Recruitment and Participants
When thinking about recruitment there are two important questions to answer: 1) Who will you be recruiting to participate in your research; and 2) How will you recruit them?
The answer to the first question (who) will likely shape the answer to the second question (how).
Participants
Your research question will obviously shape who you are trying to recruit - you will not be able to answer questions about the experiences of medical students by talking to preschoolers, nor figure out how to improve early childhood education techniques by observing medical students.
It is important to think carefully about who you will recruit, and how many people you will need to include in your study to produce meaningful results. If your work presents risks to participants it is equally important to make sure you are not oversampling (and exposing additional participants to the risk unnecessarily) or under sampling (thereby exposing participants to risk without producing beneficial results).
Risk Sensitive or Vulnerable Populations
Some groups, for structural or historical reasons, are considered vulnerable populations. For these groups the recruitment and consent process may be complicated and therefore extra caution must be taken. For some of these groups there are extra regulatory requirements that must be met.
Below we will discuss some of the groups that are typically considered vulnerable populations, but it is important to think about the specific context of your research as well. A group that might not be considered vulnerable ordinarily, could be at extra risk given the particular topic or methods of your research. It is the responsibility of the researcher to think through these possibilities, and make sure that the recruitment methods and research procedures work to reduce such risks.
Research with Prisoners
In regulatory terms, “prisoner” does not simply refer to someone who has been sentenced to a penal institution under criminal or civil statue. It also includes individuals detained in other facilities by virtue of statutes or alternative commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
Prisoners are one of the populations for which there are special regulatory requirements. For instance, the definition of 'minimal risk' is different for prisoners and only certain types of research can be approved. See here for more information.
Prisoner research cannot be exempted, and LUC requires many projects involving prisoners to be reviewed by the Full Board at a convened meeting. Investigators will also need to secure IRB or administrative approval from the penal institution and/or State Department of Corrections.
In accordance with the regulations, the LUC IRB has at least one board member who represents the prisoner population and can act as an advocate on their behalf.
Research with Children
Children are considered a vulnerable population under the federal regulations, and therefore receive extra protections. These include special procedures around consent, and limits on how exemption category two may be applied. Research involving children who are wards of the State requires further protections. See here for more information on the regulatory requirements for research with children.
The main difference for many research projects involving children will be the informed consent procedures. Because minors are not legally able to give their own consent, research involving children requires obtaining consent from parents or guardians and assent from the children. See the Informed Consent section for more information.
Research with people that do not speak, read, or write English
The regulations state that consent must be presented to participants in a language understandable to the subject. When a participant does not speak English, the IRB will require information on how consent will be obtained. Study materials may also need to be translated. If so, the IRB will need to know about the translation process and translated materials should be uploaded along with the original materials. Translators must be appropriately qualified.
Research with Employees
Employees are not considered a vulnerable population, but some exemption categories cannot be applied in cases where there is a risk to the employability of the participants.
Additionally, the consent process may be complicated if the researcher is working on behalf of an employer, or recruiting employees through management. The researcher needs to make sure that employees do not feel unduly pressured to participate, or as if there may be negative consequences should they decide not to participate.
The IRB requires extra language in the consent materials stating that employment will not be affected by the decision to participate or not participate. See our templates for guidance.
Research with LUC Students
College students are not considered a vulnerable population under the federal regulations, but some exemption categories cannot be applied in cases where there is a risk to the educational advancement of the participants.
Additionally, there are additional concerns if the researcher is trying to recruit their own students, especially in cases where the research team has grading authority over the students. The researcher needs to make sure that students do not feel unduly pressured to participate, or as if there may be negative consequences should they decide not to participate.
To prevent any unconscious bias, those with grading authority over students should not be aware of which students have chosen to participate or not participate until after final grades have been submitted. This may require adding additional research personnel to handle consent and data collection procedures.
The IRB requires extra language in the consent materials stating that students will not be affected by the decision to participate or not participate. See our templates for guidance.
Investigators with Dual Roles
When recruiting and consenting participants, it is important that participants are able to freely consent to participate in the research. This includes the right to choose not to participate. When an investigator has a dual role, this may create a scenario where participants feel pressured to participate or worry (rightly or wrongly) that there may be negative consequences to not participating.
Common examples include an employer, who is also a researcher, asking their employees to participate, or a teacher, who is also a researcher, asking their students to participate. In these cases, extra precautions must be put in place to ensure that potential participants have the ability to freely consent without consequences.
Recruitment Procedures
There are many ways of recruiting participants: flyers, in-person communication, advertisements, electronic communication, mail, and more.
Whatever way you chose, the IRB will need to review your recruitment materials. All flyers, scripts, and templates need to be included in the attachments section of the application. If there are changes to recruitment materials after the application is approved, you will need to submit an amendment application which must be approved before the new materials can be used.
The goal of recruitment materials is to clearly and efficiently state what will be required should someone chose to participate. If materials are confusing, or leave out important details, that can be a waste of time for potential participants or for those who are not actually eligible for the study.
With that in mind, recruitment materials should give an overview of who is eligible, the topic of the study, and the procedures broadly speaking. All recruitment materials should include the full time commitment of participation.
When thinking about recruitment there are two important questions to answer: 1) Who will you be recruiting to participate in your research; and 2) How will you recruit them?
The answer to the first question (who) will likely shape the answer to the second question (how).
Participants
Your research question will obviously shape who you are trying to recruit - you will not be able to answer questions about the experiences of medical students by talking to preschoolers, nor figure out how to improve early childhood education techniques by observing medical students.
It is important to think carefully about who you will recruit, and how many people you will need to include in your study to produce meaningful results. If your work presents risks to participants it is equally important to make sure you are not oversampling (and exposing additional participants to the risk unnecessarily) or under sampling (thereby exposing participants to risk without producing beneficial results).
Risk Sensitive or Vulnerable Populations
Some groups, for structural or historical reasons, are considered vulnerable populations. For these groups the recruitment and consent process may be complicated and therefore extra caution must be taken. For some of these groups there are extra regulatory requirements that must be met.
Below we will discuss some of the groups that are typically considered vulnerable populations, but it is important to think about the specific context of your research as well. A group that might not be considered vulnerable ordinarily, could be at extra risk given the particular topic or methods of your research. It is the responsibility of the researcher to think through these possibilities, and make sure that the recruitment methods and research procedures work to reduce such risks.
Recruitment Procedures
There are many ways of recruiting participants: flyers, in-person communication, advertisements, electronic communication, mail, and more.
Whatever way you chose, the IRB will need to review your recruitment materials. All flyers, scripts, and templates need to be included in the attachments section of the application. If there are changes to recruitment materials after the application is approved, you will need to submit an amendment application which must be approved before the new materials can be used.
The goal of recruitment materials is to clearly and efficiently state what will be required should someone chose to participate. If materials are confusing, or leave out important details, that can be a waste of time for potential participants or for those who are not actually eligible for the study.
With that in mind, recruitment materials should give an overview of who is eligible, the topic of the study, and the procedures broadly speaking. All recruitment materials should include the full time commitment of participation.