Research with human subjects is governed by rules and protections established by the Office for Human Research Protections (OHRP). The OHRP website provides information about a variety of topics related to human subjects protections, and should be considered the ultimate source of this information since all other materials prepared on these topics need to adhere to OHRP governance.
Institutional Review Boards (IRBs)
Under most circumstances, research conducted with human subjects will need to be reviewed and approved by an IRB before data can be collected. Some projects that are of limited scope and will be used only for program evaluation purposes without dissemination of findings may not be subject to review. Nonetheless, it is important that MIG researchers explore the requirements of their agency and consider whether the nature of the planned research deems it necessary for review. Each research project should work with its own IRB to meet requirements, but the following IRB handbook provides some information about the IRB process and guidelines for developing materials that meet requirements for the ethical treatment of human subjects.
Informed Consent Materials
Ethical protections of human subjects require that individuals involved in research studies should be aware of all aspects of the project and be able to make an informed decision about whether or not to participate. Formal instructions for content required when developing
informed consent materials can be found on the OHRP website. Examples of documents developed by states for obtaining informed consent are provided below.
Release of Information (ROI)
In addition to, or in place of, data collected directly for a research project, researchers may choose to utilize data that already exists in adminstrative records, such as earnings data in Unemployment Insurance (UI) records or health care utilization data in Medicaid records. Accessing these data may require the signed approval of research participants. Examples of documents developed by states for release of information are provided below.
Data Use Agreements (DUAs)
Research conducted using existing administrative data may not only require the signed consent of the research participants, but also a formal agreement between the agencies that will transfer and use the data. A
tip sheet on building data sharing infrastructure, developed by MIG researchers, provides guidelines on establishing data sharing agreements and useful types and sources of data for evaluating MIG projects. In addition, a
template for developing a data sharing agreement describes the necessary elements of a DUA. Examples of agreements developed by states for sharing data between agencies are provided below.