What is informed consent and when is it required?
Informed consent is written permission from an individual to allow a government entity to release the individual's private data to another government or non-government entity or person, or to use the individual's private data within the entity in a different way (Minnesota Statutes, section 13.05, subdivision 4).
A government entity must obtain an individual's informed consent in the following situations:
- When the individual asks the entity to release his/her private data to another entity or person
- When the government entity wants to release the individual's private data to another entity or person (government entity created the private data or government entity collected the private data from someone other than the individual)
- When the government entity wants to release the individual's private data to entities or persons other than those listed in the Tennessen warning notice the government entity gave the individual when it collected the data
- When the government entity wants to use the individual's private data in a way that is different than what the government entity explained in the Tennessen warning notice the government entity gave the individual when it collected the data
The informed consent requirements apply to Minnesota government entities subject to the Data Practices Act (Minnesota Statutes, Chapter 13) and, in some cases, to third party contractors (Minnesota Statutes, sections 13.02, subdivision 11; 13.05, subdivision 2; 13.05, subdivision 11).
For information about informed consent when government is releasing data to an insurer, see Minnesota Statutes, section 13.05, subdivision 4a.
What is valid informed consent?
Minnesota Rules 1205.1400, subpart 3, requires that individuals giving informed consent have sufficient mental capacity to understand the consequences of their decision to give consent. Minnesota Rules 1205.1400, subpart 4, requires that a valid informed consent must:
- Be voluntary and not coerced
- Be in writing*
- Explain why the new use or release is necessary
- Prior to affixing a signature*, include any known consequences for giving informed consent
*Minnesota adopted the Uniform Electronic Transactions Act in 2000, that says:
- If a law requires a record to be in writing, an electronic record satisfies the law.
- If a law requires a signature, an electronic signature satisfies the law.
If the individual is a minor or has a legally appointed guardian, the entity may also need the signature of the individual’s parent or guardian depending on the situation or the entity’s policy.
What is the connection between a Tennessen warning notice and an informed consent?
When a government entity collects private or confidential data from an individual about the individual, the entity must give the individual a Tennessen warning notice (Minnesota Statutes, section 13.04, subdivision 2). The Tennessen warning notice must include how the entity intends to use the data and which outside entities or persons are authorized to have the data. Once the entity gives the notice, the entity may use or release the data in the ways described in the notice.
After giving a Tennessen warning and collecting private data from an individual, a government entity may wish to use the data differently than it described, or may wish to release the data to an outside entity (government or non-government) or person other than it described. In either of these situations, the government entity would need to obtain informed consent from the individual.