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:
Blog
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 […]
New email for single IRB use
If you’re planning to lead, or join, a multisite study that uses a single IRB to oversee all sites, please let us know by sending an email to singleIRB@uams.edu. Single IRB review works two different ways. The UAMS IRB can serve as the IRB of record for a multisite study, in which other cites cede […]
CLARA is the entire Institution’s Research Submission System
When creating a new CLARA submission, please remember CLARA sends studies to several administrative offices, and not just to the UAMS IRB. In fact, the IRB is the last place your study will go once you’ve “signed and submitted” it in CLARA. Pharmacy, legal, hospital compliance, Research Regulatory Affairs, and biosafety are just some of […]
Tuskegee, and a whistleblower
A recent Washington Post article and podcast got us started looking around for more information about the notorious Tuskegee experiment, which, according to the Post author, “destroyed the trust many African Americans held for medical institutions – a legacy that persists today.” Clicking around the internet for more information led us to an American Scholar […]
Returning individual results to subjects, in 300+ pages
Considerations and recommendations for returning individual results to human research participants are the focus of a newly released report by the National Academy of Sciences. The full report exceeds 300 pages, but the executive summary runs to a much more manageable 27 pages. The NIH’s Office of Science Policy has a blog item about the […]