Bioethics Blogs

US research ethics agency stands by decision on informed consent in comparative effectiveness studies

United States regulators are standing by their decision that parents were not properly informed of the risks of clinical trials in which premature babies received different levels of oxygen supplementation.

In the The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) trial, premature babies were randomly assigned to receive one of two levels of oxygen supplementation. The trial was designed to test which level was best. Though the lower level was associated with increased risk of brain damage and possibly death and the higher level with blindness, the study leaders did not disclose these risks to parents because, they said, all ranges of oxygen used within the trial were considered within the medically appropriate range at the time.

The study was supported by the US National Institutes of Health. On 7 March, 2013, the US Office of Human Research Protections (OHRP) issued a letter determining that the trial investigators had not adequately informed parents about the risks to their babies in the SUPPORT trial. The NIH and many researchers disputed the decision, arguing that it would impede “comparative effectiveness research” studies that are designed to test the best use of approved interventions. Parents of children in the trial, however, and others supported OHRP’s determination that parents hadn’t received adequate information. The two sides clashed at a meeting convened by NIH and OHRP in August 2013.

Today, 24 October 2014, the OHRP has issued guidance reiterating and clarifying its position on what types of risks must be disclosed to study subjects in comparative effectiveness research studies such as SUPPORT.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.