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).

Institutional Research - IRB

Data collected or studies conducted for purposes of providing information to the University, any unit within the University, or any other organization (e.g., accrediting agency), with the purpose of addressing issues deemed important to University operations is considered to be institutional research. Studies of this nature do not require IRB review. If information collected is intended for further or wider dissemination within the University or to other organizations, for publication (including Internet), or involves more than minimal risk, it requires IRB review. 

When IRB review is not required, institutional research projects or other activities must still communicate applicable elements of informed consent (e.g., purpose, risk, benefit, voluntary participation, permission to withdraw) and include appropriate anonymity and confidentiality protections.

Other Projects:

The primary types of projects included in this category are program evaluations, policy analyses, or quality assurance studies conducted for the purpose of providing information only to the organization studied.  Such studies do not require IRB review if they involve no more than minimal risk as defined in Federal regulations and University policy and do not involve vulnerable populations.  Any such project conducted with the intent of further dissemination of results meets the definition of research according to federal and University policy and requires IRB review.

When IRB review is not required, such projects must still communicate applicable elements of informed consent and include appropriate anonymity or confidentiality protections.

Publicly Available Data

Many private organizations and public agencies make individual level data available to the public. Such files fall outside the federal regulations for the protection of human participants, once they have been classified as public use data files. Not all publicly available data, however, has been classified as public use.

To classify files as public use, producers and suppliers of such files are responsible for having the data reviewed by the appropriate IRB before making them available to the public. Information to this effect should be indicated on the documentation supplied with the file.

PIs do not need to obtain IRB approval to use public use data files nor do they need to seek IRB review of the exemption status of the data. Where applicable, such information has already been reviewed for the protection of human participants and the files produced have been certified not to violate confidentiality.

If University PI plans to obtain individually identifiable data (from the sponsor of the public use data file or any other source) and merge with the public use data file, the University investigator must seek IRB approval.

If the public use status cannot be ascertained from the documentation supplied with the file, the University PI must contact the supplier to ascertain the public use status of the data. If this status cannot be ascertained and provided to the PI in writing or if the data are not classifiable as “public use,” then the University PI must submit an application for IRB review. For example, this situation may occur when an investigator receives permission from a PI at another University to use data produced from a research project that is ongoing.

In addition to data files, any published hard copy or electronic documents (including web pages) available to the public that contain individual data (whether identifiable or not identifiable) fall outside federal regulations for the protection of human participants. PIs do not need to obtain IRB approval to use such information nor do they need to seek IRB review of the exemption status of the data.

Responsibilities in Projects

Sponsor Responsibilities in Student Projects:

All student projects must have a University faculty/staff sponsor. For class projects, this is usually the instructor.  The instructor should supervise the student researcher sufficiently to assure the protection of human research participants in accordance with ethical standards of the relevant discipline.

All faculty members or staff who supervises any type of student project using human participants must be trained in accordance with University policy, as do the students involved in the research and any student assistants involved in these projects.

The instructor is responsible for determining whether the proposed study is designed to contribute to generalizable knowledge and is subject to IRB review. If so, the instructor (i.e., faculty sponsor) must assist the student in preparing the application for review.  If in doubt, instructors are always welcome to contact an IRB representative for consultation.

Even though IRB review may not be required for some student projects, these projects must communicate applicable elements of informed consent (e.g., institutional affiliation of researcher, risk, benefit, voluntary participation, permission to withdraw, etc.) and include appropriate anonymity and confidentiality protections.  The sponsoring instructor is both ethically and legally responsible for the protection of participants.

Before conducting research, students must be taught about the ethics of conducting research with human participants.  Instruction should, at a minimum, include information on the purpose of the IRB, the informed consent process, and the principles set forth in the Belmont Report.  The instructor may require the student to complete the training program(s) offered by Saginaw Valley State University and required of other researchers. The IRB advocates that departments use this training program in research methods courses as the mechanism to insure that students have been properly instructed in the protection of human research participants.

The instructor must investigate any problem reported by the student.  If any harm to a subject has occurred, the instructor must report in writing to the IRB immediately and have the student cease research activities until a decision is made regarding continuation of the project.

Student Researcher Responsibilities:

Students must conduct only the activities approved by the instructor.  Activities must be conducted in accordance with the principles set forth in the Belmont Report and University Policy.

Students must report to the instructor any problems that arise regarding human participants.