Trump ad­min­is­tra­tion to weigh in on Com­mon Rule

Modern Healthcare - - THE WEEK AHEAD - —Maria Castel­lucci

The Trump ad­min­is­tra­tion is ex­pected to look fa­vor­ably upon changes to a rule that pro­tects hu­man sub­jects in clin­i­cal tri­als after a 60-day freeze on rules in­tro­duced by the Obama ad­min­is­tra­tion is lifted.

The Com­mon Rule reg­u­lates the treat­ment of hu­man re­search sub­jects. In 2015, the Obama ad­min­is­tra­tion pro­posed al­low­ing re­searchers to use biospec­i­mens ob­tained dur­ing med­i­cal pro­ce­dures with­out writ­ten con­sent from pa­tients. The fi­nal rule was is­sued Jan. 18, just a few days be­fore Pres­i­dent Don­ald Trump took of­fice.

The Obama ad­min­is­tra­tion was re­spond­ing to new ways biospec­i­mens can be an­a­lyzed, as well as the emer­gence of dig­i­tal health records.

The ini­tial pro­posed changes in 2015 re­ceived back­lash from the med­i­cal com­mu­nity be­cause of a pro­vi­sion re­quir­ing re­searchers to re­ceive con­sent dur­ing ev­ery step of re­search. Op­po­nents ar­gued this would slow down the work of re­searchers and greatly in­crease ad­min­is­tra­tive bur­dens.

The Obama ad­min­is­tra­tion ad­dressed these con­cerns in the fi­nal rule, which stripped the re­quire­ment that con­sent be ob­tained in or­der to con­duct re­search. But the changes re­ceived neg­a­tive feed­back from pa­tient ad­vo­cacy groups wor­ried the rules threaten pa­tient pri­vacy.

Ex­perts be­lieve the Trump ad­min­is­tra­tion will en­force the fi­nal Com­mon Rule be­cause it is busi­ness-friendly. But the ad­min­is­tra­tion also could send the fi­nal rule back for fur­ther pub­lic comment.

The 21st Cen­tury Cures Act, which passed with bi­par­ti­san sup­port and was signed into law by Pres­i­dent Barack Obama in De­cem­ber, re­quires that newly cre­ated work groups study the Com­mon Rule. That pro­vi­sion likely won’t be a pri­or­ity for the new ad­min­is­tra­tion since the pri­mary fo­cus is on re­peal of the Af­ford­able Care Act.

If the Com­mon Rule changes are ap­proved, the re­vi­sions would take ef­fect start­ing next year.

The fi­nal rule was is­sued just days be­fore Pres­i­dent Don­ald Trump took of­fice.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.