Except under certain conditions where the IRB can waive the requirements for documentation of informed consent, informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative.

Informed Consent Development

To develop a consent document for your study, you can use the sample templates, follow the instructions in blue italics, and remove text that does not apply to your study.  You may adapt the language for your study population and use the informed consent requirement checklist [PDF] to ensure inclusion of required elements. Attach in E-IRB as consent document type so that the document receives an IRB Approval Stamp. UK IRB policy dictates that only consent documents with a valid "IRB Approval" stamp can be used when enrolling subjects unless a waiver from this requirement is approved by the IRB.

The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate and an opportunity to discuss that information.

“Informed consent must begin with a concise and focused presentation of the Key Information that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate.” [45CFR46.116(a)(5)(i)] This part of the informed consent must be organized and presented in a way that facilitates comprehension. (See Key Information Samples below.)

  • The consent document needs to be in the subject's native language.
  • The consent form should be written in language understandable to the subject.
    • Whenever possible, use simple sentences.
    • Do not use medical or technical jargon.
  • Avoid exculpatory language through which the subject or the LAR is made to waive or appear to waive any of their legal rights or release the investigator, sponsor, institution, or its agents from liability for negligence.
  • For NIH-funded research or other research with a Certificate of Confidentiality (CoC) [HTML], the potential subjects must be told about the protections afforded by the certificate and any exceptions to that protection and included in the informed consent form. The UK template includes sample language that may be adapted to the needs of the potential subjects and to the subject matter of the study but must cover the basic points. 
  • A signed copy of the consent form should be given to the subject or subject's LAR.

Primary Informed Consent Templates

Medical Informed Consent/HIPAA Template

Nonmedical Informed Consent Template

  • English [F2.0150] [WORD]
  • Spanish [F2.0155] [WORD]

Tools for Developing Easy to Read Consent Documents

Key Information Samples

Sample Applications and Protocol Development Resources

The following are examples of Key Information pages created for education purposes only. They are not exact representations of actual studies. Study topics and subject matter were chosen to illustrate concepts that may be key for participant consideration. The IRB has not reviewed or endorsed the examples. The examples do not include the entire consent document.

Key Information Page Examples for Simulated Studies:

  • Comparative Effectiveness Research [PDF]
  • Placebo-Controlled Clinical Trial [PDF
  • Research Biobank [PDF
  • Clinical Outcomes [PDF]
  • Healthy Volunteer Medical [PDF
  • Healthy Volunteer Nonmedical [PDF
  • Nonmedical testing and survey [PDF

Informed Consent Checklist
UK Informed Consent Template FAQs
Informed Consent Requirements
UK Guidance on Unique Informed Consent Circumstances [D135.0000]