Bill Jenkins and the legacy of the Tuskegee Syphilis Study

•March 3, 2019 • Leave a Comment

It’s been a while – a LONG while – but here goes a renewed effort to try to keep people engaged in all things research ethics. It’s a busy time of life for us, with a ton of demands, but I’m feeling a strong pull towards trying to rekindle the Research Ethics Blog. Let’s start with a post about something with which most of you will be familiar.

Bill Jenkins died recently. Many of you will not know his name – I also admit I didn’t, until now. You can read his obituary in The New York Times here.

Dr. Jenkins, an epidemiologist, was working as a statistician in Washington in the 60s when he learned of the ongoing Tuskegee Syphilis Study. When he did his own research and reported his serious concerns about the ethical conduct of the study to his supervisor, he was told “not to worry about it”. He continued to advocate and write about the troubling ethical aspects of the study. With his efforts and those who worked with him, including Peter Buxton, the study – and a serious ethical problem – was eventually highlighted in the New York Times and finally shut down.

Many people have heard of the Tuskegee study, and most foundational courses in bioethics and research ethics teach this as a key case study to illustrate the principle of respect for autonomy, the value of informed consent, and the notions of voluntariness and vulnerability and racism in medical research. While many might nod and say “yes, yes we know about this study, sure”, there’s one thing I always emphasize to my students when we talk about this study in detail. This study did not happen in one small corner of the world, far away, or a long time ago. This study involved many stakeholders and collaborators at local, state and national levels, who passed the work on through generations of scientists, who continued the research and who didn’t ask questions about what needed to change – or stop –  for over 40 years, until 1972. We often think that we live in modern and progressive times. 1972 was not so long ago to allow us to think comfortably, “Well, something like this would never happen now….” The last widow of a Tuskegee survivor died in 2009 – and subsequent generations of Tuskegee survivors continue to bear the burden of the legacy of the Syphilis study.

Throughout Jenkins’ illustrious career, he achieved much in demonstrating that medical research was biased against persons of colour, against those who were already traditionally underserved and marginalized. Jenkins worked to not only address these challenges explicitly in a number of contexts including HIV and AIDS, and he also worked to recruit more persons of colour into public health professions. He led the work to ensure continuing medical benefits to the survivors of Tuskegee and their families and, in 1997, to generate a formal apology from the US federal government to the men of the Tuskegee study.

Next time I teach Tuskegee, I’m going to also teach about Bill Jenkins.

-Thanks to Alex Karabanow for pointing me to this story.


CIA Torture as Human-Subjects Research

•June 8, 2017 • Leave a Comment

In the piece linked below, the author (a professor of sociology at the University of California) argues that modern norms governing human-subjects research are actually stronger, or at least more clear, than those governing government-sanctioned torture. Some of us professionally involved in research ethics governance might not agree that norms of that discipline are beyond debate. Also, we might wonder whether ‘exporting’ the norms of research ethics for use in prosecuting torture is likely to be good for research ethics, or will it end with a reversal: Some will begin with the premise that the CIA’s torture/research program is justified by its public-interest objectives. And if the CIA can, er, ‘break new ground’ in the ethics of research, then why can’t others?

The CIA Didn’t Just Torture, It Experimented on Human Beings by Lisa Hajjar (for The Nation)

… No one has been held accountable for torture, beyond a handful of prosecutions of low-level troops and contractors. Indeed, impunity has been virtually guaranteed as a result of various Faustian bargains, which include “golden shield” legal memos written by government lawyers for the CIA; ex post facto immunity for war crimes that Congress inserted in the 2006 Military Commissions Act; classification and secrecy that still shrouds the torture program…

…Rather, because the concept of torture has been so muddled and disputed, I suggest that accountability would be more publicly palatable if we reframed the CIA’s program as one of human experimentation. If we did so, it would be more difficult to laud or excuse perpetrators as “patriots” who “acted in good faith….”

Slow progress on Zika vaccine development – and at the expense of Ebola funding?

•August 13, 2016 • Leave a Comment
197-Zika_Virus-ZikaVirus copy 2.jpg
The Zika Virus – Image by David Goodwill (RCSB Molecule of the Month 197, June 2016)
[CC BY 4.0 (, via Wikimedia Commons

A recent PBS Newshour story highlights just some of the challenges in getting a vaccine for Zika tested and out on the market. The article confirms that about 30 vaccines are being developed and tested. Currently there is a multi-centre open-label Phase 1 clinical trial underway using the GLS-5700 vaccine, developed by Inovio. The study has been approved not only by the FDA but also by Health Canada, and trial sites include Miami, Philadelphia and Boston.

But the article highlights the challenges of getting vaccines to market, the main one being the incredible time, expertise and costs that testing involves that means few others than the biggest pharmaceutical companies can realistically “get in the game”. As well, the so-called success rates of getting vaccines of this type to market are slim: consider some similar stories of SARS, H1N1, Ebola virus disease and West Nile. In fact, the PBS article suggests that some of the work to develop the Zika virus is being funded in part, by borrowing from funds previously set aside for research and development of an Ebola vaccine and support and rebuilding of Ebola-ravaged areas. With Ebola fading in the memories of policy makers and politicians in terms of urgency and Zika presenting a conceivably more “right now” time-sensitive urgency, it’s easy to see how the attention of those in power would shift quickly. The worry is, of course, that funds taken from one to fund the other, will never be replaced and with another outbreak of Ebola, we may be, in some senses, in a similar place to where we were before – with no viable, safe and effective vaccine and without sufficient rebuilding of necessary public health infrastructure.

In terms of Ebola, “we’re not done,” Dr. Anne Schuchat (Principal Deputy Director of the CDC) said in one interview, “People think we’re done with Ebola, but of course we’re not done.” And with the knowledge that Ebola, in some form, lives on in survivors, it’s realistic to assume that we’ll very likely be dealing with this virus again – in some form. The majority of places most affected by Ebola continue to face serious challenges in rebuilding infrastructure, strengthening public health units, providing assistance to survivors and families and enhancing preventative care and will need continued investment in these areas and more.

As Health and Human Services Secretary Sylvia Mathews Burwell states, “we don’t have the option to set one aside in the name of the other,” calling for full funding for both Zika and Ebola responses.

Bad Behaviour by Pharma, and Unforeseen Consequences

•April 17, 2015 • Leave a Comment

This is a must-read for anyone interested in the ethics of drug development and clinical trials.

It explores how genuinely bad behaviour on the part of pharmaceutical companies can lead to overreaction by journalists and the public, sometimes with tragic consequences.

By Matthew Herper, writing for How Marketing And Media Muddled The Truth About The Heart Drug Vytorin

Big bad drug companies make it easy to fall into a kind of conspiracy-thinking mentality. If Roche and Glaxo are going to behave like lying, data-burying scoundrels, their drugs must be useless, right? But, because medicines have to prove themselves in both a regulatory gauntlet and the market, that’s not always so. And we can be misled by that kind of thinking….

Is there a “Right to Try” Experimental Drugs?

•April 14, 2015 • Leave a Comment

From The State Journal-Register (Springfield, IL)
Patient freedom, ethics at the heart of ‘Right to Try’ push in Illinois

Some doctors worry that an effort to grant terminally ill people more access to unproven drugs might offer them false hope or even be harmful, but advocates for a “right to try” say patients should have more opportunities for treatments that could extend their lives.

Legislation with bipartisan support that was approved by Illinois House and Senate committees would create a Right to Try Act, letting patients seek treatments with their doctor’s consultation that have passed only the first phase of U.S. Food and Drug Administration testing…

Should a University President Resign over Research Ethics?

•April 12, 2015 • Leave a Comment

In this newspaper editorial, a former governor of Minnesota says that the current president of the University of Minnesota needs to go, because of how he has mishandled controversy over research ethics at the university:

Markingson case: University of Minnesota can’t regain trust under current leadership

…During his first year at the university, Kaler had to make a major decision. Prudent management would have involved meeting with Elliott, learning about the specific ethical issues related to Markingson and broader concerns about psychiatric clinical research, and dealing with the growing scandal. But Kaler chose instead to perpetuate the prevailing coverup. He opposed any independent review, never responded to the charges made in the media, ignored or dismissed critics, and stood firm in his belief that it would all blow over.

In so doing, President Kaler tarnished his office and abandoned the principles of truthfulness, openness and integrity….

Ethics of Research on Complementary & Alternative Medicine

•April 11, 2015 • Leave a Comment

Here are three related items to bring to your attention:

On the blog of Policy Options magazine, here’s a very good piece by our pal Tim Caulfield, called Homeopathy and the ethics of researching magic. And via the same outlet, here’s my piece in which I partly disagree with Tim: Homeopathy and Research Ethics.

And just recently, An anonymous Canadian foundation grants $3 million to study naturopathic oncology. But such a study could not be done in Canada because it a study funded by an anonymous source would violate the Tri-Council Policy Statement. Page 29 of the Policy Statement makes clear that informed consent must include identity of the funder or sponsor.

Johns Hopkins University Sued for $1bn Over Guatemalan Study

•April 6, 2015 • Leave a Comment

This story is pretty much a ‘perfect storm’ of research ethics problems: international research, on vulnerable populations (orphans, prisoners and mental health patients), lack of consent, and questionable institutional responsibility for the actions of now-dead researchers.

From The Guardian: Guatemalans deliberately infected with STDs sue Johns Hopkins University for $1bn

…Nearly 800 plaintiffs have launched a billion-dollar lawsuit against Johns Hopkins University over its alleged role in the deliberate infection of hundreds of vulnerable Guatemalans with sexually transmitted diseases, including syphilis and gonorrhoea, during a medical experiment programme in the 1940s and 1950s….

A call for “new rules” for Internet-based research

•September 16, 2014 • Leave a Comment

information-literacy-researching-online-500x312The John Hopkins Berman Institute of Bioethics put out a press release today, announcing the pre-release of an article in the Proceedings of the National Academy of Science: In Wake of Uproar Over Facebook’s Emotional Manipulation Study, Bioethics Scholars Say New Rules Are a “Moral Imperative”

It’s not actually news, many would agree, but good to know someone in bioethics has said this in print and that it seems others are paying attention. Many ethics review board members have been grappling with concerns as well as exciting new frontiers in the area of Internet-based research for a few years now. I have about six different versions of a presentation on the ethical considerations of Internet-based research, the oldest one dating from 2008. Those in research ethics have been talking about this for a few years now. It wasn’t until the Facebook Cornell “emotion contagion” study, it seems, that other people in bioethics started paying attention and asking the questions. What does it mean to be a participant? Should a virtual participant be treated similarly to a face-to-face participant? When and how should an informed consent process take place? Should the ethical standards we apply to face-to-face research apply in a virtual context? If so, how does that work?

The authors of the paper have chosen to focus, or at least begin the discussion of ethics in online research with the idea of the “large-scale social computing research” studies, citing growing public interest and concern. They also ask a number of the questions I’ve posed above to begin to guide their discussions and exploration into this topic.

The press release highlights a number of the recommendations from the paper (which is still embargoed, so not yet available in full text, to me).

They recommend that there needs to be inclusion of clear language in guidelines about what types of online research should be categorized as research involving human participants – and thus subject to a process of ethics review and oversight. Additionally, the way that we traditionally approach informed consent needs to be reconsidered in light of and in response to the challenges of online participation. Traditional approaches to and templates for informed consent simply don’t work in a virtual environment.

The authors here identify research ethics concerns that are not unique to internet-based research and that, in part, really don’t address the lack of smart, relevant guidelines in this area. They recommend that journals should act as a final and independent evaluator in deciding if a research project has been carried out with ethical soundness. That’s a great aspiration – for sure – but it’s important to remember that if we do claim that this should happen, most editorial boards and/or editors are now going to have to not only be well versed in research ethics, but also on the application of research ethics guidelines to internet-based research, which comes in many forms and types. And this of course then applies to reviewers. The burden of ensuring that internet-based research is carried out with ethical soundness lies with the researchers and ethics review boards. This then suggests that there not only be clear, relevant and explicit guidelines, but that there are also plenty of opportunities for conversations between researchers who are involved in internet-based research and ethics review boards.

They also identify that public-private collaboration is often a key part of Internet-based research initiatives and the collection of vast amounts of information and that these kinds of collaborations should not be viewed in a kind of knee-jerk negative way, but that this should provide opportunity and incentive for researchers. Finally, they state that geography and politics has an impact upon online interaction and that there is a lack of clarity regarding jurisdictional and relevant legal precedents. This lack of clarity may well provide a barrier to researchers getting approval for all kinds of projects, not just those carried out in an online environment, although it is fair to acknowledge that the online element may provide additional sources of confusion.

From these recommendations stated thus far, I think it’s also important to also consider a couple of other things, going forward:

First, it’s not just about “big data” and large-scale research. We need to think carefully in research ethics about how we consider internet-based research within our much more traditional paradigm for ethics review – which assumes a kind of relationship between participant and researcher that more often than not, does not occur in many types of internet-based research. So while it’s definitely a good starting point to consider the questions we need to ask within the context of large-scale research, we also must acknowledge the fact that many ethics review boards are reading much smaller scale proposals involving Internet-based research and are seriously grappling with how to apply traditional guidelines to funky new research studies in an online environment.

We also need to remember the fact that research in an online environment is just as diverse in terms of methods and aims as research in the F2F world context. Creating one-size-fits-all ‘Internet research guidelines’ based on large-scale research studies will not be adequate to reflect the varying kinds of research activity that goes on, in an online environment. Many research ethics guidelines are dynamic and have evolved over the years to better reflect new, emerging and innovative methods and methodologies. We’ve learned from this that a “one-size-fits-all” approach to ethics review doesn’t work – and I can confidently say that it very likely won’t work in the development of guidelines for Internet-based research – so let’s make sure we approach this exercise with that in mind.

Second, we need to consider that not only do we need to think about and develop guidelines for internet-based research, but we also should acknowledge that in many cases, children, adolescents and youth will be approached to take part in research in a online environment, rather than through more traditional F2F means. It is, of course, one interesting and compelling way to recruit and attract participants who are more likely to be digital natives, and who may be far more comfortable, as a cohort, with the notion of a fully integrated digital self. Many ethics review boards already treat research proposals involving children and youth quite differently, appropriately, and I’m not suggesting that should change. But we may find that what many ethics review board members are uncomfortable with in internet-based research, some young participants are perfectly acclimatized to, without worry or concern. This leads me to my third point here – it’s not just about the guidelines. And it shouldn’t be. It’s also about building capacity in the world of research ethics in the area of internet-based research. It means thinking about who sits around the table as members of an ethics review board and the more urgent imperative to ensure that someone with knowledge of this area is included in the membership of boards. In Canada, we have a membership and composition requirements that include an imperative to ensure that the membership includes those with expertise in ethics and in the areas of relevant law. On ethics review boards I’ve been on, we’ve already been thinking about other kinds of representation that there needs to be around the table. One such consideration might be to have someone with expertise in the methods, variations and ethics of Internet-based research.

It will be interesting to read the full article, and to see what happens in terms of next steps. I think many people who are active in the area of research ethics at all kinds of institutions with a wide variety of expertise in this area are already well beyond thinking that this conversation needs to begin, and hopefully a diverse representation of people with this expertise and experience will be invited to the table.

Facebook and ‘Being Experimented Upon’

•August 21, 2014 • Leave a Comment

Following on my recent blog posting about the Facebook emotion-manipulation study, here’s a useful piece from The Atlantic: How Much Should You Know About How Facebook Works?

The piece focuses on the ubiquity of constantly-tweaked algorithms in online services such as Google and Facebook. The algorithms such companies use today are quite different from the ones they used 5 years ago, in part because the companies are constantly experimenting and using the results of those experiments to adjust the “math” behind your Facebook newsfeed and your Google search results.

Cornell professor Jeff Hancock, one of the authors of the infamous study, is quoted as asking: “If you think about Google search and you say, ‘I don’t want to be experimented on,’ then the question is, well, what does that mean?

Good question!