What Needs to be Reviewed

What Needs to Be Reviewed

It is the task of the Institutional Review Board (IRB) to review research proposals to ensure that federal guidelines for protection of human subjects are followed. "Research" is here defined according to the U. S. Office for Human Research Protections (OHRP) as "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge," While a "human subject" is defined as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."

Human subjects research defined in this way covers a lot of work done in the social sciences, but also in the natural sciences and the humanities, and in some administrative offices. It usually applies to the direct collection of new data from individuals, through surveys, interviews, or experiments, but in some cases it also applies to new uses of pre-existing databases containing information gathered from human subjects in the past. In either case, researchers must follow specific regulations and procedures to ensure adequate protection.

Faculty, staff, and student research that involves human subjects — whether carried out at Swarthmore or anywhere else — must receive IRB approval before it begins. This is the case regardless of whether or not a project receives extramural funding. If the research is co-sponsored by another institution, Swarthmore's IRB may decide to accept that institution's IRB approval as adequate, but researchers should not assume that simply because a project has IRB approval from somewhere else it does not need review by Swarthmore's IRB. For international projects, the researcher must also comply with applicable local rules, including local laws and regulations and the requirements of a hosting institution such as a local university (see the OHRP website for more information on these issues).

Student Research (including Summer Research Opportunities)

Students must receive IRB approval for research involving human subjects if they have responsibility for the project in their capacity as a Swarthmore student. IRB approval is necessary regardless of the location of the project and regardless of whether or not the project involves the student earning academic credit.

Student research that involves human subjects — whether carried out at Swarthmore or carried out elsewhere but supported by funds provided by Swarthmore — must also be sponsored by a Swarthmore faculty member. The sponsor must review and sign a student's IRB application before it is submitted to the IRB. In signing, the faculty member takes responsibility for a proposal being ready for the committee's attention, for monitoring the conduct of the research, and for assuring that ethical procedures are followed.

Class Exercises and Service Projects

IRB review is not required for pure learning exercises (e.g. in research methodology classes) that do not lead to any kind of publication or publicly accessible material. Such exercises/projects should however be carefully monitored by the instructor to ensure that they provide adequate protection of any human subjects involved. Furthermore, learning activities that involve subjects outside the course may be subject to review if funded by the U.S. Government or if requested by the Dean of Students at Swarthmore College.

IRB approval is also not required for social service projects (such as the provision of counseling, tutoring services, or arts or drama training or experiences), even if these projects engage human participants. Such service projects may include internal evaluations that involve focus groups or surveys of the participants. As long as these assessments are intended only to provide information for assessing or improving the program and not to produce generalizable knowledge, they do not meet the definition of research as defined in the federal code (see above). As with learning exercises, standards of ethical conduct still apply even though these projects do not require IRB review.

Research at Swarthmore Conducted by Outsiders

If researchers outside the College propose to interview, observe, or conduct experiments on Swarthmore community members, or administer questionnaires other than by mail, they must request permission from the Dean's office. The Dean then authorizes the Subcommittee for the Protection of Human Subjects to review the proposed project. The Subcommittee sends the results of its review to the Dean for use in his or her decision to grant permission for the study.

As a general matter the Subcommittee on Protection of Human Subjects does not deal with questionnaires sent through the mail as the College is not responsible for the content of mailings (anyone has the right to send a student a questionnaire in the mail.) The Committee does, however, deal with cases in which human subjects are interviewed at the College and cases in which funding for the project is provided by the U.S. Government or its agencies. (i.e. approval is required as part of the application process). The Committee also handles cases in which human subjects are surveyed via the internet.