Is it Research? (cont.)

Is secondary analysis of data considered "human subject" research?

Much research in the social/behavioral sciences deals with the re-analysis of data. Such research is referred to as "secondary analysis". Remember that the goals of the Common Rule apply to any person who has the potential to be harmed because of a research project, whether or not the person is directly interviewed or identified through data collected by another researcher for a different purpose. Some data files are normally stripped of identifiable private information or "de-identified". Research that involves the secondary-analysis of de-identified data is exempt or not considered human subject research since no identifiable human subjects are involved.

When identifiers are included in the data, several issues should be considered:

• The research project should be assessed for the likelihood that identified respondents could be harmed. If the project is low risk then no special oversight is required. If the data has no identifiers, then no "human subjects" are involved.
• The project information should be kept confidential; the level of confidentiality commensurate with the level of risk applicable to all identified persons.
• The regulations do not necessesarily mandate informed consent from identified persons in secondary data sets. If the potential risk is serious and not ameliorated by confidentiality procedures, then consent may be necessary. Medical records would be subject to additional regulations.