Comments for blog.Bioethics.gov https://bioethicsarchive.georgetown.edu/pcsbi/blog The blog of the 2009 - 2017 Presidential Commission for the Study of Bioethical Issues Thu, 24 Sep 2015 14:19:05 +0000 hourly 1 Comment on Modernizing Human Subjects Research Protection: Applying the Principle of Regulatory Parsimony 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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Comment on Update: The Growing Need for a Systematic Approach to Compensation for Research-Related Injuries by A John https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/07/27/update-the-growing-need-for-a-systematic-approach-to-compensation-for-research-related-injuries/#comment-1110821 Wed, 16 Sep 2015 14:20:33 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1675#comment-1110821 This post is timely and appropriate and one that was long overdue. We need to get estimates in real time of annual numbers of research related injuries so we know how big the problem is. We also need clarification on whether unanticipated serious adverse events can be classified as research injuries. Just like cancer registries, we need to have registries to log in research injuries into international databases, perhaps into websites like clinical trials.gov so the magnitude of the problem can be assessed.

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