Informed Consent Checklists

These checklists do not need to be submitted with your protocol. They are provided as a tool to help you prepare your consent form.

Met / Required Element
Must be written on UCSC letterhead.
Written in layman’s language understandable to the people being asked to participate.
A statement that the study involves research.
An explanation of the purpose of the research.
An explanation of the expected duration of the subject’s participation.
A description of the procedures to be followed.
A description of any reasonably foreseeable risks or discomforts – including psychological -- to the subject. When there is no expected risk to the subject, the subject should be made aware of this.
A description of any benefits to the subject or to others that may reasonably be expected from the research. When there is no expected benefit to the subject, the subject should be made aware of this.
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
An explanation of whom to contact for answers to pertinent questions about the research, including concerns or complaints.
An explanation of whom to contact for answers to questions about research subjects’ rights.
An explanation of whom to contact in the event of a research-related injury to the subject.
A statement that participation is voluntary,
A statement that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled.
A statement that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subjects legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
Met / N/A / The following items generally apply only to biomedical research:
A disclosure of appropriate alternative procedures or courses of treatments, if any, that may be advantageous to the subject.
Identification of any procedures that are experimental.
For research involving more than minimal risk, an explanation as to whether any compensation is available if injury occurs, an explanation as to whether any medical treatments are available if injury occurs, and if so, what they consist of, OR where further information may be obtained.

*The IRB may waive some or all elements of informed consent if (a) the research involves no more than minimal risk to the subjects; (b) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (c) the research could not practicably be carried out without the waiver or alteration; and (d) whenever appropriate, the subjects will be provided with additional pertinent information after participation

Additional Elements, as Appropriate

Met / N/A / Additional Item
If the study involves video or audio recording, does the consent include a statement as to what will become of recordings after use, e.g., shown at scientific meetings, erased.
Place for subject to indicate explicit consent to be recorded.
Place for subject to indicate explicit consent for recordings to be used.
Place for subject to indicate explicit consent for identity to be made known from the audio or video recording.
Description of payment/reimbursement for participation.
Statement that subject has the right to refuse to answer individual questions.
Statements regarding reporting requirements for drug, child abuse and suicide.
If PHI is used, are appropriate HIPAA elements included? (e.g. HIPAA Authorization, Limited Waiver of Authorization, HIPAA Waiver of Individual Authorization)
For blood, tissues, or other specimens, has the final disposition been stated in the consent?
If samples of tissues, cells, blood, or body fluids (hereafter referred to as tissues) will be taken or banked for use in research, is the appropriate language included in consent?

Documentation of Informed Consent Checklist

Unless a waiver is granted, informed consent shall be documented by the use of a written consent form signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. The consent form may be either of the following:
LONG FORM
/ 1. A written consent document that embodies the elements of informed consent. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.
SHORT FORM
/ 2. A short form written consent document, stating that the elements of informed consent have been presented orally to the subject or the subject's legally authorized representative.
The IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, a witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
WAIVER of req't for signed form / An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects, if it finds either:
1. That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
2. That the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research