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Located Inside: Research Policy Handbook

Summary:

Discusses the responsibilities for use of human subjects in student projects, pilot studies and oral histories (non-medical), and describes conditions under which Administrative Panel review and approval is needed

Related Research Policy Handbook Documents:

1.4    Administrative Panels for Research Compliance
7.1    Federalwide Assurance of Protection for Human Subjects

SEE ALSO:  Research Compliance Office Home Page
                      Administrative Panels on Human Subjects:Non-Medical
                      Protection of Human Subjects in Research,
                               a required tutorial
                       Human Subjects Manual

Authority:

Consolidates and updates the previous documents, "Use of Human Subjects in Pilot Studies and Oral Histories (Non-Medical)" and "Student Research Involving Human Subjects (Non-Medical)," both prepared by the Administrative Panel on the Use of Human Subjects in Non-Medical Research

Compiled by the Research Compliance Office

Contact Person:

Research Compliance Director

Three types of studies have triggered questions with respect to investigators' responsibilities and the need to obtain prospective review and approval of the Human Subjects Panel:
      I. Student Projects,
      II. Pilot Studies, and
      III. Oral Histories.

These studies are sometimes less formal than other kinds of projects, and there can be confusion as to when or if they should be reviewed. Problems can arise when projects aren't reviewed when they should be.

HUMAN SUBJECT RESEARCH:
   See Determining if Activities Meet Organizational Definition of Human Subject Research (pdf file)

   1.   Student Projects

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

Generally, student research involving human subjects falls into one of two categories:

1. RESEARCH PRACTICA, the goal of which is to provide research training; and

2. directed or independent RESEARCH PROJECTS (e.g., honors or graduate theses), which employ systematic data collection with the intent to contribute to generalizable knowledge.

RESEARCH PRACTICA do not require Panel review. RESEARCH PROJECTS do require prospective Panel review and approval. If you have questions regarding the distinction between these categories, please do not hesitate to contact the Panel Coordinator for assistance

1. Research Practicum - A course of study that involves the supervised practical application of previously studied theories of research method (based on Webster's New Collegiate Dictionary)

   A number of departments offer courses that require students to undertake projects in which other people are interviewed, observed, or otherwise serve as participants. The purpose of these course projects is to train students and provide them with a closer view of social, educational, or psychological processes, and an opportunity to practice various research methods. Such projects typically do not lead to generalizable knowledge and are not undertaken with that goal in mind. Therefore, the Panel does not consider them to be research and Panel review and approval are not required.

   Although the Panel 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. We believe that explicit recognition of the existence of Human Subjects Panels at all research institutions, and discussion of their goals and concerns, should be an integral part of introducing students to research methodologies.

   2.   Pilot Studies

As the Panel interprets the concept, a PILOT STUDY is a preliminary investigation of the feasibility of a study, usually done on a small scale (usually fewer than 10 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. At the point of academic discussions, e.g., "how could this survey question be misunderstood?," such a pilot would not contribute to generalizable knowledge and therefore is not considered research and does not require Panel review.

However, the Panel has encountered cases in which information derived from pilot studies has been considered or used for research purposes, i.e., publication. The Panel urges investigators preparing pilot studies to weigh the likelihood that the pilot data will actually be used for research purposes. In those instances, Panel review and approval is required before data collection commences.

   3.   Oral History

ORAL HISTORY is a technique in which the researcher conducts a series of taped interviews with the participants in a particular historical event or period. Often, the intention is that these tapes become available to the public at a specified future time (frequently after a substantial delay) in order to convey historical insight.

In many cases, these interviews will be historical recollections of the character of a society or an institution rather than the interviewee's subjective perceptions. Such activities may or may not be considered human subjects research. While the Panel is eager to avoid interfering inappropriately with the researcher's or interviewee's freedom of expression, oral history projects should be submitted to the Panel to determine the appropriate level of review. (In many cases, these projects may meet the requirements for the Panel's Exempt review procedures.)

Special considerations for oral history projects include:

1. Are the conditions of use or publication of the recording clearly understood in advance by the interviewee?

2. Is the interviewee given an opportunity to provide effective consent to the interview?

3. Are adequate means provided for the protection of the privacy of any third parties who may be named in the interview?

   Other Types of Research

Research conducted in conjunction with program evaluations or quality assurance measures may or may not fall under the jurisdiction of the Human Subjects Panel. If such a project is conducted with the intent to develop or contribute to generalizable knowledge, it should be submitted for Panel review. For clarification, please feel free to contact the Panel Coordinator to discuss the details of your project.

Who can I call if I have questions concerning my non-medical human subjects research?

You can call or e-mail the Panel Coordinator:
(650) 723-8666 (for meeting & deadline dates)
(650) 723-2480 (for other questions)

Electronic protocol submission application (Stanford access only):
https://hatswebhs.stanford.edu

Visit our informational website at:
http://humansubjects.stanford.edu/research/nonmedical/nonmedical.html