2. Ethics in clinical research Flashcards
What is evidence-based clinical practice?
Practice that uses treatments that have been shown to be the most effective. E.g. not hypnotherapy for anorexics
What is ethics?
Ethics: norms for conduct that distinguish between acceptable and unacceptable behaviour
What are the four principles of ethical research set up by the NHMRC?
- Respect for human beings
- Research merit and integrity
- Justice
- Beneficence
Is research for the sake of it considered ethical?
No, there must be some potential long-term benefit.
Can you pay participants?
Ethics won’t allow you to pay participants, but you can compensate for time spent, travel etc. Either $50 maximum; or gift card of equivalent value.
Under what conditions is deception allowed in research? Three conditions
- Pp should get a debrief;
- Pp should be monitored throughout study;
- No other way of doing study is possible.
Why is NOT reporting data a problem?
Journals don’t want to report null effect or harmful effects. This means that information about harmful or useless treatments may not be published.
Who has to be responsible for data storage?
The researcher, but the buck stops with the chief investigator.
What kind of risks of research must be taken into account?
- physical, social, psychological
- unknown effects of treatment
- lasting effects of research on participant
What’s the difference between deontological and consequential ethics?
Deontology (or Deontological Ethics) is an approach to Ethics that focuses on the rightness or wrongness of actions themselves, as opposed to the rightness or wrongness of the consequences of those actions (Consequentialism) or to the character and habits of the actor (Virtue Ethics).
What kind of benefits can research have?
- benefits to the individual
- provide evidence for effective treatment of broader community
- refine and add to knowledge base
What is informed consent?
A voluntary social contract between researcher and participant with no coercion or manipulation.
What should the participant be informed of when doing research?
- Aims of research
- Risks involved
- Procedures
- Ability to withdraw
- Have questions answered
- How information will be used and disseminated
Why must participants read the consent form?
Otherwise lawyer could argue that Pp didn’t read and so there was no informed consent.
What classes of people might not be able to give informed consent?
- Mentally impaired
- Emotionally disturbed (anxious or depressed)
- Young children
Why is it important to keep detailed notes?
They may be subpoenaed and be read in court.
What are the pros (2) and cons (3) of deception?
PROS
- Provides measurement of natural behaviour
- Access to behaviours and mental processes not easily studied
CONS
- Conflicts with informed consent
- Dishonest relationship b/w researcher and participant
- Raises suspicion about future participation in psychological research
What is the purpose of the debriefing? 4 things
- Removes harmful effects and misconceptions
- Explains need for experimenter’s deception
- Explains need for research and their participation
- Answers questions
What confidentiality limits are there in publishing research?
The research must reflect the social contract of the informed consent –the confidentiality conditions on the form.
How should the identity of participants be treated in publishing research?
Identity of participants must be removed.
The standard practice is to change details of case history, then give to client so they can provide informed consent.
But clients can ask to change many details –if too many
details change, it’s no longer case history.
In published research, data must be used only for….
… the purposes stated in the approved research proposal.
Can you extract data from a study but with a different purposes?
No, as Pps may not have given consent for the purpose of the new study. So you may have to go back to ethics.
Or you can make clear in consent forms that data will be used for other purposes.
Why is it problematic doing research with people who are psychotic?
Because they are not in a position to give informed consent.
