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 […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
Please provide complete information on the HIPAA questions in new submissions
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, […]
Stacking documents and naming them correctly speeds study reviews
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 […]
Speed your study reviews by providing specific answers on the New Submission form
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 […]
A reminder about funding deadlines and IRB review times
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, […]
“Identifiers” and “PHI” are two different things!
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 […]
Don’t take HIPAA requirements lightly!
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 […]
Please don’t submit revised study documents with reportable new information forms
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 […]
“Internal Support” text box in CLARA new submission form
There’s an important text box in the CLARA new submission form’s “Basic Details” section. It follows the question “Which of the following support types will this study use?” and is triggered by selecting “internal support.” The text box directs you to “Describe your study support.” This response addresses important institutional needs. Both ACH and UAMS […]
Are you targeting a non-English-speaking study population?
The IRB has special requirements for investigators doing research projects designed to enroll non-English-speaking populations. PIs who expect enrollment of non-English speakers at the time of initial submission must submit translated copies of consent forms, study information sheets, brochures, diaries, and any other items that will be provided to subjects. The submission must also include […]