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 […]
Blog
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 […]
“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 […]
A reminder to check notes and draft contingencies in CLARA
When reviewing studies, please remember to take a look at the notes and draft contingencies already entered into CLARA by the office staff. We use these CLARA functions to indicate areas that we think need may need additional input by the IRB, and to note draft contingencies the IRB may want to consider. Please note […]
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 […]
Reopening a closed study in CLARA
The Study Resumption form is now available in CLARA to reopen a closed study. The form will ask why the study was closed and the reason for reopening it, whether there have been any protocol changes since it was last open, and whether any study activities have occurred since the closure. You will also have the […]