Tuesday, July 17, 2012

Common Rule Is "Out of Place" on the Streets of Bogotá

In the second article in the Professional Geographer special issue, Amy Ritterbusch argues that "when lives are at risk, socially and politically responsible action in the field becomes the driving force of human subjects protection," but that "standard human subjects protection procedures often pull initial field relations in the opposite direction, establishing distance and difference between the researcher and research population through a temporally and spatially restrictive web of institutional categorizations and paperwork that predefine participants’ identities and role in the research project."

She finds that "Although well intentioned, 45 CFR 46 is a bureaucratic discourse that positions youth in problematic ways and is out of place in the world of Bogotana street girls."

[Amy Ritterbusch, “Bridging Guidelines and Practice: Toward a Grounded Care Ethics in Youth Participatory Action Research,” Professional Geographer 64, no. 1 (2012): 16–24, DOI: 10.1080/00330124.2011.596783.]

Ritterbusch conducts participatory action research with female street youth in Bogotá, and she is frustrated by Common Rule requirements that can be irrelevant or even counterproductive.

Specifically, she complains that Common Rule requirements for consent (and children's assent) depends on unmerited assumptions that people are either children or adults, vulnerable or not, and that the giving of consent is a one-time event:

I contend that to effectively convey the principles of consent, prospective participants must first recognize value in themselves. In the case of my field research, working with a population of sexually exploited youth whose sense of self-worth is severely debased required me to begin by working with street girls to recognize the value of their sexual health (by distributing and motivating the consistent use of condoms and lubricants and discussing safe practices), their potential to help others in the community (by identifying and exerting their rights to health and social services), and the value of their contribution to the research project both in their personal lives and for others in the streets. PAR with street girls, therefore, necessarily calls for a reframing of consent as a process stretched out over time and space and involving community activism and outreach. This in turn initiates the flow of action research and destabilizes the conventional subject–object structuring of fieldwork in general and human subjects procedures in particular. Furthermore, I suggest that the process of making an agreement on consent is in itself the initiation of reciprocity and mutuality, which underpin the entire research relationship . . .

Obtaining consent does not just happen in one place or in one moment; rather, it happens over time and in multiple spaces through the enactment of care ethics and communicative research relations.

She also notes that protection can go both ways:

On countless occasions the girls have protected me in their street spaces far more than I will ever be able to protect them from the violence and abuse of pimps, clients, or rival street gangs. Considering this, it might be presumptuous to write about the protection of human subjects when the girls have developed a much more effective system of protection, both for themselves and for me, than I can ever hope to offer them, entering their space as I do only with the ungrounded tools provided by formal human subjects protection protocols based in federal U.S. guidelines . . .

Far better than the OHRP, the girls themselves know their safe spaces and places of refuge, and only they know which state authorities can be trusted and which officials will threaten their lives to collect a brothel pay-off.

Finally, she argues that the real ethics of her work is protecting her informants not from foreign ethnographers, but from the dangers they face every day:

The reality, however, is that I will not always be literally there in the field. Therefore, I have worked with the girls to build networks of care in the streets that will continue to expand without my presence. Thus, for as long as I am in the field, I am working to construct sustainable structures of caring through collaboration with a local nonprofit organization (Fundación Social Fénix) to plan organized, embodied acts of reaching out to community actors and cultivating street-corner leadership.

Ritterbusch argues that "identifying the local specificities of human subjects protection in a society in which the law and human rights are often disregarded is not a process that can be standardized or operationalized from a handbook. Rather, it became a process of learning from the research population how to best protect their lives as well as my own . . ." She does not suggest how this insight might be encoded into federal policy, though the radical redefinition of human subjects research proposed by the American Anthropological Association would be a good start.


Anonymous said...

Who did the IRB review in this case and were they qualified to conduct the review? given the description I doubt the regulations and OHRP guidance were being followed. There is very clear instructions on a local knowledge requirement and there a lot of flexibility for sensible decision-making tailored to local specifics.

OHRP own guidance is in agreement with the statement: "identifying the local specificities of human subjects protection in a society in which the law and human rights are often disregarded is not a process that can be standardized or operationalized from a handbook."

"45 CFR 46 is a bureaucratic discourse" to the extent IRBs choose to make it such.

Zachary M. Schrag said...

Certainly some IRBs are better than others. But in a case like this, the specific requirements of, say, 45 CFR 46.116 may be impediments rather than aids to ethical research.

Dylan said...

At several PRIM&R conferences and trainings, I've repeatedly heard this theme emphasized -- that is, consent is an ongoing process, not a single event. So a fair number of IRB professionals are certainly aware of the concept and seem to support it. However, I've seen very little guidance from IRBs on how to actually make it happen -- how to make consent an ongoing process while still meeting the requirements of the regulations. Those requirements seem to be most easily met when consent is treated as an event.

Zachary M. Schrag said...

Thanks for this comment. I think Ritterbusch would agree: IRB members and staff are well intentioned, but regulatory requirements lead them astray.

PRIM&R itself, however, refuses to take responsibility, instead blaming the problem on sponsors and investigators.

Anonymous said...

The local knowledge review requirement?

Also, IRBs have quite a lot of flexibility on consent or, in this case parental permission. You reference 46.116 but you should also be referencing 46.408 in this case. It may very well be the case given the description of the work that parental consent could have been waived in accordance with the regs in this case. And one could work on crafting an appropriate oral assent process. There's a lot of flexibility on that.

At the end of the day the priority here is to undertake work in an ethical manner not implement mindless bureaucracy. Yes, the regulations set constraints and situations do arise where those constraints don't make a lot of sense, but in most cases there is flexibility to craft a sensible ethical approach if the IRB is willing to work with the researcher. If you document how the regulations have been interpreted and explain why this is the most ethical course of action, what's the problem?

A lot of the problems you cite on this blog are research institution issues. I've been to conferences and listened to OHRP officials talk about the under-use of exemption for social science research. Most social science research could be (and I would argue) should be treated as exempt. That institutions choose to create bureaucratic controls above and beyond what the regulations require is their prerogative and suggests that reforming the regulations is unlikely to solve many of the issues of concern here.

Zachary M. Schrag said...

Thanks for this comment. Whether consent is written or oral, 45 CFR 46.116 still requires several steps that would be inappropriate for the kind of research described here.

For my views on OHRP's responsibility for IRB inflexibility, please see Menikoff Passes the Buck, December 7, 2010.

And while PRIM&R's ANPRM comment goes too far to absolve IRBs of their share of the blame, it does correctly note OHRP's culpability:

"As far as we know, OHRP has never criticized any institution for using consent forms that are too long or complex. It would be incorrect to blame IRBs for this problem as sponsors, institutional lawyers, risk managers, and other executives are primarily concerned with institutional protection rather than subject information. One way to reduce some of this apprehension about changing, clarifying, and shortening consent forms is for OHRP to clarify its minimum requirements for such forms as well as its enforcement methods for consent form inadequacies."

Anonymous said...

"Whether consent is written or oral, 45 CFR 46.116 still requires several steps that would be inappropriate for the kind of research described here."

I still don't see the problem with the regs in this instance based on the details you've provided.

The research subjects are street youth so presumably there are no parents or guardians from whom one could obtain consent/permission or the conditions may be such that the parental/guardian permission is "not a reasonable requirement" --§46.408(c). The regs do discuss substituting an "appropriate mechanism for protecting the children who will participate as subjects in the research". She mentions that she worked with a local non-profit agency that was serving these children--maybe someone at that group or identified by that group could have played that role. Also, under §46.408 the IRB is basically free to determine what's appropriate assent. The whole section is about IRB's making "appropriate judgements" rather that complying with a list of pre-determined requirements.

Zachary M. Schrag said...

Thanks for this comment. Other researchers have reported that IRBs try to check off all the regulatory requirements by encouraging stilted, formalized consent procedures, whether written or oral, and my guess would be that Ritterbusch faced something like that. But you are correct that that is mere speculation. It would have been helpful for Ritterbusch to describe in more detail the conditions imposed by her IRB, as recommended by Alexander Halavais.