Research noncompliance occurs when researchers (intentionally or unintentionally) fail to comply with established regulations, policies, and/or committee-approved research protocols. Noncompliance comes in many forms. It is study-specific and not always identified by IRBs and IACUCs in the same manner. Some instances of noncompliance may be discovered through post-approval monitoring activities, while others come to the committees via whistleblowers, or reports submitted by the researchers themselves. Whatever the case, committees must decide what happens after noncompliance has been identified. Read more
TAG ARCHIVES FOR human subjects research

Ensuring that women are represented in research studies and in science fields is an important part of advancing science and ensuring that women justly benefit from research. Research done using only male animals during preclinical trials and predominantly male subjects in human clinical trials leads to knowledge gaps that negatively impact women’s treatment and health outcomes. In recognition of women’s history month, we're highlighting some PRIM&R resources that explore the importance of considering sex as a biological variable and shifting to appropriate sex balance in research studies. Read more

PRIM&R is pleased to introduce the members of the Blog Squad for our 2021 SBER and AER Conferences. The Blog Squad is made up of PRIM&R members who will share their insights before, during, and after the conference. Stay tuned as they share their conference insights on Ampersand. Read more

IRBs come in many types, focusing on dramatically different categories of research from Phase I drug research to studies focused solely on education and social science. It may seem at first that the latter entails simpler ethical problems than, say, multisyllabic first-in-human drug trials for cancer, but very low-risk nonmedical research presents its own challenges for the IRB. Read more

As hospitals have become essential treatment centers for COVID-19 patients, clinical trial participants have become increasingly averse to attending check-ups and monitoring visits at these sites. Telemedicine is now being recognized not only as an option for those who do not have convenient access to healthcare, but also as a means by which clinical trials can be accomplished. Read more