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Why Was My Research Submission/Protocol Deferred? And What Should I Do?

Why Was My Research Submission/Protocol Deferred?

Research submission/protocols are deferred when the Board is unable to determine that the regulatory criteria for approval are met (21 CFR§56.111 and 45 CFR§46.111). The institutional review board (IRB) needs adequate information to fulfill its regulatory responsibilities and to ensure that the rights and welfare of human subjects are protected. WCG’s IRB has identified two broad types of deficiencies which frequently lead to the IRB’s inability to determine the Criteria for Approval are met:

  • Regulatory status of the test article(s) is/are not provided, and
  • Submitted protocol information is incomplete.

Insufficient Regulatory Status Information

The first category includes missing or insufficient regulatory status information about the test article utilized such as: drugs, vaccines, biologics, medical devices, combination products, dietary supplements, or human cells, tissue, and cellular and tissue-based products (HCT/Ps).

Submissions Involving Drugs, Vaccines or Biologics That Do Not Have an IND from FDA

If an investigational drug, vaccine, or biologic is being evaluated for safety and efficacy, the study requires an investigational new drug (IND) application from the U.S. Food and Drug Administration (FDA) or an exemption.

The sponsor should provide the IRB with the IND number on a sponsor document, e.g., the protocol or a separate sponsor letter, an FDA letter with the IND number, or documentation from FDA that an IND is not needed. If the sponsor believes an IND application is not required, documentation of the rationale for not needing an IND, and the regulatory status that should be applied, is also needed.

Instructions for applying for an IND can be found here. In brief, complete a 1571, append the protocol, and if applicable, provide a rationale for not needing an IND, and submit that to FDA. By law, when a 1571 is submitted, FDA must respond within 30 days with a decision. Applying for an IND does not imply that an IND will be issued. FDA does not issue INDs if they are not necessary. If FDA determines that the research does not need an IND, FDA will issue a statement to that effect. If FDA considers an IND necessary, they may issue an IND or follow up for more information.

Submissions Involving a Medical Device

If a medical device is being evaluated in the research and is FDA approved (has a PMA #), cleared (has a 510k #), or is a Class I or Class II device exempted from pre-market review, and is being used in the research in a way that matches the indications on the FDA documentation, please provide the approval/exemption information.

If your device meets another exemption under the investigational device exemption (IDE) regulations, please provide a rationale for why your device qualifies as IDE exempt. 

Otherwise, if the device is investigational, the IRB must make specific determinations related to the risk of the device and whether an IDE or abbreviated IDE is required. You can either propose with a rationale why the device meets the abbreviated IDE requirements as the use does not present a significant risk, or obtain documentation from FDA.

There are two ways to ask FDA about potential or planned medical device studies. The first is to complete a study risk determination request through the Q-submission program. The FDA will give written documentation if they determine the study does or does not need an IDE. The other way is to apply for an IDE. By law, when an application is submitted, FDA must respond within 30 days with a decision. Applying for an IDE does not imply that an IDE will be issued. FDA does not issue IDEs if they are not necessary. If FDA determines that it is a nonsignificant risk device study, FDA will issue a statement to that effect. FDA may issue an IDE or follow up for questions. 

Additional information to provide related to specific types of products:

  • For investigational combination products, provide an FDA letter for the test articles with the IND or IDE number.
  • For HCT/Ps, consult the following FDA guidance’s to ensure that your product is regulated solely as a Section 361 HCT/P product and meets all the criteria stated in 21 CFR 1271.10(a) (1) to (4) as explained in the two guidance’s below. Provide a rationale either in the protocol or a separate memo for how the test article meets all the requirements of Section 361 as stated in 21 CFR 1271.10(a) (1) to (4). 
  • If your test article will be studied as a food or dietary supplement, provide supporting evidence from literature that the test article has been classified as GRAS (Generally Recognized as Safe) as appropriate. Refer to the guidance and search the FDA database for GRAS articles. Please include GRAS rationale and clearly stated claims in the protocol.
    • For dietary supplements, identify whether it is a new or previously known ingredient. Clearly state any structure/function claim in the research objectives or whether a structure/function claim is not valid with a rationale.  If you make claims in the protocol that the supplement or food prevents, mitigates, or treats a disease, the IRB will consider the test article to meet the definition of a drug which could lead to a deferral if you do not have an IND.

Insufficient Protocol Information

The second category includes protocols that are missing important information or are inadequately described. The following are some examples of common issues and how to resolve them:

  • The submitted protocol is labelled as a draft. The IRB requires final versions be submitted for review. Check to ensure there is no watermark or other indication the protocol is a draft. Also, ensure the final version submitted contains no redlining. While a separate redlined version is useful when there have been modifications, a final non-redlined version is needed for approval.

What Should I Do If My Research Submission/Protocol Is Deferred?

  • Review the Board’s concern, and if unclear, discuss via telephone or schedule a meeting with the Chair listed in the Certificate of Action for contact.
    • Address the Regulatory status of the test article, including provision of any FDA communication.
    • Revise the protocol as needed to clearly distinguish research and non-research procedures.
    • Clearly identify study population, especially any vulnerable population.
  • If general concerns regarding protocol content and format are raised, please refer to the whitepapers noted above.
  • Learn more about the submission process for IRB review and the Board’s determinations here.
  • Contact our client care team to help with the submission process:

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