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In a recent Open Letter published on Gates Open Research, Pamela Kolopack, University of Toronto, and James Lavery, Emory University, discuss the issues of informed consent in field trials involving gene-drive mosquitoes. One of the reviewers of the article was Carolyn Neuhaus, The Hastings Centre. We thought the thorough discussion that occurred in Carolyn’s peer review report warranted further exploration. This is the first of two posts in which we delve into this topic with James (JL) and Carolyn (CN), the second will be posted next week. [Update 16 March 2018: the second post is now live here] 

In their article, Pamela and James highlight the public outcry that occurred around a planned field trial involving genetically modified Aedes aegypti as a means of preventing transmission of the Zika virus, dengue fever, and chikungunya. How do you think issues around informed consent should be addressed in the future to prevent a repeat of this and maintain public support?

JL: In the trial in question, “informed consent” was being invoked by local residents as an ethical standard in the broader societal discussion and negotiations about the proposed trial. They said that the trial could not go forward “without their consent”. But consent, in this more political sense, is quite a different matter than informed consent as it is articulated in the Common Rule regulations and commonly understood among those who have experience with research involving human subjects. Part of our concern was that regulators, and other relevant authorities, might attempt to require the very narrow account of informed consent for research without adequate understanding of its very specific function.

Our effort to clarify who constitutes a research subject in this type of trial was necessary to clarify who that mechanism should be applied to, and in what circumstances. So, how should this issue be addressed going forward? First, there should be a greater effort—as we have tried to offer, and as Carolyn and the other reviewers have helped us greatly—to clarify to whom, and under what circumstances, the Common Rule informed consent requirements should apply in this type of trial.

Second, this should be complemented with an explicit account of some of the other relevant individual-level permissions and authorizations that are likely to be required by the trial protocol, including permissions to access residents’ properties, which fall outside the scope of informed consent for research. These should both be anticipated and reflected in the trial protocol. And finally, there should be a recognition, reflected in the trial plan and protocol, that an explicit strategy for community and stakeholder engagement is necessary to identify, acknowledge, and be responsive to legitimate stakeholder interests that lie beyond the scope of informed consent and these other individual level permissions.

The Common Rule is silent on these issues. We would also encourage reflection on what a claim of “public support” really means, how it can be fairly demonstrated, and what accountabilities any claim of support, or tolerance, might entail for the researchers.

CN: Jim has very nicely summed up the task ahead, and I couldn’t agree more with his three suggestions. I argued in my response to Pam and Jim’s article, and have argued elsewhere, that the Common rule regulations for human subjects research do not apply to trials that involve releasing genetically modified insects into the shared environment. But this negative argument does not tell us what to do going forward. So the question, “where do we go from here?” is very important.

I am especially interested in Jim’s third suggestion for next steps: create a strategy for community engagement as a way of considering the interests of people who are affected by, but are not strictly speaking subjects of, research. Community engagement can take a wide variety of forms. In its strongest form, the argument for community engagement holds that deciding to proceed with a proposal may require—morally—authorization from the community affected by the research. This would mean approaching communities with a genuine agnosticism about whether the research can or should go forward, and allowing the community to decide — ideally, I’d argue, through some deliberative democratic procedure. Unfortunately, I think engaging community members is sometimes taken to mean gaining public support, or convincing community members of the merit of research project or proposal, rather than listening and responding. As we see more projects that involve the release of genetically modified insects and animals, we need to be very clear about the purpose of community engagement and how calls for community engagement ought to be put into practice.

In her review, Carolyn states that she thinks it is debatable whether identifying someone’s property using GPS coordinates, as often is the case in mosquito trapping and in catch-release-recapture studies, would constitute identifiable private information. Why would this not be considered identifiable private information?

CN: According to the Common Rule, private information refers to information “about behaviour that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and…which the individual can reasonably expect will not be made public.” It continues, “Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”

One reason to doubt that GPS coordinates of trap location constitutes private information is that a person’s address typically is not private information. Where a person lives typically is contained in public records, easily searchable, and visible to others.

“It is possible to ensure that all parties are treated with respect and held accountable for their actions without invoking human subjects’ protection laws.” Carolyn Neuhaus

A more relevant reason to doubt that GPS coordinates of trap location constitute identifiable private information is that identifying trap location does not require researchers to obtain private information from or about individuals. To be sure, researchers obtain and may reveal information about a trap’s location.  With some additional digging, the name of the landowner could be discovered, and, if there is a home on the property, the home’s residents. But what would we learn about them? Only that they agreed to have a trap on their property.

Is this something that can reasonably be expected to remain private? No. The trap apparatus may be visible, other people may see scientists coming and going, or researchers may be required to notify others in the vicinity of the trap location. Indeed, it might be argued that trap location should be made public, since other people may have an interest in knowing that information.

If trap location does not constitute “identifiable private information,” then human subjects’ protection laws – requiring informed consent to research that would involve identifying trap locations – do not apply.

Still, scientists should ask people before installing traps on their private property. One can deny that informed consent is required in these cases, but insist that scientists proceed with placing traps on private land only if the resident and/or landowner agrees to the intrusion. Compensation might be in order, if the trap or the study procedures negatively impact the property or inconvenience the resident or landowner.

Researchers and residents should establish in advance how often the trap will be checked, what time, and who will be accessing the property. I’m in agreement with Pam and Jim when they say that this “may be better understood as more general requests for permission and gestures of common respect and decency, governed by social convention and relevant laws related to privacy and trespass, rather than applications of informed consent to protect research subjects.” It is possible to ensure that all parties are treated with respect and held accountable for their actions without invoking human subjects’ protection laws.

JL: Carolyn’s analysis of the Common Rule requirements is absolutely correct, and we expect that many investigators and IRBs will happily adopt the strict definition of “identifiable private information” and the narrow account of privacy that the regulations provide, which would obviate the need for informed consent. But one of the many shortcomings of this regulatory framework is its intentional exclusion of considerations related to how the conduct or outcomes of research projects might affect non-participants.

“We have seen various types of ‘social disruption’, in which even relationships between neighbours can be threatened by research-related activities.” James Lavery

There are two ways that this might be relevant here. First, for example, an early sero-prevalence study of HIV in Montreal reported and mapped study findings by the “Forward Sortation Area” of the Canadian postal code. This code did not provide personally identifying information about participants, i.e., not even individual property addresses, in the way that Carolyn describes for the Common Rule, but the small area location data did result in some significant geographically based stigmatization, including reductions in property values. The findings directly contributed to significant harm to individual property owners, even though they were not identified per se by the findings.

Second, in other controversial research, we have seen various types of ‘social disruption’, in which even relationships between neighbours can be threatened by research-related activities, e.g., decisions by some households to allow traps to be placed on their properties when neighbours may oppose the research. The Common Rule is silent on this type of potential harm. But even if they occur very infrequently, we believe they are worthy of some anticipation and vigilance. In both of these cases, identifiability, at some level of resolution, was key to the subsequent harms

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