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Hints, Help, and Examples

OHRP FAQs on informed consent This web site from the federal Office for Human Research Protections offers information about the consent and assent processes.

Consent forms:  

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." This 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 an anonymous and non-intrusive study (DOC), for a confidential study (DOC), to obtain consent for multiple specific uses of videotape (PDF), for a business environment study (PDF) (the same form in both confidential and anonymous versions), for a minimal risk psychology study (DOC), and more to come.

- 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.

Protocols:  

Samples of written and IRB-approved protocols representing various risks and data privacy are available at these links. Use them as examples and look for updates to the current protocol version.

Cold Pressor study (PDF) - invasive, physiological study but negligible confidentiality risks.  This link to the informed consent form (PDF) shows comments about the original one in the protocol.

Minimal risk behavioral science studies - a psychology study (DOC) on charismatic speech and its informed consent form (PDF) with comments; and a sociology study (DOC) on responding and its informed consent form (PDF) with comments.

Education (CEIS) protocol (DOC) with older minors, teachers, and anonymous survey.  This link provides constructive comments about the consent, assent, and recruitment (PDF) letter in the protocol. Other sample protocol #1(m) (PDF).  Other sample protocol #2(a) (PDF).

Business research protocol (DOC), student PI protocol (PDF) with an anonymous on-line survey, other business anonymous survey protocol (PDF)

Questions about research data?  

Review this publication on "Access to and Retention of Research Data: Rights and Responsibilities" Council on Governmental Relations, 2006.

Conducting research on the internet?  Consult this link:  http://internetresearchethics.org/.

Renewals and changes to methods:  

Protocols are generally approved for conduct for one year. They may be renewed if interaction with subjects will continue. They may be changed, known as being amended. Send an email to the IRB administrator describing in detail the reason for the renewal (e.g., collection of additional data from more subjects) or proposed change (e.g., recruiting men as well as women in the study).  Completion of a de novo protocol in either circumstance may be requested by the IRB.

Using copyrighted materials:  

The CSU Office of General Counsel has a manual on the Fundamentals of Copyright and Fair Use. See: http://www.calstate.edu/gc/Docs/Fair_Use.doc

Web sites and such to assist with international human subjects research:

In conjunction with the IRB policy on conducting research, individually or collaboratively, outside of America.

Other:

Deception (PDF) - This is a one page document that outlines justifications for its use, variations on informing subjects, debriefing, and dehoaxing.  It is useful to introduce concepts; the PI is encouraged to obtain more information from other sources.

Reducing the risk factor with audio and video taping (DOC) - This document, from a post to the IRB Forum list-serve, describes a tool and techniques to de-identify subjects when using these techniques.

Likert-Type Scale Response Anchors - A listing of standardized ratings for evaluation criteria. Citation: Vagias, Wade M. (2006). Likert-type scale response anchors. Clemson International Institute for Tourism & Research Development, Department of Parks, Recreation and Tourism Management. Clemson University.

PI encouragement (PDF) - In case you feel discouraged by the effort and comments while submitting your IRB protocol for review and approval, this is a reflection by someone who can sympathize with you.

A tool to evaluate the readability factor of a document - Especially useful for consent forms.

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