Last summer I wrote several times about pregnancy-related data suddenly becoming much more sensitive and potentially damaging to the participant if released. Unfortunately, now we must add transgender status, biological sex at birth (required, e.g., for GUID creation), gender identity, relationship status, and more to the list of data requiring extra care.
The NIH Certificate of Confidentiality thankfully means that researchers can't be required to release data on something like someone's abortion or transgender history for criminal or other proceedings. We are responsible for ensuring that our data is handled and stored securely, so that it isn't accidentally (or purposely) shared and then possibly cause the participant harm. I suggest researchers review their data collection with an eye towards information that may be more sensitive now than it was in the past; is this information required? If so, consider how to store and use it securely and safely.
Also consider what you ask potential participants during screening (and how screening is done in general): people may not wish to answer screening questions about things like pregnancy or hormone treatments. If these possibly-sensitive questions must be asked, consider how to do so while minimizing potential discomfort or risk.
For example, one of our studies can't include pregnant people, so we must ask about pregnancy during the initial phone screenings. We used to ask potential participants about pregnancy separately, but then changed the script so that this sensitive question was in a list, and the participant is asked if any apply. This way, the participant doesn't have to state explicitly that they are pregnant, and the researcher doesn't have any specific notes, or even respond in a specific way (e.g., we don't want them to say something like "sorry Jane Doe, but you can't be in our study now because you're pregnant").
Here's the relevant part of the new screening script:
In order to determine your eligibility for our study, I need to ask you some questions. This will take about 15 minutes.Before we collect your demographic information, I will ready you a list of four exclusionary criteria. If any of these describe you, please answer yes after I read them all; if none apply, please answer no. You do not need to say which ones apply.
- You are a non-native English speaker (you learned to speak English as an adult);
- You are over the age of 45 or under the age of 18;
- You are pregnant or breastfeeding;
- You were born prematurely (before 37 weeks, or if twin, before 34 weeks)
Do any of these describe you? Yes (I am sorry, you do not qualify to be in our study) or No (continue with questions)
