Posts Tagged ‘Research’
This month the National Institutes of Health will begin pilot testing the new governmentwide Research Performance Progress Report (RPPR).
Seven institutions will pilot the RPPR for NIH beginning in April 2012. During the initial pilot the RPPR will be used only for progress reports under awards that do not require submission of an annual detailed budget (i.e., awarded under the Streamlined Noncompeting Award Process or SNAP) and for individual fellowships. NIH anticipates expanding the pilot in the summer of 2012 to include all Federal Demonstration Partnership (FDP) institutions.
Grantees will complete the RPPR electronically through the eRA Commons. Although the information that grantees will provide is not significantly different from what is currently reported, the format of the RPPR will be new to NIH grantees. The RPPR will consist of a series of 8 screens where grantees will answer questions using a checkbox, by entering text or uploading a PDF, or selecting “Nothing to Report.”
The timing of full implementation of the NIH RPPR will be determined based upon the success of the initial pilot.
For additional information, visit the NIH RPPR web site.
Federal agencies are asking for your help in finding ways to reduce the administrative burdens and costs associated with cost principles compliance in federally sponsored research projects. Colleges, universities, grants offices, associations, and others involved in research have until July 28 to offer their ideas.
For several years, a federal interagency task force has been looking at 2 CFR 220 (Circular A-21) with respect to its application in federally sponsored research at educational institutions. That task force has gathered preliminary information on areas that could be improved, and is now inviting the public to offer their comments on these issues. Specifically, the task force is seeking input in the following areas:
- effort reporting,
- recovery of direct costs associated with administrative and project management support for investigators,
- institutional eligibility for the Utility Cost Adjustment,
- consistency among agencies that establish governmentwide
- programs with F&A reimbursement at other than governmentwide rates,
- rationalization between agencies of regulations and reporting requirements
- audits of research institutions and awards, and
- definitions of general and research equipment
All comments must be submitted electronically to:
You can read the full request for information here.
The task force plans to produce a summary of the suggestions by September, and will then begin to draft a set of recommendations that it will forward to OMB for review.
The Department of Health and Human Services is planning to overhaul its researcher financial conflict of interest regulations and is inviting public comment on the proposed changes.
Among other things, the changes would expand the scope and coverage of the regulations, amend the definition of “significant financial interest”, expand research institutions’ responsibilities for identifying and managing conflicts of interest, and strengthen the federal government’s oversight roles and responsibilities.
The conflict of interest regulations are intended to help ensure that there is no bias in the design, conduct, or reporting of government-funded research due to financial relationships between researchers and the private sector. But with the growing inter-relationship between academia, government, researchers, and the private sector, HHS said there is a need to revamp the regulations. According to HHS, financial support of biomedical research increased from $37.1 billion in 1994 to $94.3 billion in 2003, and more than half of the funding in 2003 came from industry sources. At the same time, relationships between academic researchers and industry have also increased from 28% in a 1996 survey to 53% in 2007.
You can view the full Federal Register notice by clicking here. The notice includes information on how to submit comments, which are due July 20.
The system created to review and monitor clinical trials involving humans is vulnerable to “unethical manipulation,” and government officials admit they don’t assess whether some parts of the system are adequate or even factual.
In a recent investigation of the Institutional Review Board (IRB) system, the Government Accountability Office (GAO) created a fake company with a fake review board, received approval to test a nonexistent medical device, and falsified documents—all with the approval of federal agencies.
An IRB is an entity formally designated to review and monitor research involving human subjects. IRBs have traditionally been part of large research universities, but private companies have started playing a greater role in creating IRBs to oversee clinical trials. The Department of Health and Human Services’ Office for Human Research Protections and the Food and Drug Administration are responsible for overseeing the IRB system.
In its undercover investigation, GAO created a “bogus” company and IRB. It appeared so real that a private research company contacted the GAO’s IRB about reviewing its surgical procedures. In addition, GAO filed an assurance statement with HHS, promising to protect human subjects. That HHS assurance application, which was approved, would have allowed the fake company to receive HHS research funding. And the last part of the investigation? GAO was able to get approval from an actual IRB to test a fake medical device.
In response to GAO’s investigation, the director of the Office of Human Research Protections said when reviewing assurance applications, HHS does not consider whether the IRBs listed are “adequate” nor does it review applications to determine whether the information is true.
The results of GAO’s investigation were presented recently in testimony before the House Subcommittee on Oversight and Investigations, Committee on Energy and Commerce.
To read the full GAO report, click here.