The National Institutes of Health has announced publication of the revised NIH Grants Policy Statement (NIHGPS, rev. 10/1/2013), applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2013.
The revision does not introduce any new material, but “incorporates new and modified requirements, clarifies certain policies, and implements changes in statutes, regulations, and policies that have been implemented through appropriate legal and/or policy processes since the previous version of the NIHGPS dated 10/1/2012.” NIH has provided a summary of significant changes in the revision.
October 23, 2013
RAC Offices to Close During the Annual Campus Winter Break
The Office for Animal Care and Use, the Conflict of Interest Committee Office, the Office for the Protection of Human Subjects, the Sponsored Projects Office, and the Research Administration and Compliance Office will be closed during the campus energy curtailment beginning Tuesday, December 24, 2013 until Thursday, January 2, 2014. Offices will reopen on Thursday, January 2, 2014. Please note that limited staff and service will be available on Monday, December 23, 2013 and potentially on January 2 and 3, 2014.
The RAC offices will also be closed for the afternoon, beginning at 12 noon, on Friday, December 20, 2013.
SPO Proposal Submission
SPO will process proposals due in December 2013 and January 2014 according to the VCR’s five-day proposal submission policy with the following exceptions:
*Note: Proposals submitted to SPO with a draft technical section on or before the five business day deadline will be considered “on time” if the proposal is complete in all other respects.
Principal Investigators also are encouraged to inform their SPO Research Analyst if they will be submitting a proposal with a due date just prior to, during, or just after the curtailment period. This will give SPO and the PI an opportunity to discuss the best way to handle the proposal to make sure it is submitted in a timely manner.
COI Disclosure Submission
In order to be on the agenda for any meeting, complete disclosure packets must be received no later than 10 working days prior to the date of the meeting.
Please note that all protocols and protocol revisions must be submitted via email to acuc@berkeley.edu by 5 pm on the deadline date. If you wish to make changes to an approved protocol, you must first contact the Office for Animal Care and Use (OACU) to obtain a copy of the current approved version of your protocol. Failure to do so may result in your protocol being returned to you.
Important: if your study is “greater than minimal risk” needing full board review and the approval will expire before January 24, 2014, you must submit your renewal application in time for review at a December 2013 CPHS meeting.
The RAC offices will also be closed for the afternoon, beginning at 12 noon, on Friday, December 20, 2013.
SPO Proposal Submission
SPO will process proposals due in December 2013 and January 2014 according to the VCR’s five-day proposal submission policy with the following exceptions:
| Deadlines | Due to SPO* |
|---|---|
| From Tuesday, December 24, 2013 through Thursday, January 2, 2014 | Noon on Tuesday, December 17, 2013 |
| Friday, January 3, 2014 | Noon on Wednesday, December 18, 2013 |
| Monday, January 6, 2014 | Noon on Thursday, December 19, 2013 |
| Tuesday, January 7, 2014 | 8 am on Thursday, January 2, 2014 |
*Note: Proposals submitted to SPO with a draft technical section on or before the five business day deadline will be considered “on time” if the proposal is complete in all other respects.
Principal Investigators also are encouraged to inform their SPO Research Analyst if they will be submitting a proposal with a due date just prior to, during, or just after the curtailment period. This will give SPO and the PI an opportunity to discuss the best way to handle the proposal to make sure it is submitted in a timely manner.
COI Disclosure Submission
In order to be on the agenda for any meeting, complete disclosure packets must be received no later than 10 working days prior to the date of the meeting.
- The deadline for submission for the December 19, 2013 meeting is December 5, 2013.
Please note that all protocols and protocol revisions must be submitted via email to acuc@berkeley.edu by 5 pm on the deadline date. If you wish to make changes to an approved protocol, you must first contact the Office for Animal Care and Use (OACU) to obtain a copy of the current approved version of your protocol. Failure to do so may result in your protocol being returned to you.
- The deadline for full committee review of protocol submissions for the January 15, 2014 meeting is Monday, November 18, 2013.
- Likewise, the deadline for protocol submission for the February 12, 2014 meeting is noon on December 20, 2013.
Important: if your study is “greater than minimal risk” needing full board review and the approval will expire before January 24, 2014, you must submit your renewal application in time for review at a December 2013 CPHS meeting.
- The deadline for protocol submission for the December 6, 2013 CPHS-1 meeting is Monday, November 4, 2013.
- The deadline for protocol submission for the December 13, 2013 CPHS-2 meeting is Tuesday, November 12, 2013.
- There is no CPHS-1 meeting in January 2014.
- The deadline for protocol submission for the January 24, 2014 CPHS-2 meeting is Monday, December 16, 2013.
- The deadline for protocol submission for the February 7, 2014 CPHS-1 meeting is Monday, January 6, 2014.
October 17, 2013
Federal Government Reopens
On October 17, 2013, the President signed into law H.R. 2775, the Continuing Appropriations Act, 2014, providing fiscal year 2014 appropriations for the federal government through January 15, 2014, ending the 2013 federal shutdown. The effective time for the continuing resolution begins on October 1, 2013.
Federal agencies are providing procedures for resumption of business, including updates on proposal submission deadlines and funding for pending awards.
See Impact of Federal Shutdown on Sponsored Projects on the SPO web site for the guidance received from these federal agencies. SPO will continue to update this page as more information is provided.
September 30, 2013 Research Advocate: Federal Government Shutdown: Lapse in Federal Appropriations
Federal agencies are providing procedures for resumption of business, including updates on proposal submission deadlines and funding for pending awards.
See Impact of Federal Shutdown on Sponsored Projects on the SPO web site for the guidance received from these federal agencies. SPO will continue to update this page as more information is provided.
September 30, 2013 Research Advocate: Federal Government Shutdown: Lapse in Federal Appropriations
October 08, 2013
Implementation of New USDA NIFA RCR Requirement
The U.S. Department of Agriculture National Institute of Food and Agriculture now has a requirement for responsible conduct of research training for grantees, published in the USDA NIFA Research Terms and Conditions. UC Berkeley implementation of the new requirement is available on the Required Responsible Conduct of Research (RCR) Training on the Research Administration and Compliance web site.
The responsible and ethical conduct of research (RCR) is critical for excellence, as well as public trust, in science and engineering. Consequently, education in RCR is considered essential in the preparation of future scientists. By accepting a NIFA award the grantee assures that program directors, faculty, undergraduate students, graduate students, postdoctoral researchers, and any staff participating in the research project receive appropriate training and oversight in the responsible and ethical conduct of research and that documentation of such training will be maintained. Grantees are advised that the documentation of the training are subject to NIFA review upon request.
Note that the training referred to may be either on-campus or off-campus training. The general content of the ethics training, at a minimum, will emphasize three key areas of research ethics: authorship and plagiarism, data and research integration, and reporting misconduct. Each institution will be responsible for developing its own training system, as schools will need flexibility to develop training tailored to their specific student needs. UC Berkeley has membership in the Collaborative Institutional Training Initiative (CITI) program for RCR. Research project staff should choose the most appropriate RCR online modules to complete or attend one of the face-to-face training courses offered by University Extension or the Office of the Vice Chancellor for Research as described on the campus RCR Training page under NIH RCR training options.
The responsible and ethical conduct of research (RCR) is critical for excellence, as well as public trust, in science and engineering. Consequently, education in RCR is considered essential in the preparation of future scientists. By accepting a NIFA award the grantee assures that program directors, faculty, undergraduate students, graduate students, postdoctoral researchers, and any staff participating in the research project receive appropriate training and oversight in the responsible and ethical conduct of research and that documentation of such training will be maintained. Grantees are advised that the documentation of the training are subject to NIFA review upon request.
Note that the training referred to may be either on-campus or off-campus training. The general content of the ethics training, at a minimum, will emphasize three key areas of research ethics: authorship and plagiarism, data and research integration, and reporting misconduct. Each institution will be responsible for developing its own training system, as schools will need flexibility to develop training tailored to their specific student needs. UC Berkeley has membership in the Collaborative Institutional Training Initiative (CITI) program for RCR. Research project staff should choose the most appropriate RCR online modules to complete or attend one of the face-to-face training courses offered by University Extension or the Office of the Vice Chancellor for Research as described on the campus RCR Training page under NIH RCR training options.
2013 Sponsored Projects Annual Report Published
The Sponsored Projects Annual Report, Fiscal Year 2013 is now available on the SPO web site. The report provides information on campus proposals and awards during the past year; in the fiscal year ending June 30, 2013, the Berkeley campus received $709.9 million in contract and grant awards.
October 01, 2013
CPHS Develops Two Guidance Documents for Undergraduate-Initiated Research Activities
The Committee for Protection of Human Subjects (CPHS) and the Office for the Protection of Human Subjects (OPHS) have developed two documents to help guide undergraduate-initiated research activities (UIRA).
These documents are on the CPHS/OPHS web site under CPHS Guidelines. The first document, Ethical Issues in Undergraduate Research Activities with Human Participants, walks undergraduate researchers through important ethical considerations that arise in human subjects research: designing the research to minimize risks to participants, creating an environment where participants are informed and are free from coercion, and providing protection for individuals who are members of a vulnerable group.
The second document, Guidance on Designing Undergraduate-Initiated Research Activities, is a practical step-by-step document on how undergraduates should select their population, recruit subjects without undue influence, obtain informed consent, minimize risk, and keep data confidential.
Please note that undergraduate students may also reference the Student Investigators Guide on the CPHS/OPHS web site. For further guidance contact the OPHS Analyst of the Day at (510) 642-7461 or email ophs@berkeley.edu.
These documents are on the CPHS/OPHS web site under CPHS Guidelines. The first document, Ethical Issues in Undergraduate Research Activities with Human Participants, walks undergraduate researchers through important ethical considerations that arise in human subjects research: designing the research to minimize risks to participants, creating an environment where participants are informed and are free from coercion, and providing protection for individuals who are members of a vulnerable group.
The second document, Guidance on Designing Undergraduate-Initiated Research Activities, is a practical step-by-step document on how undergraduates should select their population, recruit subjects without undue influence, obtain informed consent, minimize risk, and keep data confidential.
Please note that undergraduate students may also reference the Student Investigators Guide on the CPHS/OPHS web site. For further guidance contact the OPHS Analyst of the Day at (510) 642-7461 or email ophs@berkeley.edu.
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