Page 29 - Experience Based Co-design - a toolkit for Australia

Experience Based Co-Design – A toolkit for Australia
Ethics and EBCD
There is an overarching responsibility to ensure that the rights and dignity of patients are protected always. This includes ensuring patients understand what is being done, can withdraw from participation at any time without impact on the care they receive and that these conditions continue as a project proceeds. Patients should not be exposed to harm by the activity.
In 2007, the National Health Service in the United Kingdom issued an ethical statement specifically for staff involved in EBCD work. The seven principles of good practice it describes are:
1. The improvement initiative should be designed and undertaken in a way that ensures its integrity and quality
2. All people who are involved, including staff patients and carers must be informed fully about the purpose, methods and intended possible uses of any information they provide
3. All participants must formally consent to the use of any information they provide including attribution of quotations, film extracts etc
4. All people involved participate on a strictly voluntary basis free form any coercion and able to withdraw at any time without need for explanation
5. All people involved must not be knowingly exposed to harm or distress
6. Provision must be made for responding to queries and complaints about the work
7. Privacy and confidentiality must be respected as requested.
Does your project require approval by an ethics committee?
Any improvement activity must be conducted in a way that is ethical. In general quality assurance and quality improvement work, such as EBCD projects, does not require ethical approval provided it meets certain criteria.
The NHMRC document “Ethical Considerations in Quality Assurance and Evaluation Activities” lists several triggers which may indicate a need for formal ethical review. The triggers are:
Q Where the activity potentially infringes the privacy or professional reputation of participants, providers or organisations
Q Secondary use of data - using data or analysis from QA or evaluation activities for another purpose
Q Gathering information about the participant beyond that which is collected routinely. Information may include biospecimens or additional investigations
Q Testing of non-standard (innovative) protocols or equipment Q Comparison of cohorts
Q Randomisation or the use of control groups or placebos