The informed consent process is one of the primary ethical requirements when conducting research with human participants; it reflects the basic principle of respect for persons. Obtaining informed consent seeks to ensure that potential participants will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. The elements of informed consent are mandated in the regulations at 45 CFR 46.116, 38 CFR 16.116, and 21 CFR 50.25. 

The IRB recognizes that the uses of deception or incomplete disclosure in research are valuable research techniques.  However, the use of such techniques raises special issues that the IRB will review closely.  Deception occurs when subjects are deliberately given false information about some aspect of the research.  Incomplete disclosure occurs when subjects are not given information about the real purpose or the nature of the research. 

The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Individuals in these groups may be considered potentially vulnerable because they may not be able to make informed decisions for themselves, they may be in situations in which they can easily be manipulated, or they may be a convenient and readily available study population.

Minimizing harm to subjects is a core consideration when designing human subjects research, and being mindful in how you ask about your participants’ sex and gender is an important consideration in doing so.  Guidance is based on current best practices and intended to help researchers collect accurate and representative data while respecting their subjects’ needs. 

Please see the Resources/Further Readings section for links to more details, terminological definitions, examples, primary research, and further justifications.

The IRB holds the faculty advisor(s) responsible for the overall management of an approved research protocol in conjunction with the student PI.

Responsibilities apply to faculty supervising students as a Principal Investigator (PI).

The IRB holds all research personnel responsible for meeting certain obligations. Research personnel includes Principal Investigators (PI), Co-Investigators (Co-I), Coordinators, and Research Assistants (RA) who are eighter students, faculty, or staff involved in the research protocol.

Researchers external to Swarthmore College wishing to conduct research on Swarthmore faculty, staff, and/ or students must secure permission prior to initiating any research with the Swarthmore community. 

Refer to the glossary for definitions and descriptions of key terms and processes.