the unhappy marriage of IRBs and ethnography

A student submits an IRB application to study “media freedom” and the struggles of citizen journalists for her doctoral dissertation. The study methodology includes immersion in a community of underground reporters living in Syria. The student has a personal contact who will serve as a translator, guide, and informant. Her dissertation committee supports the project. The student submits her IRB application with a cover letter explaining that her flights are scheduled and she leaves in two weeks.

This is the kind of IRB application that raises blood pressure.

Would the presence of an American student call unwanted attention to other journalists? Would this research reveal information that could jeopardize the safety of journalists?

There are many unanswered questions in this fictional example that illustrates the competing agendas of ambitious ethnographers and research ethics committees called Institutional Review Boards (IRBs), which are tasked with the protection of human participants in research. Contrary to popular belief, IRBs are not research obstructionists but groups committed to protecting the rights of research participants (i.e., human subjects) in compliance with federal regulations.

This example is not a dramatic departure from real ethnographic projects that may involve investigation of illegal activities or political strife, immersion in foreign cultures and/or communities, interaction with marginalized populations, and possibly, the use of deception to accomplish research objectives. In this way, not all ethnographic methods are the same nor are they automatically considered to be “high risk” or “unapprovable” by default. Also, it is not uncommon for ethnographers to remain in “the field” collecting data for years. For these reasons, IRBs must consider ethnographic proposals on a case-by-case basis with careful review of the research goals and potential harms to the studied populations, communities, or environments. How do IRBs ensure that these harms are minimized? Easier said than done.

IRBs rely on guidance from federal (see the Common Rule – 45 CFR, part 46) and institutional regulations on human subjects research to approve or disapprove research proposals prior to direct interaction with study participants. The primary purpose of IRB review is to assess whether the risks of the proposed research (to human subjects) are balanced in relation to the anticipated benefits of the research. In reality, social research offers few direct benefits to study participants (oftentimes, not even a lousy gift card). Moreover, the long-term, and sometimes extremely personal interactions between ethnographers and the persons they are studying may put IRB committees on high alert for imbalanced risks and benefits.

And it gets worse.

Federal regulations were not written with ethnographic research in mind. The Common Rule more precisely explains how investigator-controlled research conditions, specifically clinical conditions, should be regulated. This presents a quagmire when the details required by IRBs to assess risk to participants may not be known by the ethnographer until they have begun fieldwork. In this way, IRBs and ethnographers often “talk past each other” resulting in confusion, delays, and frustration—i.e., a very unhappy marriage.

Problems may worsen if institutions review few ethnographic proposals regularly and/or do not have IRB members well-versed in qualitative methods. Moreover, IRB committees may balk when confronted by especially bold and unconventional ethnographies proposed by inexperienced student researchers. Students can sometimes be creative in selecting the most-vulnerable-and-most-challenging populations to study. Think drug dealers. Think illegal gamblers. Think persons in recovery.

This is not to say that these populations are unworthy of study or that they cannot be studied responsibly. Most IRB committees working in university settings have seen their fair share of ethnographic proposals and have responded proactively to facilitate quality reviews. For instance, some IRBs may have subcommittees assigned to review ethnographies or a list of subject-matter experts to consult with.

In order to further ease the pain of IRB review, I would like to offer five steps to a successful IRB application that includes ethnography:

  • Read the American Anthropological Association’s “2012 Ethics Statement.” The seven principles of professional responsibility described in this statement directly address critical ethical issues unique to ethnography. Allow your awareness of these issues to shine through in your research proposal and IRB application.

(For additional insights, please also read the American Anthropological Association’s “Statement on Ethnography and the IRB.”)

  • Talk to your IRB administrator before you fill out any IRB application forms! Ethnographic research may not represent the “average protocol” at your institution. Most IRBs have public rosters of their committee members. If you suspect that your institutional committee may need assistance, offer to provide the names of experts familiar with the community or culture that you are studying. Better yet, when your study is complete, volunteer for your local IRB as an ethnographic consultant or committee member.

IRB administrators also appreciate advance notice for particularly controversial protocols so that they can prepare their committee ahead of time and/or consult with subject-matter experts (if necessary). Give your IRB a “heads-up” if you think that might be the case.

  • Clearly articulate the study risks and benefits in your IRB application and in any communication with the IRB. Don’t sweep potentially problematic details under the rug! It is better to be forthcoming so that you can be properly advised on issues of data security, participant privacy, and confidentiality of records. For instance, if data collection involves sensitive information that, if released, may harm participants or communities in any way (e.g., socially, psychologically, financially, etc.), your IRB administrator may recommend that you apply for a Certificate of Confidentiality (CoC) through NIH. A CoC grants investigators the right to refuse to disclose identifying information in legal proceedings at the local, state, and federal levels.
  • Provide a detailed description of your field site and/or the anticipated participant interactions in your IRB applications so that a general audience (IRBs are required to have diverse membership) will understand what you are trying to accomplish. Remember, you may be the expert on drag performers in India but there is no guarantee that your IRB committee will understand your topic or why you wish to study it from a scholarly perspective.

Based upon your detailed description, outline the informed consent procedures that you feel are appropriate and the steps that you will take to ensure that participants understand the possible risks prior to participation. Written consent? Verbal consent? Does your project involve covert observation where consent might jeopardize the integrity of the project?

Ultimately, your research proposal should address the ethical principle of “respect for persons” (Belmont Report 1979). This principle ensures that all potential research participants are able to exercise autonomy in deciding whether or not they wish to participate in research before any study-related interactions begin. IRBs may waive the requirement for written documentation of informed consent under specific circumstances (see 45 CFR 46.117 part c). Your IRB will have an application to request a waiver of documentation of informed consent for you to complete and submit along with your IRB application. In the context of ethnography, the issue of informed consent is especially important as researchers must develop relationships at their field site and gain the trust of those they wish to study. Therefore, the ethnographer should do as much preparatory work as necessary to understand the context of their field site and populations of interest before designing consent procedures.

IRBs will typically provide informed consent templates for oral or written consent. These can be helpful for most research projects. Yet, there are times when even these boilerplates are useless to ethnographers. For instance, consent and approval may need to be sought by a village elder, advocate, or group leader before the researcher may commence. The burden lies upon the ethnographer to clearly communicate to the IRB what might be the most appropriate method (and why) for ensuring that participants are fully informed about what the research entails and the risks involved.

If the ethnography is covert and/or some degree of deception is needed to conduct the research and possibly, to protect studied populations, an argument can be made to the IRB that some (or all) elements of informed consent must be waived or altered. Under federal regulations, IRBs are permitted to waive informed consent under certain circumstances (see 45 CFR §46.116 part d) as long as the rights and welfare of participants will not be adversely affected and that the research could not be practicably conducted without a waiver or alteration of informed consent. Your IRB will have an application for waiver or alteration of informed consent for you to complete and submit along with your IRB application.

  • Once your ethnography is initiated, you may find that circumstances “in the field” require you to revise your research questions, methods, population of study, or data collection timeframe. IRBs welcome amendments. They are more painless to process than protocol deviations or noncompliance reports, which can result in tedious audits or study suspension.

As an ethnographer, adaptability is a fieldwork skill. The IRB can support changes to protocol if they are justified and requested before implementation with human subjects. For this reason, it is important to be able to communicate with your IRB, even if you are collecting data covertly or outside of the U.S. If you feel as though your “carefully laid plans” are about to go awry, contact your IRB before you breach protocol. Your IRB can advise you of how to proceed and what to do to request a formal amendment, if necessary.

The unhappy marriage of IRBs and ethnography has existed since the Common Rule was published in 1991. Just last year, the U.S. Department of Health and Human Services in collaboration with fifteen other federal agencies, announced revisions to modernize the common rule in a Notice of Proposed Rulemaking (NPRM).

Research institutions across the U.S. responded to the proposed revisions with a mixture of praise and criticism. There have been town halls, requests for formal comments, and ethical debates. One of the major disappointments in the NPRM was the absence of regulatory revision and increased clarity in regard to IRB review of ethnographic research. Now that the deadline for comments has passed, it is in the hands of the feds to determine how this unhappy marriage can be made a bit easier in the future. IRBs and researchers are patiently waiting for reduced administrative burdens and superior protections for research participants.

Abigail E. Cameron is a certified IRB manager and survey research specialist at the Department of State Health Services in Austin, Texas. She is happy to answer IRB questions and can be reached at abigail.cameron@dshs.state.tx.us.

Comments 2

Robert Dingwall

April 20, 2016

The proposed Common Rule revisions may not explicitly use the word 'ethnography' but their effect will be to exclude most ethnographic research from Federally-mandated IRB review - see my analysis in http://www.socialsciencespace.com/2015/11/deregulating-social-science-research-ethics-clipping-the-wings-of-irbs/ The challenge will be to get universities to roll back IRB intervention in accord with this rather than continuing to 'gold-plate' Federal requirements.


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July 14, 2016

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