On July 20, the Office for Human Research Protections (OHRP) published three new draft guidance documents related to the three “burden-reducing provisions” institutions can take advantage of during the “delay period” before the general compliance date of the revised Common Rule. [Update] On July 25, OHRP issued a Federal Register Notice and the community and public has until August 24, 2018 to Read more
I had pondered my role on the 2018 IACUC Conference Blog Squad multiple times in the days leading up to the event and throughout the three days of the meeting. My musings, and a conversation with my niece about the work we do, led me to one of those extraordinary “Aha!” moments. Read more
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
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
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
The rapid proliferation of new digital health applications, tools, and technologies is reshaping the health care and research environments. Companies that develop these products may not have strong foundations in health care norms and ethics standards, and, in the the absence of FDA oversight, these products may not have been developed with an explicit focus on safety and effectiveness. It is important for IRBs to have the knowledge and strategies for evaluating these tools' adequacy to protect the data, privacy, and confidentiality of research subjects in trials involving digital health technologies. On February 8, PRIM&R hosted the webinar to provide guidance for IRBs in the assessment of new technologies in the health care field. Presenters answer follow-up questions from the webinar for readers of Ampersand. Read more
PRIM&R recently submitted comments in response to National Institutes of Health (NIH)’s March 14 request for information (RFI) on how best to improve the coordination of regulations and policies with respect to research with laboratory animals as prompted by a mandate in the 21st Century Cures Act. Comments on the RFI are due June 12, and I wanted to share what PRIM&R submitted in case the comments are helpful as you consider developing and submitting your own comments to NIH, which is coordinating the RFI with the Food and Drug Administration and the Department of Agriculture (USDA). Read more
