The Participant Summary section assembles all of the created Participant Groups and combines the number of participants provided in each group into a grand total. In addition it provides an opportunity to highlight the experience of the principal investigator and the research team (where applicable), as well as describe the relationship that the principal investigator and any other individuals associated with the study have with the participants.
Researcher experience is an important factor when the IRB-SBS weighs the risks of the study against its potential benefits. An experienced researcher who is familiar with a population and knows how to work sensitively with them is far more likely to yield generalizable results while understanding how to best protect a participant as compared with an undergraduate student embarking on his or her first study. That said, it doesn’t mean that the undergraduate’s researcher isn’t valuable but rather the researcher may need to design a study that has reduced risk and also needs to demonstrate that he or she has adequate supervision through their faculty sponsor. Providing a good description of the principal investigator’s experience as well as the rest of the research team (where applicable) can help the IRB-SBS have a better understanding of the overall experience level of the group and how prepared they are to work with their proposed participants.
Providing consent free of coercion is a central tenant of the ethical foundation for human subjects research. Even though a researcher may assure a participant that they can participate without pressure, simply being a subordinate of the researcher may make the participant feel compelled to participate. The IRB-SBS will want to know if anyone on the research team holds any authority over their participants or if there is any other type of relationship between participants and researchers. Being in a position of authority doesn’t necessarily preclude a researcher from including a participant, but the IRB-SBS may require specific steps be put in place to create layers of separation between the researcher and participant.
In addition, the final question asks about financial relationships. It is important for the IRB-SBS to understand any relevant financial relationships that may create a conflict of interest for researchers.
- The questions have been answered adequately.
- The researcher will take appropriate precautions to protect participants from coercion.
- The researcher’s experience is appropriate for the study.