Documentation of Informed Consent

Documentation of Informed Consent
Depending on the risk posed by the research, a concluding consent statement at the “Documentation of Informed Consent” must be included.

If the research is exempt but requires written informed consent or if the research is not exempt but contains procedures which are clearly less than minimal risk, the consent form must contain the following standard concluding consent statement in bold type:

You are voluntarily making a decision whether or not to participate in this research study. Your signature certifies that you have decided to participate having read and understood the information presented. You will be given a copy of this consent form to keep.

Printed Name of Subject Date

Signature of Subject Date

In my judgment the subject is voluntarily and knowingly giving informed consent to participate in this research study.

Signature of Investigator Date

If the research includes procedures that are minimal risk or greater, the consent form must contain the following standard concluding consent statements in bold type:

You are voluntarily making a decision whether or not to participate in this research study. Your signature certifies that the content and meaning of the information of this consent form have been fully explained to you, and that you have decided to participate having read and understood the information presented. Your signature also certifies that you have had all your questions answered to your satisfaction. If you think of any additional questions during this study, please contact the investigator(s). You will be given a copy of this consent form to keep.

Printed Name of Subject Date

Signature of Subject Date

My signature as a witness certifies that this subject signed this consent form in my presence as his/her voluntary act and deed.

Printed Name of Witness Date

Signature of Witness Date

In my judgment the subject is voluntarily and knowingly giving informed consent and possesses the legal capacity to give informed consent to participate in this research study.

Signature of Investigator Date

Note: a witness signature is required for greater than minimal risk research.

If the subject recruitment process (for example, mailed consent forms) precludes the use of the investigator’s concluding consent statement, it should be omitted. If it is logistically impossible or unwarranted to ask the subject to sign and return the consent form the subject’s concluding consent statement should be modified as needed.