Should terminally ill patients be recruited into clinical trials?
☛ Yes, if the trial objective is to improve the quality of life and
↳ there is possible benefit
↳ the potential for harm is low
↳ the patient is fully informed of all that is involved
☛ No, if it is a phase 1 trial of an experimental anticancer agent or other intervention for which
↳ the chance of benefit is very small
↳ the potential for harm is significant
Informed consent for a clinical trial must include understanding of
☛ the purpose of the research
☛ any foreseeable risks
☛ any possible benefits
☛ any appropriate alternative procedures or treatments
☛ confidentiality of records
☛ participation being voluntary
☛ ability to withdraw at any time
☛ that continuing care is not dependent on participation in the trial
Palliative care patients are particularly vulnerable and susceptible to proposals to enrol in clinical trials
☛ they may be desperate for treatment options
☛ they may be physically ill and exhausted
☛ they may be depressed
☛ they may be cognitively impaired
☛ they may feel obliged to participate, to show their appreciation to the doctors caring for them
There is an ethical responsibility to protect palliative care patients from studies that are not in their best interests whilst preserving the informed patients’ freedom of choice
☛ experience suggests that many terminally ill patients enjoy collaborating in ventures which might help others, feeling that they are still useful members of society
↳
Source:
The IAHPC Manual of Palliative Care 3rd Edition
https://web.archive.org/web/20210122105526/https://hospicecare.com/uploads/2013/9/The%20IAHPC%20Manual%20of%20Palliative%20Care%203e.pdf
