5.4 Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects
Discusses the responsibilities for use of human subjects in student projects, pilot studies, oral histories, and QA/QI projects, and describes conditions under which Administrative Panel (IRB) review and approval is needed.
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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:
- Student Projects
- Pilot Studies
- Oral Histories
- Quality Assurance/Quality Improvement Projects
Human Subject Research
2. Student Projects
Stanford University supports a wide range of both undergraduate and graduate student research projects involving human subjects -- from course-related research exercises to Ph.D. dissertation studies.
Generally, student research involving human subjects 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.
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. Experience has taught us that time spent with students discussing matters such as courtesy, and avoidance of unnecessary discomfort or invasion of privacy, will be time well spent. 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 involve human subjects, employs systematic data collection, is intended to contribute to generalizable knowledge, and does not fall under the definition 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. It is possible that a research project may be exempt from ongoing IRB review, but it must meet explicit criteria and the IRB must certify the exemption.
If you have questions regarding the distinction between these categories, please do not hesitate to contact the IRB 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 subjects) 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. Such a pilot would not contribute to generalizable knowledge and therefore is not considered research and does not require IRB review. Data collected from a pilot study cannot be used as research data.
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 study 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, although if the project is intended to develop or contribute to generalizable knowledge, and involves human subjects, the project should be submitted for IRB review:
- Visit the Human Subjects informational website for more information about what constitutes human subject research and whether IRB review is necessary
- To verify whether your project requires IRB review, please contact the IRB directly at (650) 724-7141 or at IRBEducation@lists.stanford.edu
- The IRB offers written documentation as a courtesy. To submit a written request for a Human Subjects Research determination, submit the Determination of Human Subject Research application via eProtocol by selecting ‘Create a Protocol’ on the ‘My Dashboard’ webpage, entering a small amount of information about your project, and selecting the ‘HSR’ or ‘Human Subject Research’ category of review
- To submit an IRB protocol, access the electronic protocol submission application and go to ‘My Dashboard’
