Forms, Policies & Procedures

NIH Genomic Data Sharing Policy

The National Institutes of Health (“NIH”) has issued NOT-OD-24-157 which implements heightened security requirements for controlled-access human genomic data, effective January 25, 2025. The updated NIH Security Best Practices for Controlled-Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy (“NIH Security Best Practices”) requires compliance with NIST SP 800-171 Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations (“NIST SP 800-171”) for accessing, handling, and storing applicable datasets.

The NIH Genomic Data Sharing Policy (NOT-OD-14-124) issued in 2014 sets forth the federal agency’s expectations for the sharing of large-scale human and non-human genomic data. It is important to note that the new NIH Security Best Practices is only applicable to human genomic data accessed from an NIH controlled-access repository (“Covered Repository”) listed here.

Beginning January 25, 2025, NIH Security Best Practices will apply to NIH competing and continuation proposals which include proposed access to human genomic data in a Covered Repository; the security requirements should be taken into consideration when preparing a Data Management and Sharing Plan. The heightened security requirements will also apply to new and renewed NIH Data Use Certification Agreements (“DUCAs”) for access to the controlled data.

Applicable awards will include an award term requiring NIH Security Best Practices. Investigators who are approved to access controlled datasets (“Approved Users”) must secure the human genomic data in compliance with NIST SP 800-171, and a Technology Control Plan (“TCP”) must be established at UD prior to accessing the controlled data. Please submit TCPs to the Research Office for review and approval.

Approved users will also be required to attest to protecting the controlled data in accordance with NIST SP 800-171. Approved Users utilizing a third-party IT system and/or cloud service provider for data analysis and/or storage must provide NIH with an attestation affirming that the third-party system is compliant with NIST SP 800-171.

NIH Security Best Practices requirements do NOT apply to the following:

• Existing NIH DUCAs unless renewed on or after January 25, 2025. Approved Users operating under an existing DUCA signed prior to that date may continue under the terms of access and data security standards detailed in the agreement until the project ends or the DUCA is renewed.
• Data repositories not included in the list posted here.
• Large-scale human genomic data generated by UD as part of an award and stored either by UD or a third-party vendor.
• UD systems which do not interact with the controlled data.

Approved users may utilize UD’s third-party vendor for NIST SP 800-171 compliance, TetherView, which provides a cloud-based virtual environment for information security. TetherView’s monthly data management fee is $125 per user.

Questions? Please contact RO-Agreements@udel.edu. Additional NIH learning resources are available here.

Related Links

• NOT-OD-24-157

The complete policy and more can be found on the NIH’s web site.

NIH Manuscript Submission Portal

1. Deposit Files:
   Anyone can submit; however, an author or PI should serve as the reviewer. Reviewers are notified of submissions via e-mail.
2. Initial Approval: Reviewer associates funding and approves the material for processing.
3. NIHMS Conversion:
   NIHMS converts complete deposits to PMC-ready documents and notifies the reviewer via e-mail when they’re available. (approx. two to three weeks)
4. Final Approval:
   Reviewer requests corrections to, or approves, PMC-ready documents for inclusion in PMC.
5. PMCID Assigned: A PMCID is assigned when Final approval is complete and the manuscript is matched to a PubMed Record.

The NIH Manuscript Submission (NIHMS) system supports the deposit of manuscripts into PubMed Central (PMC), as required by the public access policies of NIH and other participating funders.

NIH Manuscript Submission Requirement Addendum

This intellectual property form helps to manage, record and protect the intellectual property generated by research done at the University of Delaware. For more information regarding intellectual property and research, please refer to the Regulatory Affairs page. If there are specific questions, please contact Regulatory Affairs at 302-831-2136.

Related Links

• NIH Manuscript Submission Requirement Letter
• NIH Manuscript Submission Requirement Addendum

NIH Manuscript Submission Requirement Letter

This intellectual property form helps to manage, record and protect the intellectual property generated by research done at the University of Delaware. For more information regarding intellectual property and research, please refer to the Regulatory Affairs page. If there are specific questions, please contact Regulatory Affairs at 302-831-2136.

Related Links

• NIH Manuscript Submission Requirement Letter
• NIH Manuscript Submission Requirement Addendum

Non-governmental Research-related Agreements

1. SCOPE OF PURPOSE

   To facilitate the handling and administration of small grants, research and service contracts which do not require federal compliance.

2. POLICY
   College Deans, the Director of DBI, and, with written approval, heads of other academic units which report directly to the Provost or Vice President for Research, Scholarship and Innovation have the authority to enter into and administer certain contracts/agreements that have total dollar amounts up to $50,000. This authority is limited as follows …

The complete policy and more can be found on the General Counsel’s web site.

NSF Two-Month Rule Policy

As a general policy, NSF limits the salary compensation requested in the proposal budget for senior personnel to no more than two months of their regular salary in any one year. It is the organization’s responsibility to define and consistently apply the term “year”, and to specify this definition in the budget justification. This limit includes salary compensation received from all NSF-funded grants. This effort must be documented in accordance with 2 CFR § 200, Subpart E, including 2 CFR § 200.430(i). If anticipated, any compensation for such personnel in excess of two months must be disclosed in the proposal budget, justified in the budget justification, and must be specifically approved by NSF in the award notice budget.

Under normal budgeting authority, a grantee can internally approve an increase or decrease in person months devoted to the project after an award is made, even if doing so results in salary support for senior personnel exceeding the two-month salary policy. No prior approval from NSF is necessary unless the re-budgeting would case the objectives or scope of the project to change.

University Post-Award Guidance

By this policy, NSF intends to limit the amount of funds institutions request from NSF, and therefore the amount NSF will award. Departments should review the proposal budget, budget justification, and award notice to confirm if compensation in excess of two months was already approved within the NSF award. If not already approved and additional effort in excess of two months is required to successfully address the research aspects of the proposed project, submit a re-budget request for internal approval. NSF prior approval is necessary if the objectives or scope of the project change.

Although the NSF two-month rule identifies the salary limit as applicable to “any one year”, for award expenditures UD has defined the year as September – August. Departments should routinely reconcile budget versus expenses, and conduct an annual fiscal review of salary expenditures for the one year period (September – August). Lack of approval and appropriate justification can lead to removal of the salary in excess of two months.

Related Links

NSF Proposal & Award Policies & Procedures Guide (PAPPG)

The complete policy and more can be found on the UD Research Office’s web site.

Occupational Exposures to Hazardous Chemicals in Laboratories

1. SCOPE OF PURPOSE
   To ensure all activities related to the use of hazardous chemicals in laboratories are conducted in a safe manner as well as in compliance with OSHA regulations as specified in 29 CFR Part 1910.1450. …

The complete policy and more can be found on the General Counsel’s web site.

Outside Employment

1. SCOPE OF POLICY
   This policy addresses employment outside of the University and applies to all exempt and non-exempt employees.
2. POLICY
   The first duty and responsibility of University employees is to render to the University the most effective service possible. No outside service should be undertaken that might interfere with the discharge of this prime responsibility or bring the employee into conflict with the interests of the University.

   The University will assume no responsibility for outside services rendered by eligible employees, and it must be made clear to any person with whom the University employee works that the work has no official connection with the University. …

The complete policy and more can be found on the General Counsel’s web site.

Patent Policy

A patent for an invention is the grant of a property right to the inventor, issued by the U.S. Patent and Trademark Office. Generally, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States or, in special cases, from the date an earlier related application was filed, subject to the payment of maintenance fees. U.S. patent grants are effective only within the United States, U.S. territories, and U.S. possessions. Under certain circumstances, patent term extensions or adjustments may be available.

The right conferred by the patent grant is, in the language of the statute and of the grant itself, “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. What is granted is not the right to make, use, offer for sale, sell, or import, but the right to exclude others from making, using, offering for sale, selling, or importing the invention. Once a patent is issued, the patentee must enforce the patent without the aid of the U.S. Patent and Trademark Office.

Throughout the world the first party responsible for filing a patent application is the undisputed owner of the invention. The United States has a one-year time period to file a patent application. This period begins at the formal presentation of the invention. A formal presentation of an invention includes any publication, journal, conference presentation, poster session, newspaper article, Internet publication on a Web page, blog, listserve, etc. In most other countries, you are banned from obtaining patent protection once an invention has been publicly disclosed.

You must file in the United States within one year of the first disclosure of the invention — filing of a provisional application may protect international rights.

It takes an extended period of time to obtain a patent. The patent application can be kept secret while it is pending if you request it; otherwise, it is published by the U.S. Patent and Trademark Office 18 months after filing.

Related Links

• United States Patent and Trademark Office
• USPTO guide to types of Patents
• University of Delaware Intellectual Property Policy
• USPTO: Laws, Regulations, Policies, Procedures, Guidance, and Training

The complete policy and more can be found on the UD Research Office’s web site.

Personal Protective Equipment

1. SCOPE OF PURPOSE
   To establish personal protective equipment requirements for the University.
2. SCOPE AND APPLICATION
   This policy applies to all University personnel, contract personnel, and visitors in applicable University facilities and/or University operations. …

The complete policy and more can be found on the General Counsel’s web site.

PI Eligibility

Principal Investigators and Co-Principal Investigators have primary institutional responsibility for providing scientific/technical leadership and administrative and financial management of sponsored projects. As such, the University has designated the following personnel as eligible to serve as Principal Investigator or Co-Principal Investigator on sponsored projects*:

• All full-time faculty regardless of academic rank
• Visiting faculty/visiting scientists during the time they draw salary support for the performance of the sponsored project through the University
• Adjunct faculty during the time they draw salary support for the performance of the sponsored project through the University
• Full-time, academic non-administrative professionals in classified positions at or above Level 31E
• All full-time postdoctoral fellows* and researchers
• Under exceptional circumstances documented in writing, other qualified individuals may be designated as a PI. Such designation requires the approval of the Vice President for Research, Scholarship and Innovation, and must be endorsed by the chair of every unit and the dean of every college in which the research project is to be performed. If granted, this PI designation is limited to the proposed research project under consideration, i.e. it does not afford blanket status to serve as a PI on other proposals. To qualify for an exception, the following criteria must be met:
• Only individuals identified to the external sponsor as a PI or CPI in the submitted proposal need to have the PI eligibility approval form completed
• The proposed research must be a programmatic priority of the University
• There must demonstrably be no qualified member of the UD faculty who is capable of serving or available to serve as the PI
• The proposed PI must possess the academic and experiential qualifications that are prerequisite to service as a PI at UD, and his or her participation as the PI must be demonstrably necessary for the successful funding and execution of the research project
• The proposal PI must enter into a signed contract with the University assuring that (a) the work will be conducted in accordance with the high standards of quality expected of all PIs; (b) the PI will comply with all University policies relating to the conduct of research; and (c) the research project will be conducted consistent with all federal laws, rules, and regulations relating to the conduct of research
• Completion of the Research Office PI approval form and submission of a curriculum vitae (CV)

* Principal Investigator/Co-Principal Investigator status may be rescinded for cause.

*A PI approval form is required to permit postdoctoral fellows to serve this role

If an exception is made to make someone an eligible PI and that person isn’t a full-time University employee, the chair or dean must be a co-PI on all proposals for that person.

Retired Faculty Serving as Principal Investigators

Some faculty members wish to continue their research programs after retirement from the University, but do not qualify for status as principal investigators because they are no longer full-time UD employees. Retired faculty members may apply for PI status using the existing Research Office PI approval form.

If the request is approved, retired faculty members may serve initially as co-PIs on proposals with a full-time faculty member as PI (this would typically be the department chair or another senior faculty member). If the proposal is funded and the retired faculty member is hired to work on that grant, he or she may then serve as the PI during the life of the grant. At the time of hiring, the retired faculty member may be appointed to an appropriate professional staff position (such as, for example, senior research fellow), but under no conditions may be re-hired on the faculty (as, for example, a research professor).

Graduate Students as Principal Investigators

The Research Office acknowledges the importance of permitting graduate students to lead sponsored projects where appropriate. There are several sponsors who offer pre-doctoral grants whereby the work is conceived of and carried out entirely by a graduate student. In these cases, a faculty member is identified as a mentor and oversees the project nominally. (examples: NASA: Harriett G. Jenkins Predoctoral Fellowship Program (JPFP), NIH: Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships (F31) to Promote Diversity in Health-Related Research, NIH: Predoctoral Training at the Interface of the Behavioral and Biomedical Sciences, DOE: The National Methane Hydrates R&D Program – Graduate Fellowship Program).

To that end, the eligible PI approval form may be used at the time of proposal routing to permit the graduate student to have this role. Also, please have the department administrators ensure the graduate student’s supervisor code is associated with a chair and dean code. This will allow the proposal approval web form to be routed appropriately. The required completed form must be sent to the Research Office at least ten (10) working days before the deadline for submittal of the proposal to the funding agency.

There are still other sponsors for whom the need for submission and approval from an Authorized Representative of the University is not required. The student may submit these applications directly to the sponsor without coordination with the Research Office or a PI eligibility form (examples include: NSF Fellowship, Ford Foundation Diversity Fellowships for Achieving Excellence in College and University Teaching).

If there are questions concerning which type of funding the grad student is applying, contact the Research Office for guidance.

Policy on Disclosure of Other Support

1. PURPOSE

   This policy addresses the federal requirements for disclosing Other Support (also known as Current and Pending Support) and applies to all University faculty, or potential Senior/Key Personnel on Sponsored Federal Research Projects. The National Institutes of Health requires institutions to have a policy and training on the disclosure of other support.

2. SCOPE OF POLICY

   To comply with the provisions of federal law, the Office of Management and Budget’s regulations, including 2 CFR 200, the Uniform Guidance, and other relevant sponsor requirements.

   To establish expectations with faculty and staff about other support information.

3. DEFINITIONS
   1. Other Support– All resources made available to Senior and Key Personnel in support of and/or related to all their research endeavors, regardless of whether or not they have monetary value or are based at the institution the researcher identifies for the current grant or contract. This includes resources and/or financial support from all entities, foreign or domestic, including, but not limited to, financial support for laboratory personnel and provision of high-value materials that are not freely available (e.g. biologics, chemicals, model systems, technology, etc.).
   2. Senior and Key Personnel – An individual who contributes in a substantive, meaningful way to the scientific development or execution of the scope of work of a project proposed to be carried out with a sponsor, whether or not they receive salary or compensation under the grant. This definition may include consultants, postdoctoral research associates, or other roles beyond Project Director or Principal Investigator/Co-Investigator.
4. POLICY STATEMENT
   1. It is the policy of the University of Delaware that all researchers who engage in sponsored projects will comply with federal law, university policies, and sponsoring agency requirements regarding the provision of information on other support documents.
   2. University of Delaware requires that every disclosure to an external funding agency of a researcher’s active, pending, or previous sources of support for research and other sponsored activities be current, accurate, and complete to the best of the researcher’s knowledge.
      1. This requirement applies regardless of the source of support, whether or not University of Delaware is the recipient of the support. For example, if a researcher with a joint appointment is listed as a principal investigator on a award to another institution, that must be disclosed in the other support.
      2. The requirement for disclosure applies at the time of proposal submission, prior to the award of support, as part of the annual progress report, and at any subsequent time the agency determines appropriate during the term of the award.
   3. It is the investigator’s responsibility to ensure the accuracy of other support documents for the project team, in accordance with the application guidelines or the sponsor’s instructions.
   4. False, fictitious, or fraudulent statements or claims (including intentional omissions) in violation of this policy are a violation of UD policy and may lead to disciplinary action and may result in sponsor administrative, civil, or criminal penalties.
5. POLICY STANDARDS AND PROCEDURES
   1. Research Office Website: UD Procedure/Guidance for Preparation of Other Support (Current and Pending Support)