19.6 () Ethical issues in palliative care research

Question 1

List five major ethical issues to consider in palliative care research

Answer 1

1. The study’s potential benefits to future patients
2. The study’s benefits to subjects
3. The study’s risk to subject
4. Subjects’ decision making capacity
5. the voluntariness of subjects’ choices about research participation

Question 2

List two elements of a study that should be maximized to increase its potential benefit for future patients. List two strategies for this

Answer 2

validity and value (likelihood of benefit for future patients)

adequate sample size to answer question posed (power)

increase generalizability of study results

Question 3

Give a strategy for maximizing the benefit of a study to the participants in:
A. descriptive study
B. an intervention study

Answer 3

A. investigators can design standard operating procedures that help ensure problems (ie. symptoms) are identified and triaged appropriately

B. Subjects may benefit from learning about results after study is over

Question 4

List three requirements that must be in place to make use of a placebo acceptable in palliative care research on symptoms

Answer 4

Placebos are acceptable if:

• a patient receives a placebo in addition to the standard of care
• The symptom under investigation has no effective treatment
• Subjects have adequate access to ‘breakthrough’ or rescue tx

Question 5

What are the four components that must be demonstrated to say a patient has decision making capacity

Answer 5

understand relevant information

appreciate significance of that information

reason through to a conclusion that makes sense for them

communicate decision

Question 6

List two important strategies for ensuring voluntariness of research participation

Answer 6

ensuring that a subject’s choice to enrol is made with full knowledge available of alternatives and with the understanding that they can withdraw at any time

recruit from environment with excellent palliative care standards - if patients receive excellent care they will be best able to make free and uncoerced choice about research participation