Research Involving Human Subjects
- 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.
- Smithsonian Institution Federal-wide Assurance of Compliance
Any institution that performs research using human subjects must submit a Federal wide Assurance to this US Department of Health and Human Services, Office for Human Research Protections. The Smithsonian FWA evidences our commitment to comply with federal standards for the protection of human subjects in research.
- U.S. Department of Health and Human Services (DHHS) Code of Federal Regulations (Common Rule) Title 45 (Public Welfare), Part 46 (Protection of Human Subjects), click here.
- The Belmont Report: In addition to complying with the Common Rule as stated in the Code of Federal Regulations, Title 45, part 46, the Smithsonian is committed to following the principles set forth in the Belmont Report.
In addition to complying with the above ethical standards, researchers may wish to review the following for additional guidance:
- 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 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
- Exempt Research. SD 606 described categories of research that are exempt from the requirements of the regulations. Many simple survey and interview studies may be considered exempt, if they meet the requirements of the policy. However, the IRB must make the determination that the project is exempt. If you believe your project is exempt, you must complete the Application Form for Review of Human Subjects Research and submit it for IRB review along with any survey documents or interview guides.
- Expedited Review. IRB review for projects involving no more than minimal risk may be reviewed by expedited review. Depending on the content of the project and whether or not there are modifications requested by the reviewer, this can take one to two weeks.
- Full Convened IRB Review. Projects involving more than minimal risk to subjects must be reviewed by the convened IRB. Please allow at least one month prior to your desired start date for IRB review if your project may involve any deception, psychological or emotional upset or distress, or legal or financial risk to subjects as a consequence of their participation in the project.
- Adverse Events. Any adverse events that occur during Human Subject Research must be immediately reported to the IRB.
- Changes in Project or Personnel. Submit the Application Form for Renewal of Human Subjects Research and/or Changes in Project Personnel for personnel changes. 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.
- Continuing Review Procedures
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.
- If you have completed the project, an email reply informing us of this fact will suffice.
- If you are still conducting the research, you must submit a Progress Report for Review of Human Subject Research. 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.
- The Progress Report must be submitted before the expiration date of the approved protocol. If the protocol is allowed to expire, all research under it must stop, until a new protocol can be reviewed and approved by the IRB.
Application Form for Review of Human Subject Research
This form is to be used by all PIs intending to use human subjects in their research, and by PIs making protocol changes to approved projects.
Application Form for Renewal of Human Subjects Research and/or Changes in Project Personnel
This form is to be used when a human subjects project is in need of annual review or when there is a personnel change which needs to take place during an ongoing human subjects research project.
Request for Determination of a Non-Human Subjects Research Project
This form is to be used when a project may or may not meet the definition of “human subject research.”
Institutional Review Board Adverse Affects Form
The Adverse Affects Reporting Form is to be used by any PI who needs to report and adverse affect during the course of their research.
Progress Report for Review of Human Subjects Research
This Form is used by any PI who needs to submit a progress report to the IRB in order to continue an ongoing human subjects research project previously approved.
- Collaborative Institutional Training Initiative (CITI)
- National Institutes of Health (NIH), Office of Human Subjects Research (OHSR) Training
- Smithsonian Office of Sponsored Projects (OSP)
Resources for Researchers (Back to Top)
- OSP Human subjects contacts:
- Karen Elliott Otiji, Assistant Director for Grant Management, (202) 633-7111, firstname.lastname@example.org
- Susan Askren, Compliance Officer,