We often get calls from researchers asking about the status of a modification or contingency response they submitted weeks ago. However, these items aren’t submitted to the IRB unless you hit the “Review and Submit” button at the lower right of the browser window. This button can sometimes be hidden if your screen is not […]

Paying close attention to each question on the CLARA new submission form and writing responses that include the specific information requested will help your study get through the review and approval process faster. Each new submission form query addresses a key piece of information that either the IRB or another institutional office needs to approve […]

The IRB asks that all materials used to recruit study subjects be submitted to the IRB before use. These materials include items such as recruitment flyers and brochures and the content of any advertisements, letters, emails, or social media postings that will be seen by potential participants. The IRB will review these materials to ensure […]

CLARA’s new submission form includes a section specific to HIPAA. If you indicate that you will be accessing existing PHI for your project, you will be asked to “Describe the PHI that will be accessed for the research.” The IRB asks that you briefly summarize the specific information to be accessed, e.g. diagnosis, treatment history, […]

Please remember to stack the new document versions upon previous versions using the “Revise” button in CLARA when submitting revised items in a modification or contingency response.  Stacking items ensures that the newest version of each document can be easily identified and that the correct version will be listed in the approval letter. Please also […]

Each free-response question on the New Submission form requests specific information. We know that can be tempting to cut and paste text from the protocol or consent form in response to these queries, and we’ve noticed that some submission forms repeat the same cut-and-pasted response to multiple questions. Sometimes the answer to the question being […]

The IRB routinely receives submissions from PIs asking for approval before a certain date to meet deadlines imposed by a funding agency. If you are facing such a deadline, please note that the IRB review and approval process can take a month or more for a full-board review study (particularly if the IRB has contingencies, […]

The IRB’s new submission form asks about the protected health information, or PHI, that is going to be accessed or collected as part of the research. PHI is information that identifies the individual and that relates to past, present, or future physical or mental health; provision of health care services; or payment for the provision […]

If your study is subject to the HIPAA regulations, please make sure to carefully follow all HIPAA-related requirements. Use of protected health information without the appropriate regulatory safeguards in place can jeopardize your entire study and result in a breach that must be reported to all affected subjects, and possibly to federal oversight offices as […]

Sometimes events that prompt a reportable new information submission in CLARA indicate a need to change a protocol or consent form. Please note that the IRB cannot approve revised documents submitted with a reportable new information (RNI) form. Instead, we ask that you submit a separate modification form to revise study documents, even if the […]