President’s Bioethics Commission releases results of investigation of 1940s US Public Health (USPH) STD Studies in Guatemala

http://www.bioethics.gov/

UMBC's FWA has been renewed

The University of Maryland, Baltimore County has a Federalwide Assurance (FWA00000069, approved through 09/13/2016) from the Office for Human Research Protections.

See this as well as other IRB related policies and procedures at http://www.umbc.edu/research/ORPC/IRBpolicyregs.html

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.

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.ofr.gov/OFRUpload/OFRData/2011-22341_PI.pdf)

Update to NIH changes to conflicts of interest rules

The March 17, 2011 issue of "Report on Research Compliance ", published by the by National Council of University Research Administrators and Atlantic Information Services, says the Office of Management and Budget is reviewing NIH's final rule imposing new requirements for managing and reporting on financial conflicts of interest. Regulations are typically reviewed and released by the OMB within 90 days of this process, but stay tuned for further details.

The original Notice of Proposed Rulemaking from the NIH regarding these changes to financial conflict of interest rules and reporting may be found at http://grants.nih.gov/grants/policy/coi/

Temporary fax number for ORPC

The suite where ORPC is located will be going under renovations beginning next week which will affect our ability to accept faxed documents. Renovations that affect the ORPC should be complete by March 18, 2011.

We will still accept and review information electronically via our email submission addresses (irbsubmissions@umbc.edu and iacucsubmissions@umbc.edu) and will process applications and answer questions related to protocols.

We have a temporary fax number that investigators may use in the meantime. Please use 410-455-8750 to send signed application pages.

Thank you for your patience.

RCR instruction for NIH awards

The NIH has made a policy change regarding RCR instruction for Institutional Training Grant Applications (Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Training grants and Non-NRSA Institutional Training grants). See link on the ORPC page for Regulations and Policy.