Bioethical considerations for bioinformatics Flashcards
What is needed for bioinformatics to successfully help patients?
Data sharing
- to increase cohort size and experimental power
- to include under-represented communities (important for rare diseases)
Expertise sharing
- complementary analysis
- holistic approach
Defining data standards
What is the Health Research Authority?
A non-departmental public body with responsibility for UK-wide Research Governance Framework
- National Research Ethics Committees
- Gene therapy Advisory Committees
- Confidentiality Advisory Groups
What is Information Governance?
- Holding information securely and confidentially
- Obtaining information fairly and efficiently
- Recording information accurately and reliably
- Using info effectively and ethically
- Sharing information appropriately and lawfully
To do this requires:
- an appropriate balance between openness and confidentiality in the
management and use of info
- full acknowledgment of public accountability, but equally placing an
importance on the confidentiality of personal information and
commercially sensitive info
- recognition of the need to share info with other organisations in a
controlled manner consistent with the interests of release and in some
cases, public interest
What are the main laws involved in medical ethics?
The data protection act 1998
Freedom of Information act 2001
Caldecott Principles
Confidentiality (NHS code of practise 2006)
Info and security management (NHS code of practise 2006)
Info sharing (NHS code of practise 2007)
Data quality and records management (NHS code of practise 2006 and 2007)
What are the six Caldicott Principles applying to the handling of patient-identifiable information?
- Justify the purpose of every proposed use or transfer
- Don’t use it unless absolutely necessary
- Use the minimum necessary
- Access should be on a strict need-to-know basis
- Everyone worn access should be aware of their responsibilities
- Understand and comply with the law
What is the Declaration of Helsinki?
By the World Medical Association
A set of Ethical Principles for medical research involving human subjects
How are the guidelines for medical ethics applied to research bioinformatics?
Experimental data must be separated from patient identifiable data = anonymised
Keep an audit trail of data and analysis
Control access to data and results of analysis
UK Clinical Ethics Network: what are CECs?
Multidisciplinary groups, inc health professionals and lay members aiming to provide support for decision making on ethical issues arising from the provision of patient care within NHS trusts and other healthcare institutions
Deal with confidentiality and consent
What are the features of informed consent?
Must be voluntary, informed and the patient must have capacity
Consent must be gained for future re-analysis and research participation.
Who will explain the test and implications?
Is wider consent needed from relatives?
- Who ‘owns’ your genome?
How are patients re-contacted in light of new developments?
How are incidental findings handled?
What should you tell the patient?
What is medically actionable?
Right to know vs right NOT to know
Litigation concerns
There could be discrimination on the basis of genetic information
- health insurance
- employment
Who’s is the duty of care?
The international code of medical ethics:
- a physician shall act in the patient’s best interest when providing
medical care
NHS:
- health professionals must use reasonable care and skill and
patients are entitled to receive care of a standard of which a
‘responsible body of medical opinion’ considers to be appropriate to
their condition
What are the issues for clinicians?
Who interprets the data? Which part of the data to interpret Who explains analyses to the patient Time limitations of appointments Lack of consensus
