• What is Informed Consent?


• How should Informed Consent be Documented?


• Basic Principles of Informed Consent


• Required Elements of Informed Consent


• Requesting a Waiver of Informed Consent


• Requesting a Waiver of the Requirement for a Signed Consent Form


• Deception and Misleading Information


• Resources/Training


• Informed Consent Checklist


• OHRP FAQ on Informed Consent


• Sample Informed Consent Documents

What is Informed Consent?

Informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a research project, after having been informed of all aspects of the research that are relevant to the subject’s decision to participate. 

Documentation of Informed Consent

Informed consent should be documented by a written form that is signed by the subject or the subject’s legally authorized representative. The researcher should keep the signed consent forms for at least three years after the research has ended.

The consent form may be either of the following:

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.

2. A short form written consent document, stating that the required elements of informed consent have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation.  Also, 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, the 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.

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Basic Principles of Informed Consent

Unless a waiver is granted, the researcher must obtain the informed consent of each subject to participate in the research. If the subject is legally incompetent to give consent, it must be obtained from the subject's legally authorized representative such as a parent, guardian, or conservator.

The researcher should seek such consent only under circumstances that give the prospective subject or the representative sufficient opportunity to consider the matter carefully and that minimize the possibility of coercion or undue influence. The information that is given should be in a language and in words understandable to the subject or the representative. It should be a full, clear, but succinct explanation, without jargon or technical terms, calculated to inform a person with at least 8 years of elementary school education.

No informed consent may include any language, whether oral or written, through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, including release of the researcher, the sponsor, the University, or its agents from liability for negligence.

When research involves minor children, special rules apply. The researcher should obtain the assent of the children insofar as they are capable of providing it, taking into account their age, maturity, ability to read, and psychological state. If the children are old enough to read and write, they should be invited to sign the consent form along with their parents. Except in unusual cases, the researcher should also obtain the informed consent of each child's parents or guardians. If only one parent is reasonably available or has legal responsibility for the care of the child, that parent's consent is sufficient. Researchers are encouraged to consult the UCSC IRB for more information on this matter.

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Required Elements of Informed Consent

The following information should be given to each subject:

1. Identification: The researcher's name and the nature of the researcher's affiliation with the University of California at Santa Cruz should be stated in the first paragraph. In any medical or semi-medical research, the title "Doctor" should be used only by M.D.'s.

2. Invitation: An invitation to the person to become a research subject should be offered, not a request that is in the nature of a requirement or demand.

3. Purpose: A statement that the study involves research and a clear explanation of the overall purposes of the research.

4. Procudures: Give a description of the what participation will involve:

• Describe what the subject will be expected to do, who will conduct the procedures, where and when they will take place, how often they will be performed, and how much time will be required.
• Identify any procedures that are experimental.
• Prospective respondents to surveys or interviews should be warned of any sensitive personal or questions and should be provided with several examples of these.
• If a researcher is to seek data about the subject indirectly, such as inspecting private records, describe the data and how they will be obtained.
• Be sure to describe any photographing or video or audio tape recording of the subject.

5. Risks or Discomforts: A clear description of any reasonably foreseeable risks or discomfort to the subject. If there are no risks or discomforts, then include a statement to the following effect: "There are no anticipated risks in this study."

6. Benefits: A clear description of any benefits to the subject or to others that may reasonably be expected from the research. If of no direct benefit to the subject, include a sentence to the following effect: "Although there will be no direct benefit to you for taking part in this study, the researcher may learn more about ___."

7. Treatment: When appropriate (for example, in cases of therapeutic trials), the researcher should (a) make a clear distinction between those procedures that are in the interests of research and those that are part of treatment, and (b) state appropriate alternative procedures or courses of treatment that might be advantageous to the subject.

8. Confidentiality: A clear statement of the extent to which the confidentiality of private data identifying the subject will be maintained. Subjects may be willing to agree to the release of identifiable data. If so, this agreement should be spelled out explicitly in the consent materials.

- For projects in which the private information collected is not sensitive, it suffices to inform the subject that the researcher will take precautions to preserve the confidentiality of the research data and that all reports of the research will be devoid of identifiers. When dealing with more sensitive information, the researcher should specify some of the precautions relating to storage, use, and disposition of the materials; for example, that data will be kept in locked files, that only the researcher will have access to them, that subjects will be identified by a code the key to which will be kept separate from the data. In most cases, the researcher should give subjects full information on the proposed management, use, and disposition of photographs and audio or video recordings.

- If the researcher intends to retain the human subjects data after the immediate project is completed for possible use in future projects by the researcher or others, this should be spelled out in the consent materials.

- When appropriate, subjects should be told that while confidentiality cannot be guaranteed against legal processes, including subpoena, it will be protected to the full extent of the law.

- If the study will be anonymous, use works to the following effect: The information that you give in the study will be anonymous. Your name will not be collected or linked to the data.

- If it is possible to deduce the participant’s identity, state the following: Because of the nature of the data, it may be possible to deduce your identity; however, there will be no attempt to do so and your data will be reported in a way that will not identify you.

- If the study involves information that legally must be reported to government agencies, then include the following: Your part in this study is confidential within legal limits. The researchers will protect your privacy unless they are required by law to report information to city, state or federal authorities, or to give information to a court of law. Otherwise, none of the information will identify you by name.

9. FINANCIAL CONSIDERATIONS: A full explanation of any remuneration or costs to the subject that may result from participation in the research.

10. INJURIES: In research that involves risks of harm greater than those encountered during routine examinations or tests, the researcher must include the following notice on the availability of medical treatment and compensation if injury occurs. The statement should read:

"If injured as a result of taking part in this study, medical care and treatment will be available to a participating subject. The costs of this care may be covered by the University of California depending on a number of factors.”

11. DISCLAIMER: The consent materials must contain a clear statement that participation in the research is voluntary, and that the subject is free to refuse participation altogether or to discontinue it at any time without penalty or loss of benefits or services to which the subject is otherwise en titled.

12. QUESTIONS: The researcher must offer to answer any questions about the research and the subject's rights, including, when appropriate, whom to contact in the event of a research related injury. The telephone number or address of the researcher must be provided. NOTE: If researcher is not within local calling area of subject(s), provisions should be made to allow calling without long distance charge to subjects.

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Waiver of Informed Consent

The UCSC IRB may waive the requirement to obtain informed consent, or it may approve a consent procedure that alters some of the elements of informed consent described above. Before the UCSC IRB does so, the researcher must satisfy the requirement that:

1. The research presents:
- No risks of harm, considering probability and magnitude, greater than those ordinarily encountered in daily life or during the performance of routine examinations or tests; and
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- The research could not practicably be carried out without the waiver or alteration; and
- When appropriate, the subjects will be provided with additional pertinent information after participation; or

2. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
- Programs under the Social Security Act, or other public benefit or service programs;
- Procedures for obtaining benefits or services under those programs;
- Possible changes in or alternatives to those programs or procedures; or
- Possible changes in methods or levels of payment for benefits or services under those programs.

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Waiving Documented Consent

The UCSC IRB may waive the requirement for the researcher to obtain signed written consent for some or all subjects. Before the UCSC IRB does so, the researcher must satisfy the UCSC IRB requirement that either:

• The only record in the researcher's possession 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. The UCSC IRB requires that each subject be asked whether they want documentation linking them with the research, and the subject's wishes will govern; or
• The research presents no risks of harm, considering probability and magnitude, greater than those ordinarily encountered in daily life or during the performance of routine examinations or tests, and the research involves no procedures for which written consent is normally required outside of a research context.

When the documentation requirement is waived, the UCSC IRB requires that the researcher provide subjects with a written or oral statement containing the elements of informed consent, when appropriate.

Negative consent, when a potential subject's failure to decline or respond to an invitation to participate is treated as consent should almost always be avoided. In some cases, the researcher may want subjects who decide not to participate to indicate this on the consent form and return it. In those cases, the researcher should add an assurance that prospective subjects who decide not to return the form will not be included in the study.

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Deception and Misleading Information

Informed consent implies that subjects will be correctly informed and not deliberately misled. In exceptional cases, the UCSC IRB may allow a researcher to give subjects somewhat misleading information about the nature of the research.

Before the UCSC IRB does so, the researcher must include in her/his protocol a detailed explanation of:

• Why the research could not practicably be carried out without the deception; and
• Why the deception will not significantly affect the well being of the subjects.

Moreover, after participation by the subjects, the researcher must:

• Correct the misleading information; and
• Give the subjects an opportunity to reaffirm or withdraw their consent.

A copy of the final consent and debriefing form must be submitted for Committee review and approval.

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Resources/Training

Individuals involved in the Informed Consent Process should consider completing an online training course.  Click here to link to the CITI Program, which provides ethics education to all members of the research community at UCSC.