OHRP FAQs on informed consent This web site from the federal Office for Human Research Protections offers information about the consent and assent processes.
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 for:
Anonymous and non-intrusive study:
for a confidential study (DOC),
Multiple Specific Uses of Videotape:
to obtain consent for multiple specific uses of videotape (PDF)
Business Environment Study:
for a business environment study (PDF) (the same form in both confidential and anonymous versions)
Minimal Risk Psychology Study:
for a minimal risk psychology study (DOC), and more to come.
Clinical Study and Other:
The NIH Clinical Research Policy Analysis and Coordination Program has released a compendium of current ('07), publicly available NIH resources on informed consent (DOC).
- An IRB list-serve discussion about obtaining consent on-line is presented in this Electronic Online Consent Document (DOC).
- Example statements for 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"(DOCX).
Experimental subject's bill of rights for medical research (DOC) This consent form is to be used as well for clinical procedures.
Anonymous versus Confidential (DOC) 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 protocol. During protocol review, the level of protection described will be evaluated by the IRB. Click the link at the beginning of this paragraph.