Glossary | Human Research Protections

Key Information Section:

A section of the informed consent document that presents a concise and focused presentation of key information of the study to assist prospective subjects in understanding reasons to enroll in a protocol or not.

The regulatory preamble lists 5 items that would generally be considered key information (but are not explicitly required as such by the regulations):

that consent is being sought for research and that participation is voluntary;
the purposes of the research, the expected duration of the prospective subject’s participation, and the procedures to be followed in the research
the reasonably foreseeable risks or discomforts to the prospective subject;
the benefits to the prospective subject or to others that may reasonably be expected from the research; and
appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject.

Key Personnel:

Key Personnel are the individuals who have access to Protected Health Information (PHI) and generate data either through direct interactions with subjects or through access to their medical records. Key Personnel and their study roles must be listed on an IRB submission.