Non-Profit and Academic Institution Grants Administration Policy

Preface

This grants administration policy, serves as the terms and conditions of research grants and contracts awarded by the California Institute for Regenerative Medicine (CIRM). In addition, it provides guidance to applicants, Grantees and Recipients on their responsibilities as CIRM Grantees. Principal investigators, program directors, and organizational officials with grants management responsibilities are urged to read this document carefully and to refer to relevant sections for answers to questions that arise concerning the administration of CIRM grants. Applicants Grantees and Recipients may be required to document compliance with any and all provisions set forth in this policy.

This policy applies to all CIRM applicants, Grantees and Recipients who receive CIRM funding through an Award to an academic or non-profit institution. By accepting CIRM funding, the Grantee and Recipients agree to comply with the provisions set forth in this policy.

This policy may be amended or revised periodically. Any new or amended regulations adopted by the Independent Citizens’ Oversight Committee (ICOC), the governing board of CIRM, will be applied to currently active awards on the start date of the next Budget Period except as provided in the relevant CIRM Intellectual Property Regulations. CIRM will notify principal investigators, program directors and organizational officials with active CIRM grants of amendments to or revisions of this policy as they are released. Amendments or revisions will be posted on the CIRM website (https://www.cirm.ca.gov).

CIRM’s right to enforce this policy shall survive the end of the term of the Project Period, and should CIRM no longer exist, those rights may be enforced by the State of California.

GENERAL INFORMATION
GRANT APPLICATION AND REVIEW PROCESS
PRE-AWARD AND AWARD
AWARD ACCEPTANCE
PAYMENT AND USE OF FUNDS
SPECIAL POLICIES FOR TRAINING GRANTS

GENERAL INFORMATION
1. CIRM Background and Mission
2. Abbreviations
  - CFR – Code of Federal Regulations
  - CIRM – California Institute for Regenerative Medicine
  - DHHS – U.S. Department of Health and Human Services
  - FDA – U.S. Food and Drug Administration
  - FWA – Federal-Wide Assurance
  - GMO – Grants Management Officer
  - IACUC – Institutional Animal Care and Use Committee
  - ICOC – Independent Citizens’ Oversight Committee
  - IDE – Investigational Device Exception
  - IND – Investigational New Drug
  - IRB – Institutional Review Board
  - NGA – Notice of Grant Award
  - NIH – U. S. National Institutes of Health
  - OHRP – Office for Human Research Protections, DHHS
  - PD – Program Director
  - PHS – Public Health Service, DHHS
  - PI – Principal Investigator
  - RFA – Request for Applications
  - SCRO – Stem Cell Research Oversight Committee
  - GWG – Scientific and Medical Research Funding Working Group
  - SPO – Scientific Program Officer SRO – Scientific Review Officer
3. Defined Terms
4. Types of Support
5. Roles and Responsibilities
GRANT APPLICATION AND REVIEW PROCESS
1. Eligibility
  1. PI and PD Eligibility
  2. Organizational Eligibility
  3. Other Requirements
2. Application Submission
3. Legal Effect of Signed/Submitted Application
4. Application Review
5. Criteria for Review of Research Grant Applications
6. Appeals of Scientific Review
7. Approval for Funding
8. Policy on Collection and Use of Personal Information
9. Public Access to Public Records

PRE-AWARD AND AWARD

Pre-Funding Administrative Review (PFAR)

Applications approved for funding by the ICOC are then reviewed by the GMO and SPO to ensure that they meet all applicable CIRM funding requirements, including the submission of required public policy assurances. CIRM reviews the Application budget to ensure that all proposed costs are allowable, as specified in this Grants Administration Policy and the pertinent RFA. During the administrative review CIRM reserves the right to revise individual budget items as appropriate.

Issues that arise during administrative review generally must be resolved before CIRM will issue an NGA. CIRM may, however approve an Application for funding contingent upon the acceptance (by the PI and AOO or AEO) of a condition.

Liability

CIRM is not responsible for the conduct of CIRM-funded research or for the acts or omissions of Recipients of CIRM funding, because such conduct is the Grantee as both are under the direction and control of the Grantee and subject to its organizational policies. Further, Grantee organization personnel compensated in whole or in part with CIRM funds are not considered employees of CIRM.

Grantees shall indemnify or insure and hold CIRM harmless against any and all losses, claims, damages, expenses, or liabilities, including attorneys’ fees, arising from research conducted by the Grantee pursuant to the award, and/or, in the alternative, Grantees shall name CIRM as an additional insured and submit proof of such insurance. (Health and Safety Code section 125290.45, subd. (a)(2).). If the Grantee chooses only to insure, such insurance must provide coverage in amounts appropriate and proportional to cover the risks described in the previous sentence. Grantees that fail to provide evidence of such insurance prior to issuance of the NGA will on execution of the NGA be deemed to have agreed to indemnify and hold CIRM harmless.

In all cases, the Grantee will maintain, or cause to be maintained, in full force and effect, insurance or a self-insurance program that provides for general liability coverage that is (a) applicable to the CIRM-funded research, (b) in an amount not less than $1 million per occurrence, $3 million aggregate and © that is comparable to coverage held by institutions of similar size and nature. Upon request, the Grantee shall provide CIRM with certificates of insurance evidencing such coverage.

Public Policy Requirements

Organizations and individuals that receive support from CIRM shall comply with, and where applicable provide evidence of compliance with, the following public policies. Initial funding or continued funding of any CIRM-funded Project or Activity is contingent upon compliance with these requirements. Documentation that certifies or verifies compliance generally must be submitted before CIRM will issue an NGA. In cases where research requiring public policy assurances will be conducted at a later phase of the funded research. CIRM may issue an NGA imposing a condition or restriction on the use of funds until documentation of required assurances is submitted.

The Grantee shall retain records and supporting documentation that demonstrate compliance with public policy requirements for a minimum five years from the date of submission of the final expenditure report for the Award. If related audit findings have not been resolved documentation must be maintained for longer than five years, until such findings are resolved. Records and supporting documentation may be audited by CIRM or other appropriate state agencies, including the Office of the Attorney General of California.

Research Conduct
1. “Research misconduct” means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. “Fabrication” means making up data or results and recording or reporting them. “Falsification” means manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. “Plagiarism” means the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion.
2. Grantees and Recipients must conduct all research in accordance with the highest medical and ethical standards for scientific research and all applicable laws. The Grantee bears the ultimate responsibility for preventing, detecting and imposing sanctions for research misconduct. Grantees must adopt, maintain and ensure compliance with written policies and procedures for inquiry, investigation, and adjudication of allegations of research misconduct. An acceptable standard for such policies and procedures, for example, is found in the Public Health Service Policies on Research Misconduct (42 CFR Part 93)(effective May 17, 2005).
3. Within 30 days of concluding an investigation of research misconduct, Grantees shall notify CIRM in writing of any finding of research misconduct against a Recipient of CIRM funding and of any related proposed corrective actions.
4. The administrative actions imposed by CIRM for research misconduct may include, but are not limited to, the following: correction of the scientific literature; special plan of supervision to ensure integrity of the scientific research; certification of the accuracy of the scientific data; certification of the accuracy of sources and contributions for scientific ideas and writings; disqualification of the Grantee or Recipient from eligibility for CIRM funds; or return of CIRM funds. The duration of these actions will depend on the nature and seriousness of the misconduct. Additional actions that CIRM may take are described in chapter V, section J, Failure of Compliance.

Conflict of Interest

Grantees must establish safeguards to prevent employees, Consultants, contractors, collaborators, and members of governing bodies who may be involved in CIRM-funded Activities from participating in or in any way attempting to use their position to influence those activities in which they know or have reason to know they have a financial interest.

Grantees must enforce within their institutions all such applicable safeguards. If the Grantee uses contractors or collaborators to conduct CIRM-funded research, the Grantee must take reasonable steps to ensure that such contractors or collaborators comply with the Grantee’s safeguards. An acceptable standard for such a policy, for example, may be found in 42 CFR Part 50, Subpart F (Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought)(effective October 1, 2000). The Grantee must promptly notify CIRM if and when it takes a suspension or separation action involving a financial conflict of interest against a PI or other Recipient of CIRM Funding.

Administrative Actions

The Grantee promptly shall notify CIRM of the results of any investigation and any administrative, civil, or other action taken by any funding agency, the Office of Research Integrity, the Office of Laboratory Animal Welfare, the Office for Human Research Protections (OHRP), the Grantee itself, any other institution, or any law enforcement agency concerning a charge of research misconduct made against a Recipient of CIRM-funding concerning the Recipient’s research activities.

Use of Human Stem Cell Lines

Grantees shall abide by the CIRM Medical and Ethical Standards (commencing with Title 17, California Code of Regulations, section 100010) developed by the CIRM Scientific and Medical Accountability Standards Working Group (Standards Working Group or SWG) and adopted by the ICOC for the use of “Covered Stem Cell Lines” or use of human oocytes or embryos. This requirement includes use and derivation of Human Embryonic Stem Cells. Consequences of failure to comply with CIRM regulations governing medical and ethical standards are described in chapter V, section J, Failure of Compliance. All CIRM-funded research involving “Covered Stem Cell Lines” must comply with CIRM regulations relating to SCRO committee review or notification as described in Title 17, California Code of Regulations, section 100070. CIRM will not issue an NGA or continue payment on active Awards without current documentation of approval or notification as required or without imposing limiting conditions. The documentation must include the name of the organization hosting the SCRO, the name of the committee, the name of the PI, the name of the Grantee, the CIRM Application number, the specific Covered Stem Cell Lines approved, the project title, and the period for which approval has been granted or expiration date of the approval. Unless otherwise required by CIRM, this information shall be provided just-in-time for approved Applications prior to issuance of an NGA (see chapter III, section D, Just-in-Time Procedures).

Use of Human Fetal Tissue

When using human fetal tissue in research, CIRM Grantees shall abide by Title 17, California Code of Regulations, section 100085. Unless otherwise required by CIRM, the certifying statement required pursuant to Section 100085 © shall be provided just-in-time for approved Applications prior to issuance of the NGA (see Chapter III, Section D, Just-in-Time Procedures). Consequences of failure to comply with the CIRM regulations are described in chapter V, section J, Failure of Compliance.

Research Involving Human Subjects
1. An organization is engaged in research involving Human Subjects when its employees or agents (1) intervene or interact with living individuals to obtain data for research purposes, or (2) obtain individually identifiable private information for research purposes.
2. PIs and Grantees engaged in CIRM-funded research involving Human Subjects must certify that the research has been reviewed and approved by an IRB and will be subject to continuing review by the IRB. In addition, the Grantee and any collaborating organizations (within the United States) must be covered by a Federal-Wide Assurance (FWA) approved by the OHRP, or an IND or IDE approved by the U.S. Food and Drug Administration (FDA).Grantee organizations must apply California Health and Safety Code 24170- 24179.5 to all CIRM-funded human biomedical or clinical subjects research. Compliance with this requirement may be demonstrated through written institutional policies or through provisions or full accreditation through the Association for the Accreditation of Human Research Protection Programs.
3. The Grantee bears ultimate responsibility for protecting Human Subjects involved in CIRM-funded research, including Human Subjects at all participating and collaborating sites. At CIRM’s request the prospective Grantee must provide the following documentation regarding itself and each collaborating site to the GMO:
  1. Documentation of IRB review and approval specifying the name of the PI, the name of the Grantee and any collaborating organization or site, the CIRM Application number the project title, and inclusive dates for which IRB approval has been granted;
  2. Sample human subject (patient) information and informed consent documents;
  3. Documentation of human research subject education of Key Personnel;
  4. For clinical trials, a data safety monitoring plan;
  5. Institutional assurance that the research is conducted in accordance with relevant national, state, and local laws; and
  6. A copy of the FDA-IND or IDE letter, where applicable when a clinical investigation involves the use of any drugs or devices.
  CIRM will not issue an NGA or authorize continued funding without current and complete documentation for Human Subjects research. Unless otherwise required by CIRM, this information (where applicable) shall be provided justin- time for approved Applications prior to issuance of an NGA (see section D, Just-in-Time Procedures).
4. Evidence of updated IRB approvals and related documents must be submitted with the annual Progress Report (see chapter V, section H, Reporting Requirements). CIRM will not authorize continued funding of active Awards without current and complete documentation for Human Subjects research.
5. Serious Adverse Event Reporting. In the case of an adverse event occurring during a CIRM-funded clinical trial or program that is both serious and unexpected, the PI must notify CIRM of such an event at the same time that the IRB and Grantee are notified.
6. Consequences of failure to comply with required Human Subjects research assurance are described in chapter V, section J, Failure of Compliance. The AOO shall promptly inform CIRM of any investigation or administrative action by OHRP or by the Grantee concerning Recipients of CIRM funding and their use of Human Subjects in research.
7. Women and members of minority groups must be included in all CIRM funded Clinical Research, unless a clear and compelling rationale and justification establishes to the satisfaction of CIRM that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. This policy applies to research subjects regardless of age in all CIRM-funded Clinical Research studies. Since a primary aim of research is to provide scientific evidence leading to a change in health policy or standard of care, it is imperative to determine whether the intervention or therapy being studied affects women or men or members of minority groups and their subpopulations differently. This requirement ensures that all CIRM-funded clinical research will be carried out in a manner sufficient to elicit information about individuals of both sexes/genders and diverse racial and ethnic groups and, particularly in clinical trials, to examine differential effects on such groups.
8. PIs must include in their annual Progress Report the cumulative subject accrual and progress in conducting analyses for sex/gender and race/ethnicity differences (see chapter V, section H, Reporting Requirements).

Animal Subjects
1. The PI. Grantee and any collaborating sites are responsible for the humane care and treatment of animals involved in research activities and must establish appropriate policies and procedures that are based on the standards set forth in the Guide for the Care and Use of Laboratory Animals prepared by the National Academy of Sciences and released January 2, 1996.
2. The PI, Grantee and any collaborating sites conducting CIRM-funded research that involves the use of vertebrate animals shall comply with all applicable federal, state, and local laws. Sites where CIRM-funded animal research is conducted must be accredited or seeking accreditation by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC).
3. The Grantee must appoint and maintain an Institutional Animal Care and Use Committee (IACUC) to provide oversight of research involving vertebrate animals.
4. The prospective Grantee must provide evidence of IACUC review and approval of research involving the use of live vertebrate animal subjects. The documentation must include the name of the PI, the name of the Grantee, the name of the organization hosting the committee, the CIRM Application number, the project title and inclusive dates for which approval has been granted. CIRM will not issue an NGA without current documentation of such approval or without imposing limiting conditions. Unless otherwise required by CIRM, this information shall be provided just-in-time for approved Applications prior to issuance of an NGA (see section D, Just-in-Time Procedures).
5. Evidence of updated IACUC approvals must be submitted with the annual Progress Report (see chapter V, section H, Reporting Requirements). CIRM will not authorize continued funding of active Awards without current documentation of such approval.
6. Consequences of failure to comply with required animal subjects research assurance are described in chapter V, section J, Failure of Compliance.

Biosafety

Prior to the issuance of an NGA, a prospective Grantee shall certify to CIRM that any approval required by the Grantee and/or federal or state law for the proposed use of biohazardous materials, radioisotopes, and/or controlled substances is current and in effect. Where applicable, the applicant shall additionally certify that all research personnel will obtain appropriate training and authorization for the use of biohazardous materials, radioisotopes, and/or controlled substances prior to their commencing work on the proposed project or activity. A prospective Grantee shall provide documentation that verifies such organizational approvals upon request. Grantees are also responsible for meeting applicable federal, state, and local health and safety standards, and for establishing and implementing necessary measures to minimize their employees’ risk of injury or illness in conducting CIRM-funded research.

Sharing of Intellectual Property: Publications, Biomedical Materials, Patented Inventions

PIs and Grantees shall share intellectual property generated by CIRM-funded research including research results in scientific articles, publication-related biomedical materials, and patented inventions for research use in California as required by CIRM regulations duly adopted by the ICOC.

Preference for California Suppliers

It is a goal of Proposition 71 that more than 50 percent of the goods and services used in CIRM-supported research is purchased from California Suppliers (Health and Safety Code section 125290.30, subpart (i); Title 17, California Code of Regulations section 100502). To achieve this goal, CIRM expects the Grantee to purchase from California Suppliers, to the extent reasonably possible, the goods and services it uses in its CIRM-supported research. The PI and Grantee must provide a clear and compelling explanation in the Progress Report for not purchasing more than 50 percent of its goods and services from California Suppliers. Please see chapter V, section H, part 2, Progress Report.

Just-in-Time Policy
Just-in-time procedures allow CIRM to defer review of certain required information until after an Application is approved for funding by the ICOC and prior to issuance of an NGA. When the required information is requested of the prospective Grantee, the information is to be submitted to the GMO. Just-in-time information includes, but is not limited to the following:
1. Certification
  CIRM requires documentation from the Grantee organization that:
  1. verifies IACUC review and approval of the project’s proposed use of live vertebrate animals; or
  2. certifies SCRO committee (or equivalent) notification or review and approval of the project’s proposed use of Covered Stem Cell Lines as specified in Title 17, California Code of Regulations, section 100070; or
  3. certifies IRB review and approval (including applicable documents outlined in the chapter III, section C, part 6, Research Involving Human Subjects) of the project’s proposed use of Human Subjects.
2. Other Support
  As part of the just-in-time procedures, the PI, Co-PI and Grantee shall provide information on all other active and pending support. Before an NGA is issued, the SPO and GMO will review this information to ensure the following:
  1. PIs, Co-PIs, PDs (and other Key Personnel when requested) are not committed beyond a total effort of 100% for all active and other approved but not yet funded projects, whether or not salary support is requested in the Application.
  2. There is no scientific or budgetary overlap. Scientific overlap occurs when substantially the same research, or a specific research aim, proposed in the approved Application is funded over any part of the Project Period by another source. Budgetary overlap occurs when funds from more than one source are used to cover the same item or the same part of a budgetary item (e.g., Equipment, salaries) and may be evident when duplicate or equivalent budgetary items are requested in an Application but are already funded by another source.
Award Notice

Once CIRM funding requirements are fully met, an NGA will be sent to the AOO or AEO designated in the Application. The NGA specifies the Project Period (start and end dates of the project or program) as well as the monetary allocations (itemized Direct Research Funding Costs (including Facilities costs) and an amount allocated for Indirect Costs) for each Budget Period. The NGA also incorporates this Grants Administration Policy and all other applicable CIRM regulations by reference and specifies any special terms and conditions of the Award. During the active award period, the NGA may be amended in response to Prior Approval Requests or documentation of GMO implementation of the GAP regulations.

AWARD ACCEPTANCE

An Award is accepted when an NGA is signed by the PI and AOO or AEO, and returned to and received by CIRM. In accepting an Award, the PI and Grantee assure CIRM that any funds expended under the Award will be for the purposes set forth in the approved Application. Further, the PI and Grantee agree to comply with terms and conditions of all applicable CIRM regulations, including this Grants Administration Policy. The NGA must be signed and returned to CIRM within 45 days (or more, if extended in writing by CIRM) of issuance. Payment will not be issued until the Award is accepted. If the PI or Grantee cannot accept the Award, including the legal obligation to perform in accordance with its provisions, they shall so notify CIRM in writing immediately upon receipt of the NGA.

Urgency is one of the component values of CIRM’s mission. Therefore, CIRM requires that all NGAs have a start date no later than six (6) months after the date the ICOC approves an Application for funding, unless this provision is waived in writing by the President.

PAYMENT AND USE OF FUNDS
1. Payment
2. Costs and Activities
3. Budgetary Overlap
4. Prior Approval Requirements
5. Equipment Management
6. Accounting Records, Documentation, Access to Records and Audits
7. Misuse of Funds
8. Reporting Requirements
9. Grant Close-Out
10. Failure of Compliance
SPECIAL POLICIES FOR TRAINING GRANTS

This chapter supplements the general policies described in chapters I through V and provides information on policies and requirements that apply specifically to CIRM training grants.

Criteria for Review of Training Grant Applications

Training grant Applications are evaluated by criteria established by the ICOC, which may include but are not limited to the following factors:

Overall quality of the (proposed) training program
Qualifications of the program leadership
Research and training strength of the proposed mentors
Quality and diversity of existing training programs
Strength of the stem cell research at the institution

Trainee Policy

Appointment

The PD should appoint trainees, giving appropriate consideration to the level of training, academic qualifications, and the inclusion of women and minorities. The NGA specifies the maximum number and type of trainees that may be appointed and supported by the CIRM training grant. Each trainee must be sponsored by an eligible faculty mentor who will supervise the training and research experience. The PD must complete and sign a Trainee Appointment Form for each trainee and submit the form to CIRM at the time of appointment (see section E, Reporting Requirements for Training Grants.)

Degree Requirements

To qualify for appointment, a trainee must have acquired the necessary academic preparation and degree(s) that are appropriate for the level of proposed training as set forth in the RFA.

Training Period

The training period for any individual trainee will be as specified in the RFA. An awarded trainee position cannot be shared among multiple individuals. CIRM trainees must devote full-time to training activities, which, in addition to their research, may include relevant coursework, workshops, and scientific conferences. Clinical trainees should confine clinical duties to those that are an integral part of their training experience. Clinical trainees may not expend more than 25 percent of their appointment time on clinical duties that are unrelated to or independent of the CIRM training program.

Allowable Costs and Activities for Training Grants

Stipend Levels

Annual trainee Stipend levels should be commensurate with the individual’s experience and the level of training as specified in the RFA. CIRM encourages the Grantee to supplement trainee Stipends when necessary to meet institutional requirements and maintain equity among trainees, provided that the supplementation is without obligation to the trainee. Grantees must re-budget within the total amount already awarded to accommodate any variation in Stipend levels. CIRM will not provide additional funds for this purpose. (See section D, Prior Approval Requirements for Training Grants.)

Trainee Stipends and allowances are not provided as a condition of employment with CIRM, the state government, or the Grantee. Accordingly, Grantees may not seek funds, or charge training grant Awards, for costs that normally would be associated with employee benefits (e.g., FICA, workman’s compensation, and unemployment insurance). This limitation does not include health insurance for trainees, which is described under part 3 of this section.

A trainee may not be concurrently supported with another fellowship or similar Award that provides a Stipend or otherwise duplicates provisions of the training grant Award.

Tuition and Fees

“Tuition and fees” means costs charged by the Grantee for the enrollment and instruction of a student. and may include costs of health insurance for the student . Tuition and Fees may only be claimed for trainees who are enrolled in an accredited certificate, undergraduate, or graduate program. Grantees may request for each trainee up to 100 percent of the first $3,000 incurred for Tuition and Fees and 60 percent of expenses in this category incurred thereafter up to a maximum of $16,000. CIRM does not cover Tuition and Fees that are otherwise subsidized by the Grantee.

Tuition and Fees at the postdoctoral or clinical trainee levels are not allowed.

Health Insurance for Postdoctoral and Clinical Trainees

If the postdoctoral or clinical trainee’s health insurance is not otherwise covered by the Grantee institution, the Grantee may request up to 100 percent of basic health insurance costs for the trainee and immediate family (if applicable). Health insurance may include coverage for costs such as vision and/or dental care if consistent with organizational policy.

Trainee-Related Research and Travel Funds

Grantees may request an annual allowance for trainees for research training-related expenses such as books and laboratory supplies and for trainee travel to scientific conferences or workshops.

Grant funds may be used to cover the costs of a trainee’s travel to attend a scientific meeting that would benefit the trainee’s research experience. Funds may not be expended to cover the costs of travel between the trainee’s place of residence and the training institution or to the training institution for the purpose of recruitment.

Generally, research training experiences away from the Grantee must be justified on the basis of the type of opportunities for training available, the opportunities offered that are different from those at the Grantee, and the relationship of the proposed experience to the trainee’s career stage and career goals. Expenditure of CIRM funds for this type of research training requires Prior Approval by CIRM. This general rule, however, may vary by RFA.

Textbooks required for coursework, specialty volumes that will enhance training, laboratory and technical manuals are appropriate for purchase provided they are not available in the Grantee’s library or at the training institution. Professional journal subscriptions covering the period of the appointment are not allowable costs.

Program Administration Funds

Grantees may request funds for administrative costs as part of direct project costs. Unless otherwise specified in the RFA, allowable program administrative direct project costs include administrative support salaries, seminar speakers, outside speakers for courses, audio-visual equipment or supplies, and costs of developing or delivering new courses. Up to 25% of the amount awarded in this category (i.e., program administration funds) may be used for the PD’s salary.
The cost of advertising the training program to all prospective candidates may be allocated to program administration costs.
The cost of food and meals served at a seminar or meeting is not an allowable cost.

CIRM supports direct project costs for the training program that are specifically associated with trainee support (i.e., parts 1-4 below) and program administration (i.e., part 5), including administrative support salaries. Indirect Costs, which cannot be specifically associated with the training grant program, are limited to 10 percent of the direct project costs.

Prior Approval Requirements for Training Grants

Grantees must perform project activities as described in the approved Application. A Grantee must request Prior Approval for any post-award changes by submitting to the GMO such requests in writing together with appropriate justification for the proposed change (see chapter V, section D, part 7, Submitting Prior Approval Requests). The request must be signed by the PD and the AOO. Such approval must be obtained in writing before expending CIRM funds for the proposed activity. Notwithstanding chapter V, section D, Prior Approval Requirements; the following are examples of post-award changes for training grants that require approval:

Stipends – Rebudgeting funds out of the Stipend category.

Training Period for Clinical Trainees – Appointing a clinical trainee for a period that is less than 12 consecutive months.

Trainee-Related Funds/Program Administration Funds/Indirect Costs – Rebudgeting between 1) trainee-related funds (i.e., Stipends, Tuition and Fees, health insurance or research and travel), 2) program administration funds, and 3) Indirect Costs; however, funds may be re-budgeted into the trainee-related funds category for use as Stipends without Prior Approval.

Carry Forward of Funds – Carry-forward of unexpended funds from one Budget Period to the next that exceed 25 percent of project costs for the expiring Budget Period. If the carry-forward amount is greater than 50 percent of the expiring Budget Period’s project costs, payment of funds for the next Budget Period may be postponed.

Extensions – Extending the Project Period beyond the scheduled end date. A one-time no-cost extension for up to one year beyond the scheduled Project Period end date is allowed with Prior Approval. The written request for Prior Approval shall be submitted to CIRM at least 30 days in advance of the scheduled Project Period end date.

Change in Program Director –Appointing a new PD for the training grant program.

Change in Sponsor, Mentor, or Collaborating Institution – Appointing a new trainee sponsor or mentor. Any mentor changes approved by CIRM shall be reported in the annual Progress Report (see section E, Reporting Requirements for Training Grants).

Addition to Number of Approved Trainees – CIRM will not provide additional funds for increasing the number of approved trainee positions but will consider use of carry-forward funds or interest earned on CIRM funds for this purpose.

Reporting Requirements for Training Grants

Notwithstanding chapter V, section H, Reporting Requirements, the PD must submit financial and Progress Reports as described in this section to CIRM on an annual basis. The Progress Report is due 60 days prior to each anniversary of the Project Period start date stated in the NGA. Funding for the subsequent Budget Period will not be paid until CIRM has received, reviewed, and approved this report. In addition, the PD must submit an annual financial report within 90 days after each anniversary of the Project Period start date.

Annual Financial Report

The Grantee shall submit to the GMO an annual financial report, within 90 days after each anniversary of the Project Period start date stated in the NGA. The annual financial report must include all actual costs incurred during the expired Budget Period and any carry-forward amounts.

Upon initial appointment of a trainee and on each subsequent annual reappointment, costs for Stipend, Tuition and Fees, health insurance, and research and travel that cover an entire 12 months should be charged to the current Budget Period. The full amount not yet expended at the end of the Budget Period should be reported as a cost incurred but not yet paid.

Annual Progress Report

Training Program Report

A programmatic description of progress made since the initiation of the Award is required. The training program report requests information such as:

Trainee selection process
Current number and type of trainees in the program
Program activities (e.g., seminars, workshops, retreats)
Course developments or changes
Changes in the administration of the program
Plans for the upcoming year
Anticipated budget changes in future Budget Periods

Trainee Report

In addition to the training program description, the annual Progress Report must include data for all trainees who were or are supported by the training grant. The trainee report requests information such as:

Mentor and trainee assignments
Description of proposed trainee research and progress
Curriculum vitae of each trainee
List of relevant publications

The Grantee shall submit an annual report detailing progress and activities of the training program during the Budget Period. This report is due 60 days prior to each anniversary of the Budget Period start date indicated in the NGA. The Progress Report for training grants includes two components: a description of the training program and an account of the appointed trainees.

Appointment

Trainee Appointment Form

A Trainee Appointment Form must be completed for each trainee and submitted at the time of appointment. The form requests information about the appointment such as the name of trainee, name of mentor, anticipated period of training, level of Stipend support, and anticipated program of training. The mentor, trainee, and PD must sign the form and in so doing all parties agree to comply with the proposed training program, period of support, Stipend level, and the terms and conditions specified in this Grants Administration Policy. The completed and signed form is the official document for establishing the Stipend, which should be reflected in annual financial reports.

Trainee Termination Form

A Trainee Termination Form must be completed for each trainee and submitted to CIRM at the time of termination of the trainee appointment due to the expiration of the appointment period or early termination prior to the pre-determined appointment period. The form requests information about the appointment term, such as the final term of appointment, a summary of the training received during the appointment period, the Stipend support received during the appointment period, post award activities (if known) of the trainee, and trainee contact information after completing CIRM support. The trainee and the PD must sign the form.

Other Reports

Grantees are also required to report to CIRM publications, inventions, patent applications, licensing and invention utilization activities that result from CIRM-funded Activities. Specific reporting requirements may be found in regulations adopted by the ICOC governing intellectual property for.

Overdue Reports

Failure to timely submit financial, progress, or other reports may result in action reducing, delaying or suspending payment until required materials are received. Further, if a report is delinquent for more than 60 days, CIRM may take action as described in chapter V, section J, Failure of Compliance.

Ethical Research Practices

Appointed trainees (and their faculty mentors, where applicable) must conduct research in accordance with the highest medical and ethical standards, including compliance with institutional requirements, and regulations set forth and approved by the ICOC. See Title 17 California Code of Regulations section 100010, et seq. Trainees may not initiate or engage in research activities without documented institutional approvals where required by CIRM or the Grantee. The Grantee must submit to CIRM, with the Annual Progress Report, documentation that certifies that each appointed trainee has current institutional approval (where appropriate) to conduct research involving 1) the use of the live vertebrate animals, 2) use of Covered Stem Cells Lines (as specified in Title 17, California Code of Regulations, section 100070), or 3) use of Human Subjects; Certification must be given by the Grantee’s official institutional approval committee. The documentation must include for each trainee, the period for which approval has been granted, the name of the PI, and the approval number or identifier.

Non-Profit and Academic Institution Grants Administration Policy

Preface

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