Consent Form Writing and Examples

[updated 24 May 2018]

The IRB 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  Note:  the specific information may be outdated, so use these only as guides.

 

Informed consent forms (ICFs):

Anonymous* and non-intrusive study: 

  anonymous and non-intrusive study

Confidential* 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:

  for a minimal risk psychology study

Other relevant resources about ICFs: 

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

- http://www.online-utility.org/english/readability_test_and_improve.jsp