A Fight Against Providing Informed Consent in SUPPORT- Part II

6 years ago Bernard W Freedman, JD, MPH 0


There have been a number of articles written by well-known physicians and bioethicists expressing great concern over the recent Office for Human Research Protection, OHRP, letter of criticism with respect to the SUPPORT clinical trial. This blog discussed this controversy in the post of May 23, 2013. This controversy has turned dark with efforts to intimidate the OHRP.. Not attractive in the arena of customarily well reasoned debates in the bioethics community.

The latest in this saga is a plea signed off on by, as they describe themselves, a group of scholars and leaders in bioethics that was published in the New England Journal of Medicine of June 5, 2013. Yet these otherwise noted scholars’ plea is remarkably devoid of academic integrity and disciplined analysis. They “protest too much” when they should be supportive of these criticisms issued by the OHRP for the safety and benefit of all research subjects. 

The OHRP is absolutely correct in their findings and should stand fast in their criticism  of the informed consent process in this clinical trial.

The parents of these research subjects, infants less than 28 weeks, were not provided with complete information or a clear understanding of the information available and the  risks involved in this clinical trial. This group of scholars and leaders in bioethics, which indeed they are, accuses the OHRP of being “both foolish and risky” in their criticism. They say this while at the same time admitting that the consent forms could be improved.  How? They don’t say.

They ignore the legally mandated full disclosure owed to the parents involved in this study. They instead assert that the criteria for disclosure should not be the full disclosure because it is unfair to the investigators and institutions involved in this clinical trial. Their worry that full disclosure will  “impede the ongoing and future patient centered outcome studies. Such studies are crucial for advancing medial practice, reducing risks…” So, these scholars wish to sacrifice full disclosure and a legitimate informed consent process for the sake of conducting admittedly critically important research that might not be conducted if full disclosure is provided.

They argue that the informed consent process for human research subjects could be better dealt with by “relevant stakeholders” instead of the OHRP.  It is, however, hard to imagine a greater “stakeholder” than the research subjects themselves. It is the job of the OHRP to protect research subjects. These scholars therefore want the OHRP to quiet themselves and allow researchers to decide what research subjects should or should not be told. It does not work that way, at least not ethically.

This august group of scholars did not raise or discuss – in any fashion whatsoever – the specific criticisms set forth by the OHRP. They do not factually challenge or quarrel with the conclusions of the OHRP as to the available information that should have been provided to the parents. They merely argue that the findings of the OHRP lack merit, and claim that the process of determining proper informed consent be left in the hands of  “properly constituted IRBs” behind closed doors and if logic follows, have the Office of Human Research Protection close their doors.It is damning to note that in this clinical trial the IRB was told by the principle investigators in the clinical trial protocol that  oxygen restriction could result in damage to neurodevelopment. They failed, seemingly by design, to tell the parents the same thing in the consent form given to the parents.

When explaining the proposed SUPPORT trial the investigators told the IRB:

"However, oxygen toxicity can result in increased risk for CLD, [chronic lung disease] retinopathy of prematurity (ROP) and other disorders. Alternatively, oxygen restriction may impair neurodevelopment.”(emphasis added).

Their argument that "properly constituted IRBs" will provide sufficient protection to research subjects is conspicuously contradicted in the purposeful failure in this same clinical trial. They apparently feel strongly that if full disclosure is demanded of them their research will be threatened. This is precisely why we need the OHRP for the protection of patients whom we try to recruit for research.