Discussion responses
For this week’s discussion we took a look at the SUPPORT (Surfactant, Positive Pressure, and Oxygenation Randomized Trial) Trial. This trial evaluated the use of high oxygen and low oxygen pressure in pre-mature babies. However, both treatment arms came with risks without concrete data.
Reading:
https://www.science.org/content/article/us-weighs-informed-consent-rules-wake-infant-study-controversy
In the article by Arthur Allen, it was noted that researchers were unsure of whether to inform patients on the risks of either treatment (high O2 saturation and retinopathy, low O2 Saturation and death) because of they were considered standard of care regimens. Kathy Hudson, an NIH deputy director, felt that SUPPORT research did not need to mention the risks of death associated with low O2 saturation because there was no recent data indicating that risk.
Do you think that design of the SUPPORT study was ethical, why or why not?
In your opinion, did the SUPPORT study team deviate from the ethical principles during the informed consent process?
As pre-mature babies are a vulnerable population, and despite the lack of data and the classification of these treatments as standard of care, do you think researchers should have emphasized these risks to parents? Why or why not?
Some neonatologists were noted to have had concerns about the use of low oxygen support, and study investigators should have been aware of these risks. What reasons do you think could have swayed the research team to leave this risk off of the consent form? Explain.
There are concerns about the inequality of informed consent requirements when it comes to research studies and general everyday medical treatment. Do you think medicine would benefit from a stricter informed consent process, similar to how research participants must be consented? Why or why not
Place yourself in the shoes of the researcher conducting the SUPPORT trial, what steps could you have taken to fulfill the concerns raised by OHRP.
The article “Legally Blind: The Therapeutic Illusion in the SUPPORT Study of Extremely Premature Infants” mentioned the distinctions between “Treatment” and “Research” (Therapeutic Treatment and Experimental Research), how can a potential subject determine the difference between both if approached during an extremely vulnerable time based on the clinical setting, such as an Intensive Care Unit? What would you do as a researcher to ensure the subjects (or their legal representative) that you are recruiting understand the difference?
week 8
Readings:
Miller FG, Wendler D, Swartzman LC. Deception in Research on
the Placebo Effect. PLoS Med 2005; 2(9): e262. DOI:
10.1371/journal.pmed.0020262.
• UCI Office of Research. Placebo Controlled Studies. © 2015. At:
https://www.research.uci.edu/compliance/human-researchprotections/researchers/placebo.html. Last Accessed May 17,
2020.
1. Deception in clinical trials is considered to be ethically problematic. Describe ways in which use of deception conflicts with ethical norms governing clinical research.
2. In deciding whether or not to disclose research findings to participants, “the possibility that psychological or other harms may result from learning of the results” is considered. Does this conflict with Ethical Considerations to “respect self-determination as it relates to participants’ needs for information relevant to their health and well-being.” Why and why not?
3. The article “Deception in Research on Placebo Effect” discusses that deception related to the nature of the research trial plays a major role in achieving the placebo effect. The ethics of deception as used in this type of trial has received little to no push back.
Based on the information we have covered so far in this course; do you agree that deception in this type of research is vital in analyzing the “placebo effect”? Why or why not?
Do you personally believe in the “placebo effect”? Why or why not?
Can the “placebo effect” be achieved and analyzed without withholding or misleading participants with respect to the nature of the trial? Explain.
week 10
International
In the same article a statement was mentioned: “After the Pretoria conference, the leaders of the World Medical Association indicated their willingness to consider further the issues that were raised. We applaud this effort. They subsequently announced the formation of a working group to examine these issues and to meet with other groups to “harmonize guidelines.”
Do you think that the formation of the working group will be the solution to the countless ethical dilemmas that exist in developing countries?
What further measures or regulations would you suggest to ensure that researchers in developing countries are held to the same standards as the rest of the world?
Emergencies
In the article (Assessing the Ethics of Medical Research in Emergency Settings: How Do International Regulations Work in Practice?) by Halila R. it is explained that informed consent or authorization for conducting research in emergency can be waived after the approval of an ethics committee as long this emergency trial brings significant benefit for the patient.
Do you agree/disagree that human subjects are not able to give consent in all emergency trials? Why? Or Why not? Explain any differences you identify, if applicable.
In your opinion, what other challenges or barriers exist when conducting clinical trials during emergencies?
Covid-19
Did your opinion(s) regarding challenges or barriers in clinical trials during emergencies change after viewing Equity and Ethics video we just watched? (https://www.youtube.com/watch?v=jsD-1pBeGEw) Explain.
If you were a principal investigator overseeing a clinical trial during the current Covid-19 Pandemic, how would you balance autonomy and informed consent while waiving certain requirements in order to expedite the trial due to the current emergency?
how would you ensure justice throughout the trial?
Take-Away
Has the COVID-19 pandemic affected the way the clinical research community shares data and knowledge?
In what ways has it hindered data and knowledge sharing?
What are the hurdles to sharing data and knowledge in clinical research? The scientific/technological hurdles? The societal/investment hurdles?
What is needed to make data and knowledge sharing more effective and more the norm?
