National Science Foundation Wants Investigators to Use Research.gov Before Mandatory Shift on March 15, 2013
The National Science Foundation (NSF) is asking investigators to "stop submitting new project reports through FastLane," the agency's electronic grants management portal, as of February 1, it said in a "dear colleague" letter issued January 10. "We also urge submission to NSF of any due or overdue project reports prior to this date. Any reports that are prepared in FastLane prior to February 1st, but are not submitted, may need to be re-entered into Research.gov." After March 15, only Research.gov will be available as NSF moves the filing of interim, annual and final reports to the new website. In addition, NSF said, "awardee institutions must use Research.gov to access all online financial services required for grants management." NSF said Research.gov will be an improvement over FastLane, with features such as a "consolidated project reporting dashboard" and "a federal-wide data dictionary to increase the consistency of implementation across federal research agencies."
Sequestration Still Looms; OMB Reminds Agencies to Prepare
Because Congress delayed the cuts called for under sequestration only until March 1, the Office of Management and Budget (OMB) is warning federal agencies they need to be looking for ways to save money -- including among their funding recipients. In a memorandum issued January 14, Jeffrey Zients, OMB deputy director for management, said it was not known if, or how, Congress will act to prevent the reductions, so agencies "must continue to prepare for the possibility that they will need to operate with reduced budgetary resources." Among the suggestions are to " review grants and contracts to determine where cost savings may be achieved in a manner that is consistent with the applicable terms and conditions, remaining mindful of the manner in which individual contracts or grants advance the core mission of the agency," Zients wrote. The Budget Control Act called for $1.2 trillion in cuts and tax increases over a 10-year period, with $600 million to occur in 2013 alone. If sequestration begins March 1, those cuts will be spread out over a 10-month period, rather than a year, and will have an even greater impact on federal programs and expenditures. The House is in session this week, but the Senate does not return until January 22, so no legislation is currently under consideration that would affect sequestration.
Research Compliance Training Modules
Are you new to research? Are you hiring someone new to work in the lab? Is there work with animals or bio-hazards? Have you been frustrated in the past with all the different places you had to go to get training? Then no more frustration! Research compliance training in Human Subjects Training, Responsible Conduct of Research, Conflict of Interest, Occupational Health and Safety, and Animal Care and Use training (basic and species specific) are now in one place. JMU is utilizing the Collaborative Institutional Training Initiative (CITI) website for all of the above training. The Bio-Safety training curriculum is expected to be on-line in early December.
Simply go to http://www.jmu.edu/sponsprog/research_compliance/conducttraining.html and select CITIProgram.org. Follow the instructions to create a profile and answer the questionnaire as to the training you need to complete. The designated training courses will appear in your profile. Completion reports are automatically sent to you and the Office of Research Compliance. They can be accessed at any time and the training is good for three years. The system will automatically notify you by email when retraining is due. If you have questions contact Pat Buennemeyer, Research Compliance, at 568-7025.
When should you notify NIH of a change in an animal activity supported by PHS funds?
All changes in animal activities requires the review and approval of the IACUC, however, keep in mind they may also require approval by NIH. Any significant change or change in scope would require notification to the NIH funding component. As defined by the NIH Grants Policy Statement, a change in scope refers to a change in direction, type of research or training from the objectives, purposes, or aims of the approved work.
Examples includes in the Grants Policy Statement include change in specific aims, shift of research emphasis, substation of animal models, application of a new technology such as changing assay methods. Ultimately, consultation with NIH grants management personnel may need to be sought since not every change in animal model or use represents a change in scope. Please be aware that the IACUC is not responsible for notifying NIH of any changes. The request should be made in writing to the funding component no less than 30 days before the proposed change. The NIH Office of Laboratory Animal Welfare addresses this question at: http://grants.nih.gov/grants/olaw/faqs.htm#b13
When is an Institution Considered to Be Engaged in Research?
The Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP) has clarified in a revision to the frequently asked question regarding "engagement in research." Any institution which receives a direct award from the DHHS to carry out non-exempt human research is automatically considered to be "engaged." This applies even where all activities involving human subjects are carried out by a subcontractor or collaborator. In general, an institution is considered to be engaged in human subject's research when its employees or agents:
- obtain data about living individuals for research purposes through intervention or interaction with them,
- obtain individually identifiable private information for research purposes (45 CFR 46.102(d) (f)) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102; or
- obtain the informed consent of human subjects.
Employees and agents, including students, are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.
In general, simply informing potential subjects about a research study is not considered engagement in research. Also, providing written information about a research study, including how to contact the investigators for information and enrollment, and seeking and obtaining prospective subjects' permission for investigators to contact them are not considered engagement in research. On the other hand, if one is seeking informed consent from a research participant then this activity would be considered engagement in research. For specific details, go to DHHS OHRP's guidance on this topic at: http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html
REMINDER: If the PI of a project is unavailable to conduct research, as when on extended leave, the responsibility to make arrangements for another investigator to assume all responsibilities for the study these modifications must be submitted as a change PI of the project and approved prior to implementation.