CLINICAL RESEARCH. Sahlgrenska University Hospital’s management group has recently decided that the hospital will resume research studies that include patients. “We need to resume other research than just studies related to COVID-19 to allow us to advance medical care with the help of our research studies,” says Caterina Finizia, director of research, education, development and innovation.
Sahlgrenska University Hospital’s management group has decided that other studies than COVID-19 studies that include patients may resume from 10 August. At that point, nearly five months will have passed without research with patient participation. Because of the pandemic, there are some limitations in the decision about what studies may resume and how patients will be included.
The following applies:
- Operations managers decide whether patients can be included in a study and which studies are allowed to do so.
- No healthy volunteers may be included.
- During the period August 10–31, studies are prioritized with patients that come to the hospital for reasons other than only inclusion in the study.
What is required to be allowed to include patients in a research study?
- The study has to be about patients and their treatment or follow-up.
- The head of research has to be able to show access to staff who are not needed in the medical care system.
- Protective equipment required for the study is to be available to such an extent that the medical care system’s needs for protective equipment are always ensured.
- Follow-up appointments should, if possible, be replaced with phone calls or video meetings to reduce the risk of infection for the patients.
Considerations for ensuring safe study inclusion:
- Study staff are to be free of symptoms and healthy.
- Patients with symptoms are to stay home and not visit the hospital, in accordance with current recommendations.
- At meetings, a distance of about 1.5 meters is to be maintained.
- For measurements and tests where it is not possible to maintain a distance of about 1.5 meters, study staff are to wear gloves, a mask, and eyeglasses (or a visor).
- In procedures where aerosols may form, study staff are to wear full protective equipment, that is to say, masks that can withstand fluids, visor, protective clothing and gloves.
- Clean between meeting patients – pens for signatures, seating surfaces and table surfaces are to be cleaned according to relevant recommendations.
Because of the pandemic, closed entrances, and visitor restrictions, it has only been possible to conduct COVID-19 research and studies without patient participation since mid March. No healthy volunteers have been permitted to come to the hospital, and patients have only been able to come for their care. Since we do not know how the pandemic will develop in the coming months, these routines apply provisionally until October 31, when new decisions about priorities for research studies will be made.
TEXT: SAHLGRENSKA UNIVERSITY HOSPITAL/SAHLGRENSKA ACADEMY