2. Ethics in clinical research

Question 1

What is evidence-based clinical practice?

Answer 1

Practice that uses treatments that have been shown to be the most effective. E.g. not hypnotherapy for anorexics

Question 2

What is ethics?

Answer 2

Ethics: norms for conduct that distinguish between acceptable and unacceptable behaviour

Question 3

What are the four principles of ethical research set up by the NHMRC?

Answer 3

1. Respect for human beings
2. Research merit and integrity
3. Justice
4. Beneficence

Question 4

Is research for the sake of it considered ethical?

Answer 4

No, there must be some potential long-term benefit.

Question 5

Can you pay participants?

Answer 5

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.

Question 6

Under what conditions is deception allowed in research? Three conditions

Answer 6

1. Pp should get a debrief;
2. Pp should be monitored throughout study;
3. No other way of doing study is possible.

Question 7

Why is NOT reporting data a problem?

Answer 7

Journals don’t want to report null effect or harmful effects. This means that information about harmful or useless treatments may not be published.

Question 8

Who has to be responsible for data storage?

Answer 8

The researcher, but the buck stops with the chief investigator.

Question 9

What kind of risks of research must be taken into account?

Answer 9

• physical, social, psychological
• unknown effects of treatment
• lasting effects of research on participant

Question 10

What’s the difference between deontological and consequential ethics?

Answer 10

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).

Question 11

What kind of benefits can research have?

Answer 11

• benefits to the individual
• provide evidence for effective treatment of broader community
• refine and add to knowledge base

Question 12

What is informed consent?

Answer 12

A voluntary social contract between researcher and participant with no coercion or manipulation.

Question 13

What should the participant be informed of when doing research?

Answer 13

1. Aims of research
2. Risks involved
3. Procedures
4. Ability to withdraw
5. Have questions answered
6. How information will be used and disseminated

Question 14

Why must participants read the consent form?

Answer 14

Otherwise lawyer could argue that Pp didn’t read and so there was no informed consent.

Question 15

What classes of people might not be able to give informed consent?

Answer 15

1. Mentally impaired
2. Emotionally disturbed (anxious or depressed)
3. Young children

Question 16

Why is it important to keep detailed notes?

Answer 16

They may be subpoenaed and be read in court.

Question 17

What are the pros (2) and cons (3) of deception?

Answer 17

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

Question 18

What is the purpose of the debriefing? 4 things

Answer 18

1. Removes harmful effects and misconceptions
2. Explains need for experimenter’s deception
3. Explains need for research and their participation
4. Answers questions

Question 19

What confidentiality limits are there in publishing research?

Answer 19

The research must reflect the social contract of the informed consent –the confidentiality conditions on the form.

Question 20

How should the identity of participants be treated in publishing research?

Answer 20

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.

Question 21

In published research, data must be used only for….

Answer 21

… the purposes stated in the approved research proposal.

Question 22

Can you extract data from a study but with a different purposes?

Answer 22

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.

Question 23

Why is it problematic doing research with people who are psychotic?

Answer 23

Because they are not in a position to give informed consent.