It ain’t over until the … publication appears in the Federal Register, and sure enough, today’s Federal Register contains the final* Final Rule. Since most people don’t have the daily Federal Register delivered to them at home, here’s a link to today’s publication. Note that much of this document is a discussion of the slow, […]
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The Final Rule (Revised Common Rule) finally shows up
The updated final version of the Common Rule was made available for review Wednesday, January 18, with its publication in the Federal Register slated for Thursday, January 19. The Common Rule, you no doubt recall, is the federal regulation setting the basic requirements for the protection of human subjects in research. A proposal to revise […]
Keep it short and to the point when responding to modification contingencies
So you’ve submitted a modification, the IRB had a question on it that was returned to you as a contingency, and now you’re responding. And then you remember you just received some new information from the sponsor that the IRB needs to see, or that you need to make a change to a study document […]
New online blog quiz can earn you 0.5 hours of CRS credit
The next IRB Research News and Tips blog quiz is now available at learnondemand.org. Log in at the site, type “IRB” into the search box, and get started on earning the most convenient 0.5 hours of Certified Research Specialist education credit you’ll ever see. (At least until next quarter, when we’ll post a new quiz.) […]
The feds weigh in on electronic consent
It’s becoming increasingly rare for us to transmit large chunks of information via pages and pages of printed text. One notable exception is the documenting of informed consent for research. While the research community continues to explore ways to make informed consent forms and processes easier for subjects to understand, relatively long and complex research consent forms […]
Ensuring clinical study populations look like the community they’re drawn from
Researchers and IRB members are aware of the need to ensure study populations reflect the community. Careful attention to enrollment helps ensure study results are valid and generalizable, and allows the IRB to determine that subject selection is equitable (which is one of the criteria for approval). A recent New York Times article addressed the […]
Change to the modification review process
Beginning January 3, 2017, ALL modifications submitted on studies with approved CLARA budgets will route through the Research Finance Team for review BEFORE they are sent to the IRB. What this means for investigators is that modification reviews and approvals may take a bit longer than they have in the past. This new procedure pertains […]
Can an investigator also be a research subject?
Can investigators also be research subjects in their own studies? Science Magazine recently published a piece discussing the regulatory and ethical issues about researchers doing their research on themselves. As the piece points out, self-experimentation can lead to results that are life changing, for better or worse – two scientists went on to win Nobel […]
Returning data to study participants — the pros and cons
Research subjects provide a tremendous service to subjects, at a sometimes not-negligible cost, in terms of time and inconvenience (and potentially needlesticks, radiation exposure, etc.) to them. Some research procedures may yield information important to the participant’s health, or that could minimize that person having to have the same procedures done as part of their regular […]
Remember: A contingency isn’t real until it shows up in a letter to you
We at the IRB have taken steps to increase the transparency of the review process. This change is typically a good thing, but can also create opportunities for miscommunication. IRB reviews of submissions can take hours or days to complete. The reviewer may start and stop working on it several times, drafting notes and contingencies […]