Table 1.
Generalized category | Type of consent | Definition | Authors | Disagreement |
---|---|---|---|---|
No consent given | Presumed | Consent is presumed to have been given by donors to use their samples and information for all research unless they actively choose to opt out | Master et. al. and Hofman | |
Passive/tacit/silent consent | Presuming that the persons object if they do not consent | Hofman | ||
Hypothetical consent | Consent under the presumption that a person would have consented to the treatment or research were she or he able to consent | Hofman | ||
A broad or specific consent | Future/deferred consent | Postponing the consent procedure | Hofman | |
An extremely broad consent | General/blanket/open consent | Donors can actively consent once for the current study and all future research involving the general use of their samples and information | Master et. al., Hofman and Salvaterra et al. | Salvaterra refer to this as broad consent |
May be either broad or specific depending on how the consent is formulated and the definition used by the reviewers | Broad | Donors can actively consent once for the current study and all future research within a broad field, e.g. cancer, diabetes or heart disease | Master et. al., Hofman and Salvaterra et al. | Salvaterra refer to this as partially restricted consent |
Delegated trustee | Donors can transfer consent to a trustee who is at arm’s distance from the biobank and consents on behalf of donors | Master et al. | ||
Third-party oversight | Donors can actively consent to a general, broad or other model, but an ethics board must approve the study before the commencement of research using stored samples and information. This approach is emerging as a common component of biobanking governance schemes | Master et al. | ||
Tiered | Donors can actively consent once for the current study and choose one or more broad fields of research or other options, i.e. whether they would be willing to have their samples used in research that result in commercialization. Other terms: line item or multilayered consent | Master et al. | ||
Re-consent | Donors are informed and are required to consent to the current study and to each future research study involving the use of their samples and information | Master et al. | ||
Specific informed consent | Allows the use of biological specimens and related data only in immediate research; forbids any future study that is not foreseen at the time of the original consent | Salvaterra et al. |
Note: Terms used in literature are not always univocal and may also be used with different levels of specificity. In the table, the specific definitions described by the authors have been clustered into more general of consent described in accordance with this article. The more specific definitions are listed in the column ‘Definition’, and the terms used to name them are outlined in ‘Type of consent’ and ‘Disagreement’.