Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects

1. Introduction

Some specific types of studies have triggered questions with respect to investigators' responsibilities and the need to obtain prospective review and approval of the IRB:

2. Student Projects

Stanford University supports a wide range of both undergraduate and graduate student research projects involving human participants, from course-related research exercises to Ph.D. dissertation studies.

Generally, student research involving human participants falls into one of two categories: research practica, and directed, independent research projects. 

A. Research Practica

Research Practica are class projects designed to provide students an opportunity to practice various research methods such as interview, observation, and survey techniques, as well as data analysis. Such projects typically do not lead to generalizable knowledge and are not undertaken with that goal in mind. Research practica do not require IRB review. Data that are collected during a research practicum project may be used in independent research projects at a future time. In such a case, the IRB should be consulted, because an IRB application for use of existing data may be required and there may be limits to its usage.

Although the IRB does not review such class projects, we strongly encourage instructors to become fully familiar with each student's project(s), and to discuss it with the student. Professors should discuss with their students matters such as courtesy, and avoidance of unnecessary discomfort or invasion of privacy. Explicit recognition of the existence of the IRB and discussion of its goals and concerns should be an integral part of introducing students to research methodologies.

B. Directed or Independent Research Projects

Directed or Independent Research Projects are any research conducted by students, graduate or undergraduate, which involves human participants, employs systematic data collection, is intended to contribute to generalizable knowledge, and does not fall under the category of research practicum. These projects include, but are not limited to, independent undergraduate research projects and honors theses, masters' theses, and dissertations. Student projects in this category must be reviewed and approved by the IRB before initiation. It is possible that a research project may be exempt from  regulatory requirements, but it must meet explicit criteria and the Research Compliance Office (RCO) must first review it and issue an exempt determination.

If you have questions regarding the distinction between these categories, contact the RCO at (650) 724-7141 for assistance. 

3. Pilot Studies

A pilot study is a preliminary investigation of the feasibility of a study, usually done on a small scale (approximately 10 or fewer participants) and exploratory in nature. It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. Data collected from a pilot study cannot be used as research data. Such a pilot would not contribute to generalizable knowledge and therefore is not considered research and does not require IRB review. Medical interventions or interactions for research purposes, especially those involving invasive procedures, do require IRB review regardless of the size of the study.

4. Oral History

An oral history project may not require IRB review because it is not generally thought to be a systematic investigation designed to contribute to generalizable knowledge beyond the individual being interviewed. However, when using oral history as a technique in human subject research it may require IRB review. Researchers proposing such work are strongly encouraged to contact the IRB to determine whether their project requires approval.

5. Quality Assurance or Quality Improvement Projects

Research conducted in conjunction with program evaluations or quality assurance measures may not fall under the jurisdiction of the IRB if that is the sole purpose of the project. However, if the project is also intended to develop or contribute to generalizable knowledge, and involves human participants, the project should be submitted for IRB review.