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Common IRB Submission Errors

PITFALLS TO AVOID TO PREVENT DELAYS IN THE IRB REVIEW PROCESS

 

Why It Matters?

Investigators are often concerned with the time it takes to obtain IRB approval. Taking appropriate steps to avoid common submission errors can decrease the average time to IRB approval by 8 - 30 days.  Accurate and complete submissions also help investigators avoid potential study non-compliance. In short, if a procedure or research step is not contained in your submission, you are not approved to do it. Conducting interventions, interactions or collecting data not detailed in your submission can result in non-compliance findings and loss of permission to use subject data.

See below for common pitfalls:

Inconsistency Between Study Submission Documents

Information provided is inconsistent between the following (e.g., sample size, duration of research procedures, description of risks):

  • Protocol (Local and Sponsor)
  • Consent Form(s)
  • Recruitment Materials
  • RSP Gateway Application

 

Incomplete Project-Specific Disclosure Forms

Disclosure of significant financial interests (SFIs) is required on a per study basis using the PSD Form.  Frequently, incomplete forms are submitted and must be returned to the PI for correction.  Common errors on this form include:

  • Submitting old version of form
  • Missing signatures or personnel (all active study personnel must have a completed disclosure on file via the PSD form)
  • Typed name instead of electronic or hand-written signature

 

Consent/Authorization Form Issues

Common errors include missing elements of consent, as well as typos and grammatical errors. The consent form should be written to the subject, not the IRB (i.e. 2nd person/you). It is recommended to use one of the available consent templates and/or check lists to ensure all elements are included. Templates and check lists are located on the Templates and Check Lists page.

If your research involves protected health information (PHI), the consent document must also include template HIPAA Authorization language that is customized (see highlighted sections in template) for your study.  If you are requesting to use non-template HIPAA Authorization language, your study submission must contain an additional copy of the consent form that highlights and numbers the required 6 elements and 3 statements as proof that the authorization section contains all required content.

 

Incomplete Local Protocols

If the local protocol does not contain enough information the IRB cannot make the required findings and determinations it needs to grant approval. It should contain specific details (what, where, who) such that a member of the research team would know exactly how to conduct the study after reading it along with the application itself.

Frequently, the IRB receives local protocols that are simply copied sections from the sponsor protocol with no information about how the study is going to be conducted locally. These study submissions are normally returned to the PI for corrections.

It is recommended that you use the local protocol check lists located on the Templates and Check Lists page.

 

Missing Investigator Credentials

All individuals who meet the definition of an investigator for the study must have up-to-date credentials to be able to be approved to conduct the research.  New study approval will not be granted until all investigators have met the credentialing requirements.  Wright State credentialing includes completion of CITI training modules, uploading a current CV to profile at least once every 3 years, and completing the annual research disclosure (conflict of interest) form in RSP Gateway. Please see the Training & Education page for current credentialing requirements.

 

Data Collection and Management Issues

The IRB is responsible for evaluating whether there are sufficient provisions in place to keep subject information confidential.  Data collection, management and storage processes need to be written in a detailed manner. How much detail? Like a recipe, the IRB should be able to independently conduct your research project based on the amount of detail provided.

 

Incomplete Amendment Submissions

Non-exempt research must be conducted exactly in the manner contained in the approved study documents.  Any changes must receive prospective IRB approval before being implemented. Frequently, investigators forget to amend and submit related study documents when submitting an amendment request.  For example, if changing a study procedure be sure to submit a clean and tracked-changed version of the local protocol along with the amendment form.

When requesting changes to previously amended documents, be sure to create a tracked-changed version from the last clean version, rather than add revisions to the previous tracked-changed version.  The IRB needs to clearly understand what changes you are requesting for that amendment to be able to make the findings needed for approval.

It is also helpful to label revised documents with an updated version number and date, as well as clearly label the file names with title, version number and date.  This makes it easier to identify the correct document from the submission table to review. These steps help keep the IRB record clear and consistent – which can help speed up the IRB review process.