What are the required elements of informed consent?

The basic required elements of informed consent can be found in the U.S. Department of Health and Human Services (HHS) regulations under 45 CFR 46.116(a). The HHS Office for Human Research Protections (OHRP) also publishes Tips on Informed Consent
The regulations and UCSC policy require that the following information must be conveyed to each subject:
  • 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-always include the Principal Investigator/Faculty Sponsor.
  • Purpose: A statement that the study involves research and a clear explanation of the overall purposes of the research.
  • Procedures: 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.
  • Risks or Discomforts: A clear description of any reasonably foreseeable risks or discomfort to the subject. Non exempt research should at least include risk of inadevertant breach of confidentiality of records.
  • 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 ___."
  • 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.
  • 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 (allegations of abuse for mandated reporters, sexual harrassment and violence allegations for responsible employees who must report), 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.
  • For studies involving video or audio recording: subjects should have places to indicate explicit consent to be recorded, for the recordings to be used (e.g., for this study; in future studies; shown at academic conferences), and for the subject's identity to possibly be made known from the audio or video recording.
  • For studies involving blood, tissues, cells, or body fluids: the consent form should describe the final disposition of any collected samples.
  • Financial Considerations: A full explanation of any remuneration or costs to the subject that may result from participation in the research.
  • 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.”
  • Voluntariness: 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 entitled.
  • Skipping questions: The consent materials should include a statement that the subject has the right to refuse to answer individual questions.
  • Contact Information: The researcher must offer to answer any questions about the research, 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. ORCA's contact information must also be provided to subjects as a resource for any questions regarding subjects' rights. NOTE: If researcher and/or ORCA is not within local calling area of subject(s), provisions should be made to allow calling without long distance charge to subjects.
  • Overall Readability: The consent form should be written in layman's language understandable to the people being asked participate. A general guideline to use is that the consent form should be written on an 8th grade reading level.
  • Exculpatory Language: 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 investigatory, the sponsor, the institution, or its agents from liability or negligence.

Image Release & Consent Forms

If the recorded images collected during your study will only be viewed and coded by the investigators specified in the project proposal, an explanation of your intended use of images can be included in a standard consent form. If you plan to publicly display participants' images - for example, in a film, photo or video installation, or on the internet - image release forms may be necessary. The image release process is not overseen by the IRB.

Documentation of informed consent

Informed consent should contain the required requlatory elements of informed consent and be documented by a written form that is signed by the subject or the subject’s legally authorized representative (unless a waiver or alteration of consent or waiver of documentation of consent is requested and approved). The researcher must keep the signed consent forms for at least three years after the research has ended. 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.

Waiver of documentation of informed consent (unsigned consent)

The required elements of informed consent have been presented to the subject or the subject's legally authorized representative (e.g., orally, visually, etc.) but the subject does not sign the document. A copy of the summary may be required be given to the subject or the representative by the IRB.

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.

Waiver or alteration of informed consent (no consent or some elements missing)

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

  1. The research involves no more than minimal risk to the subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. The research could not practicably be carried out without the waiver or alteration; and
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation; or
  • 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.
Waiver of Parental Consent
Alternatively, under 45 CFR §46.408 (c), parental consent may be waived if the IRB determines that parental or guardian permission is not a reasonable requirement to protect the subjects, such as in cases of neglected or abused children. In these cases, an appropriate mechanism for protecting the children must be substituted.

Translation of Recruitment and Consent Materials

Federal regulations for the protection of human subjects require that informed consent information be presented "in language understandable to the subject" and in most cases the process needs to be documented in writing (45 CFR §46.116 and 45 CFR §46.117).  When writing the consent document, the readability/literacy level and English language proficiency of subjects must be taken into consideration. (Also see Informed Consent: Readability/Literacy Level)
Translation into other languages
Researchers who intend to work with participants who do not speak English, or who have limited literacy in English, should ensure that consent forms are translated into the participant’s primary language.
Is a professional or certified translation required?
In general, whether a professional translation is required for consent/assent forms and materials for participants depends on the risk level of the study.  Studies that are deemed minimal risk (typically those studies that are either exempt or eligible for expedited review) do not require professional/certified translation – the IRB will accept documents translated by any individual fluent in the target language along with their attestion of accuracy. For studies that involve greater than minimal risk (typically those requiring full committee review), a professional or certified translation may be required.When should I submit my translated consent form or script for oral consent?
Investigators should submit both the English and the translated consent document(s) with their application. Note that you cannot begin obtaining participant consent until the translated form is approved. If subjects requiring a translated consent won’t be recruited until later in the project, it is acceptable to submit the translated consent form at a later date as a modification.

Informed Consent: Readability/Literacy Level

Federal regulations for the protection of human subjects require that informed consent information be presented "in language understandable to the subject" and in most cases the process needs to be documented in writing (45 CFR §46.116 and 45 CFR §46.117).  When writing the consent document, the literacy level and English language proficiency of subjects must be taken into consideration. (Also see Translation of Recruitment and Consent Materials

Readability Standard
Generally, consent and study materials intended for participants should be written at the 8th grade level (the average reading level of adults in the United States) or lower. If appropriate, the literacy level can be adapted to your target audience – e.g. if your study involves interviews with university faculty – but clear, straightforward language is always recommended.
How can I check the readability of my documents?
There are a variety of tools for assessing the literacy level or readability of written documents. Microsoft Word includes such a tool.
For Word 2003:

  • Go to the Tools, Options, Spelling and Grammar.
  • Under Grammar, click on Show readability statistics and click OK.
  • Word will take you through your spelling and grammar check and then display information about the reading level of the document. 

For Word 2007:

  • Click on the Office icon in the upper-left corner of the Word window
  • Click Options, Proofing.
  • Check the box next to "show readability statistics.”
  • Run spell check as you usually would and after Word takes you through your spelling and grammar check, it will display information about the reading level of the document.

For Word 2010:

  • Go to Word, Preferences.
  • Click on the Spelling and Grammar icon.
  • Under the Grammar section, check the box next to "show readability statistics."
  • Click OK.
  • Run spell check as you usually would (Tools, Spelling and Grammar) and after Word takes you through your spelling and grammar check, it will display information about the reading level of the document.

Interpreting Readability Statistics
Microsoft Word describes readability according to three different tests. The “Flesch-Kincaid Grade Level” test produces an approximate U.S. school grade level – for example, a score of 8.0 represents an eighth grade reading level. For most documents, a score between 7.0 and 8.0 is recommended (note that lengthy proper nouns may skew to a higher grade level).

Regardless of reading level, consent documents should contain all the required elements of informed consent.

Informed Consent: Surrogate Consent

If a capacity assessment determines that an individual is unable to give thoroughly informed consent, surrogate consent must be obtained from the participant'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 and the representative sufficient opportunity to consider the matter carefully and that minimize the possibility of coercion or undue influence. 
Additionally, for research protocols involving subjects who have fluctuating or limited decision-making capacity, the IRB will seek to ensure that investigators establish and maintain ongoing communication with involved caregivers or designated legal representatives. Periodic re-consent may be considered in some cases. Third party consent monitors may also be used during the recruitment and consenting process, or waiting periods may be required to allow more time for the subject to consider the information that has been presented.
Investigators can use several procedures to enable persons with decisional impairments to make voluntary and informed decisions to consent or refuse participation in research. Potential measures include repetitive teaching, audiovisual presentations, and oral or written recall tests. Other measures might be follow-up questions to assess subject understanding, videotaping or audio-taping of consent interviews, or involvement and/or concurrent consent of a trusted family member or friend in the disclosure and decision-making process. 

For more information, review University Guidance on Surrogate Consent for Research (published by the University of California Office of the President, 2003).

Child or Adolescent Assent to Participate in Research

In human subjects research projects that include children or minors as participants, the consent process should include the assent, or agreement, of the child/adolescent and the permission of the parent(s) or legal guardians. Children and adolescents should be given the opportunity to have the elements of consent described to them in language they can understand and voice their opinions: either expressing their assent to or dissent from participation in a study. This is especially relevant in studies that may cause discomfort to participants or are unlikely to provide direct benefit to participants.  It may be challenging for children to weigh possible indirect benefits to others. However, the need for and type of assent process may vary depending on various factors including, the age of the participants, literacy, or development.
The following guidelines have been proposed by the National Institutes of Health:
Age 6-7
A simple oral description of the child's involvement is given to the participant and verbal assent is requested. The procedure may be documented on the informed consent form by the presence of the signature of a witness (note: it cannot be the parent).

Age 8-13
A more complete oral description of the research (in simple terms) is given to the participant. Verbal assent is requested. The procedure may be documented on the informed consent form by the signature of a witness.

Above age 13
Written assent should be requested from both parent and child, using age-appropriate and developmentally-appropriate documents.
Note: the need for a witness to document verbal assent procedures depends upon the complexity of the research and the risks to the participant.
As in any consent process, the primary focus should be enabling the participant to fully understand the explanation of the study.

What is passive consent?

Consent requires a subject to actively agree or decline to participate. Passive consent is the term used when a prospective participant's failure to either agree to or decline an invitation to participate is intentionally or unintentionally interpreted as opting in. Passive consent is not true consent because it does not assure that participation is truly voluntary. This method requires requesting a waiver of informed consent.

Consent FAQ