We were thrilled to stumble across this newly available, open-access, paper titled Promoting Ethical Payment in Human Infection Challenge Studies in The American Journal of Bioethics. The paper discusses the process to determine ethically defensible compensation levels for research subjects, with special emphasis on trials that involve intentionally exposing participants to infectious agents, such as the virus that […]
AAHRPP Resources for IRB Reviewers
The Association for the Accreditation of Human Research Protection Programs, or AAHRPP, sets standards for human research protection programs (HRPPs). AAHRPP is our accrediting body, and its website has several resources that may help IRB reviewers in their review. Of particular note are AAHRPP’s tip sheets, which delve into detail about specific topics. We use […]
Personal data everywhere. And it’s for sale.
Today’s blog post theme isn’t so much about the specific items mentioned in these articles as it is about the general availability of data. When we think about data protections, it’s helpful for us to remember the context in which to think about confidentiality. First, here’s an article about how the intelligence community uses smartphone […]
New question added to modification and site addition forms
Sticklers for neatness that we are (as anyone who has ever stopped by IRB Blog Headquarters can attest – heh), we have added a query to CLARA’s “modification” and “site addition” forms. These forms now have a free-text box labeled “Notes for the IRB reviewer(s).” Please use this area to add any information the IRB […]
Tracking document changes
Since the IRB has started allowing the submission of only tracked-changes copies of revised documents, we’ve found that our reviews are a little easier, and CLARA document files are a little cleaner, for studies that only submit the tracked-changes copy. Therefore, the IRB now asks that you submit only a single copy of any revised documents, […]
What’s new in 2021 for the IRB
Happy New Year to all! Here’s our best guess as to what our IRB reviewers can look forward to in 2021. We’ll cover this information in our in-person education in January. Some of you will be selected to meet with our AAHRPP accreditation site visitors. We’re not quite sure when the site visit will take […]
Wearables/apps in research, end user license agreements, and research – Considerations for researchers and IRBs
Digital data collection tools, such as small wearable devices (think FitBits or Apple Watches) and apps downloaded onto a subject’s phone, are becoming increasingly common in human subject research. Some projects are testing the products themselves, while others use them merely to collect research data. You know that giant document that you never actually read […]
Consolidated single/central IRB review resource
The IRB’s website has been updated to make it easier to find information about single/central IRB review (we refer to that as “xIRB review). We’ve added a separate webpage consolidating an overview of the process and associated forms and information. The page also includes a link to a video of our most recent virtual class […]
HIPAA “Review Preparatory to Research” form to go online starting 12/14/20
Among the many blessings HIPAA has rained upon us (ahem) is a requirement pertaining to reviews preparatory to research. “Review preparatory to research” refers to accessing protected health information solely to prepare a research protocol before getting a signed HIPAA authorization or a HIPAA authorization waiver. A review preparatory to research can be done only […]
New policy for DoD-supported research
Additional agency-specific requirements apply to human subject research studies conducted or supported by the federal Department of Defense (DoD). Because we’re seeing a slight uptick in DoD funding applications, a trend we’re expecting to gain momentum, we’ve drafted a policy specific to DoD-supported research. Please note these policy requirements are in addition to all the […]