IRB Mythbusters – Special Populations
The VCU Human Research Protection Program presents IRB Mythbusters — a periodic newsletter clarifying common misconceptions about conducting human research and the IRB!
In this issue, “myths” surrounding special populations are addressed. Access previous editions of IRB Mythbusters by visiting the “mythbusters” tag on our blog.
MYTH #1:
In my IRB submission, I should select any special population that may possibly be included in my study.
FACT: Special populations should only be selected (1) when the population is specifically targeted, and/or (2) individuals will be identified as being part of a special population within the research data. For example: an online survey of high school teachers may theoretically include pregnant people, but if the research questions are not specific to pregnant people, and the questions that are asked in the survey would not reveal that the respondent is pregnant, then pregnant people should not be selected in the IRB application. Conversely, an online survey of high school students would require the researcher to select children in the IRB application, because the research is specifically targeting children.
TIP: Consider your study’s target population and whether or not that includes any special populations. Keep in mind that while there are only three categories of federally-recognized vulnerable populations (pregnant people, fetuses, and neonates; prisoners; and children), there are many other types of populations that may warrant special considerations when developing an IRB submission. For example: including decisionally-impaired adults in a study will have implications for consent and assent requirements. The VCU IRB offers guidance and policies on several different special populations, including the federally-recognized categories of special populations, in addition to other populations, such as Limited English Proficiency (LEP) individuals and decisionally-imparied adults. The IRB submission form also identifies other populations that may have special considerations, such as students. When considering whether a population is potentially “vulnerable,” take into account things like existing power structures, historical inequities, and the risk for coercion or undue influence.
MYTH #2:
Including pregnant people or children in my research will automatically upgrade my study from expedited to full board review.
FACT: The regulations specify three special populations that have additional regulatory requirements that must be met before they can be included in a study: pregnant people, fetuses, and neonates; children; and prisoners. While it is true that certain populations may not be included in exempt research, the inclusion of special populations will not necessarily disqualify a study from expedited review.
TIP: Pregnant people may be involved in research at any level of review (exempt, expedited, or full board), provided the additional regulatory requirements set forth in Subpart B of 45 CFR 46 are met. Children may be included in exempt research only as allowable under exempt categories 1, 2, and 4. You can learn more about the restrictions on the involvement of children in those exempt categories by reviewing the exempt categories on the IRB’s “Review Types and Requirements” webpage. Children can be involved in any research reviewed at the expedited and full board level, provided that the additional regulatory requirements set forth in Subpart D of 45 CFR 46 are met. Prisoners may not be included in exempt research, unless their inclusion is incidental to recruiting a larger population and prisoners are not specifically targeted (i.e. a review of medical records that may incidentally include prisoners, but prisoners are not specifically the population of interest). Expedited review for research including prisoners is only allowable under specific circumstances. Most research involving prisoners will require full board review. At all levels of review, research involving prisoners must satisfy the additional regulatory requirements set forth in Subpart C of 45 CFR 46.
MYTH #3:
It is acceptable to exclude Limited English Proficiency (LEP) individuals from my research if I don’t have the resources for translation/interpretation
FACT: In order to meet the ethical and regulatory requirement of equitable subject selection, efforts should be made to include LEP individuals in research whenever possible, particularly in research which may have a direct benefit to participants. Mere inconvenience or lack of resources are seldom sufficient justifications to exclude LEP individuals from a research study.
TIP: Consider the inclusion of LEP individuals early on in the development of your research study, and determine what resources (personnel, financial, etc.) may be required in order to include LEP individuals in your research study. Be aware of VCU’s policies regarding the inclusion of LEP individuals in research, including when a “short form” consent process may be used versus when a fully-translated consent form is required, and the IRB’s requirements for documenting translator/interpreter qualifications. Familiarize yourself with the the IRB’s guidance document on the topic.
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