Any untoward or unfavorable physical and psychological harms that a human participant experiences, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or disease, occurring simultaneously with (whether or not related to) research participation. Although they occur primarily within biomedical research, they may occur in social and behavioral research.
When an organization/institution's employees or affiliates conduct (non-exempt) research projects obtaining (1) data about research participants through intervention or interaction; (2) identifiable private information about research participants; (3) informed consent research participants; or (4) when the institution receives a direct federal award to conduct human participant research, even when subcontractors (employees or agents of another institution) carry out all research activities.
The primary researcher who assumes responsibility to protect research participants. Seattle University recognizes the importance of active research experience for its students, and thus permits students to serve as primary investigators. However, in these cases, the faculty adviser remains ethically and legally responsible for all research activities, and must provide appropriate oversight to ensure the ethical conduct of all aspects of the project, even if determined to be "exempt."
When the proposed study does not involve risks/harm greater (in magnitude or likelihood) than those normally encountered in daily life or during routine physical or psychological examinations or tests.
Examples include, but are not limited to: information about sexual attitudes, preferences, practices; the use of alcohol, drugs, or other addictive products; information that could damage an individual’s financial standing, employability, or reputation within the community; information in a participant’s medical record that could lead to social stigmatization or discrimination; information about a participant’s psychological well-being or mental health; and/or other records, such as medical, academic, photographic, audio tapes, and videotapes. NOTE: According to Federal regulations, "sensitive" means that -- if disclosed and linked to the participant -- data could potentially cause economic, social, psychological, or other harm, or put the participant at risk for criminal or civil liability.
Any untoward or unfavorable physical and psychological harms that a human participant experiences, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or disease, occurring simultaneously with (whether or not related to) research participation. Although they occur primarily within biomedical research, they may occur in social and behavioral research.
When an organization/institution's employees or affiliates conduct (non-exempt) research projects obtaining (1) data about research participants through intervention or interaction; (2) identifiable private information about research participants; (3) informed consent research participants; or (4) when the institution receives a direct federal award to conduct human participant research, even when subcontractors (employees or agents of another institution) carry out all research activities.
The word "subject" implies a hierarchical relationship between the researcher and those enrolled in the study. Although individuals may not "participate" in the research design, they nevertheless participate in the study, and the term recognizes their sense of agency vs. being acted upon. Read more about language choices and Conducting Ethical and Inclusive Research.
Withholding key information or providing inaccurate information about a study, for purposes of not influencing participants or generating certain research conditions. Current practices in human participant research strongly advise against these methodologies. Read more information about these methods here.
The primary researcher who assumes responsibility to protect research participants. Seattle University recognizes the importance of active research experience for its students, and thus permits students to serve as primary investigators. However, in these cases, the faculty adviser remains ethically and legally responsible for all research activities, and must provide appropriate oversight to ensure the ethical conduct of all aspects of the project, even if determined to be "exempt."
When the proposed study does not involve risks/harm greater (in magnitude or likelihood) than those normally encountered in daily life or during routine physical or psychological examinations or tests.