Ethical Considerations in Research Flashcards
Why do researchers need to obtain ethical approval?
To make sure that no harm will come to the px - esp if vulnerable group
Makes the purpose of the research clear
When a child is is involved in research, what is the form of consent they are able to give?
Assent (not informed consent)
Give some examples of scenarios where participants are vulnerable or may feel pressured to take part
Prisoners
Children
Learning difficulties
Researcher’s relatives
Researcher’s pxs
What are the ethical issues of a trial for a completely new intervention?
Side effects are unknown
May give false hope to the px if they are suffering
What info is needed to apply to an ethics committee for a research project?
Info about researchers - research CVs, conflicts of interest
Project background - how important is the research, what are current treatments, what is currently known, is there any preliminary data?
Research protocol - who’s invited to take part, what info will they be given before, how will consent be recorded. Any risks or benefit to the participant? How will data be analysed and will participants receive any feedback?
What is important to make sure the participant information does?
It is neutral and presents the study as it will occur, not creating excitement and false hope or downplaying the trial (making it seem less important than it is)
What might a long-running study suffer from?
Loss to follow-up
If placebo involved, is it ethical to provide placebo for so long?
Who is involved on an ethics committee?
Members with relevant experience
Members with a range of expertise
Members of the public
What should an ethics committee do?
Weigh up risks and benefits to the participants and wider society.
Have contact with researchers to modify any potential issues with application.
What are the ethical issues surrounding trials which analyse tissue from pxs?
Px must be informed if anything untoward found.
If samples are to be used for a different purpose, consent must be obtained for that purpose.
Should be made clear if the sample will be kept or destroyed after.
