Research Involving Human Subjects

What is research with human subjects?

In the Common Rule (45 CFR 46) and in SD 606, human subject research is defined as an activity for which both of the following are true:

  • Research - A systematic investigation, including study, development, testing and evaluation, designed to contribute to generalized knowledge.
  • Human subject - A living individual about whom an investigator conducting research
    • (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
    • (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

    Policy

    The Smithsonian Institution is covered by FWA00007183. Our Institutional Review Board is registered with the Office of Human Research Protections as IORG 0005809, IRB 00007004.

    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.

    Procedures

    Institutional Review Board (IRB) Procedures

    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 request the Application form for Review of Human Subjects Research from the IRB office (see below), and return it 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. Contact the IRB office (see below) and request assistance.

    Renewal or Progress Report Submission - Continuing Review is only required for projects that were approved by Full Committee Review. You will be contacted by the IRB office about a month in advance of approval expiration, and asked to submit a renewal application. 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 (completed within the last two years) 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 as an amendment request, and may not be implemented until approval is given by the IRB.

    Closing a Protocol - If you have completed the project, you must submit a final report. Contact the IRB Office (below) and request the Final Report form.

    Training

    Collaborative Institutional Training Initiative (CITI)
    CITI Main Website

    Contacts

    Institutional Review Board (IRB) Office contact:

    Susan Askren, Research Compliance Officer,
    (202) 633-7118, OSPCompliance@si.edu