Tuesday, August 2, 2011

ANPRM: May I Be Excused?

One of the boldest proposals in the ANPRM, and one of enormous importance to social scientists, is the idea of replacing the current category of exempt reseach with a new category of "Excused" research. This proposal could reduce IRB and IRB-office intrusion into a great deal of social research. But, depending on the details, it could instead convert an enormous amount of presently exempt research into research subject to expedited or even full-board review.

Social scientists will need to be very careful as they respond to this proposal.

What Excused Means

Here are the basics of the Excused category, as described in Section 3 of the ANPRM.

* The current exemptions would no longer operate. Instead, various types of research that present risks to privacy but not immediate psychological or physical risks would be deemed "Excused."

* "Oral consent without written documentation would continue to be acceptable for many research studies involving educational tests, surveys, focus groups, interviews, and similar procedures."

* Excused research would be subject to "mandatory data security and information protection standards for identifiable information and rules protecting against the inappropriate re-identification of de-identified information that is collected or generated as part of a research study to minimize informational risks and thereby eliminate the need for IRBs to review informational risks of the research. For purposes of the Common Rule, we are considering adopting the HIPAA standards regarding what constitutes individually identifiable information, a limited data set, and de-identified information, in order to harmonize these definitions and concepts."

* Institutions might be required to audit a sample of excused research, but they would be discouraged from the "current practice of routinely requiring that research that meets the current exemption categories undergo some type of review before it is permitted to proceed."

How the Excused Category Could Help Social Science

* The criteria for excusal would be more objective than the current criteria for exemption.

The Common Rule currently exempts "Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation."

These ambiguous criteria now plagues social researchers. Iowa State's IRB, for example, ruled that a survey was non-exempt because it counted as a risk to reputation the danger that "some may find your opinions in the free-response section at variance with their own." More generally, the exemption has always been somewhat nonsensical in that it does not require an IRB to determine what was risky, even though the point of the Common Rule is that only IRBs should determine what is risky. Replacing the vague language about risks of liability, reputation, and the like with more objective criteria would be helpful.

The Excused category would do this with three criteria:

  1. The research would have to be conducted with legally competent adults, a category that the ANPRM asserts is relatively clear.
  2. The research would have to conform to rules about identifiable information, most of which are fairly objective as well.
  3. The research could involve only "the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior." The Excused category might also include some psychological tests, such as those in which "a researcher might ask subjects to watch a video, or read a paragraph or solve puzzles, and then ask them some questions to elicit word associations or time performance of activities."

That's it. No more judgment calls about the risks of liability or harm to financial standing, employability, or reputation. No more squabbling about what those terms mean.

* Researchers could begin more quickly

Current regulations do not require administrative approval of exempt research, but OHRP recommends it, and that seems to be standard practice at most universities. Getting this approval is usually fairly quick, but not always. For example, at the University of Michigan 8 percent of exempt applications at the main-campus IRB took more than four weeks for approval, and more than half required some change to get approval.

Under the new system, "researchers would file with their institution or IRB a brief registration form (about one page long) that provides essential information about the study, including, for example, information about who will be the principal investigator, and the purpose of the study. The researchers would then be authorized to begin conducting the study after the filing (unless the institution chose to review that filing and determined that the research did not qualify as Excused)."

* Oral consent might be highlighted

The current Common Rule does not require written consent forms for exempt research and allows IRBs to waive the requirement for written consent forms if "the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context." But this provision is easily overlooked in a system that presents written consent as the norm and oral consent as an exception.

Under the ANPRM, "oral consent without written documentation would continue to be acceptable for many research studies involving educational tests, surveys, focus groups, interviews, and similar procedures." Perhaps this provision could be made more prominent.

* Real names might be explicitly allowed

The current Common Rule does not require that participants' identities be withheld, but its emphasis on confidentiality has led many IRBs to insist on inappropriate anonymity. ANPRM proposes that the rules for Excused research would explicitly "allow subjects to authorize researchers to disclose the subjects’ identities, in circumstances where investigators wish to publicly recognize their subjects in published reports, and the subjects appreciate that recognition."

Pitfalls of the Excused Category for Social Science

* Subjective criteria for questions could be re-introduced

The ANPRM imagines a number of possibilities for the category, including denying Excused status for "surveys and related methodologies" involving "topics that are emotionally charged, such as sexual or physical abuse." (Question 16) If this happens, we can imagine IRBs insisting that researchers write out all their questions in advance, so an administrator can screen them for questions about abuse, and we can expect long debates about what topics are emotionally charged. Once again, researchers who do not begin their projects with scripted questions will be turned into low-level cheaters.

* Geographical indicators would trigger IRB review

This is a big one. The ANPRM imagines that research in the Excused category would have to avoid sharing any of the 18 identifiers in the HIPAA Privacy Rule. That includes "all geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes." (One can use the initial three digits of a zip code if the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people. I think this means that I can report I am studying people in zip code 222xx, but not in Arlington, Virginia. Go figure.)

This means that any community studies that identified their sites--like "interviews with undocumented Latinos in Southern California" or observations of the function of Maori meeting houses in Aukland--would have to go through expedited for full-board review simply because its geographical specificity. This would add to IRB and researcher burdens, contrary to the goal of the ANPRM.

* Participant observation and focus groups might trigger IRB review

The proposal for the Excused category imagines that

research involving the collection and use of identifiable data, as well as data in limited data set form, could be required to adhere to data security standards modeled on the HIPAA Security Rule.

In particular, for research involving individually identifiable information, all biospecimens, and limited data sets, data security standards could require the use of reasonable and appropriate encryption for data maintained or transmitted in electronic form and strong physical safeguards for information maintained in paper form, audit trails, and access controls that allow only authorized personnel to have access to the information. (44526)

How would this work when information is gathered from groups? For example, members of a focus group see each others' faces. ["Communication Scholars’ Narratives of IRB Experiences," Journal of Applied Communication Research 33 (August 2005), 204.] And a researcher doing participant observation might strike up a conversation within hearing of other research participants.

Perhaps the rule could be interpreted to mean that all participants in a research project could be considered "authorized personnel," but that would have to be made explicit.

* Quasi-anonymous reporting might trigger IRB review

Some social scientists use pseudonyms to protect the privacy of their informants but still provide information that could be used to identify them, though with some effort. Take this passage from Kathryn Marie Dudley's End of the Line: Lost Jobs, New Lives in Postindustrial America, which uses fictitious names but not "falsified biographies."

"The mentality of many people in this community was that American Motors or Chrysler was going to be the salvation," says Ron Carleson, a business adminsitrator in the Kenosha school district. Ron grew up in Kenosha, and as the son of an optician who served many clients in the blue-collar community, he feels he has a special understanding of the day-to-day realities factory workers must deal with. (188)

Presumably, some of Carleson's co-workers and friends could identify him from this description, but most readers cannot.

I am not a big fan of such quasi-anonymity; I wonder if "Carleson" would have wanted a pseudonym had Dudley not presented that as the default choice. And maybe if a researcher concludes that a statement is so sensitive that a pseudonym is called for, research including that statement should undergo some kind of ethical proofreading before publication.

Still, social scientists preparing comments on the ANPRM should be aware that this kind of work might not be Excused.

* Unreasonable data security requirements might be imposed

The ANPRM suggests requirements for "the use of reasonable and appropriate encryption for data maintained or transmitted in electronic form and strong physical safeguards for information maintained in paper form." This could be consistent with the professional practices of social researchers, but past experience has shown the danger of relying on IRBs' and administrators' sense of what is "reasonable."

(Thanks to an anonymous commenter for pointing this out.)

* A waiting period could delay research and increase administrative burden

Question 19 imagines "a brief waiting period (e.g. one week) before a researcher may commence research after submitting the one-page registration form, to allow institutions to look at the forms and determine if some studies should not be Excused."

This would immediately defeat the ANPRM's design to "discourage having each of these registration forms undergo a comprehensive administrative review prior to commencing the study or even afterward." For what is a determination that some studies should not be Excused if not an administrative review at least as comprehensive as the ones currently used for exemption? A waiting period risks imposing prior review on all studies and retrospective review on some, thus increasing, rather than decreasing, the administrative burden.

The requirement would be particularly onerous for researchers who want to react to breaking events or whose research builds on daily observations and lacks defined starting and ending points.


If the standards are rewritten so that IRB review is triggered only if a project crosses clearly defined thresholds, one can imagine a system that functions much more in the ways intended by the authors of the original Common Rule, who sought to "exclude most social science research projects from the jurisdiction of the regulations."

But if the revision to the Common Rule imposes HIPAA standards, without modification, upon social science, it will be a disaster for researchers, administrators, and participants alike, since a great deal of research that is currently exempt would trigger expedited or full review on the grounds that it includes geographical information. Depending on the exact provisions concerning sensitive topics, anonymity, data security, and waiting periods, matters could be worse still.

My recommendation, then, is that while scholars in the social sciences and the humanities may be cautiously supportive of the Excused category proposal, their first choice should be a redefinition of the scope of the regulations to align them to federal law. More on that soon.


MontereyBayBliss said...

I stumbled on your blog today and I'm finding it very informative as I prepare my IRB for ANPRM response updates. The link you currently have for the Illinois white paper is no longer correct though. It's now at: http://www.primr.org/uploadedFiles/PRIMR_Site_Home/Resource_Center/Articles/11.%20Illinois%20Whitepaper.pdf

Zachary M. Schrag said...

Many thanks. I have updated the link.