Welcome to the Research and Patents section of our webpage. 

This front page will reflect our most current information on sponsored research, technology transfer, patents and related law affecting educational institutions. 

 

Request for Public Comments on Deemed Export Advisory Committee Recommendations, 73 Fed. Reg. 28795 (May 19, 2008)
Two issues are raised for comment by BIS (due August 18, 2008):  1) whether technologies on the Commerce Control List (CCL) should be narrowed, and 2) whether a more comprehensive assessment of foreign national affiliation should be used for purposes of making home country determinations in the deemed export licensing process. 

Human Subject Protection; Foreign Clinical Studies not Conducted Under an Investigational New Drug Appliciation, 73 Fed. Reg. 22800 April 28, 2008 Effective Oct. 27, 2008

The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign
clinical studies) as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) issued by the World Medical Association (WMA), specifically the 1989 version (1989 Declaration), with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies.

AAMC/AAU Advisory Committee Report: Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of Conflict of Interest Policies in Human Subjects Research (Feb. 2008) An 87 page report covering both individual and institutional conflict of interest poilcies.

Complying with the NIH Public Access Policy-Copyright Considerations and Options: SPARC/Science Commons/ARL white Paper by Michael W. Carroll; Feb. 2008: The paper notes as follows on two new mandates effective April 7, 2008 for schools:  

First, the grantee must ensure proper manuscript submission. ***Second, the grantee also has a distinct obligation to grant NIH copyright permission to make the manuscript publicly accessible through PMC not later than 12 months after the date of publication. This obligation is connected to manuscript submission because the author, or the person submitting the manuscript on the author’s behalf, must have the necessary rights under copyright at the time of submission to give NIH the copyright permission it requires.

The white paper analyzes the second  requirement and suggests options for compliance.

 

AAU and COGR Response to Report of Deemed Export Advisory Committe  (Feb. 2008)
This report makes suggestions to the Secretary of Commerce on the findings and recommendations of the Deemed Export Advisory Committee report (titled the Deemed Export Rule in the Era of Globalization and submitted Dec. 20th, 2007.

 

HHS Inspector General Report on Conflicts of Intersest in Extramural Research (January 2008)
This report issued by the Office of the Inspector General of the Dept. of Health and Human Services covers NIH (National Institute of Health) oversight of grantee institutions. The report found that NIH could not provide an accurate count of the financial conflict of interest reports it received from grantees during years 2004-06; NIH was not aware of the types of financial conflicts of interest that exist within grantee institutions because details are not required to be reported; and also that many institutes relied upon good faith of the grantee institutions. The report recommended that NIH take a more active oversight role.

 

NACUANOTE on Compliance with DHS Chemical Facility Anti-Terrorism Standards January 18, 2008

 

Final Rule, Federal Acquisition Regulation; FAR Case 2006-007, Proposed Contractor Code of Ethics and Business Conduct, 72 Fed. Reg. 65873 (Nov. 23, 2007)

This final rule, effective December 24, 2007, affects government contractors with contracts of $5M and a performance period of 120 days or more. These contractors will need to implement an employee training and compliance program if one is not already in place. The program must be combined with an internal control system to facilitate discovery of improper contract. Contractors must also display Inspector General OIG Fraud Hotline Posters. The requirement for a formal training program and internal control system is not applicable to small businesses. All subcontractors meeting the threshold must also comply. This rule does not apply to contracts for commercial items or contracts performed outside the U.S. A Contractor Code of Business Ethics and Conduct clause (codified at 48 CFR 52.203-13 will have to be included in covered government contracts. The Council on Government Relations had urged deferral of this new requirement for R and D contracts to universities and non-profits pending completion of the National Science and Technology Council's initiative to develop government wide voluntary compliance guidance for schools that received federal funding.

The Department of Homeland Security Appropriations Act of 2007: Security of High Risk Chemical Facilities; Public Law 109-295, Section 550. 72 Fed. Reg. 65395 (Nov. 20, 2007)
The rule went into effect June 8, 2007, but the list of chemicals of interest (Appendix A) was only tentative. On Nov. 20, 2007 DHS published the final rule, a revised Appendix A with the final list of chemicals covered by the new law.  The final appendix, unlike the proposed appendix, does not trigger reporting obligations based on possession of an STQ of "any amount." This change was due in part to comments upon the reporting burden of the interim rule.

Under the newly published list of chemicals, any facility that has listed chemicals in quantities that meet or exceed the screening threshold quantity must complete and submit a Top-Screen to DHS by Jan. 19, 2008. A 60 day extension may be sought. For more on this new rule see The Campus Safety Health and Environmental Management Association web page. The page includes a Q and A which is most helfpul.

Standardized Research Performance Progress Report, 72 Fed. Reg. 63629 (November 9, 2007)

The NSF is soliciting public comment on a standardized Research Performance Progress Report (RPPR) format. Although different Federal agencies utilize a variety of formats for reporting progress on activities supported by research grants, similar information is usually collected. These variations increase administrative effort and costs for recipients of Federal awards and make it difficult to compare research programs across government. Development of standard reporting categories will facilitate the development of a common electronic solution for collecting the information in lieu of collecting it through numerous agency-unique reporting forms currently used. Comments due January 8, 2008.

Penalties
The International Emergency Economic Powers Enhancement Act of 2007 significantly increases penalties for export violations, including deemed export violations.  See the Oct. 16, 2007 article titled Increase in Fines for Export/Sanctions Violations: President Bush Signs IEEPA Enhancement Act, by Steptoe and Johnson. The penalty increase applies to almost all economic sanctions programs administered by OFAC, and the anti-boycott and export control rules in the Export Administration Regulations. Click here for a summary of how the IEEPA provides the statutory authority for the continuation in force of the EAR.