Further use of data in research: Current trends, legal background, and typical problems

Current trends in the further use of material and data for research

The further use of biological material, routine clinical data, or research data in Switzerland has significantly increased over the last several years, as shown by the following statistics from the Federal Office of Public Health’s (FOPH’s) annual report Human Research in Switzerland 2020¹ (Figure 1) and the internal statistics from the Cantonal Ethics Committee Zurich (Figure 2). This development also implies that increasingly more people who are not engaged in patient treatment are working with patient data.

In parallel with this increase in further use projects, the use of general consent has greatly increased. Consequently, the proportion of project applications to ethics committees (ECs) without consent according to Article 34 of the Human Research Act (HRA) has decreased relatively in relation to the total number of further use studies (see Figure 3). In other words, the more recent the data records are that are the subject of an EC application, the more likely it is that there is project-specific consent, general consent for the further use of clinical data, or specific study consent covering research data reuse.

Scope and legal background

Not only are existing biological materials and patient data extremely valuable for research, but the extent to which they are used is tremendous. And research based on patient data continues to increase. These circumstances and the sensitivity of data protection have prompted the Swiss legislature to set up special rules regarding the protection of the right to self-determination in the further use of material and data.² 

The further use of biological material, genetic data, and non-genetic health-related personal data was legally regulated for the first time in Switzerland with the HRA and its corresponding Human Research Ordinance (HRO), which came into force on 1 January 2014. Consent and the substitution of consent for the further use of data and biological material are based on Articles 32–34 of the HRA and Articles 24–40 of the HRO.

As the relevant ordinance/regulation, the HRO broadly defines the concept of further use as any handling of biological material that has already been removed or data that have already been collected (Art. 24). This includes, in particular, the procurement, merging, or collection of biological material or health-related personal data (Art. 24, let. a), the registration or cataloguing of biological material or health-related personal data (let. b), the storage or inclusion in biobanks or databases (let. c), or making accessible, providing, or transmitting biological material or health-related personal data (let. d).

The introduction of regulations on the reuse of biological material, genetic data, and non-genetic health-related personal data is also in line with the internationally recognised soft law regulations of the Declaration of Helsinki. According to Article 32 of the HRA, the reuse of identifiable human materials or data requires physicians to obtain informed consent.

Involving humans in research should be restricted to projects that are not feasible without doing so. Such a postulate for a conservative approach to exposing participants to research is the basis for the principle of subsidiarity, which is an essential part of human research law (HRA, Art. 11). The further use of data is then of particular importance, since some research projects with humans might be replaced by the further use of data. Further use in this sense means the second and possibly subsequent research-related use of biological material, genetic data, and non-genetic health-related personal data. It is immanent that the material or data have already been taken or collected for another purpose, for example for diagnostic purposes or as part of another research project.

Further use and consent: Typical problems encountered by ethics committees

1. Absence of informed consent
Article 34 of the HRA lists the exceptional situations in which consent is absent yet consent and/or providing information to the individual concerned regarding the right to dissent to the further use of biological material or health-related personal data may be substituted by the ethics committees for research purposes. These exceptions are allowed only if certain preconditions are fulfilled cumulatively: 1) it has to be impossible or disproportionally difficult to obtain consent or to provide the required information on the right to dissent, or this would impose an undue burden on the person concerned; 2) no documented refusal is available; and 3) the interests of research outweigh the interests of the person concerned in deciding on the further use of his or her biological material and data. Therefore, whenever possible, informed consent should be obtained. However, if a consent was not obtained, there is no clear timeframe beyond which the application of Article 34 would generally be excluded. Thus, different research ethics committees in Switzerland tend to handle this issue in different ways. Templates for general consent forms were created in 2017 by the Swiss Academy of Medical Sciences (SAMS) together with swissethics. In response to ensuing discussions, a new template was created in 2018 under the leadership of unimedsuisse and with the cooperation of the five university hospitals. This template for general consent can be found on swissethics’ website.

As of 2016, the EC Zurich generally requires that applications for further use projects include (general) consent from patients whose data are to be used. Institutions that were able to implement general consent shortly after the HRA came into force are now at an advantage. For data that have been collected more recently, there have to be very good reasons for why consent cannot be obtained. If reasons exist, the EC Zurich carefully assesses whether or not the scientific significance outweighs the intrusion into the privacy of individual patients. Reasons that might be accepted by the EC Zurich are that patients passed away prior to the application or that the circumstances of treatment did not allow time to properly inform the patient, as can be the case in emergency situations. If feasible, consent usually has to be subsequently obtained.

2. Data collection in emergency situations
Patients often enter an intensive care or emergency unit under exceptional circumstances. Obtaining informed consent in these situations is often not possible. Thus, in most cases the only option is to obtain consent from relatives (i.e. representatives). Due to the special circumstances, this may only be specific consent. The usual form currently being used in hospitals for general consent seems inappropriate in this situation. It is not in line with Articles 30 and 31 of the HRA. General consent applies to all data instead of just the data needed for a certain situation. However, the exclusion of intensive care or emergency patient data from research would not seem reasonable and would not be justifiable ethically. Suitable solutions therefore have to be found. A consent form specifically for intensive care patients has turned out to be the best way to make research with these data possible in an ethically and legally satisfying manner. Relatives are able to consent to the use of data related only to the current situation. As soon as patients are able to give their re-consent, it should, of course, always be sought.

3. Evaluating sample size or screening participants
Usually, the number of potential patients to be included in a study has to be known in order to obtain approval from the EC. Otherwise, it is possible that not enough patients can be recruited for a study. Under certain circumstances, estimating the number of suitable patients can only be done successfully by viewing patients’ records. The same problem occurs when pre-screening is necessary for selecting participants, who may be asked to give their consent to research. When pre-screening is needed, researchers have to be aware of the implications of the duty of confidentiality. This duty of confidentiality forbids disclosure (i.e. any behaviour that results in an outsider receiving knowledge of secret information). So any disclosure of patient data assumes that the physician’s duty of confidentiality will be violated. Thus, viewing patient data is certainly in line with criminal law (Swiss Criminal Code, Art. 320 et seq.) if it is done by the treating physician and as long as the viewing/screening itself does not go beyond a point that could be considered research (HRA, Art. 3, let. a; Art. 62 et seq.). If pre-screening is done by doctors from the same department as the treating physicians, one can still argue that they are allowed to view the data because the confidentiality obligation does not necessarily apply to doctors from the same department and because data were created during the patients’ treatment in that department. In practice, it becomes trickier when, for instance, masters students are foreseen to do such pre-screening. This is an aspect that should clearly be regulated in the context of the pending revision of the regulations that concretise the HRA (HRO, ClinO, and ClinO-MD).

For the time being, it can be argued that patients who have given general consent for their data to be part of research have also agreed to screening as part of a research activity. However, what should be done if there is no documented consent? This could especially be the case in projects in which the substitution of consent on the basis of Article 34 of the HRA is needed. The application of such a project to an EC must specify for how many patients the responsible EC is to grant a substitution of missing consent. Ideally, the number would be clarified via an automated, anonymous query of patient data. In practice, this often does not work out to the desired extent. Often fewer suitable patients are found in an automated query than would actually be available. Therefore, emerging feasibility tools that retrieve aggregated data only from automated, anonymous queries on institutional data warehouses may become increasingly important in planning research projects, especially with the expected increase in data interoperability. Another option is that the treating physician clarifies how many patients are involved. In case of doubt, only an estimate can be given in the ethics application, which may have to be corrected later in the approved protocol. Last but not least, until the FOPH provides clarification in the form of suitably revised regulation, case-by-case decisions may be made in a legal grey area.

4. Revocation of consent
The law stipulates that patients can revoke their consent to the use of their data and biological samples for research projects. Project managers are responsible for ensuring that in the event of revocation, the revocation is also registered at other institutions to whom they pass on data or samples and for ensuring that those locations no longer use the affected data and samples. It is therefore of tremendous importance that project managers keep track of all other institutions with whom they share data and biological samples. As a rule, data and samples that have already been used for research projects can continue to be used for ongoing projects (as described in an interpretation guide to ClinO (Art. 9)).³ However, the data and samples can no longer be used for new projects. If data and samples are being passed on, it is absolutely necessary to draw up a transfer agreement so that in the event of revocation, it can be guaranteed that the data and samples affected will no longer be used at the other location. Such an agreement should also ensure that data and samples are not being used for any purpose other than the intended one.

Conclusion

Accessing sensitive data for the purpose of science while at the same time protecting data privacy represents a challenge. The issue of consent as it relates to the further use of biological material and patient data for research purposes is not always clear cut. Grey areas remain that may trigger different interpretations, fuel discussions within ethics committees, and result in different ways of handling the issue in practice. This article reflects the authors’ experiences at the Cantonal Ethics Committee Zurich. Different ethics committees do not necessarily handle these typical, problematic issues in the same way. The pending revision of regulations (HRA, HRO, and ClinO) may resolve some of the issues mentioned in this article.

References

1. Federal Office of Public Health (FOPH) and Coordination Office for Human Research (kofam) (2021) Human research in Switzerland 2020: Descriptive statistics on research covered by the Human Research Act (HRA). Accessed 12 May 2022: www.kofam.ch/statisticalreport2020
2. Rütsche B (2016) § 10 Humanforschung IV. 2. c. In Aebi-Müller RE, Fellmann W, Gächter T, Rütsche B, and Tag B (eds) Arztrecht. Bern: Stämpfli Verlag. [in German]
3. Federal Department of Home Affairs (2012) Erläuternder Bericht über die Verordnungen zum Humanforschungsgesetz [draft from 30 July 2012]. Accessed 24 May 2022: https://fedlex.data.admin.ch/filestore/fedlex.data.admin.ch/eli/dl/proj/6012/26/cons_1/doc_4/de/pdf-a/fedlex-data-admin-ch-eli-dl-proj-6012-26-cons_1-doc_4-de-pdf-a.pdf [in French and German]