Participants

human subjects = participants

In federal regulations relating to research with people, the term "human subjects" is used, but in practice, the terms are used interchangeably. The term "participants" is used throughout UNI's IRB policies and procedures.

Grant Budget Context

human subjects ≠ participants

Investigators applying for external funding for their research should be aware that "participant" has a different meaning in federal regulations when it comes to budgeting. In the budgeting context, a participant is someone who is receiving the benefit from a project, such as a trainee whose travel expenses are paid to attend a conference. It is important to use the correct budget categories for expenses related to human subjects vs. participants. This Human Subject Participants chart (PDF) may be used for budgeting purposes.

Determining Participants / Subjects for IRB Purposes

Who actually are the participants (subjects) in a research project? The answer is obvious in most studies, but there are some nuances that investigators should be aware of. Below are examples of when individuals are and are not considered participants in a study. This is important in part because anyone who is considered a participant must provide assent or consent in order to be included in the study.

1. When individuals provide any kind of information about themselves, they are obviously participants.
2. When individual-level information is included in a dataset (whether individuals can be identified or not), those individuals are typically participants.
3. When an individual provides information about other individuals, the others are the participants. For example, when a principal provides information about individual teachers, such as their age, gender, and college degree, the teachers are the participants, not the principal. However, if the principal offers opinions about how well-prepared each of the teachers is, then the principal also becomes a participant. If the principal only provides aggregate data about the teachers (e.g., 50% have MA degrees), then there are no participants involved at all – it is not human subjects research. 
4. Somewhat similar criteria as shown in item 3 can be applied to parents and children. If parents provide individual factual information about their children, the parents are only informants and the children are the participants. More commonly, if they also share feelings, attitudes, or opinions about their children, both the parents and the children are participants. 
5. Multi-phase studies involving “helpers” versus participants can be a little tricky. Here are some examples:
   1. In phase 1, a panel of teachers with special expertise is invited to review and suggest further developments for a new curriculum developed by the researchers. These teachers would be considered expert “helpers”. In phase 2, a second larger group of teachers is recruited to use the curriculum, likewise provide a critique and suggestions for development, and share outcome data from the children in their classes. This one is in a gray area - the teachers are both expert commentators (helpers) as well as participants, because their performance using the curriculum is also being assessed. Unless the student outcome data provided by the teachers to the researchers is in aggregate (e.g., 50% of the students got A's), the students are also now participants. In phase 3, another group of teachers are invited to use the curriculum and provide attitudinal data (opinions) about how well the curriculum worked, as well as student outcome data. These teachers are only participants, not helpers. 
   2. In phase 1, a group of individuals is recorded speaking English. In phase 2, these videos are shown in systematically varied ways to ESL students learning to speak English, and the students are asked to rate the confidence level of the speakers as well as take language tests assessing their own speaking abilities. The individuals taped in phase 1 are providing stimuli for the study – they are not participants. The students who are rating them and providing data about themselves are the participants in the study. (Although they are not research participants, the individuals who were recorded should still give their permission before their recordings are used.)

The purpose of this discussion has been to distinguish when individuals involved in a research project are or are not serving in the role of participants because participants must typically provide informed consent before participating in the research. However, there is some overlap between this discussion and the question of whether or not a given data collection activity is research with human participants and thus needs review by the IRB. That question is answered more fully in Which Projects Require Review.