While some research studies pose very little risk to subjects, there’s no such thing as an entirely risk-free study. Even if a project involves nothing more complicated than looking at previously collected information to gather study data, there’s still a risk of loss of confidentiality of private information. This same risk applies to studies involving […]

Some studies involve reviewing patient charts for encounters that have not yet occurred. Investigators sometimes ask to waive the entire consent process for these prospective chart review studies. Please keep in mind that the IRB’s ability to waive the entire consent process is restricted by current regulations, and many prospective chart review studies would not […]

The CLARA new submission form asks investigators about the source of any protected health information (PHI) they may be using for the research. One query asks whether any PHI will be collected directly from subjects, and another asks whether you will access PHI from medical records. Please note that if you are doing a chart review […]

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 […]