Policies and Procedures

NWH is dedicated to advancing research that will address conditions that affect women specifically, differently, and disproportionately. We sponsor a range of projects that aim to address the foundational gaps in knowledge that are required to promote a deeper understanding of women’s health. NWH seeks to fund research that will positively impact how we diagnose, care and treat women across their lifespan. All grants awarded by NWH will be on an objective and non-discriminatory basis.

A. Deployment of Funds
Any grantee must comply with the Policies regarding use of funds, spending of funds and distribution of funds in a timely fashion.

B. Notifications
NWH requires grantee institutions to provide notice to NWH, within ten (10) business days, of the following, except as prohibited by law:

1. any investigation by the Internal Revenue Service (“IRS”) or other state or federal governing body of such grantee institution;
2. if a grantee institution’s federal exempt status is pending, under review, or revoked; or
3. any changes in key personnel relating to the grant, as further described in Section 36.

C. Review of Grant Status Following Notification
NWH, upon receipt of a notification described above, shall determine whether to terminate any grant agreement, which, in NWH’s discretion, may result in a refunding of unexpended granted funds.

NWH will not tolerate research misconduct, defined as fabrication, falsification and plagiarism, and does not include honest error or differences of opinion. A finding of such misconduct shall result in an immediate termination of the grant agreement and a refund of any unexpended funds.

Award or Grant
NWH uses the terms award and grant interchangeably. The award or grant is the provision of funds by NWH, based on an approved application and budget or progress report, to an organizational entity to carry out the approved project.

Grantee
NWH uses the terms “institution”, “grantee” and “grantee institution” interchangeably, and may refer to a nonprofit or for-profit organization.

Key Personnel
Key personnel include the principal investigator (“PI”) (or organizational equivalent) and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation. This may include co-investigators, collaborators, postdoctoral research associates or equivalent employee positions.

Principal Investigator
The term PI includes the individual (or individuals) judged by the applicant institution to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. If the grantee is a nonprofit institution, the PI(s) must hold a Ph.D., M.D. or equivalent degree, and such PI(s) must have a faculty position or equivalent at a college, university, medical school or other research facility. If the grantee is not a nonprofit institution, the PI(s) must hold a permanent position of appropriate seniority, as determined by NWH. The PI is responsible and accountable to the applicant institution and NWH for the proper conduct of the project or activity, including the submission of all required reports. The PI will act as the main point of contact for NWH and should be noted as personnel in the budget even if not requesting a salary. The PI or PIs should request the needed minimum effort to complete the proposed work in the stated time period, and, if approved, shall be required to allocate effort accordingly. PIs can request up to 100% of their effort if that is consistent with the scope of work and within their stated expertise. The PIs (and, as appropriate, other staff approved by NWH) will join the collaborative community of NWH Investigators, and will be expected to partake in the conferences, workshops and symposia that NWH organizes, at the invitation of NWH.

Subject to the approval of NWH, the applicant institution may designate multiple individuals as PIs who share the authority and responsibility for leading and directing the NWH project, intellectually and logistically. Each PI is responsible and accountable to the applicant institution or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of all required reports.

In circumstances where the applicant institution designates multiple PIs, the PI under whose name the application is submitted will serve as the contact PI for administrative purposes. The contact PI must be affiliated with the institution submitting the application. The contact PI will be responsible for communication between NWH and the rest of the leadership team.

Co-Investigator
A co-investigator is an individual involved with the PI in the scientific development or execution of a project. The co-investigator must hold a Ph.D., M.D. or equivalent, and be employed by or be affiliated with the grantee institution or another organization participating in the project under a consortium agreement. NWH does not require a minimum effort from the co-investigator. Instead, the effort from the co-investigator shall be consistent with the scope of the work proposed and the co-investigator’s expertise, provided that such effort is not duplicative with any other co-investigator or the PI(s). The designation of a co-investigator, if applicable, does not affect the PI’s roles and responsibilities, nor is it a role implying multiple PIs.

Collaborator
A collaborator is an individual involved in the scientific development or execution of a project. A collaborator is considered key personnel and may or may not be supported by funds from the grant.

Consultant
A consultant is an individual providing professional advice or services on the basis of a written agreement. These individuals are not normally employees of the organization receiving the services. Consultants also include firms providing professional advice or services.

Signing Official
A signing official (“SO”) has the authority to legally bind the institution in grant administration matters. The individual fulfilling this role may have any number of titles in the applicant/grantee institution. The SO is responsible for the proper administration of the grant, including but not limited to overseeing the submission of the electronically signed grant agreement, budgets, progress reports, and semi-annual reports. Additionally, the SO is required to certify that all information submitted is accurate, that the terms of the award are acceptable, and that the grantee will comply and has complied with all applicable laws and NWH policies. Each award must have at least one SO.

Financial Officer
The financial officer (“FO”) is designated by the grantee institution and is responsible for the proper accounting of grant funds. The individual fulfilling this role may have any number of titles in the grantee institution and, for the avoidance of doubt, need not be a formal officer of the institution. In this role, the individual is required to complete the required annual financial statements as part of any progress reports and semi-annual reports, and any budgets. Additionally, the FO is required to certify that all information submitted in the financial statements or budget is accurate, that the terms of the award are acceptable, and that the grantee institution will comply (or has complied) with all applicable laws and the Policies. FOs may be given access to any number of awards on Proposal Central from Altum (hereinafter, “Proposal Central”). Each award must have at least one FO.

NWH Investigators
The term “NWH Investigators” shall refer to the community of PIs and related personnel who have worked on projects funded by NWH grants

PIs, postdoctoral fellows, authorized institution officials, SOs, FOs and contact delegates, as well as any additional staff members as needed, may be granted access to and must use the web-based tool Proposal Central for submitting electronically signed award letters, progress reports, financial statements, publications and other documents to NWH during the grant period. The applicant/grantee institution must submit all required documentation to NWH through Proposal Central; hard copies will not be accepted. Proposal Central can be accessed through a link on NWH website or via their website: https://proposalcentral.com/

The grantee agrees to consent to transact business using electronic communications, to receive notices and disclosures electronically, and, to the extent permitted by law, to utilize electronic signatures (e-signatures) in lieu of using paper documents; provided, however, that the grantee is not required to sign documents electronically.

If a grantee is in a country where e-signatures are not legally binding or if grantee chooses to not sign documents electronically, NWH requires that a PDF of the physically signed documents be uploaded to Proposal Central. If this procedure is not followed, NWH shall be entitled to rely on the electronically signed copy (if any).

For international grants, NWH requires that an organization be the equivalent of a U.S. public charity, and/or use the funds in a manner that will further NWH’s tax-exempt purposes and be tracked accordingly, before awarding the grant.

If an organization has a determination letter from the IRS stating exemption under 501(c)(3) of the Internal Revenue Code, as amended (the “Code”), and furthermore, either a Code section 509(a)(1), (2) or (3) classification, this letter must be included in the grant application. If an international institution does not have the aforementioned documentation, NWH, in its discretion, will require that the institution either (i) complete an equivalency determination if an award is recommended for funding, or (ii) undertake such other reporting obligations as are necessary to satisfy NWH’s requirement under federal law to exercise “expenditure responsibility” over such sums (as described under “Use of Funds and Reporting” below). For the avoidance of doubt, international grants to grantees that are not the equivalent of U.S. charities but are conducting work that is in furtherance of NWH’s mission will require the formalities of expenditure responsibility, and applications will be subject to enhanced scrutiny by NWH.

A grantee’s failure to comply with the equivalency determination or expenditure responsibility process will terminate the institution’s grant agreement with NWH. Furthermore, to the extent applicable, a mid-award determination that an institution is not the equivalent of a U.S. public charity may also result in the termination of all grants to the institution if the institution is not able to fulfill the requirements of expenditure responsibility outlined below.

Under U.S. law, NWH grant funds and income earned on those funds (to the extent retained by the grantee) only may be spent for charitable, religious, scientific, literary or educational purposes. Grants are made only for the purposes stated in the grant agreement, and it is agreed that grant funds will be used only for such purposes, substantially in accordance with the budget submitted with the grant proposal and with no substantial changes made from the approved budget or grant proposal without NWH’s prior approval in writing (except as provided in Section 29).

For the avoidance of doubt, to the extent that a grant agreement provides for payment of an award in installments, no installment shall be released until the requirements of the grant agreement have been satisfied, including the timely submission of reports and accomplishment of specified metrics.

A. Reporting Requirements
Grantees (whether U.S. or non-U.S. based, and whether nonprofit or for-profit) agree to cooperate with NWH to assure that NWH, if desired, is able to satisfy all of the requirements of an expenditure responsibility grant in accordance with Section 4945(h) of the Code and the regulations thereunder and agree to the terms outlined below:

• All NWH grant funds received by the grantee institution must be maintained in a separate account dedicated to the charitable purposes described in the award letter. NWH defines a separate account as a (i) a physically separate bank account restricted to the described charitable purposes or (ii) a separate bookkeeping account (limited to the described charitable purposes) maintained as part of the institution’s financial records.
• Grantees are required to maintain records of receipts and expenditures and make their books and records available to NWH at reasonable times. Financial records with respect to a grant, along with any copies of progress or semi-annual reports submitted to NWH, are required to be maintained by the grantees for at least four (4) years following the year in which all grant funds are fully expended.
• Grantees will repay any portion of the amount granted that is not used for the purposes of the grant.
• Grantees agree not to use grant funds for any of the following restricted activities:
  • To carry on propaganda, lobbying, or otherwise to attempt to influence any legislation (within the meaning of Section 4945(d)(1) of the Code).
  • In support of a candidate or party seeking elected office or to influence the outcome of any specific public election or to carry on, directly or indirectly, any voter registration drive (within the meaning of section 4945(d)(2) of the Code).
  • To make grants to individuals for travel, study or other similar purposes by such individuals (such as scholarships, fellowships or grants for research), unless such grants satisfy the requirements of section 4945(g) of the Code.
  • To make any grant to any other organization (other than to public charities or exempt operating foundations) that does not comply with the requirements of section 4945(d)(4) of the Code.
  • To undertake any activity for any purpose other than the charitable purposes specified in section 170(c)(2)(B) of the Code.

B. Compliance with U.S. Laws and Regulations
Grantee agrees to use all grant funds in compliance with all applicable U.S. laws and regulations, including, without limitation, the Bayh-Dole Act, the Export Administration Regulations, Executive Order 13224, the Global Terrorism Sanctions Regulations set forth in 31 C.F.R. Part 594, and other applicable U.S. anti-terrorism laws and regulations. Grantee certifies that it will not knowingly provide financial support to, employ, or transact business with terrorists, terrorist organizations, or designated state sponsors of terrorism as defined in U.S. anti-terrorism laws and regulations. Grantee certifies that it will not knowingly distribute the received award funds directly or indirectly to terrorist organizations or to designated state sponsors of terrorism as defined in U.S. anti-terrorism laws and regulations.

C. Duties for Subcontracts
Grantees with subcontracts are responsible for entering into agreements with the investigators and/or other institutions that are consistent with the terms of the grant and NWH policies.

If the grantee institution is an organization that is recognized as tax-exempt under section 501(c)(3) of the Code, earned interest up to $5,000 per project may be retained by the grantee institution, to be used solely for the purposes of the grant.

Upon the termination date of the grant, any earned interest shall be transferred to NWH within ten (10) days.

Investigators and their institutions must abide by all applicable laws and regulations, including those governing the conduct of research on humans or animals. Subject to change at any time by NWH, NWH follows the NIH guidelines for the humane care and use of animals, which can be viewed at https://olaw.nih.gov/, and for the use of humans, which can be viewed at https://grants.nih.gov/policy-and-compliance/policy-topics/human-subjects.

All grants with human participants and/or animal research must have up-to-date ethical approval documentation that is consistent with the scope of the project, finalized within three (3) months of the execution of the grant agreement (unless otherwise approved by NWH), and applicable at all times throughout the life of the grant or fellowship. The grantee is responsible for obtaining all human and/or animal ethical approvals.

A. Publications
No publications (which shall include, without limitation, abstracts submitted to external meetings) by NWH grantees relating to a project supported by a grant shall be permitted without NWH first having reviewed and approved of the conclusions therein as reflective of proper scientific processes. NWH must receive a minimum of 30 days to review submissions of abstracts and two (2) months to review publications.

NWH requires its grantees to pre-print its data. In addition, NWH may request that the grantee’s data be shared at any point, including in advance of publication or pre-printing.

Prior to any publication, NWH and the PI shall reach a consensus on the content of the publication which, in all events and in any media, shall be presented objectively and with proper scientific integrity.

Subject to the foregoing, scientific research will be published as soon as reasonably practicable, as agreed by NWH and the grantee in a format that is available to the interested public, subject only to delays pending the filing of a patent application, including through bioRxIV, medRxIV or other similar platforms that subject to NWH’s approval.

Upon publication of results, the PI(s) shall use the PI’s best efforts to deposit all research-generated data into public databases that are widely accessible, without charge, to the scientific research community.

Publication expenses, including Open Access costs, are an allowable budget cost.

Research that is published in accordance with the foregoing paragraphs (in any form and in any media), including articles, preprints and books resulting from projects supported by NWH must carry the following acknowledgement: “This work was supported by a grant from Nuttall Women’s Health (Grant Number, Awardee Initials).”

B. Permitted Disclosures
NWH may distribute information regarding the project supported by a grant, including, without limitation, the project title, abstract, publications, and PI biographical information and photo, on its website, in its annual reports, in press releases, and in other venues relevant to the scientific community as NWH determines.

C. Acknowledgments
NWH’s support should be acknowledged by the grantee and by the institution in all public communication of work resulting from a grant, including scientific abstracts, posters at scientific meetings, press releases or other media communications and Internet-based communications; provided, however, that any such content must receive NWH’s prior written approval.

Any inventions conceived and/or reduced to practice by grantee personnel and arising directly out of work under a grant or through use of the proceeds of the grant (collectively “Grant IP”) shall be owned by NWH and shall be subject to a fee-free license, without the right to grant sublicenses, to the grantee institution for non-commercial, research purposes. The PI shall, and shall cause all personnel working under the grant, to agree to assign their entire right, title, and interest in and to any Grant IP to NWH. The PI and any individuals working under a Grant shall keep accurate and contemporaneous records of work conducted under a Grant and shall record any potential inventions in a format as provided by NWH. NWH shall evaluate all invention disclosures conceived and/or reduced to practice under a Grant and shall have the option, at NWH’s sole discretion, to prepare and prosecute one or more patent application(s) claiming an invention under the Grant IP. However, notwithstanding the foregoing, in the event that NWH elects not to pursue a patent application on Grant IP, NWH shall notify the grantee institution in writing and the grantee institution may then do so at its sole expense and, if the grantee institution elects to do so, any resulting patent application shall be assigned by NWH to the grantee institution and be subject to a fee-free non-exclusive license back to NWH for any commercial purpose.

Rights of grantee personnel to any invention conceived and/or reduced to practice jointly between grantee personnel and non-grantee personnel (“Joint IP”) shall be subject to the obligation to assign rights to NWH as provided above. NWH shall have the option, at NWH’s sole discretion, to negotiate a license to any rights owned by non-grantee personnel in any Joint IP.

NWH, in furtherance of its tax-exempt purposes, shall have the sole right to commercialize or otherwise exploit Grant IP except as noted above, and the proceeds of such efforts shall remain the sole property of NWH (unless otherwise agreed with the institution). However, in the event that NWH elects, at its sole discretion, not to commercialize any Grant IP or Joint IP in a manner determined at NWH’s sole discretion within five (5) years of the filing of a patent application claiming such Grant IP, NWH shall assign its rights to such non-commercialized Grant IP to the grantee institution, retaining a non-exclusive commercial license to such Grant IP.

NWH shall retain all rights implied by intellectual property ownership in any Grant IP not specifically excepted in this Section 13. The provisions of this Section 13 shall apply regardless of the location or facilities used in the work giving rise to Grant IP.

To the extent applicable, to close out the grant agreement, the PI(s) must provide any cell lines or model organisms developed under a Grant within a month of the initial publication, whichever occurs first. An embargo period for access to a model organism or a cell lines, negotiated on a case-by-case basis in consultation with the PI(s), will be maintained until the initial results are published by the PI(s), at which time it will expire. The PI(s) is responsible for transferring the animals/cells to the appropriate center. Once the transfer has occurred, NWH will pay costs assessed by the third-party repository for maintenance of the reagent at the depository. In specific cases at NWH’s discretion, NWH may contract with the repository to pay the additional costs necessary to maintain the model organism as a viable colony versus preservation in a frozen repository or to backcross the model into a different strain in the case of rodent models.

NWH has the right to release a summary of findings of the grantee’s project within a reasonable period of time (typically, within six (6) months of the date of the grant expiration).

NWH promotes information sharing among its grantees. Further to NWH’s mission, NWH funded PIs are obligated to share unused biosamples, reagents, model systems, data/metadata with other NWH funded and/or NWH approved investigators, as requested by NWH. At NWH’s discretion, the PI may be required to provide NWH with an electronic copy of all properly de-identified research-generated data prior to the end of the grant term. NWH shall release such data and materials in its sole discretion. With respect to biosamples used by a grantee, for the avoidance of doubt, use of such samples to complete the grantee’s NWH funded project shall be prioritized, and the grantee will not be compelled to share such materials unless the grantee’s project needs have been met.

Salary support guidelines for NWH grantees are outlined below, in each case subject to Section 33. Staff will be compensated in a manner that is commensurate with their expertise, the size and scope of the project supported by the grant, and the time dedicated to such staff member’s work on the grant. Such amounts shall be set forth in the budget approved with respect to each grant, noting that there is no definitional salary cap for any position.

Faculty or equivalent senior employee position
As described above, PIs and other supportive personnel will be expected to dedicate such amount of their time to the grant-supported project that is commensurate with their expertise and the size and scope of the project supported by the grant (to the extent that such time is not duplicative with the time of others). Further, it is expected that PIs will join the collaborative community of NWH Investigators and partake in conferences, workshops and symposia organized by NWH.

Postdoctoral Research Associate/Scholar/Scientist/Fellow or equivalent employee position
The postdoctoral research associate or equivalent employee must be an employee, with benefits, of the grantee. Funds may not be used for fellowship stipend supplementation unless specifically authorized by NWH.

Graduate Research Assistant or equivalent
There is no cap on the compensation package for a graduate research assistant (“GRA”) on a NWH grant; however, the compensation package is prorated according to the GRA’s percent effort on the grant and shall be set forth on the budget related to the approved grant. It is expected that graduate student compensation will be within the usual norms of the relevant department or program. The compensation package may include salary or wages; health-care allowance or fringe benefits; and tuition remission. Funds may not be used for stipend supplementation unless specifically authorized by NWH.

Except as otherwise agreed, NWH funds will not be deployed for equipment that would be intended for the long-term use of the institution. NWH funds may be used towards freezers in an amount up to $15,000 as approved by the budget. In addition, equipment with a value of less than $10,000 is allowable with appropriate justification as set forth on the budget. Equipment purchases exceeding $10,000 generally will not be approved (except with respect to freezers), unless an exception is allowed as set forth on the budget.

Expenses for leasing equipment during the grant period are allowable as approved in the budget if the equipment is essential to the project and used specifically for the duration of the grant. Any costs allocated to equipment (including costs allocated to leasing equipment during the grant period) shall be set forth on the budget relating to the approved grant.

With respect to non-profit grantees, indirect costs to the primary institution are limited to 15% of direct costs (calculated to include the award amount), and indirect costs paid by a grantee to a subcontractor may not exceed 15% of the modified total direct costs paid to such subcontractor. Projected indirect costs shall be identified on the budget that shall be approved as part of the grant agreement. With respect to for-profit grantees, indirect costs will not be covered. Please see allowable direct costs for further information.

All payments are made in U.S. Dollars (“USD”). Payments shall be made in the amounts and timing set forth in the grant agreement awarding a grant, with such payments to be made subject to meeting the milestones and requirements set forth therein and the Policies. NWH makes payments via electronic fund transfer (“EFT”), unless otherwise specified. All domestic payments are made via Automated Clearing House (“ACH”) transfer to the institution’s account at its financial institution. All international payments will be made by wire transfer (“WT”) unless the institution requests to be paid using a U.S. bank. All payments are made payable only to an institution, university or equivalent organizational entity. Checks will only be sent directly to the FO. Under no circumstances will NWH make payments payable to an individual. The grantee will be responsible for providing NWH with accurate and complete EFT information prior to the payment of any grant funds and shall acknowledge the receipt of funds immediately upon receipt. The grantee will receive a hard-copy check in the event a WT is not available.

As described in the Policies, all awarded funds shall be maintained in a separate account, which shall be funded promptly upon the grantee’s receipt of funds, and thereafter released for immediate use by the PIs for the project, with such release to occur no later than ten (10) business days upon the grantee’s receipt of funds. The grantee shall notify NWH contemporaneously of its release of funds for the use of the PI, which NWH thereafter may confirm directly with the PI.

NWH will not reimburse, nor may grant funds be used for, costs or losses of funds that are a result of exchange-rate fluctuations or bank fees associated with the transmission of funds via EFT (including to the institution or to subcontracts paid by the institution).

In addition to and not in lieu of the other provisions of the Policies, payments may be withheld (in whole or in part) or subject to reimbursement to NWH, and agreements may be subject to early termination, in the following events:

• Failure to provide timely and complete financial statements, progress reports, semi-annual reports or other required deliverables.
• If the investigator’s semi-annual or more frequent progress reports (as the case may be) or semi-annual or more frequent (as the case may be) financial statements indicate limited progress toward goals or failure to meet milestones set forth in the grant agreement.
• If a change in key personnel is deemed unacceptable.
• If the research plan is changed without prior written approval.
• If provided by law or otherwise necessary to protect the purposes of the grant and mission of NWH.

In all of the foregoing events, payments may be resumed upon written approval by NWH staff. This approval will be based on stated plans and discussion with the PI and, to the extent necessary, shall include a new timeline and ending date for reporting research progress (which, for the avoidance of doubt, may include amending the grant agreement).

Because interaction among scientists working at different levels can facilitate the evolution of questions, theories and methodologies, NWH will foster communication among research groups by hosting small workshops, teleconference lab meetings and using online tools for data sharing and discussion. As described herein, NWH Investigators are expected to share data, results, reagents and other research products developed with NWH funds.

We expect that NWH Investigators will participate in the conferences, workshops and symposia that NWH organizes. Reasonable travel and accommodation expenses exclusively related to in-person meetings may be satisfied from the award funds, as set forth in the budget approved by NWH.

In addition, travel costs are allowed as part of an approved budget if they are necessary for project execution or dissemination (e.g., for sample collection, collaboration meetings, or presentation of findings). All travel should be justified and aligned with the project goals.

For applicants/grantees who are notified that they have been selected for funding via Proposal Central or by a representative of NWH, an executed copy of the grant agreement is required to be submitted electronically to NWH within ten (10) days of such notification. If the grantee does not timely submit the signed and completed grant agreement, the award will be terminated without activation. No funds will be paid toward the award.

Progress and financial reports are to be submitted to Proposal Central and/or directly to NWH (as determined by NWH) twice a year at six (6) months and twelve (12) months in the funding year; provided, however, that more frequent reporting may be required for certain grants and informal interim reports may be requested from time to time. Such reports should clearly outline key developments and challenges on milestones and show how funding was spent across budget areas and subcontracts.

Final progress reports are due within one hundred and twenty (120) days of the award end date (along with a final financial statement, as discussed in Section 24). Requests for renewal of the grant may be made six (6) months prior to the grant’s termination. Any extension of the grant term or issuance of an additional grant is subject to NWH’s discretion.

If relevant to the progress of the grant, the progress of the subcontract must be included on the grant’s overall progress report. A separate progress report for the subcontract should not be submitted, unless stated otherwise in the grant agreement.

The contact PI/collaboration director must submit one overall semi-annual or Final progress report for the entire project, even if the project has PIs at different institutions, unless stated otherwise in the award letter.

Financial statements are due within one hundred and twenty (120) days following the end of each funding year, one hundred and twenty (120) days following the end date of the grant and/or within one hundred and twenty (120) days of the termination of an award, unless stated otherwise in the grant agreement.

Semi-annual financial statements may be required for certain grants and informal interim reports may be requested from time to time. Such reports shall be submitted with the progress and annual reports described herein.

Expenses must be reported in the award period the expenses are incurred. NWH does not allow negative expenditures.

All reporting to NWH must be denominated in USD. Using the institution’s normal practices for foreign currency exchange, expenses incurred in local currency should be reported back to NWH in USD and may not exceed the amount in USD awarded for any given annual award period. Any gains or losses due to exchange rate fluctuations will not result in increases or decreases to the total USD award amount. Underspending due to expected costs not being incurred remains subject to NWH’s carryforward and unspent funds policies.

NWH will not accept revisions under $500 to financial statements that were previously submitted and approved by NWH. NWH will accept revisions over $500 within one year of the due date of the financial statement only while the grant is active. NWH will not accept any revisions over one year of the due date of the financial statement or if the award is inactive and closed out.

Financial Statements can be accessed and completed online in the Budget section of the award on Proposal Central.

Financial statements must be submitted for each subcontract in a formal consistent with the grantee’s financial statements, with direct and indirect costs explicitly identified.

For grants with multiple MPIs at multiple institutions, separate financial statement must be completed online in the Budget section of the award on Proposal Central for each institution that receives funds directly from NWH.

After review and approval of the financial statement, NWH will email the grantee institution to request any unspent funds. Unexpended funds must be returned to NWH within ten (10) days of the request for unspent funds.

Grantees should not send a check for the unexpended balance until they receive an email from the NWH requesting the unspent funds.

Unless noted in the grant agreement, NWH will not be responsible for any expenditure made before funds are committed (i.e., the date the award letter is issued). Expenditures must be consistent with the approved budget. NWH is not responsible for unallowable expenditures, expenditures that are inconsistent with the approved grant proposal or research plan, or expenditures that exceed the total funded amount of the grant annually. If NWH, in its discretion, demands reimbursement of any such improper expenditures, the grantee shall be required to reimburse them.

Funds may be reallocated without prior approval within budget categories within a funding year in a manner consistent with the approved budget and grant proposal or research plan, unless stated otherwise in the award letter. Funds may not be moved across budget categories within a funding year without prior NWH approval. Reallocations may not exceed annual funding of the grant.

With respect to multi-year grants, subject to the approval of NWH, unspent funds will be carried over from one year to the next to use within approved budget categories toward the approved aims of the grant. However, as described herein, NWH, in its discretion, may terminate a grant agreement or require a reimbursement of unexpended funds if such carry-forward is the result of a failure of the grantee to perform.

In the event of a carryover of funds, the schedule of payments set forth in the grant agreement may be subject to amendment.

NWH has the right to request and receive from the grantee and/or PI(s), or review during a site visit, copies of any and all documents including research records and other information related to the grant at any time during or after the term of the grant for up to four (4) years following the year in which all grant funds are fully expended, unless specified otherwise in the grant agreement.

As a condition of accepting the award, the grantee agrees to maintain books and records documenting the expenditure of NWH grant funds in accordance with customary accounting procedures. NWH reserves the right to review all financial books and records of the grantee institution and PI related to the grant and to perform an audit or other accounting procedures of all expenses related directly or indirectly to the grant.

Research records are materials that document the research effort for laboratory research, animal research and clinical trial research. These may be electronic or hard copy, such as various forms of logs, notebooks, correspondence, libraries, videos, computer databases or records, audio or digital records, or even the actual products of experiments, such as gels. In addition to maintaining accurate and complete research records for data analysis, all records relating to the conduct of the project are important, including those that document the management of the research funds and the intellectual property.

Although not an inclusive list, research records typically include:

• Laboratory research: lab notes, notebooks, computer databases, microscopic slides, gels, images, photos, videos, laboratory equipment printouts and records of statistical and other data analysis.
• Animal research: protocol binders that include Institutional Animal Care and Use Committee (“IACUC”)–approved protocols with all approved modifications, animal health records, surgical or treatment records, breeding records, drug records and research data files.
• Human research including de-identified metadata and biosamples with details of processing, storing and use.
• Clinical trials: regulatory binders that include Committee on Human Research (“CHR”) approvals, protocols, informed consent documents, monitoring reports, adverse event reports and other documents pertaining to sponsors, drugs and devices. Other clinical records can include records for research data, data analysis, audio and videotapes of subjects, images of subjects and any other type of record that can identify persons from whom those data were collected.
• Funding: records and correspondence relating to the grant financial records, purchasing records, scope of work, budgets and service records.
• All correspondence with granting agencies, institutions and collaborators.

In addition, any clinical trial must be registered with the ClinicalTrials.gov Protocol Registration and Results System (PRS), found here: https://register.clinicaltrials.gov/.

Site visits and evaluations may occur for any NWH grant. Grantees will be notified in advance of an upcoming on-site evaluation, which shall occur at a mutually agreed-upon time. Payments for subsequent funding periods may be tied to the evaluation results.

NWH, with reasonable notice to the grantee and accommodating the grantee’s scheduling conflicts, shall require the grantee to participate in NWH’s annual meeting and further may require additional reporting or require the grantee to participate in telephone conferences, or presentations.

In no event shall the PIs and related personnel be deemed to be employees of NWH. Nor shall any grantee and NWH be deemed to be joint employers or operating as part of a single enterprise for any reason. Further, where employees are involved, it is the responsibility of the grantee to ensure compliance with all applicable employment laws. If consultants are engaged, the grantee shall be responsible for ensuring that they are properly classified as such. In the event of a conflict between this section and any section that deals more specifically with employees, the more specific section should apply. NWH defers to the institution’s policies with respect to its employees’ parental or personal leaves or other employment matters.

Any changes to the original grant proposal, research design and/or specific aims require a formal request and prior written approval by NWH before implementation (which changes may be uploaded to Proposal Central). Minor adjustments in approach do not require written approval; however, they should be communicated to NWH staff and further documented in the Progress Report. Changes without prior written approval may result in suspension of payments, early termination of the grant and/or reimbursement to NWH of any expended or unexpended funds.

With approval by NWH, NWH PIs may transfer their grant and related project to a new institution, provided that both the old and new institutions agree to the change of institution. If NWH does not approve the transfer by a NWH PI to a new institution, or, if the new institution does not agree to the grant agreement, NWH may, in its discretion, terminate the grant agreement. The following documentation is required for a change of grantee institution.

Required from the original institution:

• A transfer request form signed and submitted by the institution’s SO, which must state the reason for departure, plans for continuation of the project (including personnel), confirmation that the transfer will not alter the project’s plans and an effective date of transfer.
• A Financial Statement completed online in the Budget section of the award on Proposal Central. Unexpended funds, if not transferred to a new institution, must be returned to NWH within ten (10) days following the successful submission and approval by NWH staff of the Financial Statement.

Required from the new institution:

• A transfer request form signed and submitted by the institution’s SO. The request must confirm the PI’s appointment at the new institution and indicate the new institution’s support for the project (in the form of funds, personnel or otherwise), the PI start date, any changes in personnel, and the updated contact information for the PI, SO and FO. The web form can be accessed and completed online in the Deliverable section of the award on Proposal Central.
• A renewable reagents and data sharing agreement, if applicable. The agreement must be uploaded to the web form as a PDF.
• A budget for the remainder of the funds. The budget must be uploaded to the web form as a PDF.

Change of institution approval
Once NWH has approved the change of institution web forms from both institutions, NWH will send a close-out letter to the original institution and a grant agreement to the new institution for countersignature. Upon receipt of the countersigned grant agreement, unexpended funds received from the original institution will be made payable to the new institution.

As described herein, changes in key personnel may be the basis for the termination of a grant and a refunding of unexpended grant funds to NWH. In NWH’s discretion, a change in PI or other key personnel will be approved. All such changes require a formal written request, which must be signed and submitted by the institution’s SO. The form must state the reason for the personnel change and provide verification of the new person’s eligibility, qualifications and availability and a description of how the change will affect the scope of work, implementation and timeline of the research project. The new PI’s curriculum vitae and/or biosketch must be uploaded to the web form. The web form must be submitted to the Deliverables section of the award on Proposal Central. For the avoidance of doubt, if an institution does not permit the NWH-approved PI to receive the grant, any alternative PI at the institution must be approved by NWH as described in this Section.

Changes to the grant proposal in percent effort of project or key personnel shall require prior request and the approval of NWH. All such changes require a formal written request, which must be signed and submitted by the institution’s SO.

In the event that NWH terminates the grant for any reason, NWH will not be responsible for new obligations after the effective date of termination or suspension and the grantee must cancel as many outstanding obligations as possible. NWH will allow full credit to the grantee for NWH’s share of otherwise approved and allowable costs if the obligations were properly incurred by the grantee before suspension or termination — and not in anticipation of it — and, in the case of termination, are not cancelable.

All early terminations require, within one hundred and twenty (120) days after the effective date of termination, the submission of a final report, a final financial statement, and within ten (10) business days of the submission and approval of the final financial statement, a check for any unexpended funds after withholding any costs that were not cancelable.

To close out a NWH grant, the grantee must submit the following:

• Final progress report via Proposal Central, due within one hundred and twenty (120) days of the end date.
• Final financial statement via Proposal Central, due within one hundred and twenty (120) days of the end date.
• Unexpended funds must be returned to NWH within ten (10) days following the successful submission and approval by NWH staff of the final financial statement (no funds should be returned until NWH has approved the Financial Statement and requested the refund).
• Unexpended funds must be returned via a check made payable to “Nuttall Women’s Health” and mailed to the attention of:

[Grants Payment Manager]
Nuttall Women’s Health
1285 Madison Avenue
New York, NY 10128

Upon receipt and approval of all deliverables and refund, if applicable, NWH will email via Proposal Central the PI and institution to notify them that the award is closed out.

Please reference the PI’s name, the title of the grant and the Proposal Central Award ID in all post-award correspondence with NWH.

For payment related questions:
[email protected]

To update contacts:
[email protected]

For all other inquiries:
[email protected]