18
Jun2018

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials," which was published in the Federal Register on April 9, 2018. PRIM&R suggests a few areas for further clarification, but generally applauds the agency for taking this important step to fill current regulatory gaps around the inclusion of pregnant women in FDA-regulated clinical trials and ultimately believes that the draft guidance will be of great benefit to relevant stakeholders, including industry, IRBs, and research subjects. Read more

13
Jun2018

Just a year or two ago most people didn’t even know what the term “wearable” meant. Today, they are one of the largest growing technology segments, and are predicted to continue growing exponentially. As this technology continues to improve, more uses are being invented and implemented, including in the realm of health care and clinical trial research. Read more

4
Jun2018

You are a member of an IRB that is reviewing a diagnostic study for a new viral disease, PVD, that, in exactly 50% of those infected, causes Polaiteir dementia. The PVD virus has infected the entire population. Dementia does not evidence itself until age 70. If detected before age 30, it can be treated successfully. The experimental test is believed to be 100% accurate in identifying who will get dementia. However, it has the unique “quantum” effect of flipping the medical condition of the person tested. A person who would not have gotten dementia will leave the test and later get dementia, and vice versa. In other words, the test itself will cure 50% of those tested, and give dementia to the other 50%. The test can be taken only once. In either case, study participants will learn whether they have the condition, and can then plan their lives accordingly. In addition, results from the study will tell the researchers how to end the quantum flipping effect. Read more

30
May2018

As we wrap up Member Appreciation Month, PRIM&R would like to highlight some of our members—individuals who work daily to advance ethical research on a daily basis. Today, we highlight Tyler Ridgeway, who works as the IACUC/IBC research compliance administrator at the University of Denver. Mr. Ridgeway shared with us what has shaped his professional experience so far and how PRIM&R events and programs connect him to the larger research ethics community. Read more

29
May2018

As we wrap up Member Appreciation Month, PRIM&R would like to highlight some of our members—individuals who work daily to advance ethical research on a daily basis. Today, we highlight Connor Bryant, Research Coordinator at Liberty University in Lynchburg, VA. Mr. Bryant shared with us what has shaped his professional experience so far and how PRIM&R events and programs connect him to the larger research ethics community. Read more

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