Smithsonian Directive 606 “Research Involving Human Subjects”
The purpose of this SD is to ensure that all Smithsonian research activities involving human subjects comply with applicable laws, regulations, and ethical principles. The SD defines the Smithsonian’s policies, procedures and institutional officials in regard to conducting human subjects research.
The IRB reviews all protocols for research involving Human Subjects and has authority to approve or disapprove the research. The IRB is also responsible for ongoing compliance with SD 606. Investigators are not permitted to conduct research involving Human Subjects until the IRB has reviewed their protocols.
Please submit the Application form for Review of Human Subjects Research to OSPCompliance@si.edu, along with any survey instruments, interview guides, informed consent documents or other relevant materials, at least two to four weeks prior to your desired start date
Continuing Review Procedures
Adverse Events Any adverse events that occur during Human Subject Research must be immediately reported to the IRB.
Renewal or Progress Report Submisison. Submit the Application Form for Protocol Renewal and/or Progress Reports. Once your project has been approved, the approval is in effect for one year. About one month prior to the expiration of your approval, the IRB will send you a reminder, requesting an update. In order to change an approved Protocol, an Progress Report must be submitted. The Progress Report should describe how many subjects have been enrolled to date, how many will be recruited in the upcoming year, whether there were any unexpected occurrences or outcomes, will there be any new personnel working on the project and so forth. All personnel working with human subjects must have training certification on file with OSP. Changes to the conduct of the project (new survey instruments or changes in procedures, for example) must be submitted to the IRB using the Application Form for Review of Human Subject Research.
"When the Principal Investigator becomes aware of serious adverse events, unanticipated problems involving increased risk to subjects, protocol deviations, non-compliance, or subject complaints he/she MUST report them to the Institution Review Board (IRB) using the following form Problem Reporting Form (OSP-HS-09)"
Closing a Protocol.If you have completed the project, you must submit a final report.