ARCHIVED: Requirements for working with research data collected from human subjects

Indiana University's Human Research Protection Program (HRPP) policies list the requirements for conducting human subjects research at IU.

The IU Human Subjects Office and campus Institutional Review Boards (IRBs) are charged with protecting the rights and welfare of human research participants recruited to participate in research conducted under the auspices of IU. The campus IRBs are responsible for reviewing and approving all research involving human subjects at IU, and for ensuring that IU researchers comply with all federal and state regulations and university policies governing the collection and use of research data collected from human subjects.

For information about federal and state regulations, IU policies, and requirements and responsibilities associated with research involving human subjects, see Guidance on the conduct of human subjects research.

New studies submitted for IRB review must include data management plans that include provisions for protecting the privacy of human subjects and maintaining the confidentiality of collected data. Principal investigators also must implement data retention, storage, and disposal protocols that protect the confidentiality of their human subjects while enabling reviews of their data by funding agencies supporting their projects and other researchers seeking to reproduce and test their findings. For additional guidance, see the following IU Human Subjects & Institutional Review Boards pages:

• HIPAA
• Data Safety