Compliance News is a recurring compliance communication for the University research community.  Established in March 2004, articles are published through the Research News Online.  Collected and submitted by OAR, Compliance News aligns with OAR's mission to promote compliance awareness in sponsored projects management with the University through assistance, education and communication.

Sources of news items includes: policy changes affecting research compliance, NCURA Research Compliance Newsletter, Chronicle of Higher Education, and all University research compliance offices.

Submissions should be sent to Jennifer Englund.

August 2009

Update on Patent Reform Legislation
Excerpted from the July/August issue of NCURA Magazine

Because of the importance of patents to universities and their role in technology commercialization and economic development, the university associations in Washington led by the Association of American Universities have been heavily involved in Congressional patent reform activities. Over the course of the four-year patent reform process, the associations have raised a number of issues with Congress, some university-specific, other shared by other groups.

Complete article can be found here.

July 2009

Universities Must Disclose More Data on Animal-Research Procedures
Excerpted from The Chronicle of Higher Education, July 3, 2009

Animal-research facilities, including those operated by universities, will now be required to publicly disclose more information about experiments involving animals' pain or distress. The requirement comes out of a court settlement signed Wednesday by the U.S. Department of Agriculture, which oversees such facilities, and the Humane Society of the United States, which had sued the department. The agreement, however, has raised concerns that the information could lead to more violence against scientists by animal-rights extremists.

Complete article can be found here.

June 2009

NIH Encouraged to Increase Conflict of Interest Oversight

Excerpted from The Chronicle of Higher Education, June 11, 2009

The Association of American Universities and the Association of American Medical Colleges submitted a joint letter on Wednesday to the National Institutes of Health suggesting ways to increase federal oversight of conflicts of interest in federally supported research. The recommendations are intended to strike a balance between protecting the integrity of research and maintaining productive partnerships between universities and industry. The groups recommended requiring investigators to report to their institutions all financial interests that are related to their research, either directly or indirectly, regardless of the amount. The groups also suggested that the NIH lower, from $10,000 to $5,000, the threshold at which institutions must report to the agency the external financial interests of their researchers.

Complete article can be found here.

May 2009

NSF to Implement New RCR Requirement

Excerpted from the Arpil/May 2009 issue of NCURA magazine

This article presents an overview of NSF's proposal of Responsible Conduct of Research (RCR) requirements for students and postdoctoral researchers. It states that effective October 1, 2009 any institution who submits funding proposals to NSF "must certify that it has a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students and postdoctoral researchers who will be supported by NSF to conduct research." Read the complete article, on pages 26-27, at http://www.ncura.us/docs/magaprmay09.pdf.

OVPR's RCR program has begun partnering with several key departments and administrative units across the University to better understand the impact of this potential requirement and to plan a flexible, effective, and efficient means to comply with it. If you have any questions or comments on this topic, please contact Carol Foth at fothx001@umn.edu or at 612.624.1854.

April 2009

Professor Awaits Sentencing Over Export-Law Violations
Excerpted from The Chronicle of Higher Education, April 21, 2009

On May 13, John Reece Roth, a retired University of Tennessee professor, is expected to walk into a Knoxville courthouse and be sentenced to at least five years in prison for allowing unauthorized foreign citizens access to classified technology. The chief prosecutor in Mr. Roth's case has openly wished that it would make universities and their professors more careful about how they handle militarily sensitive information. But as Mr. Roth's sentencing approaches, federal authorities are also trying to calm universities by portraying Mr. Roth as a deliberate scofflaw whose prosecution doesn't signal a broad new enforcement drive of complicated federal laws and regulations over who can work with potentially sensitive technology on college campuses.

Article can be read in its entirety http://chronicle.com/daily/2009/04/16330n.htm.

March 2009

New Web Resource Addresses Whistleblowing Issues

Excerpted from the March 2009 Office of Research Integrity newsletter

The University of Alabama has developed a video-driven illustration with lessons illustrating how to anticipate the issues that would arise in a case of possible misconduct and to think ahead about what to do. It has recently been made available on the web for all universities and research centers to use free of charge. See http://www.uab.edu/graduate/rcr/index.html

January 2009

GUIRR Examines International Research Collaborations

Excerpted from the Dec '08/Jan '09 issue of NCURA Magazine.

In October 2008, the Government-University-Industry Research Roundtable (GUIRR) launched a Working Group on International Research Collaborations, which has been designing a work plan to conduct a systematic, practical study of international research collaborations. This group was brought together out of common concern for strengthening international research collaboration and addressing the major issues integral to such collaboration. Nine issues and concerns are discussed, as well as next steps the group will undertake.

December 2008

Levels and Trends: FY 2008 Awards and Proposal Data

Levels and Trends is the annual report of research, training, and public service work performed by the University of Minnesota and funded by external sponsors. The FY08 institutional proposal and award data will be available after December 15, 2008. For more information or questions, contact Mary Bendtsen.

November 2008

ORI Study Finds Deficient Mentoring for Trainees in Misconduct Cases

Excerpted from the September 2008 Office of Research Integrity newsletter

A study, “Mentoring and Research Misconduct: An Analysis of Research Mentoring in Closed ORI Cases,” was reported by David Wright, Sandra Titus, and Jered Cornelison in Science and Engineering Ethics, July 10, 2008. They examined the degree and type of involvement of faculty in ORI cases in which the trainee was found guilty of misconduct. Trainee misconduct accounts for one third of the ORI findings. 

They found that “almost three quarters of the mentors had not reviewed the source data of the trainee and two thirds had not set research standards. These two behaviors are positively correlated.”  The study reviewed ORI case files that were created by institutions in conducting their investigation. Also, ORI oversight added comments to the record in its evaluation of the case.  Hence, these data did not rely on interviews, but on existing records. The authors point out that the value of using unobtrusive measures means that the data are less likely to introduce the social desirability factor that is a problem when conducting interviews. 

A case example from the paper highlighting the lack of review of data: ORI reported on the oversight within the laboratory: There appeared to have been a lack of oversight as evidenced from the selection of raw tracings appropriated for publication. DIO [ORI Division of Investigative Oversight] noted that the coauthors had the opportunity to review a total of six versions of the questioned manuscript; at no time did any one of them observe errors or mistakes in the raw tracings, even though some had far greater experience with the [...] technique [than the trainee]. 

An example of the lack of standards: The Investigation Committee states: There also were concerns about how data on research records were handled in the laboratory; each investigator used his own individual approach to record keeping. ORI noted that the direct oversight and supervision was the responsibility of the laboratory chief.  The authors also found that 18 of the 49 institutional Investigation Committees had begun to ask the same question about the mentors. role in a case of misconduct. Another finding of the study noted that these 18 institutions were also concerned with whether the mentors had failed to train and supervise their students. In addition, the committees often instructed faculty members about remedial actions they needed to undertake. 

One such Investigation Committee recommended: Mentor/PIs should provide a more formal process of initial training for their graduate students as they join a research project. This should include coverage of Institutional Review Board regulations and the responsibility inherent in maintaining the integrity of research. The Board also recommends that [Mentor/PIs] should have more contact.  David Wright, the lead author, said: “These findings do not mean that if mentors pay attention to source data and sets standards that they can totally prevent misconduct in their trainees.  However, the mentors set the tone of the group and provide the social structure and rules on how to conduct trustworthy research. Their involvement can reduce questionable research practices as well as research misconduct. If we are striving to build a culture of integrity, then it is imperative to pay attention to helping mentors and advisors. Most faculty have never received any specific training on being a good mentor or advisor, and I think this is where we need to focus more resources. Institutions need to educate research mentors instead of assuming everyone knows how to be a mentor.”

October 2008

NIH policy change on resubmission applications

NIH announces a change in the existing policy on resubmission (amended) applications.  Beginning with original new applications (i.e., never submitted) and competing renewal applications submitted for the January 25, 2009 due dates and beyond, the NIH will accept only a single amendment to the original application.  Failure to receive funding after two submissions (i.e., the original and the single amendment) will mean that the applicant should substantially re-design the project rather than simply change the application in response to previous reviews.  It is expected that this policy will lead to funding high quality applications earlier, with fewer resubmissions.

For more information, see the NIH announcement.

August 2008

Study Finds Mismatch between Observing and Reporting Suspected Research Misconduct

Excerpted from the June 2008 Office of Research Integrity newsletter

A study of suspected research misconduct conducted by the Gallup organization in collaboration with ORI suggests there is a large discrepancy between the number of incidents of suspected research misconduct observed by researchers and the number of such incidents reported by institutions to ORI.

At press time, the study findings were scheduled to be published in Nature on June 19, 2008, as a commentary by Sandra Titus, Director of Intramural Research, ORI; James Wells, former Study Director, Gallup; and Lawrence Rhoades, former Director, Division of Education and Integrity, ORI. The final report is on the ORI web site.

July 2008

Export Controls--University of Tennessee Prof.  Indicted on 18 Felony Counts for Sharing Non-Public Information with a Post Doc.

John Reece Roth, Professor of Electrical Engineering at University of Tennessee Knoxville, was indicted on April 15, 2008, on 18 counts of violation of export control laws. Most counts involve the "deemed export" rule, under which communication of non-public technical information to a foreign national is "deemed" an export to the national's home country. Among other things, Prof. Roth is alleged to have shared controlled information with a PRC post-doc working in a UT plasma lab, to have personally taken controlled information to China on his laptop, and to have instructed the PRC national to transmit controlled information to another PRC national via email. The controlled information was contained in progress reports, final reports, and grant applications. Prof. Roth is also alleged to have deceived the University of Tennessee and to have violated export control laws after having been fully informed of the requirements. The case involves an SBIR grant for research related to drones, made to a small company of which Prof. Roth was-cofounder. The company also was indicted, and one of its officials has entered into a plea agreement. 

This indictment underscores the importance (a) of adhering to the "fundamental research" exclusion from export controls by assuring there are no formal or informal agreements to restrict publication of research results, and (b) of clearly identifying and strictly controlling any non-public export controlled information that the university receives--and, whenever possible, of declining to accept such information.

Additional information can be found at: DOJ press release re plea and OGC discussion of problem areas and UM practices.

For further information, contact Mark Bohnhorst, Office of the General Counsel at 624-4100 or bohnh002@umn.edu.

June 2008

Federal Agencies Gear Up to Implement Standard Research Terms and Conditions

Excerpted from the June 2008 Federal Grants News for Colleges and Universities.

In January 2008, the federal government issued the core standard research terms

and conditions for research awards, including grants and contracts. The new standard

terms and conditions should result in greater consistency in the administration of federal

research awards.

The policy was effective Jan. 25 and applies to awards made to all institutions. Federal agencies participating in the Federal Demonstration Partnership are required to use the new terms and conditions; other agencies are encouraged to use them as well. Agencies must post their implementation plans no later than July 2008 at the Research Business Models Subcommittee Web site (http://rbm.nih.gov).

At the recent FDP meeting, some of the FDP agencies provided their plans for implementation. The Cooperative Research, Education, and Extension Service announced that it would begin using the new terms and conditions on new research and education extension awards beginning in July; existing awards will continue to use the current terms and conditions. The Air Force Office of Scientific Research stated that it will be implementing the new research terms and conditions on July 1; AFOSR-specific terms and conditions will continue to be used. Other agencies are still formulating their implementation plans.

While the January announcement of the standard terms and conditions requires the agencies to post their plans on the Research Business Models Web site, the NSF will also maintain a comprehensive Web site that will include implementation statements, a statutory matrix of national policy requirements, a subaward matrix, and a prior-approval matrix.

April 2008

Ten Misconduct Findings Result in 7 Debarments
Excerpted from the March 2008 Office of Research Integrity newsletter.

Thirty-five percent of the 28 research misconduct cases closed by the Office of Research Integrity (ORI) in 2007 resulted in research misconduct findings. Seventy percent of the respondents in those cases were debarred from receiving government funding for periods ranging from three years to a lifetime. The ten respondents against whom misconduct findings were made include an associate professor, a surgical resident, two postdocs, three graduate students, a research associate, and two phlebotomists. All ten respondents were prohibited from serving in any advisory capacity to the Public Health Service. Administrative actions imposed on the three respondents who were not debarred include retraction of a published article, data certification, and the submission of a supervisory plan. From 2002-2006, ORI averaged 11 misconduct findings per year. Misconduct was found in 40% of the closed cases. Sixty-six percent of the respondents against whom misconduct findings were made were debarred.

The entire article is available at http://ori.dhhs.gov/publications/documents/Mar08ORINewsletter.pdf.

March 2008

NSF OIG '08 Work Plan Portends More Oversight of Grantees

Excerpted from the February 2008 Federal Grants News for Colleges and Universities newsletter.

Throughout the National Science Foundation Office of Inspector General (NSF OIG) FY '08 Audit Plan, the NSF OIG points out the shortcomings in both NSF's oversight of grantees and of the grantees' grants management systems, particularly in financial management capabilities. To make its case, the plan cites a number of completed audits and concludes that:

NSF must have timely and effective risk assessment; award monitoring and closeout procedures to ensure that awardees are capable of administering NSF funds and that the grant expenditures are valid; accurate, allowable, and consistent with the project's goals and objectives.

To move toward these goals, the NSF OIG lists a series of planned audits in the preaward; active; and postaward phases to assess NSF's progress as well as the compliance level of the NSF grantees. Many of these audits target colleges and universities, and the NSF OIG says that completed audits continue to demonstrate that "NSF grantees, including colleges and universities, vary significantly in their financial management capabilities."

Under the report's preaward section, the NSF OIG says it will continue audits of the terms and conditions of NSF's large facility management agreements to determine their sufficiency and of the foundation's financial and programmatic oversight of its eight center programs. Universities that have large facilities agreements or research centers may experience various forms of increased monitoring from NSF in response to this OIG activity.

Prior Audits Drive New Audit Targets

As support for its audits of active awards, the NSF OIG cites a recent audit that found that over a five-year period approximately 42% of required annual performance reports had not been submitted. The report also draws attention to $62 million in unresolved questioned costs in numerous audit reports, underscoring the need for continued improvement in this area. Because of these findings, the NSF OIG audits will continue to focus on the adequacy of awardees' systems for safeguarding and properly accounting for NSF funds and overall compliance with federal and NSF award requirements. Audits of contractors also are planned to assess compliance with disclosed accounting practices, reasonableness of indirect cost rates, validity of allowable costs, and adequacy of accounting systems to manage NSF funds.

The NSF OIG will continue its labor effort audits at colleges and universities. While not stated in the plan, it is anticipated that approximately 30 grantee institutions will undergo review.

With regard to the closeout administrative policies, the NSF OIG will look at NSF's audit resolution process to determine whether NSF has adequate procedures and has taken effective corrective actions to resolve grantee audit findings and recommendations in both A-133 and OIG audits. The plan cites a 2004 OIG audit that found approximately 61 % of final technical reports were either submitted late or not at all and notes 74 instances of investigators who failed to submit final project reports but still received new NSF funding. The NSF OIG will follow up to see what corrective action NSF has taken to address these specific audit findings.

Previous oversight has come in the form of desk reviews, onsite reviews, audits of new and continuing grants and contracts, and requests for internal audit reports, and grantees should expect continuing compliance and system reviews as well as audits and increased monitoring and enforcement activities.

Link to the plan: www.nsf.gov/oig/fy08_audit_plan.pdf.

January 11, 2008

Levels and Trends: FY 2007 Awards and Proposal Data

Levels and Trends is an annual report of research, training, and public service work performed by the University of Minnesota and funded by external sponsors. For more information or questions, contact Mary Bendtsen at mbendtse@umn.edu or 612.624.0583.