Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 36, No. 6, June, 2021

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Excerpt from pg. 3 … IRBs and Subject Safety In Dry Eye Studies (#1)

“The relatively common condition usually referred to as “dry eye” can have serious consequences for those who suffer from it. As we will see below, this is especially serious due to the relative lack of adequate treatments for dry eye.

Experiments in this field pose special challenges for the IRBs that review applicable studies.

In this article, we begin our selective coverage of the highlights of the current relevant draft FDA guidance that is titled “Dry Eve: Developing Drugs for Treatment.”

We note that the FDA, in its brief summary notice below, underscores the importance of three major IRB review areas.

The purpose of this draft guidance is to foster greater efficiency in drug development for this disease, which currently has few effective treatment options.

The goal is to enhance clinical trial data quality and to support the development of treatments for dry eye conditions. …