Consent Process & Forms

Resources on Informed Consent

Informed Consent Online Tutorial

The Process of Consent

from the Protecting Human Subjects Guide:
What to discuss, Subject understanding, What must be said about the research

FAQ about Informed Consent

Subject Recuitment & Contact Issues

Advertising, Medical Records Contacting, Finder's Fees

Samples & Templates

Consent Form Templates

For Social & Behavioral Science Studies (rtf)

For Medical & Health Studies (rtf)
includes new out-of-study contact language

For Exempt 2 and 3 Studies (docx)

Children's Assent Form

Sample Assent Form (pdf)

Sample Spanish Assent Form (doc)

Addendum to Assent for Female Minors (rtf)

Consent Form Help

What must be included on a consent form?

How to avoid problems with consent forms

Information about exempt consent forms

Appropriate Language for Studies that Exclude Women

Common Language Dictionary

New Out-of-study Contact Language for Medical/Health study Consent Forms as of Oct. 2, 2003

Out-of-study contact language should be updated in consent forms approved prior to Oct. 2, 2003 and used in consent forms drafted after this date. This change does not need to be reviewed by the IRB, but the IRB will look for this change in the consent form during future reviews.

"If you have any questions or concerns regarding the study and would like to talk to someone other than the researcher(s), contact the Fairview Research Helpline at telephone number 612-672-7692 or toll free at 866-508-6961. You may also contact this office in writing or in person at University of Minnesota Medical Center, Fairview-Riverside Campus, 2200 Riverside Avenue, Minneapolis, MN 55454.

Language and Cultural Considerations

If the majority of the anticipated subjects do not speak English or will be unable to understand the consent form written in English, the consent form must be translated into a language understandable to the subjects.

However, if the majority of subjects are English speakers, but there are a portion of the subjects who will not be able to understand the consent form written in English a short form may be used .

Consent Short Forms:

What are short forms?
When can a short form be used?
How to use short forms

Download short forms:

Available in Arabic, Croatian, French, Hmong, Khmer, Lao, Oromo, Russian, Somali, Spanish and Vietnamese

Information About Exempt Consent Forms

Even though the IRB may determine that some research is exempt from the federal regulations, adequate provisions still need to be in place to protect research participants. 

In making its consideration of exempt status, the HRPP/IRB office still has to determine that:

1. The research involves no more than minimal risk to participants
2. Selection of participants is equitable
3. If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data
4. If there are interactions with participants, there will be a consent process that will disclose such information as:
   • that the activity involves research
   • a description of the procedures
   • that participation is voluntary
   • name and contact information for the investigator
5. There are adequate provisions to maintain the privacy of participants.