UPDATE 9 September 2022: Good news! The "federal, state, or local laws" exemption is clarified in the "When can Information or Biospecimens Protected by a Certificate of Confidentiality be Disclosed?" section of the What is a Certificate of Confidentiality? | grants.nih.gov site.
The NIH Certificate of Confidentiality is sufficient to protect researchers from being forced to release data if one of our participants is charged with abortion, which is great news. However, there are still many ethical concerns about collecting sensitive data unnecessarily, and I believe it is prudent to be extra aware of how pregnancy-related questions are being asked (e.g., in a phone screen), and minimize direct questions whenever possible.
This post is an essay-style, expanded version of messages
I’ve posted on twitter (@JosetAEtzel) the last few weeks, responding to the Dobbs
v. Jackson Women's Health Organization decision overturning Roe v. Wade in the
United States, and Missouri’s subsequent trigger law outlawing abortion except in dire emergency. I hoped these issues would rapidly become outdated, but unfortunately that is
not the case; if anything they are compounding, and I very much fear no end is
in sight. I am not willing to be silent on the topic of protecting
participants, or university ethics more generally.
I am a staff scientist at Washington University in St. Louis, Missouri, USA, and have been here twelve years now. It’s been a good place to
do research, and I have great colleagues. I work with data collected on humans, mostly task fMRI. I generally spend my time at work on analysis and hunting for
missing or weird images in our datasets, but the last few weeks I’ve spent substantial amount of time hunting for pregnancy-related information in our
procedures and datasets, and seeking answers to how the legal changes affect us and our participants.
Our fMRI consenting protocols require the use of screening
forms that ask if currently pregnant; high-risk studies (PET-MR) require a
pregnancy test be performed immediately before the scan. These signed and dated
screening forms are retained indefinitely by the imaging center at the hospital
and/or our lab. Imaging studies routinely include pregnancy questions in the phone
screening to determine eligibility.
An additional source of pregnancy information in our datasets
is via studies using passive sensing data collection (e.g., via an app
installed on participants’ phones). These can include GPS and other forms of tracking,
which could e.g., show whether the participant spent time at a place where
abortions are possible or searched for abortion information. Previous data
breaches have happened with this type of research software, and the collection
of any GPS or other tracking information raises serious privacy concerns,
but my focus here is the security of this data after it is in the researchers’ hands.
We need guarantees that we will never be asked to release this
data, even in the (appalling but not totally unprecedented)
case that someone is charged with abortion and we are asked by a court to disclose whether the participant said that yes, they were pregnant on a particular date.
NIH Certificates of Confidentiality protect participants’ information from disclosure, but have exceptions in “limited circumstances”. “*Disclosure of identifiable, sensitive information (i.e., information, physical documents, or biospecimens) protected by a Certificate of Confidentiality must be done when such disclosure is required by other applicable Federal, State, or local laws.” At Washington University in St. Louis (as of 11 July 2022) we are being told it might not be sufficient to rely upon the Certificate of Confidentiality; that it is not "bulletproof" for state-level abortion-related lawsuits. University counsel here is still investigating, as I assume are those elsewhere.
I have been hoping that Washington University in St. Louis
and other research universities would promise to protect participant (and
patient) pregnancy-related information; announcing that they would fight
attempts to force disclosure in any abortion-related lawsuits. So far, this has not occurred. Universities
often have strong law departments and a pronounced influence on their
communities, both as large employers and venerable, respected institutions. Ethics-based
statements that some laws will not be complied with could have an outsized
influence, and serve as a brake on those pushing enforcement and passing of
ever more extreme abortion-related laws.
Since we currently lack pregnancy-related data confidentiality guarantees,
in our group we have begun efforts to lessen the chances of our participants
incurring extra risks from being in our studies – or even from being *asked* to
be in our studies. Reducing our collection of potentially sensitive information
to the absolute minimum is one step: even if subpoenaed or otherwise requested,
we will not have potentially harmful records to disclose. Concretely, we
submitted changed our screening procedures, such that the participant is asked if any of a group of several exclusion criteria apply, only one of
which is pregnancy (rather than asking about pregnancy separately). The
participant then does not have to verbally state that they are pregnant, nor
the experimenter note which of the exclusion criteria was met.
Participants will still need to complete the screening form immediately before scanning, but presumably anyone that reaches this stage will
respond that they are not pregnant; if they are pregnant, the scan is cancelled and the screening form destroyed. This procedure reduces risk if we assume that
recording “no, not pregnant” on a particular date has less potential legal trouble for the participant than a “yes, pregnant” response, which hopefully is the
case. However, it is not unimaginable that an abortion lawsuit could have proof from elsewhere that the participant was pregnant on a particular date before
the experiment, in which case their statement (or test result, in the case of studies requiring one) of not being pregnant on the experiment date could be
relevant and damaging. At this time we can’t avoid using the forms with the pregnancy questions, but may start warning participants in advance that they
will have to respond to a pregnancy question, and that we can’t guarantee their response will be kept private and only used in the context of the experiment.
The impact of the Dobbs decision (and in our case, Missouri state
abortion trigger laws) on non-reproduction-related human subjects research is
only a small subset of the harm from these laws, of course, but it is a new risk US-based researchers should consider. Human subjects protections are not trivial and must not be
brushed aside, even if we hope no more abortion-related legal actions will occur.
As scientists, our ethics, honor, and integrity require us to follow not just
the letter but also the spirit of guidelines like the Declaration of Helsinki; we
must work towards the absolutely best and strongest participant protections.
I hope that this essay has caused you to consider what data you are collecting, whether it puts your participants at new legal risk, and
what you can do to minimize such risk in the short and long terms. Immediate actions such as changing how pregnancy is asked about or stopping collection of
especially sensitive information seem to me the minimum ethically appropriate action; stronger, legally-binding guarantees of confidentiality may be needed
soon for many types of human subjects research to continue responsibly in the United States.
UPDATE 3 August 2022: Our screening changes were approved, so I edited the relevant text and added a link to the tweet showing the approved version.
Yesterday I tweeted that a source I trust (and in a position to know) told me that Washington University in St. Louis counsel/administration told them that pregnancy-related research records will not be released in an abortion-related lawsuit, regardless of whether the NIH Certificate of Confidentiality is sufficient protection. That is good news, but I am troubled that it came via word of mouth; my source said I shouldn’t “hold out” for an official statement. It is hard to be confident without something concrete; even a technically-phrased memo or HRPO website note would be encouraging. It seems that we are being asked to act as if nothing has changed post-Dobbs, and trust that everything will be fine, but that's an awfully big ask for issues this consequential.
UPDATE 17 August 2022: Last month Jeannie Baumann wrote an article at Bloomberg Law discussing questions about Certificates of Confidentiality protections, including, "It’s unclear how the state law versus certificates would play out because it hasn’t been tested in court."
UPDATE 26 August 2022: Tamara J. Sussman and David Pagliaccio published Pregnancy testing before MRI for neuroimaging research: Balancing risks to fetuses with risks to youth and adult participants