How To Distinguish Between Delayed Start and Delayed Onset in Human Subjects Research

Funding News Edition: April 21, 2021
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When planning an application that includes human subjects (HS) research that will not begin immediately, you might see two similar research terms—delayed start and delayed onset—which may cause some confusion. Make sure you understand the distinction between the terms, as a delayed-onset award has special application instructions.

Defining Types of Delay

  • Delayed start—you can fully describe your human subjects study in your application and include all required supporting documents with the application (or, for certain documentation, before award during the just-in-time process).
  • Delayed onset—you cannot fully define your human subjects study when you apply. You will need initial research results from the first phase to finalize plans for the human subjects study portion.

It’s important that you not confuse the two terms. If you are planning a delayed start to a human subjects study but wrongly mark it as a delayed onset study, your application will be missing important details which may negatively affect your score or result in a bar to award.

Conversely, if you are planning a delayed onset study but do not designate it appropriately, the automated application forms will require you to complete a full study record, for which you will need the research results you do not yet have.

What To Do Before You Apply

We strongly recommend that you talk to a program officer first about your potential delayed onset research and proceed only with his or her encouragement.

Additionally, check the funding opportunity announcement (FOA) for details that may allow, require, or prohibit delayed onset studies. Also, check with your institution to verify whether it allows delayed onset studies.

Apply for Delayed Onset Research

First, applicants must complete the human subjects questions on the G.220—R&R Other Project Information Form and then fill out the G.500—PHS Human Subjects and Clinical Trials Information form.

Follow the SF 424’s Delayed Onset Study instructions to complete the required Delayed Onset Study Justification attachment. Be explicit about the information you need to collect before you can develop definite plans for the involvement of human subjects: factors affecting the availability of the information, why that information is not currently available, and when the information is expected to become available during the course of the projects. If you are planning multiple delayed onset studies, address all of the included studies in a single justification attachment.

If your study meets NIH’s Single Institutional Review Board (sIRB) Policy for Multi-Site Research, you must include information about how the study will comply with the policy and provide a statement naming the sIRB of record in the just-in-time submission before award. Additionally, if your study meets the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, you should include a Dissemination Plan as part of your justification attachment.

Your justifications can affect your overall impact score. If you don’t sufficiently justify why your study is delayed onset, your application may receive an HS Code 48 restriction to award for human subject concerns. If the application is missing this or other required attachments, your application will be considered incomplete and returned without review.

It’s important to note that applicants will not select “Add New Study” and complete Section 3—Protection and Monitoring Plans for a delayed onset study because they are not able to fully define research plans for the human subjects study at the time of application.

Instead, select “Add New Delayed Onset Study” and in your Delayed Onset Study Justification attachment, discuss what information you will need to assemble human subjects protection and monitoring plans for the delayed onset study.

Finalize Delayed Onset Plans Before Proceeding With Research

After award, you must submit updated, detailed human subjects documentation and confirm NIAID’s approval before beginning the human subjects portion of your research.

Have your institutional business official send a request to your grants management specialist, with your program officer copied. List the complete grant number in the subject line of the email.

Make sure to include the following:

  • Certification that key personnel have appropriate education in the protection of human subjects
  • Federalwide Assurance (see NIAID’s Human Subjects Federalwide Assurance SOP)
  • Certification of IRB approval of the IC-approved plans for human subjects
  • Any other information required by the FOA or your Notice of Award

Remember, we must receive your prior approval request at least 30 days before any human subjects research takes place. NIAID personnel will then review your request. Upon approval, grants management staff will lift the term of award that restricted human subjects research.

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