NuGO Guideline 4

Informed consent

Informed consent for biobanks

The collection of biological material and of personal data from an individual, including the routine samples obtained within a medical or health care setting, must be subject to the donor's consent. Different consents are required for

  • the collection of the sample
  • its use in a specific research study
  • its use for other research purposes
  • its use by a third party
  • its use in a commercial application or by a commercial partner

There is one comment on this page:

Outside a therapeutic or diagnostic context, only the process of sample extraction falls under medical professional regulations.
- The extraction of body substances is a bodily injury (§ 223 ff StGB) that requires the donor's consent. Misleading information may invalidate the donor's consent.

Medical institutions planning to carry out invasive research on humans have to seek permission from an ethics committee (§ 15 MBO-Ä).
- This regulation was originally intended for clinical trials but extends to the extraction of body substances required for laboratory-based research.

[ Comment by Prof. Dr. Michael Krawczak,, 2007-09-17 12:00:00 ]