So your study is done, your dissertation is written, and you’re gearing up for graduation and bigger and better things now that you’ve completed this part of your education. It’s a busy and exciting time for you, we know, but we do have one last piece of research-related advice for you – you’re not really out […]
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Returning genetic testing results
Genetic testing poses all kinds of questions for IRBs. Are genetic testing results potentially identifiable? Are they meaningful? Should they be returned to patients? Our current ability to do genetic testing may have outpaced our ability to answer these questions, at least for now. When reviewing research, we sometimes are asked to put ourselves in […]
Please Excuse My Dear Aunt Sally — She can only understand a lay summary that’s written in plain language
The CLARA new submission form includes a question asking “What is the lay summary of this study?” When we say “lay summary,” we mean “lay summary.” As the help text indicates, this response should be written in simple, non-technical vocabulary at a no-greater-than-high-school level. Cutting and pasting text from the study summary in your informed […]
Remember, we can’t approve studies until CITI training is current
Well, you may recall the good news from a few weeks back – the required human subject protection training taken through citiprogram.org is now valid for 3 years, instead of the previous 2 years. The not-so-good news is that we still need to have all study staffers’ CITI training current before we can approve a […]
One way to simplify consent forms
Quorum Review IRB recently released an online resource recommending ways to shorten and simplify consent forms. Since overly long and convoluted consent forms are an ongoing headache for IRB members and researchers, we thought we’d share some of Quorum’s suggestions with you in a series of blog items. And we recognize that with industry sponsored […]
CRS certification holders — we need your opinion!
We’re asking everyone who has completed the Certified Research Specialist program to give us some feedback about the CRS curriculum. Please click on our SurveyMonkey link to share your opinions about the program. We’d like to get more information about what you think the program’s strengths and weaknesses are to help evaluate the overall program. We’re […]
The IRB’s on the move
While we’re not exactly heading out to claim new territory, the weekly IRB meetings are set to move, beginning Tuesday, June 7. We are returning to our old space in the Biomed 1 building, rooms 205/207 on the second floor. You can enter these rooms from the atrium at the top of the stairs. Those […]
New questions on CLARA new submission form
You may notice some new questions on the new submission form in CLARA. We’ve added some questions related to the use of external IRBs. If your study will undergo its primary review by an outside IRB, click “yes” to the “are you requesting use of an external IRB” query. The next question will ask for […]
CITI training now valid for three years
If you thought you heard the angels singing today, your ears weren’t playing tricks on you – they really were singing (the angels, not your ears). Why? Because the required human subject protection training taken online at citiprogram.org is now valid for three years, up from the previous two years. That means you and your […]
Protocol design and subject safety above the fold
One of the IRB’s criteria for approval of research is “Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk. While questions remain about the recent clinical trial in France that led to the death of one participant and serious adverse […]