The CLARA new submission form’s Risks section starts with a question asking you to list the resources available to protect human subjects in the research setting. If you are doing a record review study, please go ahead and include an answer in this box, even though you won’t be interacting directly with living individuals. The […]

If your study involves a test article (drug or device), then you’ll need to let subjects know during the consent process about the test article’s approval status. Please note that the IRB will want the approval status stated very clearly. We’ve seen, for example, long lists of all the countries in which a particular test article […]

The IRB may require you to put information in the consent form describing how subject data will be stored. If you are storing all data with only a code rather than direct identifiers, you should include consent language saying something like, “Your personal information will be identified only with a code and will not include anything […]

When we see a study submission that describes a project as a retrospective chart review, the IRB needs to make sure the project is truly retrospective. A retrospective chart review involves looking at information that already exists at the time of IRB approval. We may ask that you specify an end date to document that all the […]

The next IRB blog quiz is available at learnondemand.org. To find the quiz, go to the learnondemand.org home page and type “IRB” in the search box at upper right. Remember, these quizzes allow you to earn 0.5 Certified Research Specialist elective hours each – up to 2 hours per year – at the time and place […]

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 […]

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 […]

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 […]

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 […]

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 […]