Secondary research refers to research with existing datasets for which individual consent is not required. It must meet one of the following criteria:
- Identifiable private information or identifiable biospecimens are publicly available.
- Information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly; the investigator does not contact the subjects, and will not re-identify the subjects.
- Research involves only information collection and analysis involving identifiable health information that is regulated as “health care operations” or “public health activities or purposes” (This condition is unlikely to apply to research conducted at Bates; if you are conducting research in a health care facility, please refer to that institution’s IRB for guidance as to the applicability or not of this condition.)
- IF the research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, AND IF the research will generate identifiable private information, AND such information will be maintained on information technology that is subject to and in compliance with statutory Federal electronic privacy standards. (Any agreement with a Federal agency requiring adherence to these standards must be pre-approved by Sponsored Programs and Research Compliance and Information and Library Services.)
The first two conditions are most likely to apply to research at Bates. Adherence to the second is recommended whenever possible. Such secondary research is EXEMPT from IRB review. If you are certain that one of the above conditions describes your research, please retain this information for your records to share as needed with the Office of Sponsored Programs and Research Compliance, or authorized representatives of your sponsoring agency.