Consent Form Writing and Examples
[updated 22 February 2017]
The writing of a consent form is both art and science. It must be written to convey information and do it in an understandable way. The subject or participant must be informed, so the document is usually called an informed consent form (ICF). When written for minors, it is called an assent form.
A quote from the Wall Street Journal: "Informed consent may be the biggest misnomer in medicine. Studies show that most patients [subjects] don't read the forms they sign before undergoing surgery or medical treatment. More than half of those who do read the forms don't understand them, and only a quarter of forms include all of the data patients [subjects] need to make an informed decision."
Informed consent is a concern of the Cal Poly Pomona IRB as well. The Board requires a detailed and informative consent as part of your IRB protocol submission. Model yours from these samples of standard consent forms submitted to the CPP IRB over the years. Note: the specific information may be outdated, so use these only as guides.
Refer to the Word document protocol on the "Forms & Links" web page (at left) to learn what critical elements need to be in the ICF.
Annonymity and confidentiality are very important parts to describe in the ICF. See the "*" items below.
Informed consent forms (ICFs):
Anonymous* and non-intrusive study:
for a confidential study
Multiple specific uses of videotape:
to obtain consent for multiple specific uses of videotape
Business environment study:
for a business environment study (the same ICF in both confidential and anonymous versions)
Minimal risk psychology study:
Other relevant resources about ICFs:
The NIH Clinical Research Policy Analysis and Coordination Program has released a compendium of current ('07), publicly available NIH resources on informed consent.
An IRB list-serve discussion about obtaining consent on-line is presented in this Electronic Online Consent Document.
Example statements for CPP graduate students to use in their consenting forms, meant to avoid undue influence and coercion when recruiting subjects, is available here in the document "Undue Influence and Coercion in Consenting".
Experimental subject's bill of rights for medical research This document is often used for biomedical/clinical procedures.
* Anonymous versus Confidential Often the difference between the terms anonymous and confidential is not well understood when applied to research studies involving human participants. Yet, these concepts are very important for the protection of the subjects, and they need to be considered by researchers when designing a study and writing the ICF. During protocol review, the level of protection described will be evaluated by the IRB.
OHRP FAQs on informed consent This web site from the federal Office for Human Research Protections (OHRP) offers information about the consent and assent processes.
Evaluating the comprehension level or readability factor of a document like the ICF can be done with tools like these. IRB protocol reviewers may ask you as the PI to provide the result or score from them.
- Flesch-Kincaid, https://en.wikipedia.org/wiki/Flesch%E2%80%93Kincaid_readability_tests