Every day and with every interaction, animals learn how to respond to the people in their research environment. Positive reinforcement training (PRT) techniques can improve animals’ level of compliance with research tasks, as well as their physiological response to their environment. It’s critical that IACUC members have a working knowledge of classical and operant conditioning in order to critically assess whether research proposals include appropriate PRT.
On April 17, PRIM&R hosted a webinar to instruct IACUC professionals and members about PRT. Kelly Morrisroe, a research scientist and primate trainer at the Washington National Primate Research Center (WaNPRC) at the University of Washington, served as the speaker. After the webinar, the presenter responded to some of the attendee questions that time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more
PRIM&R’s 2018 Advancing Ethical Research Conference (AER18) was very inspiring. It provided me an opportunity to be immersed in an interesting learning opportunity, wherein I noted a common theme of this conference was to highlight the changes in the revised Common Rule and its practical implementation. Read more
As the Certified IRB Professional (CIP®) program approaches its milestone twentieth year, PRIM&R and the CIP Council are undertaking a series of activities aimed at assessing the current eligibility guidelines and the content of the CIP exam against the tasks and responsibilities that those charged with HRPP/IRB administration perform. The first part of this process is a comprehensive job analysis survey, which aims to capture the range of responsibilities for which offices that oversee IRBs are accountable. Anyone involved with the management and administration of HRPP/IRBs is encouraged to participate in this important project before the survey closes on July 12. Read more
Since the National Archives in Washington were founded they have solved historical mysteries, provided key information, and unlocked a great deal of forgotten knowledge. The power of records and record keeping is influential at all levels of human existence, but also may be harmful to the least empowered individuals in society (such as refugees or the elderly). At PRIM&R's AER Conference, presenters offered insights into essential documentation and stressed the importance of good record keeping and data management for IRBs. Read more
There’s a growing trend in Social, Behavioral, and Education Research (SBER)–machine learning–in which investigators often request to obtain, through direct interaction and intervention, various sets of data on human subjects, including their physiological (i.e., data obtained from either invasive or non-invasive means) and/or biometric data (e.g., audio/visual recordings). The research as originally conceived may or may not have been considered human subjects research, but its ultimate purpose is to teach machines how to think, draw conclusions, and process information in much the same way humans do. Read more
In April, the Food and Drug Administration (FDA) issued a discussion paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).” The paper represents FDA’s response to the growing number of medical device manufacturers who are utilizing artificial intelligence and machine learning technologies to continuously improve their products. On June 3, PRIM&R submitted comments in response to the discussion paper, thanking the FDA for their consideration of the public health implications of the use of these technologies, but also cautioning that any new regulatory approach in this area must address the protection of individuals whose personal information and data are being used in the creation and ongoing testing of these technologies. Read more