Bioedge
by Michael Cook | 21 Sep 2018
Click for embedded links:
https://www.bioedge.org/bioethics/would-you-pay-to-participate-in-a-clinical-trial-234/12822
Imagine this scenario. You are terminally ill with cancer when you hear about a clinical trial with a miracle drug. You make inquiries and discover that you can participate but it will cost you $10,000.
This is the controversial “pay to play” model for funding clinical trials. While it sounds completely unconventional, it is already being used in allied health fields like sleep clinics, physiotherapy, and weight management. A couple of years ago bioethicist Ezekiel Emanuel and colleagues argued that it should not be considered as a funding model in times of shrinking budgets. They believed that it would undermine the integrity of clinical research.
However, two New Zealand bioethicists contend in the Journal of Medical Ethics that “pay to play” funding could work if it were properly regulated. There are ethical issues – patients’ ability to give truly informed consent may be undermined by the “therapeutic misconception” and trying to please the patients may skew the objectivity of the research and so on. Mike King and Angela Ballantyne counter that there is no essential difference between public and private funding for research:
Nearly half of all global research is funded by for-profit companies and concerns about conflicts of interest, skewing of the research agenda, and potential undue influence on study design can arise here as well. This is bread-and-butter work for Institutional Review Boards/Research Ethics Committees. Reviewers should reject studies if they are not confident that the study has been designed so as to deliver scientifically valid results, or if there is unacceptable risk of therapeutic misconception, or invalid informed consent. Just like standard research, some donor-funded research may fall below the acceptable standard owing to these issues.
by Michael Cook | 21 Sep 2018
Click for embedded links:
https://www.bioedge.org/bioethics/would-you-pay-to-participate-in-a-clinical-trial-234/12822
Imagine this scenario. You are terminally ill with cancer when you hear about a clinical trial with a miracle drug. You make inquiries and discover that you can participate but it will cost you $10,000.
This is the controversial “pay to play” model for funding clinical trials. While it sounds completely unconventional, it is already being used in allied health fields like sleep clinics, physiotherapy, and weight management. A couple of years ago bioethicist Ezekiel Emanuel and colleagues argued that it should not be considered as a funding model in times of shrinking budgets. They believed that it would undermine the integrity of clinical research.
However, two New Zealand bioethicists contend in the Journal of Medical Ethics that “pay to play” funding could work if it were properly regulated. There are ethical issues – patients’ ability to give truly informed consent may be undermined by the “therapeutic misconception” and trying to please the patients may skew the objectivity of the research and so on. Mike King and Angela Ballantyne counter that there is no essential difference between public and private funding for research:
Nearly half of all global research is funded by for-profit companies and concerns about conflicts of interest, skewing of the research agenda, and potential undue influence on study design can arise here as well. This is bread-and-butter work for Institutional Review Boards/Research Ethics Committees. Reviewers should reject studies if they are not confident that the study has been designed so as to deliver scientifically valid results, or if there is unacceptable risk of therapeutic misconception, or invalid informed consent. Just like standard research, some donor-funded research may fall below the acceptable standard owing to these issues.