If you use or adapted the my plot.volume() function from niftiPlottingFunctions.R, please update your code with the version released 30 March 2023. This post illustrates the bug (reversed color scaling for negative values) below the jump; please read it if you've used the function, and contact me with any questions.
Huge thanks to Tan Nguyen for spotting and reporting the color discrepancy!
Recent participants have gotten me thinking (yet again) about the different types of motion during fMRI; causes and consequences. And more immediately practical: which motion censoring thresholds might be reasonable for particular tasks and analyses.
I've long used (and recommended) FD > 0.9 as a censoring threshold for our event-related task fMRI studies (not functional correlation or resting state-type analyses). 0.9 is more lenient than many use for task fMRI; e.g., Siegel 2014: advise 0.5 FD for adults (which we have), 0.9 for kids or clinical populations. (I need to update a previous post; I'd misread Siegel's recommendations.)
Consider the following motion plot of a run from a recent participant, using my usual conventions (grey lines at one-minute intervals, frames along the x-axis); see this QC demonstration paper, the DMCC55B dataset descriptor, etc. for more explanation (and code). The lower panel shows FD, with the red line at the FD 0.9 censoring threshold, and red x marking censored frames; the grey horizontal line is at FD 0.5.
Contrast the above plot with the following (marked with a 2 in the upper left); the same task, scanner, etc., but a different participant:
I'd characterize plot 2 as having more pronounced overt than apparent motion; there are oscillations in the trans_y, but these are dwarfed by the head motions, e.g., in the middle of the first minute. Looking at the censoring, 13 frames (corresponding to the largest overt head motions) are marked for censoring with FD 0.9; 40 are marked with FD 0.5, corresponding to more of the overt head motions. 40/562 = 0.07, well under the 20% censoring dropping threshold.
To my eye, the 0.5 FD threshold is pretty reasonable in the second case, since it censors more of the overt head motion irregularities, and only those spikes. But for the first plot the 0.5 FD threshold seems far too aggressive: censoring part of every few breaths, 23% of the total frames. What do you think?
I hope to do some proper analyses of the impact of different amounts of apparent vs. overt motion on statistical analyses, but it is not a trivial problem, particularly with task entrainment. (Synchronizing breathing to task timing.)
As a final bit of food for thought, here are the tSNR and sd images for each of the two runs, without censoring (all 562 frames), after preprocessing, and with the same color scaling. The first strikes me as higher quality, despite the greater (> 0.5 FD) censoring. I believe apparent motion could have less of an impact on image quality than overt because the head is not actually moving, and so not creating the attendant magnetic disruptions; the differences are clear to the eye when viewing these types of runs as movies, but it's not clear how those differences translate to statistical analyses.
Back in July I posted about a strangely-failed fMRI run, and yesterday I discovered that we had another case not quite two weeks ago. This is the same study, scanner (3T Siemens Prisma), headcoil (32 channel), task, and acquisition protocol (CMRR MB4) as the July case, but a different participant. I've contacted our physicists, but we probably can't investigate properly until after the holidays, and are hampered by no longer having access to some of the intermediate files (evidently some of the more raw k-space/etc. files are overwritten every few days).
I've asked our experimenters to be on the lookout, and while hopefully it won't happen again, if it does, I hope they can catch it during the session so all the files can be saved. If anyone has ideas for spotting this in real time, please let me know.
A possibly-relevant data point: the participant asked to have the earbuds adjusted after the first task run. The technician pulled the person out of the bore to fix the earbuds, but did not change the head position, and did not do a new set of localizers and spin echo fieldmaps before starting the second task run (the one with the problem). I've recommended that the localizers and spin echo fieldmaps be repeated whenever the person is moved out of the bore, whether they get up from the table or not, but the technician for this scan did not think it necessary. What are your protocols? Do you suggest repeating localizers? No one entered the scanning room before the problematic July run, so this (pulling the person out) might be a coincidence.
Here's what the this most recent case looks like. First, the three functional runs' DICOMs (frame 250 of 562) open in mango, first with scaling allowed to vary with run:
In July the thinking was that this is an RF frequency issue, possibly due to the FatSat RF getting set improperly, so that both fat and water were excited. But this seems hard to confirm from the DICOM header; this time, the Imaging Frequency DICOM field (0018,0084) is nearly identical in all three runs: 123.258928, 123.258924, 123.258924 (runs 1, 2, and 3 respectively), which is very similar to what it was in July (123.258803).
Like many, I've started a mastodon account: @JosetAEtzel@FediScience.org. My twitter account (also @JosetAEtzel) is still active, but I plan to be more on mastodon than twitter going forward. This blog is staying around, too ... who knows, maybe I'll get some of my backlog of posts written! 😅
The two previous posts described my concerns about the NIH Certificate of Confidentiality exceptions post-Dobbs; the vagueness of the "federal, state, or local laws" "limited circumstances" formulation is troubling, since it seems that it could apply to something like a state-level prosecution for pregnancy termination.
I am happy to relay that 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:
"Disclosure is permitted only when:
- Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding; [emphasis mine]
- Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;
- Made with the consent of the individual to whom the information, document, or biospecimen pertains; or
- Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research."
The highlighted clause is the key clarification: the "federal, state, or local laws" exemption would not apply to something like a state-level prosecution for pregnancy termination, because that would be a criminal proceeding. And our data isn't only protected from criminal proceedings, but from civil, administrative, legislative, and others as well.
I am relieved by this exclusion, and encourage all universities and groups covered by the Certificate to include it, not only the "*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." formulation.
While I am relieved by this exclusion and find it sufficient guarantee that our participants' data is protected from disclosure, we will continue to minimize the amount of pregnancy-related information we collect, and use indirect phrasing in our screening questions whenever possible. Privacy and sensitivity are always important, but are especially critical now in the United States and when reproduction is involved.
UPDATE 16 September 2022: Many universities already use the longer (with the exclusion) explanation on their HRPO websites when describing the Certificate of Confidentiality protections. A google search for "excluding instances of disclosure in any Federal, State" found many, including Michigan State University, the University of Pittsburgh, the University of Washington, Virginia Commonwealth University, and North Dakota State University. Hopefully these examples can serve as templates for other institutions.
The NIH's example consent language also includes it: "This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena."
UPDATE 28 September 2022: Washington University in St. Louis changed the Certificate of Confidentiality description to include the exclusion.
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.
This post is now less relevant, so I put it below the "jump".
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.
Previous post:
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 have
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
