According to 45 C.F.R 46.102(i), The Common Rule, minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Simply put, risk exists in everyday interactions. Risk in human subject research is considered minimal when it is similar to ordinary or routine encounters. Full board protocols,... Read More
Benefits in research are always considered in relation to the risks associated with the study. Beneficence, or the respectful and ethical treatment of people to ensure their wellbeing, guides how Institutional Review Board (IRB) reviewers gauge study benefits. The aim is to maximize the benefit of research while minimizing the harm or risk to participants. However, benefits do not need to be directed to the study participant, but can benefit the research field or people... Read More
It's critical to adhere to research compliance at all times. You see, when conducting and using animals in research, it's important that you're working with these animals in such a way that it adheres to the IACUC. The Institutional Animal Care and Use Committee have established a framework for compliance regarding federal policies, guidelines, as well as the principles as they relate to animals in research, testing, and teaching. A major change is recently taking place as... Read More
Research compliance is of the utmost importance, particularly when you are managing multiple IRBs. Failure to comply with guidelines and regulations can result in fines as well as inaccurate event reporting. Using technology will provide you with the ability to manage all of the protocols. The software solution can even be based online, giving you access to it regardless of where you may be. Mentor IRB is a software solution developed by Axiom... Read More
Researchers have a tedious and arduous work ethic. Even the most productive employees can struggle with efficiency because of the comprehensive processes. The good news is that introducing an online research compliance system can increase productivity, accuracy, and more. You may also find that you reduce the time spent on the process as well as costs along the way. There are a few features to explore when you begin researching an online research compliance system to... Read More
Compliance becomes a four-letter word for most of the human race by the time we reach age two. We strive as we grow to learn how to use tact, compromise, even manipulation to direct compliance in the direction that best suits our personal desires. Maybe it's time to stop this madness and look at compliance in a new light; one of cooperation instead of intimidation.
The Significance of ComplianceWhen compliance reporting is part of research requirements to... Read More
Imagine it's December 20th. You’re looking forward to your family plans for the holiday season. Yet, your million-dollar grant's deadline is December 31st. Two research faculty still have not submitted their grant narratives or compliance data—due two weeks earlier—to you. So, it's time to light a little fire under those faculty. Or else, you'll end up working through some of your planned holiday time. Your previous reminder... Read More
Congratulations! Your department has been given the go-ahead to convert its antiquated IRB compliance system to a state-of-the-art online mentor IRB system that will save researchers and their staff time and funds that are better spent elsewhere. Several systems claim that they will solve all your time, cost, and compliance needs. So how do you decide which system is right for your department?