Research And Ethics Flashcards
What is research governance? (There are different types of research, contexts and methods
It’s the core standard for healthcare organisations if they’re going to carry out any research they need to abide by it, tells you about:
- principles, requirements and standards
- monitoring and assessment
- promotes good practice (ethical awareness) when carrying out the research
What is ethics?
In law a man is guilty when he violates the rights of others. In ethics be is guilty if he only thinks of doing so.
What is IRAS?
Integrated Research Application System. It’s the NHS ethics board.
Faculty ethics: Relevant experts that know about research have a look at your application to do research and offer you independent advice.
When applying for approval to carry out research you need to go to ethics boards.
You must keep the research you’ve done for some time so that further analysis can be done and they can be monitored to ensure they were ethical.
What’s the ethical dilemma with some observational studies?
If you find out something other than what you were setting out to look for should you tell the person it affects? Eg. If screening for cleft lip and you find cancer genes should you tell? Usually not as the studies are non-interventional so you can only talk about what you set out to look for, can’t change the course of history.
Why are study aims and designs important?
-to find out if your study has already been done, it’s unethical to duplicate work unnecessarily or to do something of insufficient quality to add to the knowledge base or to do something that may knowingly cause harm
What is equipoise?
Before doing a study you should be in equipoise where the answer to your question is truly not known.
When is animal research ethical?
When it’s essential, alternative models (eg computer models) wouldn’t work.
And when the minimum sample necessary is tested and adverse effects are minimised.
When there are strict home office controls, not anybody can do it.
What is a conflict of interest?
A set of conditions in which professional judgement concerning primary interest (eg validity of research patient welfare) tends to be unduly influenced by a secondary interest (eg financial gain, prestige).
How can you look after patient safety when carrying out a trial?
- Need to have performed adequate pre-trials.
- Carried our risk benefit reviews.
- Consultation with ethical commissions.
- Follow legislation.
- Prior patient educations and consent.
What’s the problem with carrying out study on volunteers?
Self selected group, might have a particular agenda. Best to avoid it better to choose a particular sample then they’ll be more representative of the population.
What does the human tissue act (2004) say?
You must gain consent to use anyone’s tissues (alive or dead). Pre death consent or consent from families if using something from the dead.
Must be respectful use and disposal of human tissue and organs.
Data protection also important, must make sure people are aware of what belongs to who.
What is needed for consent?
- Enough information
- Participant must be able to understand (capacity)
- Must be freely given
- Informed consent for children/medically compromised adults
- Language considerations
- Community sensibilities and sensitivities
What is the mental capacity act?
Gives you the framework as to whether someone has capacity or not.
It protects vulnerable people, helps them by having someone acting as a proxy who is able to take an independent view of the persons interests, wishes and feelings.
Need to make sure that risks are in proportion to benefits.
You need to make sure people understand what you’re doing to obtain informed consent.
What was the vipeholm study?
Mentally deficient patients to test the potential for sugars to cause caries. Very unethical because patients didn’t know what they were being composed to, they didn’t have capacity.
Nature of potential outcomes also unethical.
What’s good clinical practice?
Uk: the rights, sachet and well being of participants (are the most important consideration and should) SHALL prevail over the interests of science and society.
Brackets is eu version.
Therefore now any research we do has to have ‘PPI’ patient and public involvement. To analyse and report on it.
