Huron Life Sciences Announces Webinar on the DHHS Advance Notice of Proposed Rulemaking on Protections for Human Research Subjects

--(EON: Enhanced Online News)--Huron Consulting Group:

Who:	Huron Consulting Group today announced a complimentary Huron Life Sciences webinar on the Department of Health and Human Services’ (DHHS) Advance Notice of Proposed Rulemaking (ANPRM) on protections for human research subjects.
What:	DHHS is contemplating ways to revise and modernize regulations that govern human research subjects and is requesting comment on more than 20 separate proposals and 70 questions by September 26, 2011.
	The Huron Life Sciences webinar will help the research community become more familiar with the proposed changes, including:
	• Applying standards from the HIPAA Privacy Rule for limited dataset and de-identification to all research.
	• Research to comply with data security requirements similar to HIPAA.
	• Consent and written documentation of informed consent to bank human specimens for research or to conduct research on human tissue specimens.
	• Eliminating "exempt" research, and replacing it with a new "excused" category.
	• Public reporting of new data elements to a centralized government database.
	• Requiring institutions that receive any federal funds to apply the Common Rule to all research.
	• Reporting of any IRB determinations that override default review requirements.
	• Elimination of continuing review as well as certain regulatory criteria for approval for minimal risk research that qualifies for review by the expedited procedure.
	• Creating additional regulations for informed consent documents.
When:	Monday, September 12, at 12:00 p.m. CT.
Where:	For access to the webinar, please visit: http://www.huronconsultinggroup.com/crm-briefing/ClientAlert_082511_web.html

If you are interested in speaking with one of Huron’s clinical research management experts, please contact:

Jennifer Frost Hennagir
312-880-3260
[e-mail]

Jenna Nichols
312-880-5693
[e-mail]

About Huron Life Sciences

Huron Life Sciences serves healthcare providers, academic medical centers, pharmaceutical, medical device, and biotechnology companies and the law firms that support these organizations to define, measure, and achieve financial, operational, and strategic objectives.

About Huron Consulting Group

Huron Consulting Group helps clients in diverse industries improve performance, comply with complex regulations, reduce costs, recover from distress, leverage technology, and stimulate growth. The Company teams with its clients to deliver sustainable and measurable results. Huron provides services to a wide variety of both financially sound and distressed organizations, including healthcare organizations, Fortune 500 companies, leading academic institutions, medium-sized businesses, and the law firms that represent these various organizations. Learn more at www.huronconsultinggroup.com.