application of section 980 of Reference (g); it does not affect the application of part 219 of Reference (c). This definition does not include activities that are not considered research involving human subjects, activities that meet the exemption criteria at section 219.101(b) of Reference (c), and research involving the collection or study of existing data, documents, records, or specimens from living individuals.

research monitor. Individuals with expertise consonant with the nature of risk(s) identified within the research protocol, whose role is to protect the safety and well-being of human subjects.

secretarial designee program. Defined in section 108.3 of Reference (c).

serious noncompliance. Failure of a person, group, or institution to act in accordance with this Instruction and its references such that the failure could adversely affect the rights, safety, or welfare of a human subject; place a human subject at increased risk of harm; cause harm to a human subject; affect a human subject’s willingness to participate in research; or damage or compromise the scientific integrity of research data.

UPIRTSO. Any incident, experience, or outcome that meets ALL three of the following conditions:

Is unexpected (in terms of nature, severity, or frequency) given the procedures described in the research protocol documents (e.g., the IRB-approved research protocol and informed consent document) and the characteristics of the human subject population being studied.

Is related or possibly related to participation in the research (in this Instruction, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research).

Suggests that the research places human subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, even if no harm has actually occurred.

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