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.
Tools for Developing Easy to Read Consent Documents
- Federal Plain Language Guidelines (plainlanguage.gov)
- Multi-Regional Clinical Research Glossary [HTML]
- Glossary of Lay Terms for Use in Preparing Consent Documents [PDF]
- “Basics for Easy-to-Read Informed Consent Documents” Checklist [O11.0000] [PDF]
- Lay Terms & Alternative Words
- Everyday Words for Public Health Communication (Centers for Disease Control and Prevention (CDC))
- Informed Consent Language (ICL) Database (National Comprehensive Cancer Network (NCCN))
- Simplified Assent Form Language Toolkit (Quorum)
- Standard Risk Language Database (Dana Farber/Harvard Cancer Center Office of Human Research Studies)
- Suggested Consent Language (Northwestern Office for Research Institutional Review Board (IRB))
- Tables of Possible Side Effects for Commonly-Used Oncology Regimens (National Institutes of Health (NIH) National Cancer Institute (NCI))
- Talking Glossary of Genetic Terms (National Institutes of Health (NIH))
- Readability Toolkit (Kaiser Permanente Washington Research Institute Program for Readability & Science in Medicine (PRISM))
- Sample Informed Consent Language Library: Describing Technologies Used in Research [PDF] (Harvard Catalyst: The Harvard Clinical and Translational Science Center)
- Hemingway Editor: Makes your writing bold and clear; highlights lengthy complex sentences and common errors. [HTML]
Key Information Samples
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: