The new submission form may be the longest, most involved form in the CLARA system. When creating a new submission, you’ll be asked a lot of questions — everything from the number and age range of subjects to risks of the research to whether you’ll be collecting any biological samples.
You may be tempted to zip through the form rather quickly by writing very short answers, or just cut and paste answers from the protocol. “It’s not that big a deal,” you may be thinking. “All of this information is covered in the protocol anyway.”
Actually, the CLARA form is kind of a big deal, for a number of reasons. Here are a few:
- The form’s content helps guide the types of review your project will get. We use your responses to help us figure out which committees may need to review your proposed project.
- Your form responses populate the CLARA database, and help the CLARA system decide which questions to give you. The CLARA system allows us to search all the projects uploaded into it to assess trends and workloads, but this tool only works if the data entered into CLARA are accurate and complete. Also, you’ve probably noticed that the box you check on one question guides you to specific follow-up questions tailored to your project. This is a nice change from our previous system, ARIA, which just gave everybody all the same questions to answer, regardless of the specifics of the research.
- The CLARA form is part of the documentation of the IRB’s overall consideration of the study. Each question in the new submission form addresses a specific institutional or regulatory requirement. We have to document that certain factors have been considered as we approve research, and a correctly completed CLARA form is a key part of that documentation. We can’t, for example, demonstrate that we considered the criteria for a waiver of documentation of consent if you didn’t fill out the form to indicate that you are requesting such a waiver.
And here are some tips for completing the CLARA new submission form in a way that will minimize the number of contingencies you get back asking you to correct it:
- Read each question carefully, including any help text, and put some thought into your answers.
- Cutting and pasting directly from your protocol is often a sign that someone did not accurately answer the question. An example is the “what is the lay summary of this project” question. A lay summary is to be written using simple language. Think of the way you might describe your research to family members who don’t work in research and who you see maybe once a year at Thanksgiving. When they ask you, “So, what have you been up to a work lately?”, do you read them the background section of your most recent protocol, verbatim? Not likely. So don’t just cut and paste your protocol’s background section as the response to this “lay summary” question. Write a few simple sentences that would be understandable to the average high schooler instead.
- Never, ever, ever write “see protocol” in response to a new submission form question. We’ll send that back and ask you to, you know, actually answer the question. We need that information entered into our database, and “see protocol” won’t work for that.
- Before you hit that review and submit button, think to yourself — does this form adequately describe my research? Have I given thoughtful responses to the questions that will allow the various reviewers to do their jobs?
- If something on the new submission form is not clear, please ask someone in your department, or the protocol developers at the Translational Research Institute, or the IRB office (call us at 686-5667 or send a query to irb@uams.edu) for help.