Critical consideration towards broad consent by patient experts: results of a semi-structured interview study on the secondary use of medical data

TL;DR

This study explores how patient experts view broad consent for using medical data in research, finding mixed support and highlighting the need for clearer communication and governance.

Contribution

The study provides new insights into patient experts' nuanced attitudes toward broad consent and emphasizes the importance of informed consent as a gold standard.

Findings

Participants generally agree with broad consent but prefer overarching regulations that differ from it.

Broad consent is criticized for reduced information flow and lack of concrete research objectives.

Interviewees emphasize the importance of specific governance structures for informed consent.

Abstract

Some would argue that there is a moral obligation to make the personal health data stored in databases and biobanks available for secondary research use. Yet, it is unclear what ways to gain consent to use the stored data for secondary research purposes are both effective and respectful of the patient’s autonomy. One prominent example under discussion is broad consent. As a form of consent in which specific study objectives are not defined, it is seen by many as an efficient alternative to the established consent of participants. Research on subjects' attitudes towards and their discursive reflections on broad consent is, however, limited. With our study, we aimed to gain deeper insights into the views and (normative) attitudes towards broad consent by members and representatives of patient organizations.

Semi-structured interviews were conducted with members (N = 13) and representatives (N = 9) of German patient organizations. Subsequently, we evaluated the material using content analysis.

The results initially indicate a general agreement with broad consent among members and representatives of patient organizations. In contrast to the results of some existing studies on broad consent, our analysis reveals limitations in this regard: Positive assessments relate less to broad consent in particular, but rather to overarching regulations on secondary data use that deviate from broad consent. Broad consent is criticized for exactly what it was originally intended to regulate: reduced flow of information, lack of a concrete and communicated research objective, and coverage of (too) long periods of time. The interviewees often formulated specific ideas and wishes about appropriate procedures for consenting to secondary data use, i.e., specific governance structures, thus (implicitly) conceptualizing "informed consent" as the gold standard of consent procedures.

The interviewees consider the provision of data for secondary use to be important for the improvement of treatment methods, freedom of research, and ethical considerations such as reciprocity. However, these values are linked to conditions in the stakeholders' considerations and thus appear less absolute and universal than conditional and situated. Qualitative, empirical-ethical research can make this inherent complexity of ethical attitudes of stakeholders as negotiation processes tangible and fruitful for medical ethical practice.

The online version contains supplementary material available at 10.1186/s12910-025-01326-x.