|
Informed Consent Guidelines
All protocols submitted to the IRB must utilize an appropriate recruitment and consent process consonant with the risks involved. Please find some provisional guidelines below for drafting a consent document. Sample language for consent documents can be found under the "Sample Documents" link on your left. While the CSU IRB has several approved versions of consent forms for different types of research projects, please be aware that these are guides for constructing an appropriate document tailored to your specific research needs. It is the final responsibility of the PI to properly analyze and prepare an appropriate consent document. Lastly, "informed consent" can never occur through a document. The proper understanding of informed consent is that it is a "process" from subject recruitment through study completion. The informed consent form merely documents a particular understanding of the process at a certain standpoint of the research by the parties involved. It is the responsibility of the PI or his/her designees and//or research staff to ensure that proper informed consent has been obtained by all research subjects utilized during the course of the research project. The PI should ensure that documentation of this process exists and is available for inspection by the CSU IRB at all times.
Chicago State University does not recognize "passive consent" for any research project.
All research projects involving human subjects require a consent form. This includes class assignments, master's theses,doctoral dissertations, and faculty research projects. All projects, whether funded or not, are included. The title of the document should read "Chicago State University Informed Consent Form." The body of the document should consist of information that describes the goals, aim, or purpose of the research project in clear standard English at a fifth grade reading level. Please avoid technical jargon or other technical terms. The document should conclude with signature lines for the subject (or parent/guardian), the principal investigator, and a witness. The signature blocks should also include a space for the date the form is signed.
All informed consent forms shall include the following elements:
- The document should clearly state that the study involves research.
- A clear explanation of the purposes of the research.
- A clear statement regarding the expected duration of the subject's participation in the research.
- A clear description of the procedures to be followed by the participant.
- A clear description of any discomforts or risks which the subject might encounter during participation in the project.
- A clear description of any benefits which the subject might receive as a result of participation in the project.
- A statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may withdraw or discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. This should include informing the participant of what will be done with data that has already been collected after discontinuing participation.
- In cases where this is appropriate (usually where the experimental procedure involves treatment of some type), the consent form must include information about appropriate alternative procedures that would be of advantage to the subject.
- A statement by the principal investigator that s/he is willing to answer any questions the subject might have, and a telephone number at which the principal investigator can be reached.
The most common mistakes that are made when writing a consent form include failure to include the information above as well as spelling or typographical errors. The use of person should be consistent throughout the consent document; do not begin some sentences with "I," some with "You," some with " Chicago State University," etc. The document should be clear enough to make sense to a person of average intelligence.
For more information about writing a properly constructed "Informed Consent Document," you may contact: Dr. Esther Jenkins at ejenkins@csu.edu or (773) 995-2196.
lease note that this webpage is currently developing several additional modifications and improvements to its "Informed Consent Guidelines." Please check back frequently for more information.
Top
|
