Research Involving Human Subjects
The Smithsonian Tropical Research Institute fosters an environment where research involving human subjects complies with applicable Panamanian laws, US federal laws, regulations and ethical principles, so that the rights and welfare of human subjects involved in research are protected. We acknowledge and accept the responsibility to minimize risks to human research subjects and ensure that their participation is based on informed consent.
In compliance with Smithsonian Directive 606 “Research Involving Human Subjects” all Smithsonian Institution Employees and Affiliated Persons (Visiting researchers, scientists, scholars, students, volunteers, interns, and fellows) whose research and collecting activities involves human subjects MUST demonstrate current training in human research protections and prepare protocol applications prior to beginning research data collection from human subjects. The rights and welfare of human subjects involved in research must be respected and protected.
Certification in the protection of human subjects in research is required for project investigators, persons who have contact with subjects or access to their personally identifiable information, and staff "sponsors" for SI-affiliated investigators. The certification requirement can be met through online courses of the Collaborative Institutional Training Initiative (CTI) or the National Institutes of Health (NIH), Office of Human Subjects Research (OHR).
Projects involving surveys, interviews, focus groups, observations of public behavior, such as visitor tracking, or testing of an individual’s bodily tissue or behavior, in which the results are not for internal Smithsonian use only, may meet the definition of human subject research, and may be subject to Smithsonian Directive 606.
NOTE: Your home university/institution protocol IS NOT sufficient to meet Smithsonian Institution requirements, as there are STRI-specific issues that must be addressed locally.
To apply for Smithsonian approval of your research and collecting activities involving Human Subjects, you MUST include the following in your application package:
- Application Form for Review of Human Subject Research (OSP-HS-01) duly completed in English.
NOTE: Signatures are required on the last page, including signature of Smithsonian “sponsor” and STRI Director.
- For each member of the personnel included in the Application Form for Review of Human Subject Research (OSP-HS-01) (Item 1 above) you MUST include in your permit application package the Certification of training in the protection of human subjects in research.
- OSP-HS-05 Waiver of Consent duly completed
- A one-page study summary, any survey instruments, interview guides, recruitment notices, emails or letters.
- The protocol and approval information from your home institution, if applicable.
- If you have an approved Human Subject Research protocol in need of annual review for continuing renewal, you MUST submit the Application Form for Protocol Renewal and/or Progress Reports (OSP-HS-02) duly completed in English.
- If you have an approved Human Subject Research protocol but need to make changes in personnel, methodology or research site, you MUST include in your permit application package:
- Documents outlined in points #1 and #2 above, duly completed in English. Changes to procedures or instruments should be clearly marked in the amended application.
- If your human subject project is ending, you MUST submit the Final Report for Human Subject Research Protocol (OSP-HS-03) to summarize the results of the project and close out the protocol.
- Sample Consent Document customized according to your project specifics. Prepare in English for review by the IRB.
Note: Must also be prepared in Spanish to be used in the Republic of Panama. Submit both.
- As soon as the Principal Investigator is aware of serious adverse events, unanticipated problems involving increased risk to subjects, protocol deviations or 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).
For additional information please check:
Please contact Susan Askren, Compliance Officer, firstname.lastname@example.org for information or assistance with forms.
NOTE: We recommend submission of your application Form for Review of Human Subject Research four-weeks prior to the desired submission of your project to STRI.
The Government of Panama may have additional requirements to conduct Research Involving Human Subjects.