What are your rights when you participate in a medical research study?
That question flickered through our minds last year while scrutinizing news about the trials for the COVID-19 vaccine, when Pfizer announced on November 19th: “Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose.” Over 43,000 participants enrolled in the company’s Phase III testing, and questions about the swiftness of the trials surfaced, then abated but remain, overshadowed this week by the milestone the United States has reached: half a million people dead from COVID-19.
But informed consent and the rights of those agreeing to participate in medical research is a topic that writer and scholar Harriet A. Washington has “methodically considered” since 2002, when as a research fellow at Harvard Medical School, she read Experimentation with Human Beings: The Authority of the Investigator, Subject, Professions, and State in the Human Experimentation Process, that was written by Jay Katz in 1992. “A lot of his commentary put things into a perspective you might normally not see,” said Washington, whose new eye-opening book Carte Blanche: The Erosion of Medical Consent deconstructs the concept of informed consent, from its origins in the Nuremberg Code to its coercive application in the military during anthrax vaccine trials. The most recent case she cites involves the use of the anti-malarial drug hydrochloroquine on nursing home patients in Texas last year. “I’ve been struck with how frequently the excuses [for not adhering to informed consent] come around time and time again—so it hasn’t been surprising this issue has surfaced again,” said Washington.
Harriet A. Washington
Carte Blanche is a wake-up call to the many times researchers have skirted laws about informed consent and jeopardized a participant’s right to know. Washington has a laser-focus ability to make sense of complex statistics, target obfuscating data, put in context historical records and truly empathize with the accounts of those who have experienced what she calls “investigative servitude”—harm from the deterioration of informed consent, an important human right. Editors of the Intima spoke with her about how this groundbreaking exposé has an even more heightened importance during this challenging decade.
Q: How did the pandemic become the perfect storm for the misuse of ‘informed consent’?
Misuse of ‘informed consent’ escalates when there’s an emergency, so during our pandemics you’ve got people who are urgently ill and in need of resources, often scant or unknown. There’s still so much we don’t know about COVID-19, but when it was truly a foreign entity and we knew next to nothing, yet had to do something urgently, that kind of culture tends to escalate people’s willingness to cut corners and expedite things. Speed has been important—‘operation warp speed,’ right? We knowingly sacrificed our tried-and-true processes on the altar of urgency—expeditiously—and for that reason, unfortunately, the pandemic has all the ingredients needed to induce people to cut corners.
What are the reasons doctors give for bypassing ‘informed consent?’
There are many reasons that are given, some more convincing than others, and the reasoning tends to be different when you’re dealing with strangers, so xenophobia plays into this. One of the people in my medical ethics program was a person very active in doing research around the world, and when I met his colleagues, they invoked the reason why there were few uses of informed consent in the Global South: These communities and cultures are used to giving permission to the head man, one chief, one person appointed to give permission for everyone—and they would not dream of violating the culture, they said, by forcing [each person] to undergo informed consent.
It was all I could do not to laugh in their faces; it seemed so self-serving. All I said was ‘Oh, so when the medicine is perfected and it’s efficacious you give it to all the people in this community, right?’ They said, ‘We can’t afford to do that, it is very expensive,’ then I said, ‘Well, if you’re driven by the needs of the community, surely they want this drug if it’s been effective. Clearly it was the will of the people.’ Any number of excuses is given and don’t really have anything to do with the dynamics but are convenient.
The most chilling one was what was proffered to me in 1996 when amendments into these codes of regulations were voted in that allow research without consent. The reasoning was, ‘We’re conducting research on trauma victims; these trauma victims tend to be unconscious so we can’t offer them informed consent because we can’t explain informed consent.’ I’m thinking, OK but this is not a reason—it’s not ethically valid reason. I’m kind of shocked that it did fly. Not many of the reasons hold water as far as I’m concerned.
You write a lot about clinical urgency as one of the contributors often cited for unethical consent practices. So I’m curious about your thought process on where patient narratives might serve to undo that justification or promote the necessity for change in some way; how might patient experiences detract from the legitimacy of that justification of ‘clinical urgency’ as a reason for those minimal practices?
It’s a feature of ‘clinical urgency’ that patients and subjects are typically excluded from those conversations, aren’t they? Who determines when there’s urgency? It’s not the patient or subject; it’s the attending or caregiver, so that’s part of the larger question or issue here—that patients rarely have a voice and almost never have a voice with any potency. So I don’t think it’s actually part of the conversation now.
When I wrote the book, clearly I used a lot of patient examples because I wanted people to identify with that perspective, but to right things in the clinical setting, you have to actually work. You know that more than anyone, because of Columbia’s Narrative Medicine—that you have to actually work to incorporate patients voices. It’s not a given. I will say for example: When talking about a soldier who is faced with a dilemma, such as ‘Do I take these injections or pay the price for contesting them,’ was meant to add a human dimension to make people realize we’re talking about more than abstractions here. Because from a clinical point of view, you lose sight of the patient; it becomes almost like… not a game but a mental exercise and ethically constructing and deconstructing arguments. You have to remember these are people you are talking about. A doctor—the late Columbia Professor Irving J Selikoff, MD— put it beautifully: “Never forget that the numbers in your tables are human destinies, although the tears have been washed away.”
On a related note on voice and autonomy, discussions that are taking place relating to policy change are the places you say where patients are absent and not consulted. I’m curious when thinking about policy change, where do you see the responsibility fall to include or represent patients’ voices and what recommendations do you have about how or what that change might look?
That is such a critically important question. In 2007 in Medical Apartheid, I wrote about it in the last chapter and [recommendations] haven’t changed. IRBs, the last line of ethical defense, for example, conform to ethical strictures to protect people’s rights, their dignity, right? But who’s on this IRB? Let’s say you have 15 people; only one of them has to be unconnected from the institution. Only one of them is a non-scientist. How much power or influence can that one layperson have? He is looking at 14 scientists! He won’t be able to convey his point of view. Also, he may or may not be in a position to identify with the concerns or interests of the subjects whom will be recruited, but he can’t convey those. He can bring them up but will the doctors listen to him? That’s totally up to them. They may or may not listen, and frankly he doesn’t have much leverage.
So I propose IRBs should be constituted of half scientists, half lay people drawn from the population where they’re going to get the subjects. That increases the chance you’ll have a real representation of the concerns of the subjects, and they’ll have a real voice in shaping the research. Paradoxically that could augur well for having more research studies approved, because when you have people who are invested in the study, not only will these lay people be able to add things and concerns researchers had not have thought of in that way or perceived, but by their investment in it will make it more palatable to the subject pool. Instead of it being handed down by doctors and researchers but by someone they know in their community who had a hand in it—that shift has to be done to help IRBs fulfill their mission.
I also think lobbyists have no place in healthcare. One of the reasons these troublesome laws are on the books is because lobbyists pay lawmakers to pass laws in the interests of their companies, not the interests of the people who elected them. They’re circumventing the will of the people. I will hazard to guess if you ask most Americans whether they want to be inveigled into doing research without their consent, the answer would be no. So why is this law? If I had to pick two things to change, those would be the two things.
To add to briefly to what you’re beautifully underscoring: My previous work prior to being in Narrative Medicine included conducting behavioral research with adolescents on HIV/AIDS prevention and overwhelmingly there was so much evidence demonstrating how, in community-based participatory research, having members of the community invested in both the creation of the mechanisms to be used in prevention and treatment, and then rolling people into care or research activities, was always much more successful than these disjointed relationships you were describing.
Absolutely.
How does ‘community consent’ or EFIC (Exception From Informed Consent] work?
The terminology is really bad and it’s been changed. You’ll see fewer references to ‘community consent’ – it’s now notification – but the intent is the same: ‘We know we’re not going to ask individuals permission to do research on them, but that’s okay because we’re going to go to the affected community from which we draw these people and tell people we’re doing research, and then if people don’t want to be in research, we’ll give them a way to opt out.’ The typical way to opt out is to say here’s a bracelet you have to wear 24 hours a day/365 days of the year, saying ‘I decline the PolyHeme study’ for example.
In Seattle, a community was blanketed with information and the researchers were flooded with requests for bracelets from those who didn’t want to be in the study and they ran out of bracelets for a year.
You talk about semantics and for our journal, it’s one of the things we’d like to hear more about. In Carte Blanche, you explain how language is used to mask the effects of recruitment—how terminology has changed from ‘medical experimentation’ to ‘medical study.’
An article I wrote in the Journal of Law, Medicine and Ethics about the use of semantics in medical research goes into this and the example you gave is a key one – ‘medical experimentation’ is a term that’s become verboten. Researchers discourage its use because they find the word engenders fear and suspicion in subjects who fear experimentation, they fear the worst; they want milder terms used.
I point out in the book that ‘medical experimentation’ is perfectly accurate, and it’s also that the risk of research is not necessarily tied to the lack of ethics; even well-designed research can be risky. That’s the nature of research to be risky; it’s risky because we simply don’t know. We certainly hope there will be a good outcome but sometimes we’re unpleasantly surprised by illness and death—that’s frankly no one’s fault. You can’t protect people during medical research and yet carefully inculcating the belief that people can be protected against risk is part of the problem, because instead of admitting something is research, they recruit terminology to make it sound as if it’s not research but offering people some cutting-edge new technique or treatment they will benefit from. But if it’s research, it’s not treatment, it’s not medication; you don’t know what’s going to happen. You’re recruiting them to serve the needs of other people…to take on risk for a study that may or may not benefit them, and hopefully may help or benefit people in the future.
A lot of researchers do exactly what one should do: Deliver well-informed consent that gives people the fullest possible knowledge of the situation so they know what they’re signing up for. When we have laws that remove informed consent from the equation, researchers who normally have wanted to do that have no opportunity to do that. Now it’s just a matter of finding bodies. And that’s exactly what’s done. Again, the commercialization of healthcare via commodification of patents has a lot to do with that. In some studies you see a university department has become a department of the corporation, so hands are tied and then people don’t receive what they have a right to get—what they need for informed consent. It’s a very chilling scenario; it’s scarier than something in a post-apocalyptic novel! The idea we’re slowly succumbing to this lack of volition and people don’t seem to be aware is deeply concerning.
That reminds me of a point from your book Deadly Monopolies, this overlap, the life patent and the medical industrialization complex and the overemphasis on bodies as surplus or biological material; things that can be patented or turned into a commodity, the way in which it coincides with how you write about being labeled as ‘other,’ and how that also creates influence upon language and the ability to enforce policies that see research subjects solely as bodies but not as people.
Exactly. The language around these subjects is chilling in another way: that they don’t acknowledge the individual. I really hope this book serves as a canvas to let people know this is happening and to hopefully galvanize them to protect against it, because it’s not a good road we’re going down, unfortunately. It’s a profitable one for some companies but it’s not helping anyone else.—Mario de la Cruz and Donna Bulseco
ANNOUNCEMENT
Two events are planned for discussions about Washington’s new book.
On Sunday, February 28, from 5 to 7 p.m., she will do a virtual talk with Revolution Books - New York City. The event is co-sponsored by Revolution Books - Berkeley (2:00 p.m. PST on the West Coast). Register here
On Wednesday, March 17 at 6:00 p.m., Harriet A. Washington will be doing a Columbia campus-wide zoom event with Jelani Cobb (Columbia Journalism School professor and New Yorker writer) and Dr. Olajide A. Williams of Columbia Neurology. They will be discussing Washington's book in the context of COVID-19 and the vaccine, including urging people to get the vaccine. Nicholas Lemann, CGR director, will moderate and President Lee Bollinger will introduce the event. For more information, go to Columbia Global Reports.