Research with Vulnerable Populations

OHRP defines vulnerable populations as subjects that are particularly susceptible to coercion or influence. Because of their susceptibility, it is often difficult to obtain consent that is truly informed from subjects in these populations. The Northwest IRB must give special consideration when evaluating an IRB application to ensure that subjects from vulnerable populations do not feel coerced and that consent is legitimately obtained.

OHRP specifically names the following groups as vulnerable populations:

• Children
• Prisoners
• Individuals with impaired decision-making capacity
• Economically disadvantaged persons
• Educationally disadvantaged persons  

However, there are vulnerable populations beyond these. If you are conducting research with a vulnerable population not specifically named above, such as an elderly population in a nursing home, you should still give careful consideration in obtaining consent and avoiding coercion, and the Northwest IRB may request that special procedures or documents are created to protect your human subjects.

Research with vulnerable populations must also meet two further criteria. First, the research must be directly relevant to the population. In other words, your research must be specifically interested in learning about this population rather than using them out of convenience. For example, if using children as subjects, a researcher must be interested in learning about children; it would be inappropriate to use children as subjects simply because they are readily available. Second, if the research is of more than minimal risk to subjects, then the research must have clear, direct benefits to the subjects themselves.

In addition to the guidelines above, OHRP has outlined special guidelines for certain vulnerable populations regarding which levels and categories of IRB review can be used. These special guidelines are outlined below. Please note that the information below only applies to research of no more than minimal risk. If your project may cause harm, you should review the relevant guidelines in subparts B, C, and D at this link.

Research with Children

Projects that are no more than minimal risk can be approved as exempt or expedited with the exception of exemption category 3. In addition, research with children can only be approved as exempt under category 2 if certain stipulations are met:

• Research with children cannot be reviewed as exempt if it falls under exemption category 2-III.
• Research with children fitting under exemption category 2-I or 2-II can only be reviewed as exempt if it involves educational tests or observations of public behavior where the investigator does not participate. Otherwise, research under 2-I or 2-II cannot be reviewed as exempt.

Research with Prisoners

Projects using prisoners as subjects cannot be reviewed as exempt and must undergo either expedited or full review. If the project is of no more than minimal risk and fits one of the expedited categories, it can be approved with an expedited review; otherwise, the project must undergo full review. However, prior to submitting your project for review, you should contact the Northwest IRB for further instructions related to your project.

Research with Pregnant Women, Human Fetuses, or Neonates

Projects utilizing these populations may be approved as exempt or expedited under any category as long as the requirements of the category are met. However, prior to submitting your project for review, you should contact the Northwest IRB for further instructions related to your project.