When making changes to study staff, please keep in mind the IRB cannot and will not review any revised documents submitted with staff-only modifications. Many staff changes can be made without revising any documents, which is why we created the “staff-only” modification form option. These “staff-only” changes can be reviewed and acknowledged by the IRB […]
Blog
Failure to disclose competing interest lands researcher on the front page above the fold
A New York Times piece that appeared in the printed paper Sept. 9 addressed what it termed a prominent researcher’s failure to disclose conflicts of interest in research publications. We know that appropriate disclosure is a typical requirement of conflict of interest management plans. Please click on the link above to read more. Update: The researcher […]
A very quick tour of the Revised Common Rule
We’re working furiously to prepare for the implementation of the Revised Common Rule, now scheduled for Jan. 21, 2019. Below is a recap of some of the more notable changes in the rule, followed by an explanation of how we anticipate incorporating those changes at UAMS. Please note this is only the tip of the […]
Reminder about IRB confidentiality
Please remember discussions that happen inside the IRB’s meeting room need to stay inside the meeting room. IRB determinations and contingencies are considered group decisions. Those decisions are relayed to the research team via correspondence through CLARA. Reviewers – If someone on a research team asks you for specifics about their project’s IRB review, please […]
Data and sample handling and storage tips for protocol drafters
We’ve noticed a few things in new submissions regarding data and sample handling and storage that slow down approvals. Here are some reminders of things to keep in mind when drafting protocols and CLARA completing new submission forms: UAMS Administrative Guide Policy 3.2.01 requires research data, reports, and analyses to be kept for “7 years […]
Just how finished does a study need to be before you close it?
Determining the appropriate time to close a study can be trickier than you might think. If you’ve completed your study and all that’s left is writing manuscripts and disseminating your findings, can you close the study in CLARA? How about if you’ve completed all your subject interaction and data collection, but have not finished analyzing […]
Consent form formatting hint — don’t split signature blocks
When the IRB reviews written consent forms, we try to keep in mind formatting issues that make it easier for study teams to ensure the forms are completed correctly. If you send us a consent form that has signature components split across pages (e.g. the subject signature on one page, and the subject signature date […]
Data requests must match what your IRB submission indicated
The Arkansas Clinical Data Repository managed by TRI is a valuable resource, allowing you relatively straightforward access to vast stores of patient data. We encourage researchers across campus to use this resource whenever possible for their studies. (Hint: Patient data can often be provided without identifiers, which could mean your study is not subject to […]
Trial halted after infant deaths
A study involving pregnant women and fetuses was terminated early in The Netherlands after the deaths of 11 neonates. We post this here as a reminder of some of the things the IRB has in the back of its mind when reviewing studies, and that investigators think about when they develop and join studies.
Right to Try versus Expanded Access — What’s what here?
There has been significant discussion lately about making it possible for patients to access drugs that are not yet approved for use in certain cases. Desperate patients might view this access as their last, best hope – even though the risks and benefits of these items are not yet fully known. Right to try laws […]