Additional Considerations

Contents

Human Subjects Research Considerations

Does your research involve working with human subjects? Consult with the Human Subjects Division (HSD) as soon as possible by emailing  hsdinfo@uw.edu or by contacting the HSD staff team that works with your department.

• If the proposal is multisite, work with your administrator to contact HSD immediately.
• Take the IRB 101 Online Tutorial: This tutorial covers the basics of human subjects research and provides important practical information about navigating the IRB process at UW.
• Explore Zipline, the Human Subjects Division’s e-IRB system is your portal for viewing and managing all of your IRB applications. See Zipline Learning Resources and review the HSD Researcher Guide.

The following supporting pieces may be needed for your grant application, depending upon the funding agency and nature of your study.

Impact of Study Design and Methods

Consult with HSD if your research involves a randomized cluster design or emergency medicine studies that will require the Exception from Informed Consent. Your grant application may be improved by considering the specialized regulatory issues associated with these.

Human Subjects Section

1. Determine whether this section is necessary. Some activities that you may consider to be human subjects research do not meet the regulatory definition of “human subjects research” and vice versa. If you are not sure whether your planned research meets this definition, see this guidance.
2. If this section is required it should describe: risks and risk mitigation; consent process data security protection; plans (if any) for returning study results to subjects; and any other information required by the sponsor.

Data and Safety Monitoring Plan (DSMP)

A DSMP is required for clinical trials. See the ITHS website or visit the UW Libraries guide for creating a data management plan.

Plan for Addressing Requirements to Disseminate NIH Funded Clinical Trial Information

NIH grant applications must include a plan for how the PI will meet the expectations of the NIH policy.

Letter(s) of Support from HSD

A Letter of Support from HSD is appropriate for grants involving collaborative or multi-site research for which there will be a single Institutional Review Board (IRB) that reviews all of the sites (e.g., UW relies upon another IRB, or UW IRB serves as the single IRB) and for classified research.

Note: the UW IRB will not agree to be the single IRB for multi-institutional research unless HSD has been consulted and has agreed prior to grant submission. To request a Letter of Support, or HSD consultation, send an email to hsdrely@uw.edu.

Animal Welfare

Does your research involve animals? Your administrator and the UW Office of Animal Welfare (OAW) will need to meet with you to discuss:

• Capacity to work with the type(s) of animal that are identified in your research.
• Assistance in identifying and meeting space requirements for your animal work.
• Assistance with setting up protocols. The timeframe for getting a new protocol is often six months.

Environmental Health & Safety

There will be institutional as well as sponsor requirements regarding Environmental Health and Safety. Review the EH&S Introduction to Research Safety to introduce safety practices and compliance in your research space. Researchers and their teams should also plan and apply for all necessary authorizations:

• Biological Use Authorization
• Authorization for use of radiation
• Human Gene Transfer/Clinical Trial Submission
• Select Agent Registration
• Bloodborne Pathogen Program
• Animal Use Project Review

Calculate the quantity of hazardous materials needed for your research project early and determine whether the amounts needed are within the acceptable threshold on the eGC1.

Work with EH&S for evaluation and submission of animal research protocols and protocols involving biohazards for evaluation to determine medical surveillance and vaccination requirements of research staff.Review the EH&S Guide for Principal Investigators.

Your department administrator and EH&S will help you answer these questions:

• What decisions need to be made before you start the research?
• What are your space needs? Planning for facilities is essential, especially if you require a lab, insectary, animal cages, containers for materials, storage, etc.
• Does your research involve lab work with chemical substances? Discuss Biosafety concerns and/or hazardous materials.
• What kind of materials are you working with? Are there medical training requirements for your research staff?
• What training will be required for my research area? (Discuss EH&S Health and Safety Training)
• What are the requirements for fieldwork? (See Field Operations Safety)
• Are permits required? Reach out to other agencies such as Wildlife, USDA, and the Department of Energy who will approve your research activities.
• Develop a facilities plan including safety needs and plans for moving into your lab. EH&S must review and approve all facilities.
• EH&S will review your SOPs and protocols. Begin developing these when you receive a fundable score on your proposal

Limited Submission Opportunities

Many federal agencies and foundations offer grants, awards and fellowships that limit the number of applications that can come from one institution. The Office of Research maintains a list of limited submission opportunities with procedures that should be followed.

Multiple PIs

NIH Designation of Multiple PIs

Incoming Subawards

An incoming subaward is when another institution (pass-through entity) receives funding and issues a subaward to the UW (subrecipient) for a portion of the project.

Review instructions for preparing and routing incoming subawards.

Preparing Proposals with Outgoing Subawards

Start Early! Outgoing subawards involve multiple parties and systems.  Keep in mind, subrecipients have their own routing and approval procedures.  Clear deadlines and communication to subrecipients ensures documents signed by the subrecipient’s institutional official are received in time to route and submit the UW proposal.

1. 1. 1. Obtain subrecipient proposal documentation:
         • Letter of Intent (LOI) or subrecipient face page signed by authorizing official
           • NIH Proposals with International Subrecipients? See Sample Language for Letters of Support
         • Subaward Scope of Work (SOW) that includes background info/objectives and a clear description of the work to be performed
         • Detailed budget on prime sponsor budget form or spreadsheet
         • Budget Justification that ties specifically to the budget line items
      2. Provide deadlines for subrecipients that allow all sponsor and UW required documents to be:
         • Incorporated into UW proposal,
         • Attached to eGC1, and
         • Routed in time for GIM 19 deadlines.

Review UW Policy: Preparing a proposal that includes proposed subrecipients-GIM 7.

Industry Clinical Trials

Research involving industry clinical trials has a number of steps and other processes that require planning and preparation. Review more information on planning a proposal that includes Industry Clinical Trials.

Agreements

The UW uses a wide range of agreements in support of the UW mission. Review agreement considerations before entering into a contract with an outside party.

Training Grants

Review Guidance for NIH Institutional Training Grants.