Let’s bring the informed consent process out of the shadows

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JAhlia Harrison has been bombarded with questions about psychedelics. A practicing therapist, Harrison recently graduated from the Bioethics and Science Policy program at Duke University, where I teach and served as a master’s thesis supervisor. His patients are increasingly interested in experimental regimens that use drugs like LSD, psilocybin and MDMA to treat post-traumatic stress disorder and other forms of trauma.

Harrison’s patients are not alone. Since 1970, psychedelics have been considered “Schedule I” drugs in the United States, with the federal government saying they have no accepted medical use. But in recent years the government has softened its stance and, accompanied by not inconsiderable hype, psychedelic-assisted therapies are now being tested in dozens of clinical trials. These studies can pose substantial risks to the health and safety of the patient, and a number of trials have been attached to allegations of sexual abuse. To better understand how these risks are communicated to potential study participants, earlier this year Harrison set out to collect consent forms used in more than three dozen psychedelic-assisted therapy trials listed on the website. Federal Clinicaltrials.gov.

Much to her disappointment, she was able to download consent forms for only five of the trials that met her criteria. And although she contacted the organizations conducting the studies directly, only one responded to her questions.

From the long parade of ethical scandals that plagued biomedical research in the 20th century – from Nazi doctors’ experiments to the Tuskegee syphilis study to a Brooklyn Hospital study that injected live cancer cells to patients – informed consent has been a hallmark of human research. It enshrines the idea that we cannot experiment on people without first informing them of the risks and benefits and, of course, obtaining their permission. The consent forms used in clinical trials, as dense and legal as they may be, are intended to answer questions such as: what is involved in the study? How long will it take? Will I be paid? What if it goes sideways?

But in many cases, few people outside of researchers, participants, and institutional review boards charged with approving a study see the language used in a trial’s consent form. Recently, there has been a push towards greater transparency, on the pretext that the widespread dissemination of forms used by researchers to communicate the risks and benefits of clinical trials will improve accountability, build public confidence in research and will inform the development of future consent forms. But what Harrison’s experience and what my own look at clinictrials.gov seems to show is that the scientific community isn’t pushing hard enough.


A great victory for informed consent transparency arrived in 2018, when federal authorities updated the so-called Common Rule – a regulation that covers research on human subjects funded by 20 US agencies, including the Department of Health and Human Services social services, which includes the National Institutes of Health. Effective January 21, 2019, the rule change requires federally funded clinical trials to post an approved consent form on a public federal website; the form must be posted after the close of patient recruitment, but no later than 60 days after the participants’ last required study visit. Researchers have the option of downloading the form either from Clinicaltrials.gov or from a designated folder on the Federal Regulations.gov website.

Late last year, researchers at Brigham and Women’s Hospital and the National Library of Medicine found that while the number of posted consent forms is indeed increasing, it is hardly keeping pace with the rule’s requirements. common. The authors found, for example, that less than 18% of NIH-funded studies had posted forms.

Late last year, researchers at Brigham and Women’s Hospital and the National Library of Medicine found that while the number of posted consent forms is indeed increasing, it is hardly keeping pace with the rule’s requirements. common.

In September, I did my own research on clinicaltrials.gov and found that only 283 of the 1,112 federally funded intervention studies listed on the site as having started after January 21, 2019 and ended before January 21, 2022 had uploaded consent forms. Some of the studies had yet to upload results, but even when I narrowed my search to those that had – an idea suggested to me by Geisinger research ethicist Michelle Meyer – just over half posted consent forms. (I also searched the more than 427,000 studies listed on clinicaltrials.gov – including past, current, and upcoming studies in the US and elsewhere that are not subject to the common rule – and j discovered that consent forms had only been shared by 1.3% of them.) Meanwhile, the designated record on regulation.gov, the alternative site where studies can file consent forms for meet the common rule, contained only 44 consent forms issued during the three-year window.

To be fair, some people have sounded the alarm about the public sharing of consent forms. In practice, they note, researchers often use the forms less as a way to inform participants than as a way to mitigate institutional liability. (You can’t sue us here at Big Academic Medical Center – it was all in the consent form!) At least one group of health lawyers has argued that posting requirements could prompt researchers to write even more staid and legalistic forms aimed at protecting themselves from lawsuits. The same group was also concerned that a rule requiring public display of a consent form could confuse participants and the public, as a clinical trial will sometimes use different versions of the form for different participants at different sites, and the consent form could be updated throughout the recruitment process. Who would decide which version to publish, and how? Elsewhere, there were concerns that a public display requirement could stifle innovation, for example by preventing clinical researchers from exploring new approaches to consent such as interactive video Q&As.

Publicly posting consent form language is a low-risk, low-burden act that could give motivated potential participants a chance to see what they could sign well in advance and gives all stakeholders the opportunity to report problems.

I was and remain indifferent to these complaints. Will posting consent forms make them worse? Wait what? And sharing them with everyone rather than just the people you want to participate in will necessarily increase liability risks? If so, that’s a problem with US case law and not a justification for opacity. With respect to potential confusion over multiple versions of a consent form, in a proper consent process, potential participants should always be provided with the most recent version of the consent form and the opportunity to ask questions. And a provision in the revised common rule states that multisite trials use a single institutional review board, which should help standardize consent forms across different sites. We now have evidence that this is indeed happening, although some local institutions have been reluctant to cede control.

When it comes to video consent and other innovative approaches, the updated common rule says nothing but references to “electronic format”, and it’s not clear why new consent processes shouldn’t. not be done transparently: Why not post a link to your consent video on clinicaltrials.gov for everyone to see?

As someone who has sat on an institutional review board, read thousands of pages of mind-numbing consent forms, and participated in research as a human “subject” for the past 15 years, I think the common rule does things more or less well. Publicly posting consent form language is a low-risk, low-burden act that could give motivated potential participants a chance to see what they could sign well in advance and gives all stakeholders the opportunity to report problems. This could lead to fairer, safer and higher quality research. Or maybe not. But the only way to find out is to experience it.

For patients like Harrison, who seek risky but potentially life-saving experimental therapies, the stakes couldn’t be higher. Some argue – and, for what it’s worth, I agree – that the fervor of the current psychedelic hype cycle is driven more by a messianic push for legitimacy than an unbiased search for truth. What if MDMA really worked? What if psychedelic-assisted therapy, delivered in a safe environment, could bring relief and healing to those suffering from PTSD and other trauma? Don’t we want as many people as possible given all the risks and rewards, promises and disclaimers? Couldn’t controversial psychedelic-assisted therapy studies have benefited from a few extra looks at their consent forms?

We can read millions of scientific papers, court documents, real estate listings, restaurant menus, drug prices, and movie reviews with just a few keystrokes.

So why not consent forms?


Misha Angrist is an Associate Professor at Duke University’s Social Science Research Institute and a Principal Investigator in its Science and Society Initiative.

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