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 […]

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 […]

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 […]

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 […]

If you are planning to add summer students or other new staffers to your study team, please remember to submit a staff change modification in CLARA. This form allows the IRB to confirm the new staffers have completed required training such as human subject protection training through citiprogram.org. In addition, other training and education requirements […]

When drafting informed consent forms, please make sure each page includes all the formatting elements required by IRB Policy 15.1. These include the protocol title or other specific identifier; the sponsor name; the institution where the research is being conducted; and page numbers and version date and number. These elements help researchers ensure that the […]

When submitting a study modification, please make sure that the proposed changes are clearly indicated. Some simple changes can be briefly described in the modification form and included in clean and tracked-changes versions of revised documents. However, more extensive changes may require more explanation and a separate summary. For example, if a sponsor has provided […]

Researchers often wonder how long they need to keep their study documents. Several different regulations address document retention, and it seems they all give different direction regarding how long to keep records. New UAMS Administrative Guide Policy 3.2.01 addresses record retention requirements for several different campus activities, including research. Please review this policy when making […]