opt-out
Conditions
Interventions
1. Opt-out
2. Opt-out plus
3. Informed consent.
Three consent procedures will be compared. The first, opt-out, is currently the standard condition in most Dutch hospitals. Patients are not actively offered any information abou
Sponsors
KWF Kankerbestrijding
Eligibility
Inclusion criteria
Inclusion criteria: Patients between the ages of 18 and 80 years whose tissue has been removed.
Exclusion criteria
Exclusion criteria: Unability to speak and read Dutch. Unability to complete the questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patients’ satisfaction with and preference for a consent procedure; 2. Proportion of patients aware of storage of tissue and research use; 3. Consent rates; 4. Medical staff’s satisfaction with and preference for a consent procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additionally, we will obtain information on the proportion of non-consent due to non-response; the characteristics of non-consenters and non-respondents; and the reasons for providing or withholding consent or (non-)response. We will investigate how patients perceived the information they received about residual tissue use and their knowledge about this topic. Patients’ preferences to provide or withhold consent for specific types of research (e.g. genetic, commercial) and feedback regarding unanticipated findings will be investigated as well. Further, we will examine whether consent rates, satisfaction with or preference for a consent procedure differ according to severity of disease, type of clinical procedure (e.g., biopsies or surgical removal of tissue), diagnosis, type of hospital (academic or community) or demographics. Six months after the first questionnaire, we will examine whether patients are still aware of the decision they made and whether they are still satisfied with their choice to provide or withhold consent. | — |
Contacts
Public ContactS. Rebers
NKI-AVL afdeling PSOE Plesmanlaan 121
Outcome results
None listed