Biobanks are essential structures for scientific research. The RHINEVIT biobank is used to recruit biomaterials from rheumatology patients in outpatient care and to conduct clinical research studies (e.g., cohort studies) and basic research. RHINEVIT established Broad Consents (BC) to allow extensive and relevant usage of data and biospecimens without the need for specific project restrictions. For quality assurance, we compared the consent rate of individual items of the BC versions in patients with systemic lupus erythematosus (SLE) in the longitudinal study.
BCs were used for biomaterial donation. Informed consent data from RHINEVIT were analyzed. Due to the content restructuring of the BC items due to changes from the templates of the working group of the Medical Ethics Commissions in the Federal Republic of Germany and GDPR requirements, content mapping of the items was performed for the analysis.
From September 2015 to March 2022, 291 SLE outpatients donated biomaterials. In 119 patients, the BC was renewed at least once in a subsequent biomaterial donation. Three biomaterial donations were obtained from 21 patients and four from six patients using the respective BC. However, one consent was later revoked. Consent to the BC topics showed consistently high rates of agreement (range 97.5%−100%), with only some patients disagreeing with individual topics. This remained stable over time (median 526 days [Q1 400, Q3 844]). None of the patients disagreed with a certain topic in two consecutive visits.
Modifications to the BC did not result in any relevant changes in the approval rates for SLE patients. RHINEVIT's BC is successfully used for the quality-assured handling of excellently annotated biomaterial. The long-term use of these highly valuable biospecimens for unrestricted research, also in an international context, remains assured.