Research Ethics Flashcards
In 1947, the Nuremberg code for research on human subjects was developed. State three rules included in this code.
- Voluntary, well informed consent is required from human subjects
- The experiment should produce positive results for society that cannot be obtained in another way
- It should be based on previous knowledge that justifies the experiment
- It should be setup in a way that avoids unnecessary physical or mental suffering/injury
- It should not be conducted where there is an implied risk of death or disabling injury
- The risks should be in proportion (and not exceed)the expected humanitarian benefits
- Preparation and facilities must be provided to protect subjects against risks
- Staff conducting experiments must be fully trained and scientifically qualified
- Participants must be free to quit and any point
- Staff must stop the experiment at any point when they observe that continuation would be dangerous.
State two examples of research conducted before and after the Nuremberg code.
BEFORE
- Tuskegee Syphilis study (1932-1972): no consent, penicillin withheld when it became available
- WW2 (1939-1945): Eugenics, effects of radiation
AFTER
- Willowbrook hepatitis experiments on children with LD in residential care: intentional infection of hepatitis
- CIA administration of LSD
In 1964 the Helsinki declaration was developed and later revised in 2013. What are the 4 basic principles?
- Respect for the individual, their right to self-determination and to make informed decisions
- The participants welfare must take precedence over the interests of science or society
- Ethical considerations must take precedence over laws and regulations
- Research should be subject to independent ethical review and oversight by a properly convened committee
Which studies require ethical approval?
- Studies involving human/anima participants
- Studies gathering novel data or information
- Studies creating knowledge that can be generalised beyond the participant sample of setting
Which kind of projects do not require ethical approval? Explain them.
- Service evaluations
Finds out something about thats service which can be used to improve that service- knowledge created does not generalise beyond the service to other settings/populations - Clinical audits: Evaluating service against a benchmark (e.g. NICE)
**they should be registered e.g. by the NHS trust in which they are being conducted
Which of the following require ethical approval?
- Community survey where pts recruited via charity
- Online survey with NHS patient group
- Interviews with GPs
- Service evaluation using hospital records
- Lab project using cell cultures
- Systematic review and meta analysis
- Evaluation of new BSMS curriculum initiative
- Service evaluation: telephone interviews with patients
Ethical approval NOT needed for: 1,2,3
Ethical approval needed for: 4-8
In regards to your IRP. When would it be appropriate to seek ethical approval from the
a) NHS Health research authority
b) BSMS Rearch governance and ethics committee
a) Participants are NHS patients or staff; The work is conducted on NHS site(s)
b) Participants are individuals recruited anywhere except NHS; No NHS site(s) involved
If your study requires ethical approval there are 6 things you must consider. Describe (1) Scientific rationale
- What is the point of the study
- Is it based on solid scientific rationale (does it provide important information where there is currently a gap in research available)
- What is the case for why this research should be carried out? (Benefit to society vs harm)
If your study requires ethical approval there are 6 things you must consider. Describe (2) Rigorous methodology
- It is unethical to waste participants time where a study will not produce valuable results
- You must show that you are sticking to an established methodology
- Use the most appropriate method for producing new knowledge
- The method must be most appropriate and feasible for setting and sample
- Study materials and equipment (e.g. questionnaires) must be valid and reliable
- You must exhibit skills for robust data management and analysis within the team
If your study requires ethical approval there are 6 things you must consider. Describe (3) Informed consent
“Informed” means providing and information sheet and a way in which participants can asks questions/consider the information
- Consider recruitment methods (face to face, posters, social media); openness about what the study will entail- if you need to deceive participants about the true nature of the study you need to provide a good justification
“Consent” requires a consent form to collect CLEAR, WRITTEN consent.
- Avoid coercion; participation is voluntary and they have a right to withdraw
If your study requires ethical approval there are 6 things you must consider. Describe (4) Vulnerability of participant group
Does the study include vulnerbale people e.g. children, people with dementia/LD/MH/in care facilities, overresearched population
If so, how will risks be minimised for them?
Will the study induce psychological stress, anxiety, humiliation, harm or negative consequences beyond those encountered in normal life?
if so, how will these be reduced to support their saftey and wellbeing?
If your study requires ethical approval there are 6 things you must consider. Describe (5) Data protection, confidentiality and records management
- Processing of personal information must comply with GDPR 2018
- Only the absolute minimum necessary patient identifiable data should be used, processed and stored
- Provide details on how you will anonymise data and physical and technical security measures
- Consider how and for how long information will be stored
If your study requires ethical approval there are 6 things you must consider. Describe (6) Researcher safety and wellbeing
- Any hazardous equipment or substances
- Emotionally disturbing content?
- Exposure to threats of physical/verbal abuse?
- Lone working policy
All clinical research requires a sponsor.
Which ethics committee would you apply to?
Who is the default sponsor for IRP?
What is the timescale for this?
Health research authority (NHS HRA)
University of Sussex
30 days (Sponsorship) + HRA Approval (>40 days)
What makes a strong ethics application?
- Clear project aims, purpose and methods
- Clear methods for handling potential ethical issues
- Recruitment materials written in lay language (no jargon, translation of medical terms, short sentences)
- Application includes all supporting documents e..g consent forms, adverts, permission from gatekeepers
- Evidence of training
