Categoriser

Assistent zur Kategorisierung von Humanforschungsprojekten

Das Schweizerische Humanforschungsgesetz unterscheidet verschiedene Klassifizierungen für Humanforschungsprojekte. Die Klassifizierung entscheidet, welches Bewilligungsverfahren ein Projekt durchlaufen muss und welche behördlichen Auflagen erfüllt werden müssen.

Der Categoriser hilft Ihnen, das geplante Projekt zu klassifizieren und unterstützt Sie so bei der Vorbereitung der Gesuchseingabe. Sie werden durch einen Fragebaum geführt und erhalten am Schluss eine unverbindliche Klassifizierung Ihres Forschungsprojekts. Zu jeder Frage können Sie Zusatzinformationen in Form von Erklärungstexten, Beispielstudien oder Glossarbegriffen aufrufen.

Anwendbarkeit HFG

Fällt das Forschungsprojekt in den Geltungsbereich des Humanforschungsgesetzes?



Erklärung

Der Geltungsbereich des Humanforschungsgesetzes umfasst sämtliche Forschung zu Krankheiten des Menschen sowie zu Aufbau und Funktion des menschlichen Körpers mit Personen, an Verstorbenen, Embryonen und Föten, mit biologischem Material oder mit gesundheitsbezogenen Daten. Nicht in den Geltungsbereich des Gesetzes fällt die Forschung an Embryonen in vitro und die Forschung mit anonymisiertem biologischem Material oder anonym erhobenen und anonymisierten gesundheitsbezogenen Daten. Forschung bezeichnet die methodengeleitete Suche nach verallgemeinerbaren Erkenntnissen. Forschung zu Krankheiten des Menschen umfasst die Suche nach Ursachen Prävention, Diagnose, Therapie und Epidemiologie von physischen und psychischen Beeinträchtigungen der Gesundheit des Menschen. Unter Forschung zu Aufbau und Funktion des menschlichen Körpers ist Grundlagenforschung, insbesondere zur Anatomie, Physiologie und Genetik des menschlichen Körpers sowie nicht auf Krankheiten bezogene Forschung zu Eingriffen und Einwirkungen auf den menschlichen Körper zu verstehen.

Beispielstudien

Antwort: YES
Studientitel: Physical activity and energy expenditure across occupational categories

Background:

Physical activity is defined as bodily movements produced by skeletal muscles that result in energy expenditure. This study measured the amount of physical activity, based energy expenditure and other performance criteria that people use during a normal working day. The study focused on differences between occupational categories. The results of this study were used to develope a campaign to prevent sedentary behaviour.

Methods:

300 healthy adults (aged 18-65 years), employed full-time in Canton Basel in Switzerland, were enrolled in the study. Participants were stratified by occupational category according to the ISCO-88, and were then grouped into 3 classes (low, middle and high occupational activity). Data on duration of average daily activity, total and active energy expenditure, and daily step counts were collected over 7 consecutive days, using a Sense Wear Mini bracelet (no CE-marking). Participants were asked to wear the Sense Wear Mini bracelet during working hours. The primary outcome was difference in average daily active energy expenditure during working time between the occupational categories.

Because:

This project was based on a study protocol that defines the exact procedures to be used. It included a relatively large number of persons and was not based on individual cases ("method-driven search for generalizable knowledge", defined as research by HRA). 300 healthy adults ("persons") employed full-time employed Canton Basel, Switzerland, were asked to register their energy expenditure during working time by wearing a Sense Wear Mini bracelet (no CE-marking). The investigator measured the difference in average daily active energy expenditure during working hours for the different occupational categories, defined according to ISCO-88 ("research concerning the structure and function of the human body").

Antwort: YES
Studientitel: Randomized controlled trial in adults with headache recurrence after emergency department discharge, comparing the efficacy of oral sumatriptan to naproxen

Background:

Migraine and other acute primary headaches are treated with a variety of parenteral medications in the emergency department. It is not clear which medication is best to prescribe to primary headache patients when they are discharged. This study compared the efficacy of oral sumatriptan to naproxen for treatment of post-ED recurrent primary headache.

Methods:

Adults aged 18 years or older who suffered from headache recurrence after discharge from an emergency department were randomized to either naproxen (Trade®) 500 mg or sumatriptan (Sumatriptan Spirig HC®) 100 mg. This was an open trial: patients and physicians knew who was given which medication. Both products were provided in the original package. The packages had trial-specific labels and were handed out by a hospital pharmacist. Patients were followed-up by telephone 48 hours after emergency department discharge. The primary outcome was change in pain intensity, measured during a two-hour period after ingestion. The change in the group that received 500 mg naproxen (Trade®) was compared to the change in the group that received 100 mg sumatriptan (Sumatriptan Spirig HC®). This difference was measured on a validated 11-point (0–10) verbal Numerical Rating Scale (NRS).

Because:

This project was based on a study protocol which defined the exact procedures to be used. The study is designed to answer a disease related research question. It includes a relatively large number of persons and is not based on individual cases ("method-driven search for generalizable knowledge"); thus, it is classified as research according to HRA). Adults (“persons”) who suffered from headache ("research concerning human diseases") after discharge from an emergency department were treated with either 500 mg naproxen (Trade®) or 100 mg sumatriptan (Sumatriptan Spirig HC®).

Antwort: YES
Studientitel: Balance in young female ballet students suffering from chronic knee pain: The effect of physiotherapy with and without a mirror.

Background:

In literature there is general consensus that using a mirror improves proprioception. During rehabilitation, a mirror is very useful for improving stability. In some sports, such as dancing, mirrors are widely used in training. This study evaluated the effectiveness of physiotherapy with mirror on balance in young dancers.

Methods:

This study included young dancers (aged 19-25) suffering from chronic knee pain. They were randomly assigned to receive physiotherapy, one to one, with a mirror (mirror- group) or without a mirror (non-mirror group). Their balance was evaluated by BESS (Balance Error Scoring System), which consists of three stances (double limb, single limb, and tandem) on two surfaces (firm and foam). Errors were assessed at each stance and summed to create the two subtotal scores (firm and foam surface) and the final total score (BESS). The BESS was measured at recruitment (T0) and again after 6 months of dance lessons (T1). Primary outcome was difference in total BESS between the groups.

Because:

This project was based on a study protocol that defined the exact procedures to be used. It included a relatively large number of persons and was not based on individual cases ("method-driven search for generalizable knowledge", defined as research by HRA). Female dancers ("persons"), between 19-25 years old, suffering from chronic knee pain, were randomly assigned to take ballet lessons with or without a mirror. This study investigated the effect of using a mirror on the dancers’ balance ("research concerning function of the human body").

Antwort: NO
Studientitel: Status epilepticus: a possible association with human metapneumovirus infection

Background:

Human metapneumovirus is a relatively new addition to the many viruses that cause respiratory illness in infants and children. Data on the association of human metapneumovirus with neurologic complications is limited.

Methods:

In this report, we described two toddlers with human metapneumovirus infection who presented in status epilepticus and went on to develop respiratory failure. Data was collected from the routine hospital health record.

Because:

This project was not based on a study protocol, and did not define the exact procedures used to identify and describe the cases. Instead it described two cases identified during routine clinical practice. Thus, it was not "method-driven search for generalizable knowledge". It is not classified as research by the HRA.

Antwort: NO
Studientitel: What do physicians think of somatoform disorders?

Background:

Somatoform disorders are characterised by physical symptoms that are not fully explained by a general medical condition. Somatoform disorders are common, but many healthcare workers are confused by the diagnostic terminology and are reluctant to use these diagnostic labels.

Methods:

Child psychiatrists, forensic psychiatrists, gastroenterologists, and other physicians from different practice settings were identified through professional societies, like the Academy of Psychosomatic Medicine, American Psychiatric Association, and the American College of Physicians. They were invited to respond to an anonymous Internet survey. By eliciting the views of physicians who see patients with somatoform disorders, we explored their confusion about diagnostic terminology and their reluctance to use these diagnostic labels.

Because:

This project was based on a study protocol, in which the exact procedures used to generate generalizable data (method-driven search for generalizable knowledge) were defined. Researchers used a web-based survey to anonymously collect (“anonymously collected data”) data from physicians. The survey contained questions that elicited physicians’ views on disorders that may include physical symptoms not fully explained by a general medical condition. The aim of the study was to explore confusion about diagnostic terminology, and physicians’ reluctance to use these diagnostic labels.

Antwort: NO
Studientitel: A large Swiss cohort of patients with inflammatory bowel disease shifts from oral to intravenous iron supplementation therapy over time

Background:

In 2007, leading international experts in the field of inflammatory bowel disease recommended intravenous iron supplements over oral iron supplements because they were more effective and easier to tolerate.

Methods:

The Helsana insurance database provided data from adults (aged 18 or older) living in Switzerland, who suffered from Crohn's disease. Helsana is a Swiss health insurance company that covers 18% of the Swiss population (1.2 million individuals). Helsana anonymised data (stripping names, date of birth and address). Data were automatically generated at Helsana quarters, and required no additional manipulation. We analysed the data to determine what percentage of patients with inflammatory bowel disease were prescribed iron therapy, and described the dynamics of intravenous versus oral iron prescription.

Because:

This project was based on a study protocol that defines the exact procedures to be used. It included a relatively large number of persons and was not based on individual cases ("method-driven search for generalizable knowledge", defined as research by HRA). The goal was to determine what percentage of patients with inflammatory bowel disease was prescribed iron therapy, and to describe the dynamics of intravenous versus oral iron prescription. The Helsana insurance database provided data from adults who lived in Switzerland and suffered from Crohn's disease ("health-related personal data"). Helsana’s database was automatically generated, and required no additional manipulation. Data were anonymized by an independent institution (Helsana), not involved in the project and separated in time and space. The anonymised database did not include personal identifiers (insurance number, name, date of birth or address). This "research that involves anonymised health-related data" fell outside the scope of HRA.

Glossar