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Research in Response to COVID-19

  • Stanford Research Recovery Handbook -  Includes updates on Stage 3 Clinical Human Subjects Research and Non-Clinical Human Subjects Research

  • newUpdate on Clinical and Non-Clinical Human Subject ResearchCOVID-related standard operating procedures (SOPs) are no longer needed for domestic clinical and non-clinical human subjects research projects that have an IRB-approved requirement for participants to be fully vaccinated or receive a negative COVID test within 72 hours before the research is conducted. Otherwise, SOPs continue to be necessary. Given the large number of protocols to be modified, the IRB can only make these changes at the point of the annual renewal of your eProtocol or when you are submitting an unrelated modification. 

The same policies and procedures apply to human subjects research requiring domestic travel. A separate approval for international travel and international human subjects field research remains in effect until further notice. SOPs can be found in the research recovery handbook for clinicalnon-clinical, and non-clinical off-campus human subjects research. Local departments will have full discretion to approve the SOPs.

Consent LanguageIf you are coming in-person to research visits, you are required to be fully vaccinated—2 doses (1 for Johnson and Johnson), 2 weeks out and to provide proof of your vaccination (e.g., CDC COVID-19 Vaccination Card, e-Health record, etc.) to the researcher prior to study participation.  Alternately, you can provide a negative COVID test within 72 hours of your visit. 

  • Consent Forms of all Studies involving COVID-19 Research -  The following language must be included:

Due to the coronavirus public health emergency, the federal government has issued a Declaration that may limit your right to sue if you are injured or harmed while participating in this COVID-19 study. If the Declaration applies, it limits your right to sue researchers, healthcare providers, any study sponsor, manufacturer, distributor or any other official involved with the study. However, the federal government has a program that may provide compensation to you or your family if you experience serious physical injuries or death. To find out more about this “Countermeasures Injury Compensation Program” please go to https://www.hrsa.gov/cicp/about/index.html or call 1-855-266-2427.

  • COVID-19 Clinical Research Review Panel

Researchers considering any COVID-19 clinical research, including studies that require Institutional Review Board (IRB) approval as well as quality improvement projects, are required to complete a short survey at COVID-19 Clinical Research Review. For more information, click here.

ADDITIONAL COVID RESOURCES

Quick links for researchers

Getting started

Consent Templates, Forms, eProtocol attachments

FAQs

Basics | Training | Protocol Management | Single IRB | Genomic Data Sharing | Cadavers or Deceased Individuals | Certificate of Confidentiality | GDPR | Other/Special Circumstances