Pandemic guidelines on research projects within Psychiatry, North Denmark Region

Psychiatry in North Denmark Region observes both the existing national authority guidelines and the regional guidelines/news. Moreover, Psychiatry publishes instructions and guidelines on its intranet.

Besides participating in regional COVID-19 meetings, Psychiatry has its own task force consisting of Psychiatry Management, heads of clinics, assistant heads of clinics and head of technical services. The research units do also participate/are kept informed.

The group ensures that the contingency plans are constantly updated in accordance with the authority guidelines.

There are different phases of preparedness when it comes to clinical treatment:

A1: Ordinary activity.

A2: Ordinary operation in consideration of limiting risk of infection.

B1: Partial reorganization of elective activity.

B2: Partial restriction/cancellation of elective activity.

C1: Widespread cancellation of elective activity. Early discharge of patients. Only referral of patients in acute states.

C2: Cancellation of all elective activity. Discharge of almost all patients who are not admitted to intensive wards. Merger of various operations.

D: Cancellation of everything which is not or could not be part of regulations in the Psychiatry Act about use of coercion or forensic treatment.

When it comes to research projects, we distinguish between various types of clinical projects. This distinction is part of the evaluation of the study performance according to the existing preparedness level.

  1. Patients in intervention research where presence is necessary for the intervention. This applies to e.g. studies where the patient has been tapered off in medicine or in case of follow-up. These situations have been considered as being “critical” to the patient and will be executed to the extent possible.

  2. Patients who in connection with their presence in the clinic (according to medical specialist opinion) participate in projects and have to fill out questionnaires in connection with visit.

  3. Sessions and examinations exclusively conditional on research projects which are not in connection with visits to clinics.

Any pause/discontinuation of a project because of escalation in the preparedness levels must agreed with the responsible head of clinic/head of department. Depending on the circumstances (urgency), the discontinuation/pause is agreed upon with the sponsor, or information is sent to the sponsor afterwards.

The sponsor is informed about specific guidelines, e.g. the use of face mask.