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, […]
What’s in a Quorum?
You may have heard the word “quorum” used during IRB meetings. The dictionary definition of quorum is “the minimum number of members required to be present at an assembly or meeting before it can validly proceed to transact business.” While federal regulations describe the minimum requirements for IRB membership, they do not specifically define “quorum.” […]
“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 […]
Social Media Research and related ethical considerations
Imagine a research proposal involving deliberate manipulation of participants’ emotions. The investigator proposes to subtly influence the environment to see if these changes make people feel happier or sadder, and to see if participants alter their behavior as a result. Both the environment and behavior are arguably public, and when the participants initially entered this […]
A reminder to confirm your attendance at meetings
Please remember to respond to the email you receive asking whether you’ll be at your next scheduled IRB meeting. You’ll get an email from the office staff about 2 weeks before the meeting asking if you’ll be able to attend. A quick response to that first email is appreciated – that helps us plan assignments […]
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 […]
Industry-sponsored study? Be careful about recommending changes to the consent’s injury and costs sections
New submissions may be reviewed by several other offices before they ever reach the IRB. One of these reviews is done by legal staff, who negotiate with industry sponsors about, among other items, who will cover which costs associated with the study. Part of this negotiation includes nailing down the injury and cost statements in […]