Informed Consent Form Checklist

Informed Consent Form Checklist

This form must be submitted with the research protocol and informed consent form. Failure to do so will cause review of your protocol to be deferred.

Informed consent is one of the primary ethical requirements for research with human subjects; it reflects the basic principle of respect for persons. No principal investigator may involve a human being as a subject in research, as defined in the Wofford College Institutional Review Board Policy and Procedure Manual for Research with Human Subjects, unless the investigator has obtained the subject's informed consent. The process of informed consent is constituted on two essential elements: (1) the subject has the information he or she requires to make an effective decision, and (2) the subject's participation is not coerced, i.e. his or her consent is voluntary.

The checklist below is provided to ensure that each of the following components is included in your Informed Consent form. Please notate N/A next to those items that are not applicable to the protocol being submitted.

The Informed Consent form is written in a language understandable to the subject or his/her legal representative.

The Informed Consent form is written in a consistent voice either first, second, or third person (not a combination) with the exception of the Voluntary Consent section, which is written in the first person.

Each page of the Informed Consent form is on original Wofford College letterhead, except in cases of collaborative projects when the letterhead from a hospital, university, etc. is acceptable.

If the research is externally funded, the funding agency is listed under funding source.

The title of the study and the name, address, and telephone number of the investigator(s) is listed.

If the principal investigator is a student, the address and phone number of his/her advisor(s), clinical Supervisor(s) are listed.

The phone number for the IRB Office is listed.

A statement that the study involves research and an explanation of the purpose of the research is included.

A concrete description of the study procedures, including the amount of time subjects are being asked to contribute and the nature of the questions or data to be collected, is included. Any procedures which are experimental are identified and any alternative procedures disclosed.

A description of any risks and possible discomforts to the subjects, if any, is included.

A description of any benefits to the subjects is included. If no benefits are expected, this is stated.

A statement describing the extent to which confidentiality will be maintained is included in addition to a clause which states that all information obtained is strictly confidential unless disclosure is required by law.

If subjects will be compensated for their participation, a statement has been included addressing this.

A statement that participation is voluntary, that refusal to participate involves no penalty, and that the subject may discontinue participation and have any data collected destroyed at any time is included.

A statement indicating who the subject can contact for any questions about the study is included.

The Informed Consent contains no language through which the subject is made to waive any of his/her legal rights or which releases the investigator, the sponsor, or the institution from liability for negligence.

The entire paragraph under Section VI-Voluntary Consent on the Informed Consent form appears in boldface and the first sentence reads "I have read this consent form (or it has been read to me), and I fully understand the contents of this document and voluntarily consent to participate."

A space for the subject's signature, the date, and the signature of a witness is provided.

An assent form is included for subjects 7-17 years of age.



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