IRB approval for a sensitive topic

Ross Woods, 2022

“John” is a distance student of a US-based institution and lives in Smithville, a town in Smithland. He plans to do a church growth study there by interviewing church leaders about patterns of church growth.

The first problem was the dominance of the Lodi religion in Smithland. Smithland is a democracy that allows freedom of religion; all residents are legally free to change their religion if they wish, but members of one religion may not proselytize those of another.

However, the Lodi religion is dominant; it holds sway over most of the population, pressures government, and infiltrates the civil service and the dominant political parties. Consequently, Lodi adherents are free to proselytize, and Lodi priests are intolerant of proselytizing by other religions. Although John proposes nothing illegal, a Lodi accusation is as good as a conviction; if they accuse a church of proselytizing, the local government will probably interrogate the pastor, possibly cancel the church’s worship permit for its building, and dissolve the local congregation. Any expatriate personnel would be deported at short notice. It is also possible that a Lodi mob could become violent and burn down the church building. In other words, research demonstrating that churches have grown would be viewd as evidence of proselytizing and seriously endanger the church.

Under current ethical guidelines for informed consent, researchers must disclose full information to prospective respondents in writing, explain anything orally that is still unclear, and then get them to sign an approval form. In Smithland, however, this arouses suspicion and many prospective respondents choose not to participate at all. Those who do participate tend not to tell the candid truth, but change their answers to be “safe” from embarrassment and suspicion of wrongdoing. Their inoffensive answers could not put anybody at risk, so they do not need anything to be kept confidential. In other words the procedure would probably cause the data to be inaccurate and useless.

The Code of Federal Regulations (CFR)

John's major obstacle was the normal ethical requirements for working with human subjects. US research bodies have an Institutional Review Board (IRB) to oversee the ethics of research involving human subjects, and it must follow the Code of Federal Regulations, Title 45, Subtitle A, Part 46, “Protection of Human Subjects.” The CFR guidelines for informed consent required John to get a signed form from participants.

About sensitive research

John's case fits clearly in several of those categories of sensitive research. This is a broad topic that includes:

  1. Risk of personal harm
  2. Being made complicit to an illegal act
  3. Accessing computer materials that would normally be prohibited
  4. Activities that are considered illegal and/or immoral in a foreign community
  5. Activities that are considered sensitive and/or illegal in the country of the institution
  6. Breaches of human rights
  7. Certain topics in countries where free speech is prohibited or limited
  8. Certain topics where criticism of government and/or their policies is prohibited or limited
  9. Use or dissemination of information including research findings which, if released, would incur significant contractual penalties
  10. Topics that could harm humans, animals or the environment
  11. Topics not normally 'sensitive' but would probably result in harm if published, e.g. if used for another purpose. (1)

What are the questions?

The main legal questions are:

  1. “Does the project meet the CFR criteria for exemption?” The IRB’s preferred course of action is to 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 while avoiding the complex CFR requirements that apply to non-exempt researches.
  2. “If the project does not meet the CFR criteria for exemption, does it meet the CFR requirements for non-exempt projects?” These other requirements are detailed and complex, so are not preferred.

The main ethical question is, “What is the risk of harm to subjects and others?” (2) A less important ethical question follows from the first, “How could John collect accurate data, as opposed to inaccurate and useless data?” This second question is substantially resolved if the risk of harm is eliminated and the style of questioning is culturally appropriate.

What is not the question?

The role of the IRB is limited to oversight of research ethics. It is not a research supervision body and does not have a role or right to make decisions about the validity of the research method and research questions or to consider the potential merit and benefit of the research. However, if IRB members saw something clearly dubious about its merit or its methodology, the IRB would probably direct their concerns informally to the research supervisor.

If the ethical risk is substantial, the IRB only needs to evaluate the risk, and can reject any high risk proposal now matter how significant the potential benefit of the research.

Contextual risks

The unknown variables are the risks of harm in the context of the research, and each proposal might need a separate risk analysis to identify and assess them. They are relevant in that they might determine whether or not the IRB can approve the research proposal at all. Alternatively, the IRB might approve the proposal subject to satisfactory mitigation of contextual risks.

Most field researchers are so aware of them that they naturally seek to mitigate them and omit mentioning them explicitly. For example, John in Smithville might ask the following questions about contextual risks:

  1. Do confidentiality and information security procedures ensure the safety of subjects and of the researcher?
  2. Is the researcher an expatriate or a national? In some contexts, an expatriate researcher attracts suspicion that endangers nationals, whereas a national would not attract any suspicion. If an expatriate would attract suspicion, he/she might use nationals as research assistants.
  3. What is the methodology? Free informal interviews are low risk because they are much like ordinary discussions. A more formal methodology might pose a higher risk.
  4. Where are interviews held? An ordinary discussion during a personal visit is normally very low risk.
  5. Is there current unrest or tension at the research location that could ignite and put subjects at risk?
  6. What is the current relationship of the researcher to subjects and how are subjects recruited? Risk is very low if subjects are already friends or aquaintances whom researchers meet from time to time. Risk is higher if they do not already know each other. Risk is also low if the researcher is dealing only with Christians within existing churches, but risk is high if subjects are members of the wider community.

The IRB's first option: Reject the application

For the IRB, the simple answer is to deny John’s application and ask him to choose another topic. The IRB might take the view that such research holds the potential for serious harm, and that no amount of risk mitigation would be satisfactory. Such weak proposals seldom get this far, so full rejection is probably rare. It is sensible when researchers cannot minimize risks to subjects, but it is hardly suitable as a general rule. Missiologists are interested in many countries like Smithland, and have national and expatriate staff in them.

The IRB's second option: Ask for a revised application

Another simple solution is for the IRB to deny John’s application and ask him to completely revise it. This is the most probable response to the first application for a particular project, but it begs the question of what should be in the proposal for it to be approved.

The IRB's third option: Exemption by definition ruled out

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.

The IRB's fourth (and preferred) option: Exemption as interviews

The next 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, to approve this kind of exempt status according to point (i), the IRB needs only to ask, Does the researcher have effective confidentiality and information security procedures in place to prevent identification or re-identification of subjects?

Preventing identification or re-identification

It is axiomatic that the researcher would not make any local public statements about the research, such as a call for participants. The researcher could easily omit the name of the town, the names of the churches and their denominations, and the names of respondents. This presents no difficulty at all.

Although the research was anonymized, John would also have to prevent readers from making connections that would re-identify individuals and churches. The first stage of preventing re-identification is the period during research, in which he would:

  1. interview only church leaders, making no contact with the wider community in Smithville that might create suspicion or animosity,
  2. omit full identifying information in research notes, for example, by identifying individuals by nicknames or initials only,
  3. keep hard-copy research notes and recordings in a locked cupboard, and
  4. protect soft-copy records with passwords.

As the information is sensitive, he has other ways of protecting identities, although the IRB might not decide to make them obligatory:

  1. encrypt all soft copy records,
  2. minimize the risk of intercepts of insecure telephone, mail, and email, and
  3. destroy field notes immediately after the research supervisor has verified that data is not fictitious.

The second stage is publication, which has various options for safeguards:

  1. The research is kept confidential and not made public in any form. Some institutions have procedures for research on sensitive and commercial in confidence research that prevent publication, even for doctoral dissertations. This is perhaps the best and simplest solution in some cases.
  2. The researcher could publish under a different or modified name, because a unique or uncommon name would identify the research and, by extension, the subjects.
  3. 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?
  4. 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.
  5. How and where would the final research be published? For example, it would attract unwelcome attention if it were published in the Smithland Journal of Religion, especially if it were written in the Smithese 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 churches in Smithland.

The IRB's own requirements

Even if the IRB selects the Exemption as interviews option, it must also set its own requirements, apart from the CFR, to mitigate any contextual risks to subjects and the researcher. In these cases, confidentiality and information security procedures alone are not enough to ensure safety. It can decide on any procedures it sees necessary to ensure the safety and ethical treatment of subjects. For example, the IRB would still require researchers to inform subjects, similar to the following:

  1. Describe 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 IRB's fifth option: Approve the application without an exemption

If the IRB sees other risks, it has the right to appprove the research without any exemption, in which case the full effect of the CFR comes into play. Even then, it 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)

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1. https://www.ucl.ac.uk/research/integrity/sensitive-research, Viewed 26 Nov. 2022.
2. Due to a drafting oversight, the CFR does not mention risk of harm to researchers and third parties, although the IRB should also consider it.

See also Raymond M. Lee. 1993. Doing Research on Sensitive Topics. (London: Sage Publications Inc.)