Human Subjects Research Related


Visitors

Obtaining contact tracing information is not feasible for Human Subjects research. Investigators are responsible for ensuring that subjects receive and sign the compact delineating the expectations for public health protocols, with exceptions made for COVID-19 research.

If an investigator or their team member is notified by their subjects of an illness or COVID positive test after their visit to campus, the investigator will trigger the notification and cleaning protocol for their area.

Approver: Office of Research Administration

  • Human Subjects
Safeguards and Density Limitations for Clinical Research Monitors and Other Related Visitors
  • Clinical trial monitors and auditors must be sponsored and attest to Emory’s safety standards.
  • Visitors to Research Clinics, will be limited, and if deemed appropriate must be sponsored and attest to Emory’s safety standards.

Human Subjects Research

Count of Research Participant Visits

To ensure the university understands the number of human subjects engaged in university research on campus, each research unit will be responsible for retrospectively counting the number of research participant visits in Emory University buildings for the previous month. For example, in the month of November, the count should include the number of research participants in October.

The count should include the number of research visits per month rather than the unique visitors. So if the same person visited campus as part of a research study three times in that month, a +3 count should be added to that building to represent the three visits.

This census will be done through a survey sent to the responsible party as determined by your dean’s (or equivalent) office. For monthly Human Subjects Census report, please contact your dean's office to ensure your subjects are added to the monthly survey.

Attestation Form Required for Research Participants

Human research participants will be required to sign an attestation form, available on Emory IRB's COVID-19 page, denoting adherence to the following:

Non-COVID Research

Emory’s Requirements
  • If you are sick, you are not allowed to work on Emory’s campus. You must stay home until you are well.
  • If anyone in their household has signs or symptoms associated with Covid-19, you are not permitted on campus.
  • If you or anyone in their household has been diagnosed with COVID-19 within the past two weeks, you are not permitted on campus.
  • You must comply with any temperature screening if asked to do so by Emory staff.
  • Face coverings must be worn at all times while on the Emory University campus and must not be disposed of on Emory property.
  • You must practice social distancing by keeping at least six feet of separation between people.
  • If you become ill or test positive for the virus that causes COVID-19, you must notify your Emory investigator. 
Additional Expectations

Please be aware of and follow these best practices:

  • Frequently sanitize or wash your hands with soap and water prior to eating and when arriving on campus.
  • Cover your mouth and nose with a disposable cloth when coughing/sneezing and dispose of the tissue after each use.
  • Avoid touching your eyes, nose, and mouth.
  • Do not shake hands.

Research Study—Monitor and Support

For those persons supporting university research who require on-site monitoring or support to allow initiation or continuance of research, e.g., external monitors and auditors including sponsors, CROs, and federal regulatory authorities, please contact your Emory host and/or PI/research coordinator. The PI/research coordinator and the research visitor will need to comply with the policy process to gain approval to be on campus.

Process for Research Study—Monitors and Support Personnel

This process is a self-contained application process that allows Emory authorized principal investigators and research staff to host external monitors and auditors.

  1. The host (Emory PI or research coordinator) submits an applicationThe application will request information and details about the visitor.
  2. Once submitted, the system will send an invitation for onboarding to the visitor’s email address (it can be non-Emory) that the Emory host provided in the application.
  3. The visitor will log into the application with a special link to perform the onboarding process, including attesting to the required behaviors while on campus, taking a health questionnaire, and other steps as required.
  4. Once submitted by the visitor, the Emory host and the visitor will receive an approval/denial email.

Note: Because this is a self-contained system, the information does not integrate with other applications, such as the contact tracing and other databases. As such, the Emory host needs to ensure they can act as a point of contact with their visitors, if required.