ‘vulnerable’ require special vigilance (Article 8). • Even if consent is granted by someone else legally permitted to give it, the individual must still give their assent (Article 25).

8. Protecting Research Participants. • In General you should: • Avoid harming participants (psychologically as well as physically). • Avoid personal misconduct. • Show due concern for issues of diversity and equal opportunity. • Ask participants about any factors that might lead to their harm and inform them of any actions they should take to minimise this. • Refrain from using financial compensation or other inducements to risk harm beyond that which they face in their normal life. • Inform participants of their right to withdraw without prejudice. • Inform participants that they may decline to answer any questions.

9. Privacy and Confidentiality. • You should at all times maintain standards of privacy and confidentiality: • Maintain appropriate records. • Disclose information appropriately. • Store confidential information in accordance with the Data Protection Act. • Only make audio/video /photographic recordings or take bodily fluids from participants with their explicit consent.

10. The Participant Information Sheet. • This should provide the individual with all of the information they will need to make an informed judgement about whether or not to take part. Eg: • Clearly state any exclusion criteria. • Describe the process clearly, give an approximate idea of how long it will take, and whether it will involve any physical or personal discomfort. • Mention any payments or incentives. • Mention any invasive techniques (e.g. blood samples). • Explain how confidentiality will be maintained. • Explain how the data/information might be used in the future. • Clearly state how the person can withdraw from the project. • Provide contact details (preferably email). • Avoid jargon – ensure that anyone can read and understand it. • See example

11. So, consent should be: • 1. VOLUNTARY: The decision to take part in a research study should be made by the individual without any undue coercion or inducement. • 2. INFORMED: The decision to participate in a research study should be made only after sufficient information has been provided that would make that decision ‘informed’. • 3. WRITTEN: Participants should give their informed consent in writing. However, if they are unable to do so then they may give their oral consent in the presence of an independent witness.

12. Informed Consent. • You should: • Ensure that participants are given sufficient opportunity to understand the nature, purpose, and possible consequences of their research participation. • Obtain written, informed consent. • Keep adequate records of when, how, and from whom, consent was obtained. • Ensure that where an individual cannot provide consent, then it should be obtained from others legally permitted to provide it (e.g. parents, doctors). • Take particular care when seeking informed consent from individuals who may be pressured to consent by their environment (work place, prison, school etc). • Restrict research based on observations to those situations in which individuals being studied would reasonably expect to be observed by strangers (unless they have consented). • Avoid intentional deception unless it is necessary to preserve the integrity of the research.

13. Debriefing. • You should: • Fully debrief participants at the conclusion of their participation in order to inform them of the outcomes and nature of the research, and to provide them with contact details so that they can subsequently withdraw their data. • Take particular care when discussing outcomes as seemingly evaluative statements may carry unintended weight. • Inform participants when evidence is obtained of a psychological or physical problem of which they are apparently unaware. • Exercise caution when responding to requests for advice from participants concerning psychological / physiological / emotional issues. • See example