The Protocol Summary Form (PSF) should be amended to indicate that procedures may be conducted remotely in the following sections: Consent Procedures, Study Procedures, Risks and Confidentiality.
The study procedures section of the PSF should include the following Investigator Attestation:
I attest to follow the COVID-19 Safety Guidelines for Columbia Psychiatry and NYSPI Re-Entry outlined in the NYSPI Director's June 1st memo, which include but are not limited to:
- Infection Control/PPE - Guidelines
- Research participants will only come on-site if absolutely necessary for study procedures.
- Clinical research teams will screen their participants for COVID symptoms (night before and day of onsite visit, documenting this in the chart), and escort them in and out of the building.
- COVID/COVID-like symptoms of participants will the be reported to the IRB via PRISM as an SAE.
The Consent Procedures section of the PSF should include that the risks of travel for in-person visits during covid-19 will be discussed during the consent discussion AND a consent procedure note should include this.
Some suggested language for the consent discussion: "You should exercise caution when traveling in public and follow public health guidelines, such as wearing masks in public and avoiding crowds. It is important for you to stay informed about public health recommendations and guidelines regarding COVID-19, such as those issued by the Centers for Disease Control (CDC.gov) and local government guidelines and directives. If you have any questions about how you will travel for appointments, or do not feel safe traveling, please let us know, and know that you can call to reschedule visits."
The Consent Form (CF) should be revised to state, "Some of your visits may be conducted remotely using the telephone or HIPPA-compliant video teleconferencing."
It is important to document consent for remote clinical or research procedures, and the consent discussion process should include discussion of the technology HIPAA-compliant platforms to be used and any concerns the patient may have, such as access to private space in which to take calls, or accessibility--access at home to adequate devices, cell signal, or wifi.
The NYSPI Remote Communication Guidelines should be referenced to ensure compliance with the approved platforms and processes for remote procedures. The Confidentiality sections of the PSF and CF should reference the ways confidentiality is protected (e.g., HIPAA-compliant videoconferencing and web-based platforms, encrypted email communications, etc.).