Many studies involving pregnant women also collect information about the pregnancy outcome. These studies can include both interventional and chart review studies. If you work in this kind of research, please remember that if you collect anything about the newborn, such as gestational age at birth, length, weight, Apgar score, etc., the newborn then meets the […]
PRIM&R director comments about new Common Rule’s informed consent requirements
It seems as though everyone involved in human subject protections struggles with the informed consent process. The desire to provide complete information to subjects can collide with a need to keep informed consent forms and processes simple and understandable. Eliza Hurley, director of the research professional organization Public Responsibility in Medicine and Research (PRIM&R), recently […]
NIH changes may boost young scientists’ funding chances
Perhaps in an attempt to reverse previously identified declines in research funding awarded to younger scientists (see here and here), the National Institutes of Health recently announced a plan to focus more on early and midcareer researchers in making funding decisions. More information about the change can be found in recent postings in Science and […]
Arkansas Children’s Hospital logo change — ACH researchers, this may be of interest!
We’ve learned, here at IRB Blog headquarters, that Arkansas Children’s Hospital is revising its logo. A researcher asked if she needed to submit modifications for study documents she needs to change to replace only the logo. In a word, no. If the only change you need to make is to update the logo, there is […]
UAMS Box is another data storage option
We’ve heard from some research staff, and confirmed with UAMS Information Security, that UAMS Box is now being offered as a storage option for research data. Box makes it easier to share data with collaborators, all while maintaining appropriate levels of access and security. “Box is a secure site and we have a Business Associate […]
Staff-only modifications — don’t forget to change the staff list!
Staff-only modification forms will ask you what you are changing in your study, and that’s where people write in the staff changes they’re making with the form. A couple of hints to help your staff-only modification get quick approval: –Remember that to complete a staff change, the staff list in CLARA also needs to be updated […]
Soldiers, animals, and research
This Memorial Day weekend, we honoring those who served. And since this is a research blog, we’ll guide you to a Foundation for Biomedical Research article about the animals who have served our veterans on the battlefield and in the research lab. There’s no shortage of stories about the ties between military working dogs and […]
Communicating with people who aren’t scientists, e.g. your study subjects
Researchers have to communicate with a lot of different people – their peers, their funding agency, their research staff, their subjects, and the public. It’s these latter two groups – subjects and the public – that may be the most challenging for scientists to manage. But they may also be among the most important. Adequately […]
The verbal brawling over low-risk research under the new Common Rule begins
One goal for the revised Common Rule, according to its developers, was to streamline oversight requirements based on the risk level of proposed research. IRB oversight has caused its share of grousing among researchers here and elsewhere about overreach (a.k.a. mission creep) and focus on irrelevant details. Social and behavioral researchers are now weighing in in […]
CLARA Modification form workflow change
The pilot process of routing all modifications through the Research Finance Team prior to IRB submission has ended. As of May 15, the original process of routing modification through the Research Finance Team based upon the information submitted in the modification form has been restored. This return to the original process is expected to speed […]