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Ethical and practical issues for uBiome to keep working on.

The views expressed are those of the author and are not necessarily those of Scientific American.


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Earlier this week, the Scientific American Guest Blog hosted a post by Jessica Richman and Zachary Apte, two members of the team at uBiome, a crowdfunded citizen science start-up. Back in February, as uBiome was in the middle of its crowdfunding drive, a number of bloggers (including me) voiced worries that some of the ethical issues of the uBiome project might require more serious attention. Partly in response to those critiques, Richman’s and Apte’s post talks about their perspectives on Institutional Review Boards (IRBs) and how in their present configuration they seem suboptimal for commercial citizen science initiatives.

Their post provides food for thought, but there are some broader issues about which I think the uBiome team should think a little harder.

Ethics takes more than simply meeting legal requirements.

Consulting with lawyers to ensure that your project isn’t breaking any laws is a good idea, but it’s not enough. Meeting legal requirements is not sufficient to meet your ethical obligations (which are well and truly obligations even when they lack the force of law).

Now, it’s the case that there is often something like the force of law deployed to encourage researchers (among others) not to ignore their ethical obligations. If you accept federal research funds, for example, you are entering into a contract one of whose conditions is forking within federal guidelines for ethical use of animal or human subjects. If you don’t want the government to enforce this agreement, you can certainly opt out of taking the federal funds.

However, opting out of federal funding does not remove your ethical duties to animals or human subjects. It may remove the government’s involvement in making you live up to your ethical obligations, but the ethical obligations are still there.

This is a tremendously important point — especially in light of a long history of human subjects research in which researchers have often not even recognized their ethical obligations to human subjects, let alone had a good plan for living up to them.

Here, it is important to seek good ethical advice (as distinct from legal advice), from an array of ethicists, including some who see potential problems with your plans. If none of the ethicists you consult see anything to worry about, you probably need to ask a few more! Take the potential problems they identify seriously. Think through ways to manage the project to avoid those problems. Figure out a way to make things right if a worst case scenario should play out.

In a lot of ways, problems that uBiome encountered with the reception of its plan seemed to flow from a lack of good — and challenging — ethical advice. There are plenty of other people and organizations doing citizen science projects that are similar enough to uBiome (from the point of view of interactions with potential subjects/participants), and many of these have experience working with IRBs. Finding them and asking for their guidance could have helped the uBiome team foresee some of the issues with which they’re dealing now, somewhat late in the game.

There are more detailed discussions of the chasm between what satisfies the law and what’s ethical at The Broken Spoke and Drugmonkey. You should, as they say, click through and read the whole thing.

Some frustrations with IRBs may be based on a misunderstanding of how they work.

An Institutional Review Board, or IRB, is a body that examines scientific protocols to determine whether they meet ethical requirements in their engagement of human subjects (including humans who provide tissue or other material to a study). The requirement for independent ethical evaluation of experimental protocols was first articulated in the World Medical Association’s Declaration of Helsinki, which states:

The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher, the sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No change to the protocol may be made without consideration and approval by the committee.

(Bold emphasis added.)

In their guest post, Richman and Apte assert, “IRBs are usually associated with an academic institution, and are provided free of charge to members of that institution.”

It may appear that the services of an IRB are “free” to those affiliated with the institution, but they aren’t really. Surely it costs the institution money to run the IRB — to hire a coordinator, to provide ethics training resources for IRB members and to faculty, staff, and students involved in human subjects research, to (ideally) give release time to faculty and staff on the IRB so they can actually devote the time required to consider protocols, comment upon them, provide guidance to PIs, and so forth.

Administrative costs are part of institutional overhead, and there’s a reasonable expectation that researchers whose protocols come before the IRB will take a turn serving on the IRB at some point. So IRBs most certainly aren’t free.

Now, given that the uBiome team was told they couldn’t seek approval from the IRBs at any institutions where they plausibly could claim an affiliation, and given the expense of seeking approval from a private-sector IRB, I can understand why they might have been hesitant to put money down for IRB approval up front. They started with no money for their proposed project. If the project itself ended up being a no-go due to insufficient funding, spending money on IRB approval would seem pointless.

However, it’s worth making it clear that expense is not in itself a sufficient reason to do without ethical oversight. IRB oversight costs money (even in an academic institution where those costs are invisible to PIs because they’re bundled into institutional overhead). Research in general costs money. If you can’t swing the costs (including those of proper ethical oversight), you can’t do the research. That’s how it goes.

Richman and Apte go on:

[W]e wanted to go even further, and get IRB approval once we were funded — in case we wanted to publish, and to ensure that our customers were well-informed of the risks and benefits of participation. It seemed the right thing to do.

So, we decided to wait until after crowdfunding and, if the project was successful, submit for IRB approval at that point.

Getting IRB approval at some point in the process is better than getting none at all. However, some of the worries people (including me) were expressing while uBiome was at the crowdfunding stage of the process (before IRB approval) were focused on how the lines between citizen scientist, human subject, and customer were getting blurred.

Did donors to the drive believe that, by virtue of their donations, they were guaranteed to be enrolled in the study (as sample providers)? Did they have a reasonable picture of the potential benefits of their participation? Did they have a reasonable picture of the potential risks of their participation?

These are not questions we leave to PIs. To assess them objectively, we put these questions before a neutral third-party … the IRB.

If the expense of formal IRB consideration of the uBiome protocol was prohibitive during the crowdfunding stage, it surely would have gone some way to meeting ethical duties if the uBiome team had vetted the language in their crowdfunding drive with independent folks attentive to human subjects protection issues. That the ethical questions raised by their fundraising drive were so glaringly obvious to so many of us suggests that skipping this step was not a good call.


We next arrive at the issue of the for-profit IRB. Richman and Apte write:

Some might criticize the fact that we are using a private firm, one not connected with a prestigious academic institution. We beg to differ. This is the same institution that works with academic IRBs that need to coordinate multi-site studies, as well as private firms such as 23andme and pharmaceutical companies doing clinical trials. We agree that it’s kind of weird to pay for ethical review, but that is the current system, and the only option available to us.

I don’t think paying for IRB review is the ethical issue. If one were paying for IRB approval, that would be an ethical issue, and there are some well known rubber-stamp-y private IRBs out there.

Carl Elliott details some of the pitfalls of the for-profit IRB in his book White Coat, Black Hat. The most obvious of these is that, in a competition for clients, a for-profit IRB might well feel a pressure to forego asking the hard questions, to be less ethically rigorous (and more rubber-stamp-y) — else clients seeking approval would take their business to a competing IRB they saw as more likely to grant that approval with less hassle.

Market forces may provide good solutions to some problems, but it’s not clear that the problem of how to make research more ethical is one of them. Also, it’s worth noting that being a citizen science project does not in and of itself preclude review by an academic IRB – plenty of citizen science projects run by academic scientists do just that. It’s uBiome’s status as a private-sector citizen science project that led to the need to find another IRB.

That said, if folks with concerns knew which private IRB the uBiome team used (something they don’t disclose in their guest post), those folks could inspect the IRB’s track record for rigor and make a judgment from that.

Richman and Apte cite as further problems with IRBs, at least as currently constituted, lack of uniformity across committees and lack of transparency. The lack of uniformity is by design, the thought being that local control of committees should make them more responsive to local concerns (including those of potential subjects). Indeed, when research is conducted by collaborators from multiple institutions, one of the marks of good ethical design is when different local IRBs are comfortable approving the protocol. As well, at least part of the lack of transparency is aimed at human subjects protection — for example, ensuring that the privacy of human subjects is not compromised in the release of approved research protocols.

This is not to say that there is no reasonable discussion to have about striving for more IRB transparency, and more consistency between IRBs. However, such a discussion should center ethical considerations, not convenience or expediency.

Focusing on tone rather than substance makes it look like you don’t appreciate the substance of the critique.

Richman and Apte write the following of the worries bloggers raised with uBiome:

Some of the posts threw us off quite a bit as they seemed to be personal attacks rather than reasoned criticisms of our approach. …

We thought it was a bit… much, shall we say, to compare us to the Nazis (yes, that happened, read the posts) or to the Tuskegee Experiment because we funded our project without first paying thousands of dollars for IRB approval for a project that had not (and might never have) happened.

I have read all of the linked posts (here, here, here, here, here, here, here, and here) that Richman and Apte point to in leveling this complaint about tone. I don’t read them as comparing the uBiome team to Nazis or the researchers who oversaw the Tuskegee Syphilis Experiment.

I’m willing to stipulate that the tone of some of these posts was not at all cuddly. It may have made members of the uBiome team feel defensive.

However, addressing the actual ethical worries raised in these posts would have done a lot more for uBiome’s efforts to earn the public’s trust than adopting a defensive posture did.

Make no mistake, harsh language or not, the posts critical of uBiome were written by a bunch of people who know an awful lot about the ins and outs of ethical interactions with human subjects. These are also people who recognize from their professional lives that, while hard questions can feel like personal attacks, they still need to be answered. They are raising ethical concerns not to be pains, but because they think protecting human subjects matters — as does protecting the collective reputation of those who do human subjects research and/or citizen science.

Trust is easier to break than to build, which means one project’s ethical problems could be enough to sour the public on even the carefully designed projects of researchers who have taken much more care thinking through the ethical dimensions of their work. Addressing potential problems in advance seems like a better policy than hoping they’ll be no big deal.

And losing focus on the potential problems because you don’t like the way in which they were pointed out seems downright foolish.

Much of uBiome’s response to the hard questions raised about the ethics of their project has focused on tone, or on meeting examples that provide historical context for our ethical guidelines for human subject research with the protestation, “We’re not like that!” If nothing else, this suggests that the uBiome team hasn’t understood the point the examples are meant to convey, nor the patterns that they illuminate in terms of ethical pitfalls into which even non-evil scientists can fall if they’re not careful.

And it is not at all clear that the uBiome team’s tone in blog comments and on social media like Twitter has done much to help its case.

What is still lacking, amidst all their complaints about the tone of the critiques, is a clear account of how basic ethical questions (such as how uBiome will ensure that the joint roles of customer, citizen science participant, and human subject don’t lead to a compromise of autonomy or privacy) are being answered in uBiome’s research protocol.

A conversation on the substance of the critiques would be more productive here than one about who said something mean to whom.

Which brings me to my last issue:

New models of scientific funding, subject recruitment, and outreach that involve the internet are better served by teams that understand how the internet works.

Let’s say you’re trying to fund a project, recruit participants, build general understanding, enthusiasm, support, and trust. Let’s say that your efforts involve websites where you put out information and social media use where you amplify some of that information or push links to your websites or favorable media coverage.

People looking at the information you’ve put out there are going to draw conclusions based on the information you’ve made public. They may also draw speculative conclusions from the gaps — the information you haven’t made public.

You cannot, however, count on them to base their conclusions on information to which they’re not privy, including what’s in you’re heart.

There may be all sorts of good efforts happening behind the scenes to get rigorous ethical oversight off the ground. If it’s invisible to the public, there’s no reason the public should assume it’s happening.

If you want people to draw more accurate conclusions about what you’re doing, and about what potential problems might arise (and how you’re preparing to face them if they do), a good way to go is to make more information public.

Also, recognize that you’re involved in a conversation that is being conducted publicly. Among other things, this means it’s unreasonable to expect people with concern to take it to private email in order to get further information from you. You’re the one with a project that relies on cultivating public support and trust; you need to put the relevant information out there!

(What relevant information? Certainly the information relevant to responding to concerns and critiques articulated in the above-linked blog posts would be a good place to start — which is yet another reason why it’s good to be able to get past tone and understand substance.)

In a world where people email privately to get the information that might dispel their worries, those people are the only ones whose worries are addressed. The rest of the public that’s watching (but not necessarily tweeting, blogging, or commenting) doesn’t get that information (especially if you ask the people you email not to share the content of that email publicly). You may have fully lost their trust with nary a sign in your inboxes.

Maybe you wish the dynamics of the internet were different. Some days I do, too. But unless you’re going to fix the internet prior to embarking on your brave new world of crowdfunded citizen science, paying some attention to the dynamics as they are now will help you use it productively, rather than to create misunderstandings and distrust that then require remediation.

That could clear the way to a much more interesting and productive conversation between uBiome, other researchers, and the larger public.

Janet D. Stemwedel About the Author: Janet D. Stemwedel is an Associate Professor of Philosophy at San José State University. Her explorations of ethics, scientific knowledge-building, and how they are intertwined are informed by her misspent scientific youth as a physical chemist. Follow on Twitter @docfreeride.

The views expressed are those of the author and are not necessarily those of Scientific American.





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