Final NIH Guidelines for Human Stem Cell Research

On March 9, President Obama issued Executive Order (EO)13505 Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The EO states that the Secretary of Health and Human Services, through the Director of the National Institues of Health, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.

On July 6, the NIH published final NIH Guidelines for Human Stem Cell Research, along with the public comments on the draft Guidelines. The Guidelines will be effective on July 7, 2009.

From the July 6 NIH Guide Notice:

The Guidelines will ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. Internal NIH policies and procedures, consistent with the EO and these Guidelines, will govern the conduct of intramural NIH stem cell research.

The Guidelines prescribe the assurances and supporting documentation that must accompany requests for NIH funding for research using hESCs, and describe research that is not eligible for NIH funding. NIH will provide additional guidance concerning the implementation of the Guidelines and the status of pending applications in future Guide Notices.

Ongoing NIH-supported research involving previously approved hESC lines may continue. No new uses of hESC may be initiated in ongoing funded studies unless reviewed and approved by the NIH.

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April 23 Research Advocate article: NIH Issues Implementation Notice and Draft Guidelines for Human Stem Cell Research

Berkeley eProtocol for Human Subjects Research: Required for All Exempt Protocols on July 1

Berkeley eProtocol is a user-friendly, online system for submitting, tracking, reviewing, and approving CPHS human subject research protocols. After a successful pilot testing phase CPHS and OPHS are ready to fully implement this paperless submission process for all exempt level protocol submissions beginning July 1, 2009!

To submit an exempt protocol via Berkeley eProtocol go to: http://cphs.berkeley.edu/content/eprotocolpilot.htm.

Paper-based (hard copy) submissions of exempt applications received on or after July 1, 2009 will be returned to the investigator. OPHS encourages investigators who may be submitting their exempt applications in late June 2009 to use eProtocol instead of paper.

What is Exempt Research?
For information about what it means to qualify as exempt, categories, and examples of exempt research, see the CPHS Guidelines in Exempt Research at: http://cphs.berkeley.edu/content/exempt.htm.

Question and Comments
If you have any questions or comments about the new Berkeley eProtocol system, please contact OPHS Director Rebecca Armstrong at rda@berkeley.edu or OPHS eProtocol project manager Maria Savage at mcsavage@berkeley.edu.

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March 20 Research Advocate article: Berkeley eProtocol for Human Subjects Research Goes Live!

Alert: Many State-Funded Projects may be Cut

The Governor of the State of California has issued Executive Order S-09-09 effective as of this date, June 8, 2009. This order directs all state funds encumbered on or after March 1, 2009, for contracts entered into for which goods or services have not been provided or for contracts proposed to be entered into during the 2008-2009 fiscal year by State agencies and departments, regardless of funding source, to be disencumbered. These funds are to revert to their original funding source with no legal liability to be incurred by the State.

This order does not include projects funded by the American Recovery and Reinvestment Act (ARRA). It also appears to exclude projects funded by bonds and other state-supported projects meeting certain funding criteria, but the full scope and application of the Governor’s order are unclear at this time. The Sponsored Projects Office therefore encourages all campus units with state-supported sponsored projects to immediately cease encumbering funds and to inform all subcontractors to do the same.

SPO is seeking additional guidance from the UC Office of the President and will provide the campus community with additional information as it becomes available.

Direct Charging Administrative Support Costs on ARRA Projects

UCOP has issued C&G Guidance Memo 09-02 indicating that the OMB has told the Council on Governmental Relations (COGR) that administrative support charges on ARRA proposal budgets will not be allowed strictly on the basis that the project is ARRA funded. UCOP is in the process of updating our C&G Guidance Memo web site to reflect this outcome.

COGR’s PRELIMINARY understanding is that for NIH applications that included a direct charge for ARRA Specialist salaries, each IC will have discretion in determining if the amount awarded needs to be reduced. For example, in the case of NIH Challenge Grants that are limited to total costs of $500,000 per year, the presumption is that if ARRA Specialist salary costs had not been requested, then other costs could have been justified. Therefore, awarding the full $500,000 would be appropriate, with re-budgeting of the ARRA Specialist salary costs to other allowable direct costs. Submission of a revised budget would not be necessary.

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April 10 Research Advocate article: Direct Charging Departmental Administrative Support Costs to ARRA Projects

New NIH Business Process for Documenting Changes in Scope for Proposed Research Projects

The National Institutes of Health has announced a new process for submitting revised Project Summary/Abstracts, Specific Aims, and/or Public Health Relevance Statements when changing the scope of proposed research projects. For example, NIH grant applications may require reductions in scope in order to be accomplished in the two years or less required by the Recovery Act.

Procedure

When requested by NIH, principal investigators and applicant organization officials should discuss potential changes in scope with NIH program officials, then revise sections of the application as appropriate. Applicants should email the final version of the revised sections to a designated email address as a single attached Microsoft Word or Adobe PDF file. (NIH reminds applicants that all revised application information submitted to the NIH must be approved by an Authorized Organizational Representative.)

The Word or PDF document must include three headings, listed below, even if a particular section had no changes from the previous submission. If there are no changes for a section, the header should be included in the document but the text area should be left blank. This will ensure appropriate processing by electronic systems at NIH. The May 5 NIH Guide Notice includes links to Word and PDF templates that include these headings.

Document Headings

1. Modified Project Summary/Abstract Section
Provide a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a scientifically or technically literate lay reader. This abstract must not include any proprietary or confidential information. This section must be no longer than 30 lines of text.

2. Modified Specific Aims Section
List the broad, long-term objectives and the goal of the specific research proposed, for example, to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology. One page is recommended.

3. Modified Public Health Relevance Section
Using no more than two or three sentences, describe the relevance of this research to public health. In this section, be succinct and use plain language that can be understood by a general, lay audience.

NIH Issues Implementation Notice and Draft Guidelines for Human Stem Cell Research

On March 9, 2009, President Barack Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells authorizing the Secretary of Health and Human Services, through the Director of the National Institutes of Health, to support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.

The April 17 NIH Guide includes a Notice on Implementation of Executive Order on Removing Barriers to Responsible Scientific Research Involving Human Stem Cells.

This NIH Guide Notice links to Draft National Institutes of Health Guidelines for Human Stem Cell Research. The draft guidelines were published in the April 23 Federal Register; comments must be received by NIH on or before May 26, 2009. NIH plans to issue final Guidelines within the 120 day limit set by the President.

The Notice provides the following implementation guidance:

• Ongoing NIH-supported research: Pending issuance of new Guidelines, all ongoing NIH-funded research involving approved uses for human stem cells, including human embryonic stem cells, may continue. However, until the Guidelines are issued in final, no new uses of human embryonic stem cells may be initiated in NIH funded studies unless previously reviewed and approved by the NIH for the ongoing supported research projects. Further, NIH will not consider requests for either administrative supplements or revisions to any grants that include costs for, or involve the study of, human embryonic stem cells until the Guidelines are finalized.
  
  
• Peer reviewed competing applications: Pending issuance of new Guidelines, any applications previously submitted to the NIH and already reviewed, which propose to use human embryonic stem cells, will be held for funding decisions until the final Guidelines are issued. At that time, highly ranked applications can be modified, as necessary, to comply with the Guidelines, to receive full consideration for funding.
  
  
• Competing applications pending submission and/or peer review: NIH will accept applications for research proposing to use human embryonic stem cells during the period of Guidelines development, but the review and funding of these applications will be deferred until NIH issues final Guidelines. Such applications should identify illustrative cells for the purposes of the research plan. Once the Guidelines have been issued in final, applicants will have the opportunity to revise their application as necessary to comply with the Guidelines, including utilization of eligible cells. These modified applications will then be peer reviewed and considered for funding.

Direct Charging Departmental Administrative Support Costs to ARRA Projects

Due to the extensive reporting requirements for ARRA-funded projects the UCOP Manager, Costing Policy and Analysis and the Research Administration Office has recommended that ARRA projects be considered “Major Projects” and that departmental administrative support costs be charged to sponsored projects supported by Recovery Act funds (Memo Operating Guidance No. 09-02 dated April 8, 2009).

The COGR Board also has issued a statement that it is reasonable for institutions to include direct salary charges for administrative and clerical salaries in ARRA grant applications. According to COGR the inclusion of such costs as a direct charge will not jeopardize the application from being selected for funding.

In response, SPO recommends the following if you are planning to charge departmental administrative/clerical salaries to your ARRA funded project:

1. The project budget should include salary support for specific administrative and/or clerical personnel needed to comply with ARRA requirements.

2. The amount budgeted for administrative and/or clerical personnel salaries should be based on an estimate of the percentage of time each of these staff members will directly devote to ARRA responsibilities. COGR is recommending a 5% to 10% level of effort.

3. The proposal budget justification should include a rationale for requesting departmental administrative support costs in the form of administrative and/or clerical salaries. Here is sample language recommended by COGR:

Due to the extraordinary administrative oversight and reporting activities associated with awards made under the American Recovery and Reinvestment Act, this proposal includes (insert appropriate percentage of effort) salary support for the additional administrative services required by the Act should an award be issued. Regulatory support for this request is located at OMB Circular A-21 F.6. a. (2.), which states: “Direct charging of salaries of administrative and clerical staff costs may be appropriate where administrative or clerical services required by the project are significantly greater than the routine level of such services provided by academic departments.”

4. Here is an alternative version:

Due to the extraordinary administrative oversight and reporting activities associated with awards made under the American Recovery and Reinvestment Act, this proposal includes a request for ___ positions @ ___% time or ___ FTE to support the data collection and reporting requirements specified by the terms of the Recovery Act. The administrative responsibilities and clerical duties of these personnel will support the collection, organization, interpretation and/or reporting of the required ARRA data elements including funding received and expended, completion status of project, jobs created or retained, infrastructure investment impact, and information on subrecipients and subrecipient funding.

UCRP Benefit Charge

In their September 2008 Meeting, the UC Regents approved resumption of employer contributions to the UC Retirement Plan, effective July 1, 2009. During their February 2009 meeting, the UC Regents voted to delay the resumption of contributions to mid-April 2010 because of the difficult budget situation. However, UCB Human Resources is now recommending that this expense begin to be considered when preparing contract and grant budget proposals for upcoming projects. The initial recommended amount to budget is 4% of eligible employee salary. As more information about the employer contribution rate becomes available, this information will be updated. It is expected that over time the 4% employer contribution amount will increase. This information is provided for planning purposes and is subject to change. In general, this applies to:

• Career staff employees (appointment of 50% or greater)
• Academic appointees (appointment of 50% or greater)

It does not apply to:

• Visiting academic appointees
• Staff on limited appointment (less than 1,000 hours in a 12-month period)
• Appointees whose primary purpose is education or training (GSRs, post-docs, fellows)

For more specific information on eligibility for membership in UCRP, refer to the UCRP Summary Plan Description available at: http://atyourservice.ucop.edu/forms_pubs/spd/ucrpspdwss.pdf

To maintain consistency with university accounting practices this cost should be added to the existing benefit rate for the appropriate personnel classification. In addition, a sentence (sample below) should be included in the budget justification.

Sample: These rates include an estimated increase of 4% for restarting the employer paid contribution to the University of California Retirement Program (UCRP), effective July 1, 2009, for eligible employees and is applicable to all university fund sources.

Estimating Jobs Created/Retained for ARRA Proposals

As we move forward with proposals for ARRA funds, there will be a need to “estimate” the number of jobs created and the number of jobs retained.

Here are the criteria for making these estimates at the proposal stage:

1. Any position not already in existence (including positions for Graduate Student Researchers) for which ARRA funding support is being requested should be counted as a “job created.”
2. Any position already in existence (including positions held by Graduate Student Researchers) that is currently funded by grants/contracts (soft) funds should be counted as a “job retained” if ARRA funding support is being requested for this position.
3. Any position already in existence that is funded by university (hard-continuing) funds should not be counted as a “job created” or a “job retained” even if ARRA funding support is being requested for this position.

Note: All positions (created or retained) should be expressed as FTE’s. A position may be either a “job created” OR a “job retained;” it cannot be both.

NIH ARRA Updates

Funding of Previously Submitted Applications

In general, existing applications eligible for consideration of 2-year funding under the ARRA are defined as applications submitted for funding with FY 2008 or FY 2009 funds that: (a) received meritorious priority scores from the initial peer review process; (b) received approval from an Advisory Council or Board prior to September 30, 2009; and (c) received priority scores that could not otherwise be paid in FY 2008 or 2009.

This policy includes consideration of applications in response to previously announced funding opportunities (e.g., RFAs, PAs, PARs), including those that will be peer reviewed by mid-summer and scheduled to receive Advisory Council or Board review prior to September 30, 2009.

NIH program directors will contact applicant project directors/principal investigators (PD/PIs) about applications under consideration to discuss potential modifications of the Abstract, Specific Aims, Public Health Relevance, and budget.

NIH Guide Recovery Act Notice: NIH ARRA Funding Considerations for Applications with Meritorious Scores that Fall Beyond the Pay-line

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Budgeting for Competitive Revisions and Administrative Supplements (T-3s)

Funding for competitive revisions and administrative supplements may be made in excess of programmatic cost limitations or ceilings associated with a program or activity code (e.g., direct costs stipulated for Small Research Grants [R03], Exploratory/Developmental Grants [R21]).

If a project was previously funded under a program or activity code with budget limitations or ceilings, these limitations or ceilings are not applicable to ARRA competitive revision and/or administrative supplement requests. Note: All budget requests must be commensurate with the scope of the programmatic request and will be subject to a cost analysis prior to award. In addition, budgets submitted in competing revisions will be subject to the peer review.

For electronic submissions, budget requests for competitive revisions equal to or less than $250,000 direct costs per year must still use a modular budget component; requests over $250,000 direct costs per year must use the detailed budget component. (For paper PHS 398 applications (e.g., P01), a detailed budget is always required.)

Please note the flexibility to switch from a modular to a detailed budget is only available for those Funding Opportunity Announcements (FOAs) where both the detailed budget and modular budget components are part of the application package.

For FOAs where only the modular budget component is available (e.g., SC1, SC2, SC3) competitive revisions will be submitted using the modular format for no more than $250,000 direct costs per year.

PIs should be aware that they will receive a validation warning when submitting a competitive revision through Grants.gov if the parent application was submitted using a modular budget and they are now submitting a detailed budget. The warning will read: “The parent grant for this revision uses the modular format; in most cases, this application must be submitted with a modular budget. If the budget caps permitted by the FOA exceed the modular limit of $250k, the application must be submitted with a detailed budget”. Please disregard this warning. It will not affect submission of the application through Grants.gov.

NIH Guide ARRA Administrative Supplements and Competitive Revisions: Clarifications on Programmatic Limitations and use of Modular Budgets

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ARRA Awards: Selected Terms and Conditions for T-3s

ARRA Administrative Supplements and Competitive Revisions (T-3s) issued in FY2009 may have budget/project periods up to 24 months. ARRA T-3s issued in FY2010 will be limited to no more than a 12-month budget/project period.

Rebudgeting between ARRA and non-ARRA funds is prohibited. Institutions must establish separate accounts for ARRA and non-ARRA funding.

Carryover of any unobligated ARRA funding at the end of the supplement period into the parent grant is prohibited.

The ARRA T-3s will be eligible for a one-time no-cost extension (up to 12 months) of the ARRA project period. This extension is allowable regardless of the status of the parent grant and will not impact the continued funding of the parent grant. Additional extensions beyond the initial one; i.e., those requiring NIH prior approval, will be rare.

ARRA funds provided under this award are not available for rebudgeting or carryover into the parent grant. Any ARRA funding remaining at the end of the funding period for this award must be reported as an unobligated balance.

When an FY2009 ARRA award includes a commitment for FY2010, automatic carryover authority will apply consistent with NIH’s traditional application of that authority.

There is no ability to carryover unobligated funds from a budget period funded with regular IC appropriation funds into a budget period funded with ARRA. Nor is there any ability to carryover unobligated funds from an ARRA-funded budget period into a budget period funded with regular IC appropriation funds.

No carryover is available between any of the ARRA segments and the segments funded with regular IC appropriation.

NIH Guide Recovery Act of 2009: NIH Award Terms and Additional Information for Recipients Receiving Recovery Act Grant Funding

National Academies Issues Revised Guide to Responsible Conduct in Research

The National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine have released the third edition of On Being a Scientist: A Guide to Responsible Conduct in Research. The book is available free online, or may be purchased as a PDF download or in paperback.

From the online description:

On Being a Scientist was designed to supplement the informal lessons in ethics provided by research supervisors and mentors. The book describes the ethical foundations of scientific practices and some of the personal and professional issues that researchers encounter in their work. It applies to all forms of research--whether in academic, industrial, or governmental settings-and to all scientific disciplines.

On Being a Scientist is aimed primarily at graduate students and beginning researchers, but its lessons apply to all scientists at all stages of their scientific careers.

Berkeley eProtocol for Human Subjects Research Goes Live!

Berkeley eProtocol is a user-friendly, online system for submitting, tracking, reviewing, and approving OPHS/CPHS human research protocols. Berkeley eProtocol will replace the current paper-based process, starting with exempt and expanding to expedited and full Committee applications as it is rolled out over the coming months.

Exempt Protocol Pilot of eProtocol

Currently, eProtocol is available for the submission of exempt protocols only. The purpose of the eProtocol exempt protocol pilot is to ensure that the system is running smoothly before opening it up to all submissions. Exempt applications submitted via Berkeley eProtocol will be given priority in the OPHS review process.

If you are submitting an exempt protocol and want to participate in this Berkeley eProtocol pilot, go to: http://cphs.berkeley.edu/content/eprotocolpilot.htm.

What is Exempt Research?

For information about what it means to qualify as exempt, categories, and examples of exempt research, see the CPHS Guidelines in Exempt Research at: http://cphs.berkeley.edu/content/exempt.htm.

Question and Comments

If you have any questions or comments about the new Berkeley eProtocol system, please contact OPHS Director Rebecca Armstrong at rda@berkeley.edu or OPHS eProtocol project manager Maria Savage at mcsavage@berkeley.edu.

Internal Deadlines for NIH Challenge Grants

The NIH Challenge Grant in Health and Science Research Program is a new initiative which will provide funding for approximately 200 or more two-year jump-start grants to support research that addresses specific scientific and health research challenges in biomedical and behavioral research. Challenge Areas and Topics, defined by the NIH, focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. Research in these areas should have a high impact in biomedical or behavioral science and/or public health. For more information go to: http://grants.nih.gov/grants/funding/challenge_award/#topics.

SPO anticipates a large volume of grant applications in response to this program. To ensure the successful submission of these applications, we are asking researchers to follow the following steps in submitting NIH Challenge Grant applications:

1. By Thursday, March 26th: Send a brief statement of your intent to apply to spoawards@berkeley.edu. No details about your project are required at this stage, but your statement will help us determine how many NIH Challenge Grant proposals to expect.

2. By Monday, April 20th at 5 p.m. submit an electronic and hard copy of your Grants.gov proposal including a signed Proposal Review Form and other required documents to SPO for review. The electronic copy should be submitted via the SPO Drop Box not as an email attachment: https://coeus.berkeley.edu/dropbox/. Submitting by this date will ensure you are submitting at least five days prior to the NIH deadline and in compliance with the VCRO’s “on-time” internal proposal submission policy.

3. If you anticipate that you will need to submit your proposal to SPO after the five day internal proposal deadline, follow the procedure for seeking an exception described on the SPO web site: http://spo.berkeley.edu/procedures/submission.html.

For more updated news on the American Recovery and Reinvestment Act of 2009, please see http://spo.berkeley.edu/Procedures/recovery.html on the SPO web site.

President Lifts Restrictions on Stem Cell Research

On March 9, 2009, President Barack Obama signed an Executive Order (EO) “Removing Barriers to Responsible Scientific Research Using Human Stem Cells that lifts the ban on federal funding for embryonic stem cell research.

The EO states that:

“The purpose of this order is to remove these limitations on scientific inquiry, to expand NIH support for the exploration of human stem cell research, and in so doing to enhance the contribution of America's scientists to important new discoveries and new therapies for the benefit of humankind.”

The EO directs the National Institues of Health to “review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and issue new NIH guidance” within 120 days.

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Also on March 9, the President issued a Presidential Memorandum for the Heads of Executive Departments and Agencies assigning to the Director of the Office of Science and Technology Policy “the responsibility for ensuring the highest level of integrity in all aspects of the executive branch’s involvement with scientific and technological processes.” The OSTP Director, working with heads of of executive departments and agencies, is to develop, within 120 days, recommendations for Presidential action designed to guarantee scientific integrity throughout the executive branch.

Grants.gov Submission Problems

The Grants.gov system used to submit proposals to the federal funding agencies is experiencing problems that threaten the timely submission of UC Berkeley grant applications. These problems also are affecting the submission of proposals from other universities across the country and appear to relate to the Grant.gov server’s inability to effectively process the large number of proposal submissions being submitted at the same time. Issues related to the conversion to Adobe Acrobat proposal preparation software also are creating difficulties. In some cases proposals are not making it to the target agency in time to be accepted and reviewed.

In response, the Sponsored Projects Office has decided to allow our research administrators to submit proposals after office hours to enhance the chances of a proposal making it through the Grants.gov pipeline without incident. The UC Berkeley community can assist SPO with this challenge by taking steps to submit proposals in final form by the required internal proposal deadline. Late proposals run the risk of being caught in a Grants.gov bottleneck that the funding agency may or may not recognize and accommodate.