Research News and Tips
Draft guidance on protocol deviations
A draft FDA guidance on protocol deviations has been posted for comment. This guidance contains, among other tidbits, proposed definitions for “important protocol deviation” and “protocol deviation.” The guidance touches on considerations that might minimize protocol deviation occurrence, such as careful protocol design that allows appropriate flexibility, and offers information about reporting and reviewing deviations. […]
Read moreResearch around the world
Will any part of your research project take place outside the United States? If so, the federal Office for Human Research Protections International Compilation of Human Research Standards may be of help. The most recent iteration collects in one place relevant research regulations and standards from around the world, sorted by geographic location. This information […]
Read moreDraft “tissue biopsy in research” guidance
The FDA has released for comment a draft guidance about the inclusion of research-specific biopsies in research. The draft guidance addresses the issues of risk v. benefit and informed consent, and outlines the differences between adult and minor patients when it comes to research-specific biopsies. It outlines some of the considerations investigators and IRBs must […]
Read more“Can we use these data?”
“Can these data be used?” is a question the IRB finds itself considering every now and again. It usually comes up when there has been some kind of problem on a study – say, data were collected after continuing review expired, or before a complete consent process occurred. The answer to this question, however, is […]
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Institutional Review Board Members Blog
Draft guidance on protocol deviations
A draft FDA guidance on protocol deviations has been posted for comment. This guidance contains, among other tidbits, proposed definitions for “important protocol deviation” and “protocol deviation.” The guidance touches on considerations that might minimize protocol deviation occurrence, such as careful protocol design that allows appropriate flexibility, and offers information about reporting and reviewing deviations. […]
Read moreResearch around the world
Will any part of your research project take place outside the United States? If so, the federal Office for Human Research Protections International Compilation of Human Research Standards may be of help. The most recent iteration collects in one place relevant research regulations and standards from around the world, sorted by geographic location. This information […]
Read moreDraft “tissue biopsy in research” guidance
The FDA has released for comment a draft guidance about the inclusion of research-specific biopsies in research. The draft guidance addresses the issues of risk v. benefit and informed consent, and outlines the differences between adult and minor patients when it comes to research-specific biopsies. It outlines some of the considerations investigators and IRBs must […]
Read more“Can we use these data?”
“Can these data be used?” is a question the IRB finds itself considering every now and again. It usually comes up when there has been some kind of problem on a study – say, data were collected after continuing review expired, or before a complete consent process occurred. The answer to this question, however, is […]
Read moreWant to read more stories like these?
New to Research or to the UAMS Institutional Review Board?
Hints to Get Your Studies Approved Faster
Yes, the UAMS Institutional Review Board looks at the big things when it reviews studies — are risks to subjects minimized? Are there appropriate provisions for obtaining the informed consent of subjects? etc. etc. But the little things can also slow down your study’s trek towards Institutional Review Board approval. Have you tracked your changes in […]
Read moreHow Do I Submit Something to the Institutional Review Board? FAQs
We get a lot of queries from people who are new to research asking about how to submit something to the UAMS Institutional Review Board. Here is a rundown of the most frequently asked questions related to Institutional Review Board submissions, and their responses. Does my project need Institutional Review Board review? Submit a human […]
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