The Role of the Ethics Committee Flashcards
Why do researchers have to clearly address ethical issues and use reasoned argument to justify their application for ethical approval?
Ethics matters: there are important ethical issues and research (and academic life generally) engages with these issues and should therefore give ethics serious and explicit consideration
Intuitions: “Gut feeling” and “common sense” may be a starting point for ethics but must be open to scrutiny, challenge and revision
Laws and Regulations: A growing body addressing ethical issues related to research but not exhaustive/ specific/ definitive in areas of innovation and novelty
Responsibility: applicable at multiple levels, one’s own actions, for developing the standards of the next generation of researchers and academics, to the Institution and to society.
What are examples of ethical standards in research?
Nuremberg Code
Declaration of Helsinki
DoH Tokyo (1975) – independent ethical review required
The Belmont Report 1979
DoH Brazil (2013)
All research projects need what ethical reviews?
Peer review
University Ethics Committee
National (NHS) ethics committee - Health Research Authority
What is the role of research ethics committees (RECs)?
Safeguard the rights, safety, dignity and well-being of people participating in research in the National Health Service.
Review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical.
Independent of research sponsors (that is, the organisations funding and hosting the research) and investigators.
On average RECs give an opinion in <40 days: well within the maximum allowance of 60 days.
Once a ‘favourable opinion’ is given research can commence But:
Ethical conduct is the researcher’s responsibility
Must apply for amendment (if any change to protocol)
REC has no day-to-day oversight but requires an annual report
‘Approval’ can be withdrawn
Ethical issues in research
Researcher integrity Consent procedures Consent Inducement Confidentiality
An investigation into ageing and memory requires patients with early stage dementia (and a healthy spouse or relative) to undergo repeat procedures until death or withdrawal from the study. There will be no direct benefit to participants.
Research procedures include: psychometric testing, lifestyle questionnaires, blood tests, CT and MRI scans, cognitive testing, and optional lumbar punctures.
The study has impressive scientific critique and is likely to add significantly to understanding of the progress of dementia and lead to better treatments.
What are the main ethical issues?
Freedom from coercion, constraint or deceit
The right to withdraw without prejudice (to healthcare, education, other services etc.)
The right to be informed about what the participant wants or ought to know. Freedom to ask questions
Will Patients have capacity? Might they lose capacity?
Capacity of healthy volunteers?
Does it comply with Mental Capacity Act?
Opt out from some aspects of study (e.g. Lumbar puncture)
This study will invite parents of children with rare disease e.g. Duchenne Muscular Dystrophy to join a bio-informatics study which will collate and share data from clinical records, whole genome sequencing, and omics data.
Collation of such data may be especially important in rare diseases where we still don’t know many of the causes for the diseases.
By comparing the genomes between healthy members of the same family and the family member with the rare disease, we can identify the differences that may have caused the disease.
Collating data, both from genome studies and natural history will help researchers to potentially find new ways of preventing, treating and diagnosing rare diseases in future.
What are the main ethical issues?
Children information and consent provisions (young and older children, children who reach majority)
Parental consent/ participant consent
Information need in a complex study
Consent to data sharing
Right to withdraw
What are the three aspects of confidentiality?
Confidentiality
Ethically it sits with respect for persons and their autonomy
Legally (English law)
Common Law duty of confidence
Human Rights Act
Data Protection and privacy
Human Rights Act
General Data Protection Regulation 2018 (GDPR)
