Forms, Policies & Procedures

Medication and Drug Use and Distribution

1. PURPOSE
   To outline the policy pertaining to the use and distribution of drugs and pharmaceuticals at the University.
2. POLICY
   No legend medications (drugs which require prescription) can be purchased, stored, packaged, or dispensed at the University of Delaware by anyone except persons authorized to do so by State and Federal regulations, for example, physicians, nurses acting under direct supervision of physicians, and pharmacists. This does not preclude the use of prescribed medications or over the counter (OTC) medications intended for the specific (individual) use of a patient (students and/or staff).

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

Memorandum of Understanding (MOU)

This is a template for a “Memorandum of Understanding (MOU)” agreement between the University of Delaware, a nonprofit institution of postsecondary education chartered under the laws of the State of Delaware, with its principal place of business in Newark, Delaware.

Mentoring Statement for Postdoc

Consistent with institutional tradition and federal government requirements and recommendations, postdoc mentoring activities at the University of Delaware (UD) are designed to enable postdocs to gain knowledge and skills of value in preparation for careers as independent researchers; including careers as faculty members in research-intensive university environments. The mentoring activities are developed specifically for individuals by lead
researchers and are tailored as appropriate for their fields. The UD Research Office (RO) is available to provide supporting materials and/or instruction to assist lead researchers. Typically, individual postdoc mentoring activities incorporate the guidelines that are suggested in the National Science Foundation Proposal and Award Policies & Procedures:

1. Career counseling,
2. Training in the preparation of grant proposals,
3. Publications and presentation,
4. Guidance on ways to improve teaching and mentoring skills,
5. Guidance on how to effectively collaborate with researchers from diverse backgrounds and disciplinary areas, and
6. Training in responsible professional practices.

Lead researchers typically conduct several activities that comprise a substantial portion of the mentoring experience for postdocs. The incorporation of regular laboratory meetings and seminars, regular individual meetings, and manuscript and proposal writing are frequently seen elements.

“Traditional” mentoring activities can be enriched by postdoc participation in RO sponsored workshops that address
1) the basics of proposal writing,
2) the Responsible Conduct of Research (expanded to address mentor/trainee responsibilities), and 3) quantitative andqualitative assessment of University activities.

Lead researchers are encouraged to work with the RO and other UD support units to broaden the impact of their postdoc mentoring activities in two areas. First, UD promotes the broadening via the identification and facilitation of opportunities for postdocs to mentor undergraduate-scholar researchers who are part of groups such as the UD Undergraduate Research Program or minority scholar programs like the McNair Scholars. Second, where applicable, the broadening of the impact is further enhanced at times by the University’s encouragement and facilitation of the application of postdoc-research “by-products” to outreach activities such as the consideration (or improvement) of current societal issues.

Although supported by University research infrastructure (such as the RO), it is important to note that the mentoring of postdocs is individualized (including those activities aimed at broadening impact) and is developed, conducted and overseen by the postdocs’ lead researchers.

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

NASA’s China Funding Restriction Certification Template

The federal Appropriations Acts which fund the National Aeronautics and Space Administration (NASA) include a prohibition regarding the People’s Republic of China (PRC). This restriction prohibits NASA and the White House Office of Science and Technology Policy from funding any joint scientific activity with the PRC. Since the federal restriction was implemented in 2011, NASA has included terms in grants, contracts and solicitations stating that proposers and award recipients may be ineligible for funding if the NASA project includes bilateral involvement of China or Chinese owned companies.

The China restriction on NASA funding originated in Public Law 112-10 (2011) and has been included in each subsequent U.S. Consolidated Appropriations Act.

In order to verify there will be no bilateral involvement of the Chinese government or Chinese-owned companies, the University of Delaware requires that a certification form be completed by every member of UD senior/key personnel prior to the submission of each NASA proposal. This applies to both proposals in which UD is serving as the lead or as a subrecipient. The signed form(s) should be uploaded to the UD proposal record as an attachment named “2#A#####_NASA_Cert” at the time of routing the proposal.

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

NIH Salary Cap Calculator

In order to strengthen compliance with the National Institutes of Health (NIH) Salary Cap, the Research Office has developed a tool to clarify and simplify the salary cap calculation. This tool is intended for use by both department administrators and the Research Office Post Award team to monitor cap compliance during the life of the project and close out at the end of the project. Final determination of salary JVs to move direct salary to cost share in the case of cap overage will be made by the Research Office using the calculator in coordination with the department. Click here for instructions on how to use this calculator or visit Research Training for additional information on this resource

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.