It is possible to shorten IRB review time dramatically, but it requires some resources and time. The IRB of Northcentral University serves a nontraditional population of students, some of whom want to complete a research study as part of their academic plan. The IRB’s streamlining process reduced the submission-to-approval time to eight days, down from an average of 65 days before the new process, according to new, unpublished data.
An analysis of closed medical malpractice claims related to pain management identifies common areas of risk and reveals the COVID-19 pandemic has created new possibilities for liability. A top contributing factor in 90% of all closed claims was insufficient consent between the physician and the patient or family.
Patients will no longer have to go through the discovery process during litigation to find out everything ED providers charted. Still, with patients reviewing all the clinical documentation, plenty of misunderstandings can happen.
Making the system more trustworthy requires greater transparency, clear principles of accountability, and more comprehensive laws and regulations that protect against discriminatory uses of genetic information. The results of a recent survey may reveal the work ahead.
An important and useful function of an IRB’s website is its ability to give researchers — as well as the public — access to a wide variety of forms, guidance, and tools. When created well, an IRB’s website can be easy to navigate. It also should be updated with new and revised information regularly. Like crowdsourcing websites and with permission, an IRB’s website also can adopt and adapt tools that researchers and other IRBs have found useful.
Researchers have used the 2018 public health surveillance exception to the Common Rule for the first time during the COVID-19 pandemic. In the early weeks of the pandemic, researchers might have overused this exception. Federal agencies approved some protocols involving lines of genetic materials with explicit research purposes, even if these were secondary to the public health surveillance purpose.
The most important lesson for physicians and care providers from this case is to always receive fully informed consent for the actual procedure performed. Receiving consent beforehand is a prerequisite, but if the circumstances change, or if a modification to the procedure appears appropriate, seek and receive consent again.