NewslettersWinter 2022

NEWSLETTER- WINTER 2022

IRBs from KPNW, KPGA, KPWA and KPCO Combine to Form IRB-Hydra-Like-Creature

Previous reports of a massive IRB sighted in Oregon, Washington, Georgia, and Colorado have been confirmed. Inside sources said that while massive, the new IRB is said to be nimble and highly intelligent, like some sort of regulatory compliance-kaiju. Based on early sightings, it’s estimated the multi-region IRB will arrive just in time for Fall of 2022. The regions’ affiliated research sites will still operate separately, requiring DUAs to share PHI with collaborators, and a designated PI at each participating Kaiser research site. Research sites will continue to submit in IRBNet and work closely with their IRB contacts but will soon have a larger pool of IRB experts to rely on and harmonized IRB submission processes with the regions mentioned above. KPMA and the California KPs will continue to maintain their own IRBs. We’ve posted an FAQ on our website with high-level information and expect to provide regular updates as the events unfold.

Ceded Study Updates – What does the IRB need to see and when do they need to see it?

Pop quiz hot shot: The lead site just sent you a bunch of recruitment materials approved by their IRB. What do you do? Minor updates to ceded studies where we are relying on another IRB are not required to be provided to the KPNW IRB in real time. Instead, the KPNW IRB asks that all new/revised materials be provide at the time of the annual update (the ‘Next Report Due’ date in IRBNet). This takes full advantage of the ceding arrangement to minimize the number of submissions that need to be prepared and reviewed for any given study. Major updates, including a change in study design or adding vulnerable populations, would warrant immediate submission to the KPNW IRB upon approval by the IRB of record. If you’re unsure if the changes to your study meet the definition of a major update, contact your friendly neighborhood IRB coordinator.

Consent Guidance for Decisionally Impaired Adults

The guidance document formally titled “Surrogate Consent” has been renamed “Decisionally Impaired Individuals and Surrogate Consent (Legally Authorized Representative [LAR] Consent)”. Consult this guidance when your study seeks to enroll participants with any level of decisional impairment (fluctuating impairment, cognitive decline, dementia) either incidentally or as a targeted demographic. The guidance contains considerations for assessing cognitive impairment, appropriate LARs, and the consent process. Find the guidance on the Recruitment and Consent page of our website.

Policy Updates

No new or updated policies this quarter.

Mark Mac’s Media Corner

Health Affairs’ February Issue on the Impact of Racism in Healthcare

I wanted to take this opportunity to signal-boost Lucy’s email about the recent issue of the Health Affairs publication. The issue’s focus on the impact of racism in healthcare prompted Google and Twitter to declare the issue too sensitive to share on their platform. Instead of dealing with the real problem of hate speech on social media, these media giants have decided to just ban any discussion of race in its entirety. Very unfortunate. Please take time to read through some of the articles. I personally recommend the one on the correlation of race with the use of negative language in the Electronic Medical Record (EMR). Read here and please consider sharing if you participate in social media to make these important articles widely available.