In March 2013 the Office for Human Subjects Research Protections (OHRP) at the Department of Health and Human Services (HHS) found that some of the informed consent provisions associated with the a study at the University of Alabama, Birmingham were lacking. In June OHRP sent a subsequent letter to the researchers indicating it would put its planned sanctions on hold.
In between March and June, HHS and National Institutes of Health officials interacted with OHRP staff, and that interaction prompted allegations of improper influence. The HHS Office of the Inspector General found no evidence of wrongdoing in its investigation.
But that doesn’t end the story, since OHRP put its actions on hold. That hold ended on Friday. Rather than implement sanctions against the researchers, OHRP has issued a call for comments on proposed informed consent guidelines. The proposed guidelines affect the application of human research protections to cases of ‘standard of care research.’ The major questions concern what risks could be considered ‘reasonably foreseeable’ and how those risks should be described to prospective subjects.
In the case of the SUPPORT study that prompted this whole process, there was disagreement over whether or not the study protocols put subjects at risks that warranted disclosure. OHRP felt that since the risks were greater than what subjects would reasonably expect without treatment, notice was required. Others argued that because the treatment under study was within the standard of care for the condition, that no disclosure was required.
OHRP is taking comments until December 24, and will issue final guidance sometime in early 2015.