Welcome to the BioLaw Project blog!

Welcome to the blog for the University of Utah College of Law BioLaw Project! The BioLaw Project seeks to improve the law as it relates to the rapidly evolving ares of health policy, life science, and medical and technological arts. We will be posting updates on biolaw in the news, BioLaw Project events, and unique […]

In the news – 9.17.11

Here is a small sampling of recent bioethics news stories: HHS Secretary Kathleen Sebelius plans rules making it easier for patients to access their personal electronic health records. The New York Times addresses issues raised when one sperm donor fathers 150 children. A bioethics professor challenges Michele Bachmann’s assertion of a link between the HPV vaccine […]

Part I of a series on proposed changes to the common rule: Introduction

The U.S. Department of Health and Human Services has announced an Advanced Notice of Proposed Rulemaking regarding the common rule.  The common rule, originally published in 1991, regulates informed consent and Institutional Review Boardss for human subject research.  This post serves as the first of a series that will address issues raised by this topic, including the […]

In the news – 9.23.11

A survey of healthcare industry executives finds that the healthcare industry lacks appropriate patient data safeguards A severe shortage of certain drugs forces hospitals to buy drugs from secondary vendors; blamed for 15 patient deaths Survey reveals many patients think the FDA approves only drugs without serious side effects or drugs that are “extremely effective” Opponents […]

In the news – 10.3.11

Baby Joseph, born with degenerative brain disease, died at 20 months old.  Baby Joseph had been in a Canadian hospital where his parents refused to have his breathing tube removed, but wanted a tracheotomy.  The Canadian hospital refused to perform the tracheotomy and the family was unsuccessful in seeking a court order for the procedure.  A right […]

Part II of a series on proposed changes to the common rule: background on the common rule and the IRB process

I recently had the opportunity to interview John Stillman, the Director of the Institutional Review Board for the University of Utah, to ask him his thoughts on the Advanced Notice of Proposed Rulemaking (“ANPRM”) for changes to the Common Rule.  This post will focus on the background he provided on the Common Rule and the […]

Part III of a series on proposed changes to the common rule: requiring informed consent for biospecimen research

If you’re just joining us, this post serves as third in a series discussing the ANPRM for proposed changes to the Common Rule.  I had the opportunity to interview John Stillman, Director of the Institutional Review Board at the University of Utah to get some insight into what some of the proposed changes may mean. […]

Part IV of a series on proposed changes to the common rule: standardizing informed consent

This post serves as fourth in a series addressing the Advanced Notice of Proposed Rulemaking for proposed changes to the Common Rule.  I had the opportunity to interview John Stillman, Director of the University of Utah Institutional Review Board. There is language in the ANPRM about standardizing informed consent; that the real purpose of informed […]

Part V of a series on proposed changes to the common rule: proposed excused categories

This post serves as the last of the series addressing the Advanced Notice of Proposed Rulemaking for proposed changes to the Common Rule.  For those of you just catching up, it may be helpful to read the past posts.  I had the opportunity to interview John Stillman, Director of the Institutional Review Board for the […]

In the news – 10.30.11

In what has been referred to as “an unbelievable setback for bio-medical research in the area of stem cells,” the European Union’s top court has banned embryonic stem cell patents. A federal advisory committee has recommended routine HPV vaccination for boys ages 11 and 12. The New York Times reports venture capitalists put money on easing […]