IRB Policies and NIH FAQs(Section 9)
1.1 The Office of Human Research Protection’s (OHRP) website offers a comprehensive list of -The topics include informed consent, the common rule, research with children, and investigator responsibilities.
1.2 KSU Policies
Policy on Compensating Research Subjects
Policy on Principal Investigator
Policy on Research Involving PHI
Policy on Students as Research Subjects
Policy on Non-compliant Events
Human Subjects Protection Program
1.3 IRB review of publicly available datasets:
- The IRB requires the review of publicly available data sets to ensure there is no intent to re-identify de-identified information, to help meet the terms of an agreement, including agreements related to restricted datasets, to support a grant proposal, and to ensure the request meets the criteria for exempt/level I review and any other supplemental regulations that may exist such as those related to FERPA and HIPAA.
- See exempt (level I), category 4i.
- The IRB cannot provide retroactive review or determination.
- What is meant by "public."
- “Publicly available” is defined as information shared without conditions on use. Datasets requiring a data use agreement are not “publicly available.” Per , publicly available “can apply to secondary research use of archives in a public library, for example, or to government or other institutional records where public access is provided on request, or from a commercial entity if the information is provided to members of the public on request or if the only requirement for obtaining the information is paying a user fee, registering or signing in as a visitor to an archive. It would also apply if a commercial entity made identifiable biospecimens publicly available to anyone on request or for a fee.”
- Datasets that must go through expedited review: research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes ().