Changes to fed­eral rule gov­ern­ing hu­man re­search aims for ex­pe­dited re­view

Modern Healthcare - - THE WEEK AHEAD - —Michael San­dler

Sci­en­tists and in­no­va­tors hope pro­posed changes to the fed­eral rule re­gard­ing the ethics, over­sight and trans­parency of re­search in­volv­ing hu­man sub­jects will ex­pe­dite the clin­i­cal re­view process.

They, along with of­fi­cials from HHS and 15 other agen­cies, will at­tend a town hall meet­ing in Wash­ing­ton this week to dis­cuss pro­posed up­dates that in­clude clearer con­sent rules for the re­use of stored blood or tis­sue in new re­search un­re­lated to their orig­i­nal study pur­pose.

The agen­cies be­gan over­haul­ing the reg­u­la­tions in re­sponse to the more so­phis­ti­cated ways biospec­i­mens can be an­a­lyzed, as well as in re­sponse to the col­lec­tion of dig­i­tal health records.

Industry lead­ers say changes to the so-called Com­mon Rule, es­tab­lished in 1991, are long over­due.

In par­tic­u­lar, they ad­vo­cate speed­ing up the clin­i­cal-re­view process and en­sur­ing in­sti­tu­tional re­view boards can take on mul­ti­site, in­ter­na­tional re­search projects, said Arthur Ca­plan, di­rec­tor of the divi­sion of med­i­cal ethics at New York Univer­sity’s School of Medicine.

The Com­mon Rule changes are sub­ject to a 90-day com­ment pe­riod be­fore be­ing fi­nal­ized. Com­ments must be re­ceived by Dec. 7 to be con­sid­ered.

The call for clearer guide­lines comes as the White House launches its am­bi­tious Pre­ci­sion Medicine Ini­tia­tive, which aims to in­volve as many as 1 mil­lion med­i­cal vol­un­teer sub­jects to help in­no­vate med­i­cal treat­ments spe­cific to in­di­vid­u­als.

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