In the fall of 2004, the NIH requested that the Institute of Medicine (IOM) of the National Academies of Sciences review the HIVNET 012 perinatal HIV prevention trial and provide an assessment of the validity of the study results.

The NIH charge to the IOM was to "address the methodolog [ies] and data — related to protocol design, data collection, record keeping, quality control, and analysis." The committee was asked to address the impact of these issues on the validity of the overall findings and the conclusions of the trial. The committee was to answer a series of specific questions listed in the report, which is available online at http://www.iom.edu/report.asp?id=26287.

The NIH has reviewed the report and is very pleased with the thorough and complete way in which the IOM performed its assessment. NIH thanks the committee members and staff of the IOM for this scholarly report. The IOM report finds, as previous reviews of the HIVNET 012 study have, that "the data are sound, presented in a balanced manner and can be relied upon for scientific and policy-making purposes."

NIH is also pleased that the committee devoted one of the five chapters of its report to ethical issues involved in the performance of this study and is particularly gratified that the committee found no ethical concerns about the design or implementation of the study, that would justify excluding its findings from use in scientific and policy deliberations.

NIH expects that the findings by the IOM will restore confidence in the validity of the conclusions of this study, allow the controversy surrounding this issue to subside, and facilitate policy decisions that seek to promote the health of newborns at risk of HIV infection.