What data can be recorded from patients who do not consent to be in a study?


#1

If a patients declines an invitation to participate in a study, is it ethical/reasonable to record in the research database that the patient declined the invitation?

If the patient declines for reason X, is it ethical/reasonable to record in the research database that the patient declined for reason X.

If a patient declines an invitation to participate in a study, is it ethical/reasonable to record that the patient declined in addition to basic demographic information like gender, race, and age category?

The patient in me would prefer that no information about me be included in the research database if I decline to participate. The statistician in me is curious about how the research population differs from the all-comer patient population.

Is this a question that is answered on a case by case basis with the input of the IRB?


#2

Hi,

Typically, as part of a study, there will be pre-defined patient recruitment and screening procedures that have been approved by an IRB and possibly by other regulatory bodies, if relevant. That includes the manner of patient contact, which may be via telephone, in-person, electronic, or other means.

The details may vary from institution to institution, but generally, you can create and maintain a screening log of patients that have been screened, and are not eligible and/or declined to participate. The IRB would typically provide a waiver to support this activity, to cover the collection of pre-defined data, that may or may not contain PHI, depending upon functional requirements.

If the patient declines participation, typically, any PHI that may have been collected during screening would be destroyed, unless there are overarching reasons to maintain it and that has also been approved by the IRB.

As always, the data that can be collected and maintained in the screening log should meet the minimum necessary standard to fulfill the needs of the approved study. Since this will typically take place prior to the signing of an informed consent for the study, you would want to minimize the amount of data that you record.

If you need to conduct study specific diagnostic testing to confirm eligibility for the study, then the informed consent would need to be signed and that document would typically have some IRB approved language regarding screening procedures and authorization to conduct the testing and to collect specific information.

Gender, race and age would not be PHI, unless the age is over 89, in which case, you need to create a category of “age >89” and not track the actual age in years for those patients. Thus, you would not need patient approval to collect and retain those.

The reason for declining to participate would also not be PHI, and you might have a pre-defined set of reasons that are available for consistency in collection, as opposed to free text.

There are published studies regarding patient recruitment, selection bias, why patients decline to participate, etc. So, IRBs do approve the collection of such data when there are valid reasons to do so.


#3

I agree. I believe the guidance document would depend on the institution since this will be regulated by each institutions IRB. My understanding is that Vanderbilt IRB allows study personnel viewing access to PHI and this would be considered ‘preparatory research’ but that PHI or patient data cannot be recorded without permission. Having said that, when the PI wants to capture the characteristics of people that decline to participate, they usually add a signature line to the consent document asking if the subject could provide permission to capture basic demographics even if they do not consent to participating in the study.

I’d also like to add that for our recent clinical trials, journals have been asking us to begin the consort diagram from ‘N = patients assessed for eligibility’ and detail the reasons for exclusion. So capturing reasons for not participating is important.


#4

Yes, I think this is relevant as well, and should be collected when practical. Even if no other patient information is recorded, it seems like “reason for not participating” ought to be acceptable to record…


#5

I appreciate all the feedback provided in this forum and by email. In the responses, I’ve noticed that there is some variation in what is meant by “screen”. I think it may be helpful to be more specific, and I’ve constructed a flow diagram to help me separate the different types of “screen”.

Some folks have talked about screening within an EHR prior to consent, and others have talked about a screen after consent. The gist of many responses is that data actively curated in a research registry from the “declined consent” group is guided by the IRB, and generally involves a higher standard of justification.

With regards to the idea that research projects report “Patients assessed for eligibility”, it still isn’t clear to me what that actually means. Does assess include all subjects identified in the pre-consent screen within an EHR? Does that mean studies performed, say, at Vanderbilt start with some ridiculously large number because the entire EHR was filtered to identify patients with a specific condition? That doesn’t make too much sense to me. (Happy to be convinced otherwise.) To me, “assessed for eligibility” makes the most sense as a post consent idea. “Assessed for eligibility”, in my current thinking, is a breakdown of the results from the post-consent screen.


#6

Excellent point. I admit that I was thinking of this in context of people that declined entry into a specific research study (clinical trial, or something that involved procedures outside of routine clinical care) and that this would essentially be asking them at the point of consent (i.e. when they declined to consent, ask if they would give a reason). I had not really considered this in the context of broader EHR-based studies.


#7

In Europe, this has become a lot more complex due to European data protection legislation. Despite its name, the GDPR (general data protection regulation) is not actually general, and it is left to individual countries to enshrine it in legislation.

The Irish situation is currently a nightmare, in which we have been informed by our Department of Health that we cannot open a patient’s chart to see if they are eligible for a study without obtaining their consent. So recording the demographic information of a patient plus the information that they refused to consent would not be permissible.

I understand that the situation is different in the UK, where legislators have interpreted GDPR differently. But, of course, they are about to become the British Empire again, and heaven knows what that will entail for research (they will probably reinstate the furlong and the rood and dump metric…)


#8

I recently had a conversation with some folks at RedCap (a widely used research database) about the EU’s “right to be forgotten” and what that means for research databases. Seems like there is a fair amount of uncertainty about what the new laws will require. If the most aggressive interpretation of the “right to be forgotten” is implemented, research databases may have to remove all records in the active and backup systems for a subject that requests removal. All of which generates interesting questions related to reproducible research practices in an age when storing an exact, locked copy of a research database may be prohibited by law.