Tuesday, April 8, 2014

IRB Still Isn't Peer Review

A bit off-topic here (this is a health-related study), but here's an illustration of the benefits of IRB shopping.

[Cordner, Alissa, and Phil Brown. “Moments of Uncertainty: Ethical Considerations and Emerging Contaminants.” Sociological Forum 28, no. 3 (September 2013): 469–94. doi:10.1111/socf.12034.]

Breast milk biomonitoring can be controversial because of concerns that the reporting-back of individual contamination levels may discourage breastfeeding (Morello-Frosch et al. 2009), thus potentially balancing identifiable benefits to science with uncertain benefits and harms to participants. Breastfeeding provides important health benefits compared to formula feeding, even when the milk contains chemicals (Hooper and She 2003; Jorissen 2007), but some academics and IRBs worry that a woman's knowledge of her body burden could impact her decision to breastfeed. Yet evidence supporting these fears is based on hypothetical situations described in survey research (Geraghty et al. 2008) or is anecdotal (Gross-Loh 2004). A recent study of women who shared their breast milk for a biomonitoring project found that while some women in this study stated they became more aware of chemical exposure and some made lifestyle changes, none of them chose to stop breastfeeding or to breastfeed for a shorter period of time because of their study results (Wu et al. 2009).

As an example of this ethical concern around breast milk biomonitoring research, one scientist's IRB initially denied a research protocol that would have tested for chemicals in breast milk on the grounds that the scientific benefits of learning about breast milk contamination did not outweigh the potential risks to women learning about personal contamination. That researcher looked to existing sociological and public health research showing this fear to be unjustified, and eventually did receive approval through another IRB to conduct their research. The researcher's trajectory points to both the ethical conflicts researchers can have with institutions when designing novel research programs, and to the absence of consistent institutional ethical guidelines in such areas of research. Because different IRBs have vastly contradictory stances on such issues, the ethical choices are by no means clear. Thus researchers must be attuned to the many moments at which choices come up.

In peer review, this is standard practice: you get rejected at one journal, you try again elsewhere. For the most part, however, researchers have no way to work around an IRB that is basing its decisions on unjustified fears. I wonder how the researchers in this example did it.

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