Ethics Flashcards
Operational principles of declaration of helsinki
Research should be based on knowledge of scientific background
Benefits should outweigh risks
Approved protocols subjected to independent review clearly described
Trained investigator
Study stopped if original considerations are no longer satisfied
Experimental methods compared against best current methods
Basic principles of declaration of Helsinki
Respect for individual-> right to self determination and right to informed consent
Investigators duty is solely to participants
Minimise use of incompetent subjects and minors and seek consent from legal authorised representative
Abstract Helsinki principles
Will it harm the environment
Participation must be voluntary
Seek consent for data use unless decreases validity of research
Should use subjects the researcher doesn’t know
Subjects who are mentally/physically incapable of giving consent-> may go without informed consent if in a hurry-> get consent ASAP
Duty to make research public
Can be combined with care justified by therapeutic potential
Participants share in any benefits resulting from the study
May use unproven treatment if judged as highly likely to help
What counts as human research
Any direct involvement of patients or healthy volunteers
Use of clinical data
Use of biological materials
Use of material derived from human tissue
When do we need ethical approval?
1) patients/within the NHS
2) required legally
3) healthy volunteers that fit the above or in local requirements
Patients/within the NHS
Patients and careers Recently deceased Data organs or other bodily material last and present Fetal material and Ivf Not for staff or facilities
Required legally
Adults lacking capacity to consent Exposure to ionising radiation Human tissue Investigational medical devices Investigational medicinal products
Clinical audits
Asses the level of service being provided
Measures against a standard
Usually involves analysis of existing data
Doesn’t require ethical approval
Service evaluation
Judges current care
Measures current service without reference to a standard
Usually analysis of existing data
Doesn’t require ethical approval
National research ethics committee
Research that involves NHS or legislative requirements
Volunteer members-> medical professionals, pharmacists, scientists! lay men, patients
-> protect rights, safety, dignity and well being of research participants
-> facilitate and promote ethical research of benefit
Roles of national research ethical committee
Review applications for research -> protocol, consent form, patient info sheet, advertising material
Give opinion about proposed patient involvement
Is the research ethical?
Monitor throughout via reports
Issue amendments
Local NHS research and development office
Research that involves NHS or legislative requirements Must insure: Adequate arrangement and resources A sponsor Received ethical approval Clinical trial authorisation Allocation of responsibilities Contractural arrangements in place Legislation relating to the research is followed
Local NHS organisation
Audits and service evaluations
More registration than approval
Local ethics committee
University of Nottingham ethics committee
Healy volunteers not under NHS or legislative requirements
Roles of researcher
Ensure study is performed in accordance with approved protocol
Maintain complete records
Only enrol appropriate subjects
Ensure subjects volunteers, are fully informed and give consent
Chief researcher-> protect life, health, privacy and dignity, justified research, rigorous experimental protocol design
Patient information sheets
Q and a format Explain purpose of trial Treatment and probability for random allocation Procedures and their duration Subject responsibilities Risks and benefits Confidentiality of records and anonymity Investigator contact info Statement of ethical approval
Incapacitated adults
Personal-> guardian with power to consent/relative
Professional-> doctor responsible for medical treatment or person nominated by health care provider
Data protection act
Subjects must be informed of the identity of the data controller and the ways the data will be used
Data should only be obtained for lawful purposes
Security must be appropriate to nature of data
Anonymise data
Secure password
Backed up on network space
Don’t keep for longer than needed
Human tissue act
Regulates the removal, storage and use of human tissue
Human tissue= material that has come from a human body and consists of or includes human cells
Don’t:
Remove, store or used tissue without consent
Storing or using for purposes other than original consent
Trafficking
Not having a licence
Analysing DNA without consent
Animal welfare and ethical review body
Procedure = anything that might cause pain, distress, suffering or lasting harm
Reduction-> smallest number
Refinement-> best procedure
Replacement-> must use safest alternative
Made up of -> certificate holder director of biomedical service unit, vetinary surgeon, academic members of staff with experience in biomed research, academics not involved in biomed research, lay members
Stages to project licence
Certificate of designation (PCD) -> authorises designated establishment
AWERB-> authorises need for project
Project licence (PPL)-> authorises need for the project and experimental technique
Personal licence (PIL) -> authorities the person conducting the experiment
Project licence
Defined specific objectives Itemises benefits Outlines plan of work Details and justifies the experimental protocols Identifies the possible adverse effects Sets the severity limits for procedures
Ethical principles guiding animal research
All alternatives have been investigated
Benefits justified-> including species and number used
Follow accepted guidelines
Number of animals must be minimum necessary
If it’s causing too much harm the animal has to be out down
Use animals with lowest self awareness and consciousness
Personal licence
Requires appropriate prior education
Training course-> theoretical and practical
Supervised by senior colleague
