IRB approval for ethnography

Ross Woods, 2022

“James” plans to do an ethnographic study in his local community. This includes making friends, meeting people informally, and conducting free, informal interviews. He has to apply to his institution’s Institutional Review Board (IRB) for permission. This body oversees ethics of research involving human subjects, and it must follow Code of Federal Regulations, Title 45, Subtitle A, Part 46, “Protection of Human Subjects.” (CFR).

Under these regulations, researchers must normally disclose information to prospective respondents in writing, explain anything orally that is still unclear, and then get a signed approval form from them. If the project meets the criteria for exemption, the IRB can issue the researcher with an exemption from CFR requirements, and then decide on ethical requirements apart from those of the CFR. This would meet the IRB’s obligations under the CFR.

Exemption by definition ruled out

First, John’s project fits the definition of research and has human subjects. Consequently, the most basic reasons for exemption do not apply, that is, that the project lies outside the definition of research and that it has no human subjects.

Exemption as interviews

The second basis for exempt status is that it meets one of the exemption criteria in CFR 46.104. One section specifically refers to interviews:

(2) Research that only includes interactions involving ... survey procedures, interview procedures ... if at least one of the following criteria is met:

(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

(ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

In other words, the research could be exempt if it follows IRB-approved procedures to ensure that respondents cannot be identified and could not be re-identified, and ensures that subjects are not put at risk. These generally present no difficulty at all, and it would be easy to approve ethnographic research on this basis. See the recommended procedures below for preventing identification of subjects.

Exemption as benign interventions

Another possibility is the conditions given in 46.104 (3), and the the table below contains an assessment of compliance:

1. The research is completely harmless. Compliance is easy. In fact, James could show participants his draft research and get their input.
2. Subjects must be adults. Compliance is easy.
3. Subjects agree to the research. Compliance is easy, athough the nature of agreement is not specified. It could be oral, as long as the researcher makes a contemporaneous record.
4. One of the following:  
  a. Subjects are annonymous and cannot be re-identified Compliance with anonymity is easy, although preventing re-identification is more difficult. (See below.)
  b. The research does not put the subject at risk of criminal or civil liability or of damage to their financial standing, employability, educational advancement, or reputation Compliance is normally easy.
5. Contacts are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects. Contacts are not necessarily brief in duration, but compliance is otherwise easy.
However, most ethnographic approaches are inconsistent with the examples given in the regulation: “having the subjects play an online game, ... solve puzzles under various noise conditions, or ... decide how to allocate a nominal amount of received cash between themselves and someone else.”
6. The researcher has no reason to think the subjects will find the interventions offensive or embarrassing. Compliance is normally easy.
7. The researcher may deceive subjects about the nature or purposes of the research, as long as the subject agrees to that stipulation. Compliance is very easy but might still be unethical. Its purpose seems to refer to cases where revealing the purpose would defeat its purpose. However, if an ethnography were used for missiological purposes, it would be seen to be surreptitious.

These are prohibitions and are less restrictive than the standards of ethnographic ethics, which require positive respect for the persons and culture of their research. Nevertheless, most of these requirements inform the way that interviews may be conducted, and the IRB is quite entitled to make them requirements of an exemption based on interviews:

  1. Completely harmless.
  2. Not likely to have a significant adverse lasting impact on the subjects
  3. Does not put the subject at risk
  4. Not offensive or embarrassing.
  5. Not deceptive.

Preventing identification and re-identification

The researcher could easily omit the name of the town and the names of respondents.

Although the research was anonymized, James must also prevent readers from making connections that would re-identify individuals. During the fieldwork stage, the IRB requires the researcher to:

  1. keep hard-copy research notes and recordings in a locked cupboard,
  2. protect soft-copy records with passwords, and
  3. omit full identifying information in research notes, for example, by identifying individuals by nicknames or initials only.

The second stage is publication:

  1. The researcher could publish under a different or modified name, because a unique or uncommon name would identify the research.
  2. Any unique features would be an identifier, but typicalness would conceal its identity as well as making the research more widely useful. ls the town or its population unique in some way, or is it a typical example of a particular type of town, of which there are many? Could a respondent mention a unique event or circumstance that could identify a respondent or a church?
  3. Does the research mention the country or ethnic group? A very small country or a very small ethnic group might be an identifier. On the other hand, identification is more difficult if the country or ethnic group is very large and diverse, or if the ethnic group is spread over several countries.
  4. How and where would the final research be published? For example, it would attract unwelcome attention if it were published in a locally published journal especially if it were written in the local language. On the other hand, if it were published in English in an international journal or not published and placed in an institutional repository, there would be no reason for anybody to associate it with indvidual subjects.

However, the IRB has the right to impose its own requirements apart from the CFR. These include informing respondents of:

  1. The activity in which they are asked to participate (e.g. a series of discussions during personal visits).
  2. Its purpose
  3. There will not be anything that could identify respondents. Names and locations will be confidential and not put in writing.
  4. Respondents may skip any questions if they wish.
  5. Respondents may stop at any time during the interview.
  6. Respondents are free to ask any questions about the research at anytime.
  7. Participants’ approval must be recorded at the time, either in writing or by sound or video recording.

The other option: Approve the application without exemption

If they IRB sees other considerations that weight against an exempt status, the IRB might still approve the research, in which case the full effect of the CFR comes into play with a complex set of informed consent procedures. Even then, the CFR allows some special cases.

Under normal circumstances, respondents must fill out and sign an informed consent document. (CFR §46.117 (a), (b) (1)) However, the IRB may waive that requirement if it finds any of the following:

(i) That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;

(ii) That 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; or

(iii) If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. (§46.117 (c) (1))

This section notably mentions “minimal risk of harm.” In other words, the IRB does not need to eliminate all possible risk, but only to minimize it.

The following paragraph of the CFR specifies that “In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.”

If the IRB did not waive the requirement of a signed consent form, the CFR also allows for information to be presented orally, after which the respondent signs only a short form, while a witness must sign a short form and a long form. This procedure might work well in some populations where it does not skew research results.

A short form written informed consent form stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative, and that the key information required by §46.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject's legally authorized representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject's legally authorized representative, in addition to a copy of the short form. (§46.117 (b) (2)