Do Terms and Conditions Equal Informed Consent?

Do Terms and Conditions Equal Informed Consent?

David L. Graham, MD, FASCO

@davidgrahammd
Jun 30, 2014

It’s not often that an article from the Proceedings of the National Academy of Sciences (PNAS) leads to an editorial in Forbes or discussion on morning news shows. A study from researchers at Princeton, published in the most recent issue of PNAS (PNAS Vol 111 No 24 pp. 8788-8790), has garnered more widespread attention in a way I do not think the authors expected.

In brief, the study manipulated items subjects saw in their newsfeed by emotional expression and monitored subsequent postings by those subjects to see if the emotional content was altered by what they had been exposed to. The national attention that is arising from this is focusing on Facebook, who worked with the investigators to alter what users saw. That’s all well and good, but in the context of a clinical trial, that’s not the major problem. Personally, I think the study is interesting and had some intriguing findings. My concern, however, is that the major problem is not being discussed.

Make no mistake, this is a clinical trial. Subjects had direct interventions and their responses to these interventions were monitored and reported publically. What is lacking, to my eye, is informed consent. In the paper, the authors state:

“LIWC was adapted to run on the Hadoop Map/Reduce system (11) and in the News Feed filtering system, such that no text was seen by the researchers. As such, it was consistent with Facebook’s Data Use Policy, to which all users agree prior to creating an account on Facebook, constituting informed consent for this research.”

In other words, the investigators state that informed consent was, de facto, given for this trial by simply setting up a Facebook account and agreeing to the Terms and Conditions. This is more than slightly reminiscent of a South Park episode from 2011, where agreeing to Apple Terms and Conditions lead to a character undergoing absurd medical procedures. I’ve reviewed Facebook’s Data Use Policy (https://www.facebook.com/about/privacy/your-info#howweuse accessed June 30, 2014), and I have great difficulty in finding the phrases that allow this sort of research. Statements on this page include:

“As described in ‘How we use the information we receive’ we also put together data from the information we already have about you, your friends, and others, so we can offer and suggest a variety of services and features”

“We use the information we receive about you in connection with the services and features we provide to you and other users like your friends, our partners, the advertisers that purchase ads on the site, and the developers that build the games, applications, and websites you use.”

“. . . for internal operations, including troubleshooting, data analysis, testing, research and service improvement.”

And finally:

“Your trust is important to us, which is why we don't share information we receive about you with others unless we have:
  • received your permission;
  • given you notice, such as by telling you about it in this policy; or
  • removed your name and any other personally identifying information from it.”

Do these statements constitute justification for a waiver of informed consent? There are certainly a number of situations where a global consent can serve as consent for individual research activities. Tissue banks and studies involving discarded tissue and samples operate under this paradigm routinely. These sorts of studies, however, do not involve direct intervention on a patient. The standards of informed consent also require an opportunity for the subject to ask about the trial. No section on the Facebook Data use policy page has a link to pose questions.

The paper in PNAS does not indicate whether an IRB reviewed this protocol and agreed to the informed consent waiver. This should be addressed by the authors in a public forum. If an IRB agreed, we may quibble about why but it was at least reviewed. If no IRB review was performed, that is a concerning aspect to this trial.

This does likely represent the future of data mining and clinical research. It makes sense to get it right from the start and, when they occur, use situations like this to better our work.

 

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Comments

Don S. Dizon, MD, FACP

Jul, 01 2014 7:50 PM

Dave,
Great post. And the firestorm over what Facebook did has lit up social media. Even I was offended over the research that was being performed, without the express permission of "us". It really is the worst case scenario as far as those who would consider clinical research is concerned- being treated as lab rats. Still, I have seen some arguments that this algorthmic control over content seen is exactly what's been done by the entertainment industry (when they review demographics, user preferences) and especially by the advertisting industry. I think the biggest difference is that there was de facto acceptance that this alone justifies clinical research without expressly obtaining informed consent is perhaps what is most troubling. I understand that the hypothesis tested was fairly benign- but what is to stop someone else from sliding further down that slippery slope called medical ethics? DSD

David L. Graham, MD, FASCO

Jul, 02 2014 8:54 AM

Don, thanks for your always insightful comments. Being in front of a story like this leads to new analysis and ideas that merit further discussion. There are 2 points I need to address

1. Don alludes to what a number of others are stating more explicitly as a defense of this project; that this is just normal business manipulation of data. I think that arguement falls for a few reasons. As it applies to projects being defined as clinical research, author's intent is important. We can look, internally at our practices and outcomes and it is not research. Quality review does not require informed consent. Looking at it with an intent to publish, however, makes it research and under the purvey of an IRB or ethics board. Had the authors chose to look at this internally or publish in a business or advertising journal, the arguement that this is not clinical resarch could be more easily accepted. They chose to submit and publish this in PNAS. A highly regarded research journal. In addition, the authors and Facebook, itself, continue to refer to this as "research". The "research" included in Facebook's Data Use Policy is explicitly listed as internal. With those ideas in mind, I cannot help but conclude that this crossed the line from business analysis to clinical research. I remain open to arguements to the contrary.

2. As a matter of transparency. I have amended thae date of accession of Facebook's Data Use Policy. It was not 1962, as I originally wrote. I was awfully young then.

Jos? Roberto Goldim

Jul, 05 2014 11:48 AM

Thanks for your useful post.
It's important to remember that in 1974 when the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHSBBR) was created, not only biomedical research was the target, but behavioral research too. The Belmont Report, stated in 1978, make a Science Ethics reflexion about many issues, one of them is manipulate situations in order to elicit behaviors. Thats the question. If the authors refering, as Dr. Graham notice before, their study as research, and submitted as a research, the evauation of this paper must be made as any other, using the Ethical Framework: Respecto to Persons, Beneficence and Justice. Evaluating the paper using these criteria we identify problems in respecting persons, not only Informed Consent concerns, but respect in full understanding; in benefence, thats includes do not harm, and possible harm was present; and justice, understanding justice as fairness, is another issue.
 
 
 


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