Research Consent

Patients' consent must be obtained for the further use of routinely collected patient data and samples for research purposes. This applies, for example, to retrospective data evaluations from hospital information systems or the research-related use of samples from biobanks. The process of obtaining patient consent is called research consent, in some hospitals also general consent.

What does the research consent cover?

The research consent at the University Hospital Basel (USB) covers the further use of coded, non-genetic and genetic patient data as well as biological material (samples) (Art. 29, 32 Human Research Ordinance, HRO). In addition, information is provided on possible anonymisation of genetic patient data and samples (Art. 30 HRO).

What does coded further use mean?

If samples and/or data are used for research purposes, the personal data, i.e. name and date of birth, are replaced by a code. This code is kept in a secure place and is only accessible to a few authorised persons.

How do coded data/samples differ from anonymised data/samples?

In the case of anonymised data or samples, the name and date of birth are irreversibly rendered unrecognisable, i.e. it is no longer possible to assign the data or samples to the corresponding persons. In the case of coded data or samples, a written record is kept in a safe place of which code belongs to which person.

For how long is the consent given valid?

A given consent is valid indefinitely and independently of the time at which the data or samples were collected.

Can a given consent be withdrawn?

Yes, withdrawals can be reported by telephone or in writing to the respective clinic or by email to klinischeforschung@clutterusb.ch, stating the name and date of birth of the patient. After withdrawal, the data and samples will no longer be used for new projects.

Is someone allowed to sign on behalf of the patient?

The legal representative (e.g. daughter, son or spouse) may sign the consent form on behalf of the patient if the patient is incapable of judgement. In the case of children under the age of 14, the parents or legal representative may sign. From the age of 14, adolescents must sign themselves (if capable of judgement). The representation is listed in detail in accordance with the Swiss Civil Code ZGB Art. 378 (1).

Are data and/or samples passed on to pharmaceutical industry or to foreign institutes?

In principle, this is possible. However, data or samples would exclusively be transferred in coded form. The data protection provisions of the receiving country/institution must meet at least the same requirements as those in Switzerland.

What is the current status of the research consent at USB?

Through the project management of the Department of Clinical Research (DKF) and intensive cooperation of all USB departments, the research consent process has been implemented practically throughout the entire hospital since 2016. Currently, more than 100,000 decisions have been recorded. Of these, 85% of patients agree to further use of data and samples for research purposes. At the DKF, we are still interested in continuously optimising the process with the help of the departments. Please feel free to contact us with your ideas and comments.

How does the USB research consent process work?

Patients receiving inpatient or outpatient treatment usually receive the information and consent documents from the admission staff or other staff when they enter the hospital. As of January 2020, the documents correspond to the nationally harmonised consent version. The documents are available in eight languages (German, French, Italian as well as English, Spanish, Poruguese, Turkish and Albanian). The documents consist of one and a half pages of information and a consent form. Please note that the consent form may not be copied, but printed specifically for each patient from the SAP  or Meona systems. If you have any questions regarding the creation of the form, please contact the local staff or Denis Falcetta, PhD, Specialist Regualtory Affairs, DKF.

For ethical and organisational reasons, patients who enter the hospital via the emergency department are asked for their research consent either as part of the patient satisfaction survey or during the second contact (follow-up examinations).

How and where are patient decisions made available?

Signed consent forms are recorded in the e-archive via an automated scanning procedure. The decisions are then directly visible in the most important hospital information systems (ISMed, Meona and PathoWin).

For feasibility assessments for clinical research projects, the number of eligible patients with a research consent can be prepared for researchers. Patient decisions on research consent are also taken into account by the creation of a database with specific patient data by the ICT department from the hospital information systems. Please use the DKF contact form for such requests.

What is the benefit of data and samples that are made available for research purposes?

They serve progress in medicine. For example, new procedures that enable more accurate and faster diagnosis than previously used methods can be tested. The range of therapies can be expanded so that the medical care of patients is improved in the long term.

Is consent associated with a direct benefit for the patient?

As the development of new therapies usually takes place over a longer period of time, an immediate direct benefit is rather unlikely.

However, consent makes an important contribution to the development and improvement of future patients.


Contact

Denis Falcetta, PhD

Specialist Regulatory Affairs, DKF

Email

Dezember 2021