Foglia et al1 raise an interesting question regarding a stipulation of the common rule in determining whether emergency consent waiver is appropriate: is the legal representative of the infant truly present in the delivery room? In our Ethics Rounds from November 2014,2 Dr Schreiner argued that because a newborn's mother is physically present at the time of delivery, emergency consent cannot be waived. But Foglia et al's point is well taken; at the time of delivery, the mother is often in physical pain, nauseous, and extremely worried about the well- being of her soon-to-be-born infant. If it is a vaginal delivery, she is also working very hard (literally laboring) to meet her child safely. If there is another legal parent in the room, that person is immediately preoccupied with all of the aforementioned, and additionally worries for the welfare of the delivering mom. Although they are likely not in physical discomfort, both parents would probably agree they are unable to receive information about a research study and are incapable of making a thoughtful split-second decision.
In certain delivery room situations, the time between meeting study criteria and randomization and delivery of the study's intervention can be a matter of seconds. In the proposed study in November's Ethics Rounds, for example, the determination of whether an infant born through meconium-stained amniotic fluid is “vigorous” or not immediately follows intubation for suctioning or no intubation. This is certainly not enough time for the kind of informed consent advocated by the common rule. I agree with these authors of the SAIL study group that not only is the legal decision-maker's “presence” arguable, the time (or lack thereof) makes this an emergency situation.
In November, Dr Wiswell and I argued that consent might be waived with the opportunity for parents to opt out later and with education provided to all laboring moms about the study in case their children were to meet criteria for enrollment at the time of birth. This approach is similar to the approach for which Foglia et al advocate in their “retrospective” consent. The key issue of disagreement we had with Dr Schreiner on the acceptability of waiver of consent was the meaning of “minimal risk.” Dr Schreiner maintained that the risks of participating in the study exposed a newborn to risks greater than those found in “daily life,” using the example of risks associated with laryngoscopy, an invasive procedure. Dr Wiswell and I argued that “daily life” for a nonvigorous newborn born through meconium-stained fluid, due to unproven “standard care” practice starts with this invasive procedure thanks to an unproven standard care practice.
What qualifies as “minimal risk” is becoming exceedingly important in how comparative effectiveness studies are being regulated. Joffe and Wertheimer3 contrast interpreting the risks of such studies as “absolute” versus “incremental.” If a literal interpretation of the “daily life standard” is maintained, absolute risks (ie, every risk of the study treatment, including the risks a patient is exposed to from the treatment in regular care) will make few comparative effectiveness studies qualify as “minimal risk.” Alternatively, if incremental risks (risks unique to participating in the study that do not accompany the same treatments when outside of the study) are considered by an institutional review board, many comparative effectiveness studies might be considered “minimal risk.” Unfortunately, the newest directives from the OHRP's “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care” issued in October appear to be interested in absolute risks. According to this draft guidance, “at a minimum, identified risks associated with a standard of care that are being evaluated as a purpose of research, should certainly be considered 'reasonably foreseeable.”4 This interpretation could make minimal risk determinations nearly impossible for comparative effectiveness research.
The OHRP is currently processing the general public's input on this draft guidance.5 For the sake of our patients who deserve to receive evidence-based therapies, I hope the OHRP reconsiders their stance on which risks should be considered by institutional review boards. If a patient is harmed as a result of an unproven standard care treatment, and there's no one there to research it, doesn't the patient still suffer?
Conflict of Interest: None declared
- Foglia EE,
- Owen LS,
- Kirpalani H
- Schreiner MS,
- Feltman D,
- Wiswell T,
- et al
- Joffe S,
- Wertheimer A
- 4.↵Department of Health and Human Services. Draft guidance on disclosing reasonably foreseeable risks in research evaluating standards of care. Fed Regist. 2014;79(206):63629–63634. Available at: http:/www.gpo.gov/fdsys/pkg/FR-2014-10-24/pdf/2014-25318.pdf
- 5.↵Regulations.gov. Submitted comments are open for public review. Available at: www.regulations.gov/#!docketBrowser;rpp=25;po=0;dct=PS;D=HHS-OPHS- 2014-0005
- Copyright © 2015 by the American Academy of Pediatrics