Other Studies Involving Human Participants

HUMAN PARTICIPANTS PROTECTION IN FIELD RESEARCH

Field research typically involves observation of and interaction with individuals and groups in their own environment, often over long periods of time.  It also includes other types of generally qualitative activities that fall under the definition of research, such as interview conducted for historical or biographical research and archival research on identifiable living individuals.  Interviews by journalists conducted solely for the purpose of writing an article in a newspaper, magazine, or other media outlet are not considered research and do not require IRB review.

It may not be possible to specify in an informed consent statement the detailed description of the research protocol, as the research itself may involve interactions between the researcher and participants that evolve over time.  Likewise, differences in language, culture, or the nature of the participants or topic may preclude the use of a written informed consent document.  If appropriate justification is given, the IRB may waive the requirement for some or all of the informed consent requirements or the requirement to obtain signed informed consent in certain situations; 45 CFR 46.116(c) and (d) describes the circumstances in which waiver is possible. 

The investigator should request such a waiver from the IRB if he or she determines that it is appropriate.  The IRB will make the final determination.  In addition, the sensitive nature of some field research may make it advisable for the investigator to consider obtaining a Certificate of Confidentiality.

Investigators conducting field research should consider guidelines developed by a relevant professional association, such as the American Anthropological Association, the American Historical Association, or the American Sociological Association, when designing their protocols.

OTHER STUDIES INVOLVING HUMAN PARTICIPANTS

This section sets out policy for conducting other types of studies that include human participants, but do not meet the Federal definition of research. 

Student Projects:

• Thesis and dissertations
• Projects undertaken with the intent of presenting findings at a conference (including Saginaw Valley State University or other University-affiliated undergraduate or graduate research presentation venues)
• Projects undertaken with the intent of publication, including publication on the Internet.

Many courses include projects that are designed to train students in research methods such as anonymous surveys, oral histories, field work in cultural anthropology, clinical interns practicing diagnosis, and program evaluations conducted in connection with a student internship.  Many independent directed research projects may have these same goals. While these projects do not normally require IRB review, they are subject to and require faculty oversight.

Class projects and independent directed research projects not designed to contribute to generalizable knowledge do not require IRB review unless the proposed research places the participants at more than minimal risk, usually evidenced by one or more of the following:

• Participants are members of a vulnerable population (as defined in University policy).

• The study asks identifiable participants about illegal activities (e.g., underage drinking), which may place the data at risk of subpoena.
• The study places identifiable participants at risk of a breach of confidentiality that may lead to criminal or civil liability, or damage the subject’s financial standing, employability, or reputation [45 CFR 46.109(b)(3)].
• The study places participants at more than minimal risk due to psychologically sensitive subject matter (e.g., interviews covering traumatic events).