Law Commons^™

Concordance Of International Regulation Of Pediatric Health Research, Ellen W. Clayton, Mark A. Rothstein Jd, Et Al.

Vanderbilt Law School Faculty Publications

International, multi-site, pediatric health research has shown great promise by vastly increasing the amount and heterogeneity of biospecimens and clinical records. However, considerable impediments are created by the significant costs and delays associated with obtaining regulatory approval in numerous countries, which is often complicated by varying and sometimes opaque research ethics standards and procedures. Although it is unlikely that the global community could reach consensus on a single set of research ethics policies and procedures, voluntary policy pronouncements by countries agreeing to defer to the approval of research ethics bodies in other countries might be a way forward.

Deference is …