Rethinking the "Common Rule"

Rethinking the "Common Rule" Interested in learning about human research regulations?

November 21, 2011 at 1:00 pm.

Tune in to WAMU's Kojo Nnamdi Show for a discussion "Rethinking the 'Common Rule': The Ethics of Research with Human Subjects". The show features Jerry Menikoff, Director, Office for Human Research Protections (OHRP) and Kathy Hudson Deputy Director for Science, Outreach, and Policy, National Institute of Health.

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November 21, 2011 at 1:00 pm. Tune in to WAMU's Kojo Nnamdi Show for a discussion "Rethinking the 'Common Rule': The Ethics of Research with Human Subjects". The show features Jerry Menikoff,...

http://thekojonnamdishow.org/shows/2011-11-21/rethinking-common-rule-ethics-research-human-subjects https://beta.my.umbc.edu/api/v0/pixel/news/10335/guest@my.umbc.edu/53f4ad5a8e46735bcefcda1e1e927c57/api/pixel human irb ora subjects Office of Research Protections and Compliance https://beta.my.umbc.edu/groups/compliance https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xsmall.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/original.jpg?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xxlarge.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xlarge.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/large.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/medium.png?1406813901 https://assets4-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/small.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xsmall.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xxsmall.png?1406813901 Office for Research Protections and Compliance 0 0 true Thu, 17 Nov 2011 22:58:06 -0500 Thu, 17 Nov 2011 22:59:35 -0500 UMBC's FWA has been renewed University of Maryland, Baltimore County's Federalwide Assurance (FWA00000069) is approved through 09/13/2016). ]]>

University of Maryland, Baltimore County's Federalwide Assurance (FWA00000069) is approved through 09/13/2016).

http://harponotes.blogspot.com/ https://beta.my.umbc.edu/api/v0/pixel/news/8609/guest@my.umbc.edu/8e3baba1398bde2244110c44f36c449a/api/pixel Office of Research Protections and Compliance https://beta.my.umbc.edu/groups/compliance https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xsmall.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/original.jpg?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xxlarge.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xlarge.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/large.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/medium.png?1406813901 https://assets4-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/small.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xsmall.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xxsmall.png?1406813901 Office for Research Protections and Compliance 0 0 true Tue, 13 Sep 2011 11:21:00 -0400 Comment period on proposal to improve rules changes

The comment period for the advance notice of proposed rulemaking (ANPRM) on how current regulations for protecting human subjects has changed and will end, on October 26, 2011. See the September 1, 2011 Federal Register (http://www.gpo.gov/fdsys/pkg/FR-2011-09-01/pdf/2011-22341.pdf)

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The comment period for the advance notice of proposed rulemaking (ANPRM) on how current regulations for protecting human subjects has changed and will end, on October 26, 2011. See the September...

http://www.gpo.gov/fdsys/pkg/FR-2011-09-01/pdf/2011-22341.pdf https://beta.my.umbc.edu/api/v0/pixel/news/8309/guest@my.umbc.edu/8803cfdf41c00cdeba937fecb485e9f5/api/pixel Office of Research Protections and Compliance https://beta.my.umbc.edu/groups/compliance https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xsmall.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/original.jpg?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xxlarge.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xlarge.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/large.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/medium.png?1406813901 https://assets4-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/small.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xsmall.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xxsmall.png?1406813901 Office for Research Protections and Compliance 0 1 true Thu, 01 Sep 2011 12:54:29 -0400 Mon, 12 Sep 2011 13:24:27 -0400 Conflict of Interest Rules Finalized for NIH The Department of Health and Human Services has issued an updated final rule on conflict of interest to use in identifying, managing, and avoiding investigators’ financial conflicts of interest. The regulations will be implemented after publication of the final rule in the Federal Register.

Major changes to the regulations include:

A requirement for investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities.
Lowering the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.
Requiring institutions to report to the PHS awarding component additional information on identified financial conflicts of interest and how they are being managed.
Requiring institutions to make certain information accessible to the public concerning identified SFIs held by senior/key personnel.
Requiring investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.

See this site, http://www.nih.gov/news/health/aug2011/od-23.htm, for more information and a full description of the major changes to the regulations.

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The Department of Health and Human Services has issued an updated final rule on conflict of interest to use in identifying, managing, and avoiding investigators’ financial conflicts of interest....

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The Department of Health and Human Services’ (DHHS) Office of Human Research Protections (OHRP) published an advance notice of proposed rulemaking (ANPRM), titled Human Subjects Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, proposing substantial changes to the federal regulations governing human subjects protections known as the 'Common Rule.’

The public comment period is scheduled to be open through September 26, 2011.

The attached a table from OHRP that compares the changes of the current regulations and the proposed wording.

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The Department of Health and Human Services’ (DHHS) Office of Human Research Protections (OHRP) published an advance notice of proposed rulemaking (ANPRM), titled Human Subjects Protections:...

http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html Document https://assets3-beta.my.umbc.edu/system/shared/attachments/4c0043dd4b65a447f670ab8dc902b457/69eb354c/news/000/008/006/59a3adea76fadcb6dd9e54c96fc155d1/Regulatory Changes in ANPRM.pdf?1314019450 https://beta.my.umbc.edu/api/v0/pixel/news/8006/guest@my.umbc.edu/d593300876ab4bce2718ece47dcdc9f6/api/pixel Office of Research Protections and Compliance https://beta.my.umbc.edu/groups/compliance https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xsmall.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/original.jpg?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xxlarge.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xlarge.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/large.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/medium.png?1406813901 https://assets4-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/small.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xsmall.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xxsmall.png?1406813901 Office for Research Protections and Compliance 0 1 true Mon, 22 Aug 2011 09:24:10 -0400 Updates to examples of exempt review chart ORPC has updated the Exempt Category Example Chart to assist investigators in determining if their research fits into one or more of the exempt categories. ]]>

ORPC has updated the Exempt Category Example Chart to assist investigators in determining if their research fits into one or more of the exempt categories.

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http://newsmanager.commpartners.com/primrar/issues/2011-04-28/3.html

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See what research professionals think and say at: http://newsmanager.commpartners.com/primrar/issues/2011-04-28/3.html

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The IRB has issued updated guidance for class instructors on when research projects, designed in the classroom setting, will require review and approval. Please review the below for more information.

http://www.umbc.edu/research/ORPC/IRBprotdevelop.html#classprojects https://beta.my.umbc.edu/api/v0/pixel/news/5113/guest@my.umbc.edu/0ea7e6ba4cfef829cfb206f1917414b2/api/pixel Office of Research Protections and Compliance https://beta.my.umbc.edu/groups/compliance https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xsmall.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/original.jpg?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xxlarge.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xlarge.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/large.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/medium.png?1406813901 https://assets4-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/small.png?1406813901 https://assets2-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xsmall.png?1406813901 https://assets1-beta.my.umbc.edu/system/shared/avatars/groups/000/000/163/aea9789988c08f28538422f1c3427388/xxsmall.png?1406813901 Office for Research Protections and Compliance 0 0 true Wed, 27 Apr 2011 15:42:07 -0400 Update to IRB guidance on closing a protocol The IRB has recently updated its guidance for investigators on the protocol closure process. Please review http://www.umbc.edu/research/ORPC/IRBpostapproval.html#closure for more information. ]]>

The IRB has recently updated its guidance for investigators on the protocol closure process. Please review http://www.umbc.edu/research/ORPC/IRBpostapproval.html#closure for more information.

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The IRB protocol modification form has recently been updated to reflect the IRB's current guidance on what constitutes a change to an approved protocol. Please review the web site...

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