Monday, August 18, 2008

Critiques of Consent Forms

Two items in the November 2007 PoLAR symposium question the utility of written consent forms. Both offer important insights about the difficulty of relying on written consent, though neither presents a persuasive alternative.

Shannon, "Informed Consent"

Jennifer Shannon's contribution is "Informed Consent: Documenting the Intersection of Bureaucratic Regulation and Ethnographic Practice." Shannon contrasts two experiences she had preparing written consent forms for interviews with American Indians.

From 2001 to 2003, Shannon worked as a fieldworker for the National Museum of the American Indian, part of the Smithsonian. Working with curator Cynthia Chavez, she modified an existing museum consent form to stress that the museum would seek additional approval if it wanted to use the informant's interview or image aside from a planned exhibit and related publications. This did the trick:

Whether because it was written with the aim to increase participant’s control over their contributions, the reputation of the Smithsonian was changing in Indian country, or because it was necessary in order to participate in the exhibition, in the process of fieldwork, the . . . release form was not met with resistance; Native people read the form carefully and signed it willingly. (233)

In 2004, Shannon had a new role: graduate student at Cornell University, and when she returned to fieldwork, she sought approval from the university IRB. Though "wary of inserting documents between my interlocutors and myself because of the sense of formality it introduced," she followed the IRB instructions to produce a written consent form. (236).

It bombed. Though the IRB let her write her own consent form, experts didn't like it. Joe Podlasek, the director of a Chicago nonprofit, and two National Museum curators all warned her that the document was too "legal looking," that "it inserted the institution of Cornell between community members and myself, and that once 'institutions' come into the mix, Indians are very, and rightly, 'skeptical.' [A curator] also pointed out the manipulative power inherent in saying “sign these documents, or you can’t participate.” (234) Fortunately, the IRB let her modify her proposal and substitute verbal, recorded consent.

What's interesting about this story is that no IRB member of staffer led Shannon astray. Rather, it was the IRB's standard operating procedures that made her write the bad consent form: "When preparing for the [IRB] requirements, I produced the consent form in a routine way according to guidelines for recorded interviews. It did not occur to me to make a case for exemption . . . " (235) This kind of IRB-caused harm is impossible to track, but I suspect it is rather common. When you flood the Web with bad advice about research ethics, it is bound to cause unknown harms.

On the other hand, I am a bit wary of Shannon's easy acceptance of the experts' claims that Indians don't like written consent forms, especially after her good experience with the Smithsonian form. With the exception of Podlasek, she doesn't report anyone expressing their own unwillingness to sign a written form, only people guessing that other people wouldn't like the Cornell form. That's like letting one person guess that another person will find a survey invasive. At the very least, this seems worthy of an empirical study. Of course, it would be great fun trying to devise the consent procedure for a study about consent.

Nor does Shannon convince me that verbal consent is taken any more seriously than written consent. She writes

In one interview with an anthropologist who was working on an upcoming exhibition, after she agreed to be recorded, I said, “OK, then I have to say my little spiel” about the ways in which the recording could be used. She laughed, and asked, “Human subjects?” And I said yes, laughing apologetically. It was a moment where we were both complicit, in our joking, critical of the bureaucratic hoops we must jump through. There was no resistance or negotiating. She said she had had to do the same thing when she did research for her degree. This eye-rolling compliance to formalized consent occurred a number of times during my interviews with NMAI staff . . . . (235)

How is this an improvement over written consent?

And while Shannon endorses Podlasek's claim that her verbal script "was more 'flexible' and community members could discuss their own stipulations for consent and use of the material" (234), she does not report what stipulations community members imposed or why it would be easier to do that on a recording rather than on paper.

Jacob, "Form-Made Persons"

A second item, Marie-AndrĂ©e Jacob's "Form-Made Persons: Consent Forms as Consent’s Blind Spot," suggests how little attention research participants or patients give to consent forms.

Jacob observed the use of consent forms in transplant units in American and Israeli hospitals. As part of her work in the U.S., she had to devise a consent form that met an IRB's strict guidelines:

My forms would be approved as ethical only if I was to mechanically mimic the aesthetics of a template form’s rubrics, classification, and styles, even if it meant that some categories and boxes were bound to remain blank. This aesthetic work of uniformity had to be done in very literal ways, and features such as fonts, margins, and subtitles were of great importance. One could not change the order of the presentation of the bullet points, of information points. The ethical approval of a project can be conditional upon one’s respect of the “template” and the “boiler” provided by the institution in question. This seems to imply that bureaucratic cleanliness is conflated with consent ethics, and both are purposefully composed as clear, transparent. (253)

Donors and recipients of organs were faced with even more elaborate forms, warning “Do not sign this form without reading and understanding its contents.” (255)

Yet patients, research subjects, and even donors--people who were giving up major chunks of their bodies--spent little time on the forms:

A high-level administrator and transplant surgeon, who in his work maneuvers consent forms on a daily basis, performed crisp sarcasm by signing the consent form to participate in my research without even looking at it and saying to me and to a few colleagues standing by, “Oh, I feel much more protected now that I signed this.” In signing, this surgeon both reiterated his authority above the researcher within the hospital bureaucracy and submitted to the powerful yet familiar rigor of this same bureaucracy. Here, the performance of sarcastic humor appeared as a way to defuse the submission inherent in signing itself but also to assert his authority in a rubber-stamp form, about what seemed inconsequential to him. (260)


An American mother who at the time of my fieldwork was undertaking medical tests to see if she could donate a kidney to her son characterized all the procedures and form filling as “just something to go through.” Patients expressed this sense of “going through” recurrently to me. This mother, for example, was frustrated that the screening and evaluations take so much time: “It’s like, can’t you get me through this quickly?” she lamented. (257)

In an extreme case, organ donors in an Israeli hospital willingly signed a consent form that had been through so many generations of photocopies that neither doctor nor donor could read it. Since neither Americans nor Israelis read the forms they signed, Jacob finds the illegilble Israeli form the more honest.

What is the Alternative?

While both authors present the problems inherent in written forms, I don't think either author grapples with the real purposes of such forms.

The first is to clarify responsibility when something goes wrong. If the interview or the transplant goes fine, then no one needs the form. It's when one party feels ill-used that both parties to an agreement go to their files to figure out if a promise was broken. Since neither Shannon nor Jacob observed such a dispute, it's hard to accept their dismissal of written consent. It's like hearing someone complain about how uncomfortable motorcycle helmets are, without discussing the protection they offer in a crash. Yes, they are uncomfortable, and usually unnecessary, but that's not the point.

As counter-examples, I would offer the cases of two academic psychologists: J. Michael Bailey and Elizabeth Loftus, both of whom were the subjects of formal complaints by people they had interviewed. Bailey faced an investigation by his university, and Loftus's interview became part of a $1.3 million lawsuit against her and other defendants. In both cases, interviewer and interviewee had very different memories about the circumstances of the interview.

Written forms would not have provided full information about those circumstances, and a signed consent form cannot prove that the signer read the form carefully. But, as Shannon observed, some signers do read carefully, while others at least have the opportunity to do so. Thus, written forms in those cases might have avoided or helped resolve the dispute. It's not a perfect system, but neither Shannon nor Jacob present a superior one.

A second purpose for written forms is to allow access by other researchers, an important goal of oral history interviews. Neither Shannon nor Jacob address this issue, and Shannon's essay is particularly troublesome in this regard. The written form she developed at the Smithsonian states that "images, tapes, and transcripts of interviews will be placed in the Archives of the NMAI," (247) but it provides no mechanism for those images, tapes, and transcripts to be used by researchers. That is, even if a researcher is required to seek permission before using an interview in a publication, how is that researcher to know which interviews are of interest if not even a summary can be released without permission? What happens if an interviewee cannot be located to grant permission? What happens if an interviewee dies? Is the Smithsonian required to archive the interview in perpetuity, knowing that no one will ever be allowed to listen to it?

As John A. Neuenschwander has shown, no one has yet drafted an oral history consent form that accounts for all the important contingencies without growing into a long, tangled, and legalistic contract. I'm sure that Shannon and Jacob could poke holes in any of the forms he presents, but I'm not sure they could improve on them.

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