The Revised Common Rule (RCR) requires federally conducted or supported clinical trials to post a consent form on a publicly available federal website. Because this requirement is new, we’re still figuring out how it works in practice. Here’s some information that may help. First, the RCR’s definition of a clinical trial is: A research study […]
The context in which we consider subject privacy and data confidentiality
Everywhere we go, we leave a trail of data behind. Every scan of our grocery store loyalty card, every time our phone tracks our location or activity level, every time we enter something into our diet tracker, or an online search engine, or a social media account, every time someone files a medical claim to […]
The TWO reasons to start with a fresh template every time
We know the temptation to pick up an old study’s documents and try to revise them to fit a new study is great. We also fervently hope you resist it each and every time you face it. Here are ALL of the reasons to NOT try to adapt an old document to a new study. […]
OHRP draft guidance on transitioning studies to RCR now available
The ever-timely (ahem) Office for Human Research Protections (OHRP) has released a draft guidance about transitioning studies approved prior to the Jan. 21, 2019, Revised Common Rule implementation and compliance date. While this is only a draft and subject to revision, it supports what we’ve been hearing about how to handle studies initiated before Jan. […]
Currently open studies — The process for switching to the RCR (and whether switching is worth it or not)
The Revised Common Rule (RCR), slated to take effect Monday, January 21, gives studies open prior to that date the choice of either staying with the current Common Rule regulations or transitioning to the RCR. The UAMS IRB will allow investigators to request consideration to change to the RCR with their next continuing review. The […]
FDA-regulated research and the Revised Common Rule
While we prepare for the looming implementation of the Revised Common Rule (RCR), keep in mind that some research the UAMS IRB oversees is also subject to Food and Drug Administration (FDA) oversight. While the FDA promises to work on harmonizing its regulations to the extent possible with the RCR, we’re not holding our breath […]
Exempt status “review” period will revert to annual review for new studies under the RCR
The Revised Common Rule, slated to take effect after Jan. 19, 2019, will expand the types of studies eligible for exempt status review. That’s generally good news for researchers, as it reduces the regulatory burdens they face in carrying out research. One slight change will be somewhat in the other direction – the check-in the […]
Revised IRB Policy 15.1 Informed Consent
We’ve revised IRB Policy 15.1 to reflect the requirements of the Revised Common Rule. While it will be added to the usual spot on our website after January 19, we wanted to make it available for reference before that date. A quick recap of the most notable changes to the informed consent information requirements: Consent […]
How do research participants feel about data sharing?
Sharing of participant-level data is becoming a hot topic of discussion, with valid arguments both for and against. For example, proponents argue that data-sharing can improve people’s trust in scientific publications, whereas those opposed cite privacy concerns. But what do clinical trial participants think about data-sharing? Stanford researchers recently asked more than 700 study participants […]
TRI will offer scientific review for protocols
An new scientific review service will soon be available to researchers requesting TRI protocol assistance. For investigator-initiated clinical trial protocols that have not undergone peer review, an experienced clinical researcher and/or biostatistician can provide complimentary scientific reviews of protocols. This scientific review process will run concurrently with TRI protocol assistance activities and will not affect […]