Comments on: Modernizing Human Subjects Research Protection: Applying the Principle of Regulatory Parsimony https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/23/modernizing-human-subjects-research-protection-applying-the-principle-of-regulatory-parsimony/ The blog of the 2009 - 2017 Presidential Commission for the Study of Bioethical Issues Thu, 24 Sep 2015 14:19:05 +0000 hourly 1 By: David Resnik https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/23/modernizing-human-subjects-research-protection-applying-the-principle-of-regulatory-parsimony/#comment-1111427 Thu, 24 Sep 2015 14:19:05 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1719#comment-1111427 Regulatory parsimony? Maybe and maybe not. Yes, the NRPM increases the types of studies that are declared not to be research or are exempt research, which reduce regulation in these areas. But it also adds a lot of extra requirements concerning research with biological samples, informed consent, and confidentiality. These requirements are complex and difficult to follow, as they are full of various exceptions and twists and turns. I think it will take IRBs quite a while to learn how to apply the revised Common Rule and that there may some unexpected adverse consequences, as is often the case when you revise regulations.

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