We review a whole lot of CLARA new submission forms in the IRB office, meaning we tend to notice patterns in the forms. Here are a few questions that tend to trip up study teams, and reminders for how to complete them.
Subjects section:
–How many subjects do you anticipate consenting to meet this goal? — If your study involves a medical record review or use of previously collected specimens, please enter the number of records/specimens you plan to use. This will usually match the response to the previous question asking what your enrollment goal is. Even though you won’t actually be consenting anyone, this number should NOT be zero and should instead reflect how many subjects you’ll have. The CLARA help text with the query will prompt you about how to answer.
–How will potential subjects be identified? — This question is asking how you will initially identify people (or records, or specimens) to consider including in your study. Your response should address the recruitment process, and NOT how the collected data will be identified.
HIPAA section —
–Are you obtaining Protected Health Information (PHI) directly from subjects…? — This answer is “yes” if you’re collecting identifiable health information about people you’ll interact with, and “no” if all of your study data will come from medical records.
–Are you accessing PHI for this project from medical records? — “Yes” if you’ll look in medical charts to collect identifiable health information that either existed before the research started, or that will be created during the research, e.g. test results, responses to the study treatment, etc.
If your study involves no PHI, then you can answer all of the HIPAA section answers as “no.” And remember that PHI refers to health information that allows reidentification of subjects because it includes one or more of the HIPAA identifiers. The form will ask separate questions about health information to be used and the identifiers to be collected. Please don’t put things like “name, age, date of birth” in the question asking about health information, because those are identifiers, and will be collected in response to the query asking specifically about identifiers.
Consent section —
–If you are going to use a consent process but will not obtain signed consent forms from subjects, you will need to request a waiver of consent documentation. To do so, indicate in the first question of this section that an informed consent process will occur, and then indicate in the second question that you want a waiver of consent documentation.
–If you will not have a consent process at all, which is common in retrospective chart review studies, you will request a waiver of the entire consent process in response to the first question.
Note that waivers of the entire consent process and waivers of consent documentation are two different things with different criteria. Be careful to choose the correct kind of waiver when completing the new submission form.