Category: Industry Notices

In a memorandum issued on Tuesday, March 20, 2012, OMB directed Federal agencies to consider the cumulative effects of new regulatory requirments and take active steps to avoid them. Sunstein calls on agencies to follow several steps to identify cumulative effects and reduce redundant, overlapping and inconsisten requirements. Among the steps suggested are:

• Early consultation, advance notice, and close engagement with affected stakeholders.
• Use of Requests for Information and Advance Notices of Proposed Rulemaking to gather public input.
• Identification of opportunities to increase the net benefits of regulations and to reduce administrative and other costs, while meeting policy goals and legal requirements.
• Careful consideraion, in the analysis of costs and benefits, of the relationship between new regulations and regulations that are already in effect.

“Where appropriate and feasible, agencies should consider cumulative effects and opportunities for regulatory harmonization as part of their analysis of particular rules, and should carefully assess the appropriate content and timing of rules in light of those effects and opportunities.” Agencies should avoid unintentional burdens that could result from exclusive focus on the most recent regulatory activites and should “select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits.”

The large number of Requests for Information and Advance Notices from NIH, NSF and other agencies heavily vested in funding research is clearly consistent with these guidelines from OMB.

The University of Virginia is set to launch a new platform through which they intend to support a thriving, interdisciplinary collaborative community called OpenGrounds. The underlying tenet of the approach being taken is to provide a catalyst for widespread collaboration, amongst faculty and students, but do so in a way that does not spawn unnecessary permanent centers or establish infrastructure that lasts longer than its original need.

This program, when live, will be aimed at providing a number of resources and forums that will facilitate small and large scale collaboration, but do so in a way that can provide the temporary infrastructure to support such efforts. This is intended to negate the need to establish a new center or program on campus, and therefore reduce the long-term overhead of maintaining such an establishment.

OpenGrounds will be hosting both physical resources, such as meeting spaces and studios, as well as maintaining a list of fellows to act as facilitators for collaborative efforts. The program will also be hosting workshops and providing a platform for individuals to reach out to the surrounding community to increase awareness of an effort or goal and identify new collaborative partners.

While many new initiatives have been undertaken to encourage and transform collaboration, they are often focused on large-scale digital networks or electronic interconnection. The electronic projects being undertaken are important, but it will be exciting to see the developments that a seemingly more locally focused project intended on bringing collaborators physically closer together can bring about.

Registration is open for the 2012 NIH Regional Seminars. Roger Wood, InfoEd Global Sr. Product Manager will be in Indianapolis and Washington, DC for these meetings. If you would like to learn more about InfoEd Global’s Grants and Contracts solutions during one of these meetings, please contact support@infoedglobal.com.

2012 NIH Regional Seminars
April 16-18 Indianapolis, Indiana
June 20-22 Washington, DC

The NIH Regional Seminar involves approximately 35 NIH and HHS staff who are brought to a central location in order to educate, share, and listen to attendees over the course of two days. This seminar is your opportunity to make direct contact with NIH policy officials, grants management, program and review staff, eRA Commons experts, as well as representatives from the Office for Human Research Protections (OHRP), and Office of Research Integrity (ORI). In addition, take advantage of networking opportunities to learn from fellow attendees from around the world.

The seminar and optional eRA workshops are appropriate for grants administrators, new and early stage investigators, researchers, graduate students, and anyone interested in the grants administration process. This year we are offering more networking opportunities than ever before…additional Institute/Center representation with one-on-one meeting opportunities and inclusion of sessions on NIH niche programs such as the AREA/R15 program.

The Office of Management and Budget and Office of Science and Technology Policy issued a policy memorandum to the heads of executive departments and agencies on April 21, 2010, establishing the uniform RPPR for use by agencies supporting research and research-related activities.  The uniform RPPR will replace other interim performance reporting formats used by agencies.

The RPPR was developed by the Research Business Models (RBM) Subcommittee of the Committee on Science, National Science and Technology Council.  The RBM published the proposed draft RPPR format for public comment in the Federal Register November 9, 2007, and the final format on January 13, 2010.  Additional information about this process and the RPPR Final Format are available on the federal-wide RPPR website hosted by the National Science Foundation.

The RPPR will replace:
PHS Non-competing Continuation Progress Report (PHS 2590)
eSNAP module in the eRA Commons
NIH and AHRQ Ruth L. Kirschstein National Research Service Award Individual Fellowship Progress Report for Continuation Support (PHS 416-9)

Pilot testing of the RPPR for NIH awards will begin in late April 2012 with a limited number of institutions, and will include most awards not requiring submission of an annual detailed budget.  NIH anticipates expanding this pilot to all Federal Demonstration Partnership institutions during the summer of 2012.  Full implementation for fellowships and all awards issued under the Streamlined Non-competing Award Process (SNAP) is scheduled for awards made in Calendar Year 2013.  Implementation for complex mechanisms and non-SNAP awards has not been determined and further guidance will be provided at a later date.

NIH will implement the RPPR as a new module in the eRA Commons.  NIH implementation also includes the following PHS agencies that use existing progress reports maintained by NIH:  
Food and Drug Administration (FDA)
Agency for Healthcare Research and Quality (AHRQ)
Centers for Disease Control and Prevention (CDC)

System-to-system submission of the RPPR is anticipated as a future option, however it will not be an option initially. No specific timeframe has been established for S2S submission availability. 

Information and training materials will be available on the NIH RPPR website.

The US Government Accountability Office (GAO) launched a new iPhone/iPad app this week, that links to mobile versions of its reports, congressional testimony, podcasts and videos.

For research administrators who like to keep up with new GAO activity, this app may be just the thing you need. It presents reports and other information in a chronological format and also includes a nice search utility. The app does not utilize notification services to alert users to new postings.

Just when you thought you were getting a handle on National Institutes of Health’s new FCOI policy… The US National Science Foundation (NSF) is soliciting comment on their proposal to carry out a survey to better understand how NSF grantees identify, oversee, and manage financial conflicts of interest in research funded by NSF.  NSF posted the second notice of a 30 day comment period seeking input on their planned survey, specifically on  the necessity, accuracy of their burden estimate, ways to enhance  the survey’s quality , or ways to minimize the burden on respondents.

Today’s Federal Register includes the Advance Notice of Proposed Guidance from the Office of Management and Budget requesting public input on the ideas proposed to make the oversight of Federal funds more effective and efficient, Reform of Federal Policies Relating to Grants and Cooperative Agreements; Cost Principles and Administrative Requirements (Including Single Audit Act). I provided a summary of the points on which comments are solicited in a recent post.

Comments may be submitted electronically via the newly updated Regulations.gov website. You can search by Agency and use “OMB” to find the Notice.

On February 27th, 2012, Elsevier announced its intention to drop support for the controversial “Research Works Act”, intended on limited public access to federally funded research outputs. Only hours afterwards, the bill’s sponsors in the US House of Representatives declared their end of the bill’s support.

Elsevier’s statement indicates that their support for the bill created the perception that they stood against the availability of free and low-cost methods of publishing and sharing of research findings, and that was in violation of the organization’s efforts to assist scientists in expanding the access to their findings.

Some have stated that a scientist based boycott of the company, centered on the website The Cost of Knowledge, was the impetus for the publisher’s move. The site has gained over 7,500 scientists that have committed to boycotting working with Elsevier in some fashion.

However, one can easily point to the now eased ability for the publisher to partner with research funding sources in providing systems of distribution that more widely benefit all parties involved as a good reason for the move. The company has stated that they intend on amending their pricing and access agreements in an effort to play a constructive and collaborative role in bringing the benefits of science to the wider community.

Looking forward, this will certainly not be the last disagreement as access to interoperable technologies and the widespread growth of technically skilled individuals increasingly affects the way in which science is conducted, administered, and reviewed.

In the US today, publishing powerhouse Elsevier changed course and withdrew its support of HR 3699, the Research Works Act, introduced by Reps. Darrell Issa (R-CA) and Carolyn Maloney (D-NY) on Dec. 16th. Elsevier said, “While we continue to oppose government mandates in this area, Elsevier is withdrawing support for the Research Work Act itself.” The Elsevier announcement did not directly refer to the more than 7,500 researchers who have signed The Cost of Knowledge boycott of Elsevier.

Hours later, Reps. Issa and Maloney issued a statement in which they announced that they will not be pursuing further legislative action on HR 3699, according to the Chronicle of Higher Education.

Both Elsevier and Reps. Issa and Maloney referenced open access journals as a bit of a wave of the future. In the UK, the government has recently jumped on the open access band wagon as well, in the Dec. 2011 publication Innovation and Research Strategy for Growth. The Wellcome Trust requires research papers funding in whole or in part with its awards to be deposited with PubMed Central and UK PubMed Central within 6 months. In Australia, the National Health and Medical Research Council (NHMRC) recently announced their support for public access to the results of NHMRC-funded research.

Publication policies of an array of government and foundation funders with respect to open access is documented in Sherpa Juliet, maintained by the SHERPA Partnership, based at the University of Nottingham.

NIH has posted their estimated funding amounts distribution since FY 2008 and projected through FY 2013 here. They have broken the funding down into 233 distinct categories, and include a distinction between ARRA and non-ARRA funding.

It is important to note that the categories are not mutually exclusive, so the same dollar may be counted in more than one category for a particular fiscal year.

This report can be useful to identify trends for a particular area of health research, at least in terms of allocation of funding by NIH. This is particularly true because of the breakout of ARRA related funding, so temporary increases in a particular area can be identified as such. With a relatively granular breakdown, it should be a helpful table of data to take a brief look at.