Human Subjects Researchers

Important information for students who conduct research with human subjects

What is Research?

The US Department of Health and Human Services defines as "any systematic investigation, including research development (pilot testing) designed to develop or contribute to generalizable knowledge."

Generally, student projects involving human participants fall into one of two categories:

Practica, internships, or class projects that involve the collection of data from human participants but are NOT designed to contribute to generalizable knowledge
Directed or independent research projects that are designed to contribute to generalizable knowledge.

Projects in Category 1 do not require IRB review. Projects in Category 2 must be reviewed by the IRB before any data collection begins.

Category 1: Practica/Internships/Class Projects Involving Collection of Data from Human Participants

Pratica, internships, and class projects may be designed to provide students with an opportunity to practice various methods such as interviews, observation/participant observation, and survey techniques, as well as data analysis. These projects may include, but are not limited to, those associated with research methods or data analysis classes, as well as those taught within the Praxis Program. In these cases, data may be gathered from human participants. However, because such projects are designed solely to provide training to students and not designed to lead to generalizable knowledge, they do not constitute "research" as defined by federal guidelines and do not require IRB review.

Category 2: Research Projects, Directed or Independent

Any inquiry conducted by students, graduate or undergraduate, that uses human beings as participants and does not fall into Category 1 (research practicum/internship or class project as defined above), must be reviewed and approved by the IRB before data collection begins. The IRB cannot provide retrospective reviews or approval after data collection has begun. These may include, but are not limited to, independent undergraduate research projects and honors theses, master's theses, and doctoral dissertations, all of which are intended to contribute to generalizable knowledge.

Students are encouraged to work with their Faculty Advisors prior to starting their protocol in the IRB Mentor system. Use the STUDENT CHECKLIST to guide protocol creation.

Level of IRB Review

After concluding that you are conducting research in Category 2, you must determine the IRB level of review for your research. Work directly with your faculty advisor to help determine the levels of review required. IRB Mentor has a pre-proposal survey that can be used for this determination or this decision tree from the Office of Human Protections.

Required Student Checklist for IRB Mentor Protocol Submissions

Students submitting protocols to IRB Mentor must use this STUDENT CHECKLIST when developing your protocol. Work with your faculty advisor to ensure your protocol satisfies all requirements on the student checklist.

CITI Training

There are 10 required modules in the Social & Behavioral Research - Basic/Refresher course. Work with your faculty advisor to determine if any of the optional modules would benefit your research training. Contact the IRB if additional training needs to be provided.

The IRB will automatically receive any completion reports upon a researcher completing all modules and associated quizzes. Save copies of these reports for your own records.

CITI Instructions - Students

Responsible Conduct of Research (RCR)

Student research that is funded by certain federal agencies require Responsible Conduct of Research training. Work with your advisor to determine if you need to complete these trainings. However, all students conducting research are encouraged to complete this training.

For help with Zoom, Teams, or Qualtrics contact: LITS Services for COVID-19 website: irb@brynmawr.edu or HELP DESK (526-7440 or help@brynmawr.edu).

Contact the IRB