High oxygen and low oxygen pressure.
This trial evaluated the use of high oxygen and low oxygen pressure in pre-mature babies.
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 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.