Implications of Applying Minimal Risk Standards in Clinical Research to Information Provision in Prenatal and...

There have long been minimal risk thresholds beneath which risks may not need to be discussed in clinical research. This threshold concept may be applied to clinical practice. Our research explored application of minimal risk standards in research regulations to providing information in prenatal and pre-conception care.

A case study approach applied minimal risk standards in research regulations to prenatal and pre-conception care with respect to the risks of excess alcohol consumption, folic acid insufficiency, exposure to phthalate plasticizers, and exposure to brominated flame retardants (BFRs).

Excess alcohol consumption and folic acid insufficiency were found to be above the minimal risk standards as outlined in research regulations, while exposure to phthalates and BFRs requires more evidence to determine whether they are above minimal risk. However, applying the minimal risk standard based on the daily life of a healthy adult or a fetus in a healthy pregnant woman, phthalates and BFRs are at the minimal risk threshold regardless of their potential harm since all pregnant women may be exposed to these chemicals in their daily life. Nevertheless, if there is demonstration of sufficient evidence of harm, they may be above minimal risk if such harm can be reduced by individual choice to avoid exposure.

The minimal risk concept in research regulations as applied to clinical practice may be useful to help clinicians and professional organizations determine what risks need be discussed in prenatal and pre-conception care.