Research participants are the primary focus for an IRB-SBS review and the purpose of the Participant Group section is to provide you with a tool that will help you to describe your participants accurately and clearly while identifying specific categories that may need the IRB-SBS’s additional attention.
There are no rules about what defines a “participant group,” rather it is a tool that will help you to better define the participants in the protocol so that you can explain your processes more clearly to the Board. Many studies will only need to create one participant group. If you have a more complex study with some participants participating in different aspects of the study, it may be beneficial to organize your participants in different groups.
|Study Activity||Interview and survey||Survey and classroom materials||Survey|
|Consent Form||Consent form for “Teachers”||Student Assent Form
Parent Consent Form
|Parent Consent Form
(as study participants)
|Instrument||Teacher interview protocol
|Student Survey||Parent Survey|
Participant Group Example A represents a complex study with different groups of individuals who interact with the study in different ways. Creating different participant groups helps to distinguish which group will use what consent form, study instrument, etc. The different participant groups helps to distinguish between groups with adult participants and minor participants.
|Participants||“Normal” Adult Group 1||“Normal” Adult Group 2|
|Study Activity||Anonymous Online Survey||Anonymous Online Survey|
|Consent Form||Online notification||Online notification|
|Instrument||Online Survey A||Online Survey B|
Participant Group Example B is also a complex study with different groups of individuals but their data collection and consent process is fairly similar. Even though they are taking different online surveys and may have different selection criteria, it may not be necessary to create different participant groups to describe the participants as they are all “normal” adults doing an online survey. However, it may be easier to divide the groups to better describe the selection criteria. Again, there is no rule as to the best way to use the tool but instead use your best judgement for describing your study. Once you create a participant group, you can use the participant group as a template for other groups by using the “copy” feature (select “create new participant group” and then select a group to copy), a functionality that comes in handy if you have similar participant groups.
|Participants||Residents in a remote village|
|Study Activity||Observations, short interviews,
|Consent Form||Oral consent process|
Participant Group Example C is an ethnographic study where the researcher will spend time with a community, documenting their culture and experiences. Studies like this one can be fluid at times in regards to the specific number of participants, ages, etc. While there is the potential to interact with a variety of individuals, it may not make sense to create multiple “participant groups.” In this example the principal investigator could create just one participant group to describe the interaction with the community. However, he knows that while he will probably observe and conduct short interviews with most of the community, a select group will participate in the lengthier interviews. It may be to his advantage to create two participant groups to distinguish between the different data. He could use the “selection criteria” section to provide information as to why someone would participate in the lengthier interview, etc.
Once you create multiple participant groups, data sources, etc, the “associate tools” will help to create tables that connect the correct participant groups with consent forms and data tools, so having clearly defined participants groups is a good first step towards using these tools appropriately.
Even though the checklist above asks about “minors,” the requirements and considerations for a three-year-old minor are different than a fifteen-year-old, particularly with the assent process. This box helps the IRB-SBS have a more specific picture regarding the ages of participants.
Federal regulations define specific categories of participants who are more likely to have difficulty providing consent, either because of cognitive, legal, and/or social reasons. Participants such as minors, prisoners, and pregnant women (as related to their unborn babies) are specifically listed in the regulations but additional groups such as adults with diminished mental capacity are considered in this group as well. Students (both in participant pools and not), employees, and patients/clients can also be put in situations where they feel compelled to participate in a study depending on their relationship with the researcher. The IRB-SBS evaluates these groups more carefully and has specific requirements that need to be met. For more information, see Vulnerable Populations.
Knowing how many participants are in a study can be a factor in determining risk, particularly in regards to confidentiality and anonymity. For many studies these numbers will not be exact but it’s important for the board to understand the scope of the study. If you apply for annual continuation, these numbers will be modified to reflect the current state of the protocol.
This question provides the Board with additional context regarding the participants in the study and why they would (or would not) be included in the study. Some groups may require special permission to access; for example you may need permission from a school administrator to access students in a public elementary school. You will address those issues in the “Permission to Access Data Source and Participant Group” section as well as upload proof of permission in the “Proof of Permission” upload.
The purpose of this question is twofold. First, the IRB-SBS must evaluate the ethical implications of paying a participant and ensure that payment is commensurate with the participant’s study activities. In addition, the Procurement Office has asked for our help to accurate report paying participants with UVA funds. For more information see Paying Participants.