Informed Consent


Informed Consent 


Both written and verbal consent for participation in research must involve an informed consent process. Informed consent involves an education and information exchange that takes place between the investigator and the potential subject.

Sometimes the information to be imparted to potential subjects is complex or possibly distressful and may require some time for it to be absorbed and appreciated. In these circumstances, the investigator should present the information and discuss the issues with potential subjects on more than one occasion, or allow a period of time to elapse between imparting the information and requesting a signature on the consent form. During this waiting period, potential subjects should be encouraged to discuss their possible participation with family members, close friends, or trusted advisors. With IRB approval, other approaches to communicating complex information can be used, including the use of audio-visual materials and brochures.

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Elements of Informed Consent

The elements of informed consent can be found in the U.S. Department of Health and Human Services (DHHS) regulations under 45 CFR 46.116 . The DHHS Office for Human Research Protections (OHRP) also publishes Guidance and FAQs and on informed consent. 

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General Requirements for Informed Consent

The general requirements for informed consent, whether written or oral, are set forth in the DHHS regulations at 45 CFR 46.116(a). They are paraphrased below:

  • Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative (LAR).
  • An investigator shall seek informed consent only under circumstances that provide the prospective subject/LAR sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
  • The information that is given to the subject/LAR shall be in language understandable to the subject/LAR.
  • The prospective subject/LAR must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
  • Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject/LAR in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
  • Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or LAR's understanding of the reasons why one might or might not want to participate.
  • No informed consent may include any exculpatory language through which the subject/LAR is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

Basic Elements of Informed Consent 

The basic elements of informed consent are set forth in the DHHS regulations at 45 CFR 46.116(b). The following basic consent elements (paraphrased) shall be provided to each subject/LAR:

  • A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
  • A description of any reasonably foreseeable risks or discomforts to the subject;
  • A description of any benefits to the subject or to others that may reasonably be expected from the research;
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  • For research involving more than minimal risk, an explanation as to whether any compensation is provided, and an explanation as to whether any medical treatments are available if injury occurs; and, if so, what the compensation/treatment consist of, or where further information may be obtained;
  • An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
  • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
  • One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
    • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject/LAR, if this might be a possibility; or
    • A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Additional Elements of Informed Consent 

The additional elements of informed consent are set forth in the DHHS regulations at 45 CFR 46.116(b). When appropriate, one or more of the following additional elements shall also be provided to each subject/LAR:

  • A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
  • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's/LAR's consent;
  • Any additional costs to the subject that may result from participation in the research;
  • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  • A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject;
  • The approximate number of subjects involved in the study;
  • A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
  • For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

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Additional Consent Considerations 

The following information must be conveyed to each subject.

  • The investigators’ names and the nature of their affiliation with the University of California, Santa Cruz should be included in the first paragraph of the consent. In any medical or semi-medical research, the title "Doctor" should be used only by M.D.s.
  • The first paragraph of the consent should convey that the prospective subject is being invited to become a research subject in a manner that makes it clear that the request of their participation is not a requirement or demand.
  • A description of study procedures that outlines what participation will involve, including: 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 an investigator is to seek data about the subject indirectly, such as inspecting private records, the data and how they will be obtained must be described. Any photographing or audio/video-recording of the subjects must be described.
  • If there is no direct benefit to subjects, a statement such as "Although there will be no direct benefit to you for taking part in this study, the investigators may learn more about ______” should be included.
  • When appropriate (for example, in cases of therapeutic trials), a clear distinction between those procedures that are in the interests of research and those that are part of treatment  should be made.
  • For projects dealing with sensitive information (including subject identifiable information), subjects should be informed of the specific precautions relating to storage, use, and disposition of the information (study data). For example, that study data will be kept in locked files, that only the study investigators will have access to the data, that subjects will be identified by a code in the data, that the key/log linking the code to subject identifiable information will be kept separate from the study data.
  • When appropriate, it should be made clear 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 data will be collected anonymously, a statement such as “The information that you provide in the study will be anonymous. Your name will not be collected or linked to the study data” should be included.
  • A full explanation of any financial compensation, or costs to the subject that may result from participation in the research.
  • For studies involving audio/video-recording, the consent should include a place for subjects 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/video-recording. If consent for audio/video-recording is required for study participation, this must be specifically noted; with a statement indicating that individuals should not agree to participate if they do not consent to such recording included.
  • For studies involving surveys, interviews, or focus groups, a statement indicating that the subject has the right to refuse to answer individual questions should be included.

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Parent/Guardian Permission 

As set forth in the DHHS regulations at 45 CFR 46.408 (b), human subjects research studies that include children or minors as subjects, the consent process should include the permission of the child’s parent(s) or legal guardian(s). Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient. When permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

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Child or Adolescent Assent 

As set forth in the DHHS regulations at 45 CFR 46.408 (a), human subjects research studies that include children or minors as subjects, the consent process should include the assent, or agreement, of the child/adolescent. 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 or are unlikely to provide direct benefit to subjects. 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 subjects, literacy, or development. 

As in any consent process, the primary focus should be enabling the subject to fully understand the explanation of the study.

The following are suggested guidelines:

Age 6-7

A simple oral description of their involvement is given to the child 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 8-12

A more complete oral description of the research (in simple terms) is given to the child. Verbal assent is requested. The procedure may be documented on the informed consent form by the signature of a witness (note: it cannot be the parent).

Age 13 - 17

Written assent should be requested from the child, using age-appropriate and developmentally-appropriate documents.

Note: the need for a witness (note: it cannot be the parent) to document verbal assent procedures depends upon the complexity of the research and the risks to the participant.

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Consent Form Templates

Template consent forms can be found on the IRB Forms page.

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Documentation of Informed Consent

As set forth in the DHHS regulations at 45 CFR 46.117, informed consent should be documented by an IRB-approved written consent form that is signed (including in an electronic format) by the subject or the subject's LAR. This form may be read to the subject or LAR, but in any event, the investigator should give either the subject or the LAR adequate opportunity to read it before it is signed. A written copy shall be given to the person signing the informed consent form. The investigators  must keep  signed consent forms according to the UCSC IRB Policy on Records Retention.

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Waiver of Documentation of Informed Consent

As set forth in the DHHS regulations at 45 CFR 46.117, an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds 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 they want documentation linking them with the research, and their wishes will govern; or
  • 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; or 
  • The subjects or subjects’ LARs are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

In cases in which the requirement for documentation of consent is waived, the IRB may require the investigator to provide subjects/LARs with a written statement regarding the research. 

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Waiver or Alteration of Informed Consent 

General Requirements for Waiver or Alteration

As set forth in the DHHS regulations at 45 CFR 46.116, an IRB may waive the requirements to obtain informed consent, or may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent,  provided the IRB finds and documents that:

  • The research involves no more than minimal risk to the subjects;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
    • The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
    • Whenever appropriate, the subjects/LARs will be provided with additional pertinent information after participation.

For research involving public benefit and service programs conducted by or subject to the approval of state or local officials, an IRB may waive the requirements to obtain informed consent, or may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent,  provided the IRB finds and documents that:

  • 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:
    • 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; and
  • The research could not practicably be carried out without the waiver or alteration

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Waiver of Parental Permission

As set forth in the DHHS regulations at 45 CFR 46.408 (c), the IRB may waive the requirement for parental or guardian permission if it determines that 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 subjects must be substituted.

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Passive Consent

Consent requires a subject to actively agree or decline to participate. Passive consent is the term used when a prospective subject'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. At UCSC the use of passive consent requires an IRB-approved waiver of informed consent.

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Consent Readability/Literacy Level and Translation

Federal regulations for the protection of human subjects require that informed consent information be presented in language understandable to the subject.  When writing the consent document, the literacy level and English language proficiency of subjects must be taken into consideration. 

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Readability Standard

Generally, consent and study materials intended for subjects 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.

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Verification of Readability

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).

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Investigators who intend to work with subjects who do not speak English, or who have limited literacy in English, should ensure that consent forms/study materials are translated into the subjects’ primary language.

In general, the risk level of the study determines whether a professional translation is required for consent documents/study materials. Studies that are deemed minimal risk do not require professional/certified translation – the IRB will accept documents translated by any individual fluent in the target language along with their attestation of accuracy. For studies that involve greater than minimal risk (typically those requiring full committee review), a professional or certified translation may be required. 

Investigators will need to attach an English version of the study consent document(s) to their submission and provide affirmation regarding translations, unless the IRB specifically requests a copy of the translated document(s)

Investigators cannot begin obtaining subject consent until the translated document(s) are approved. 

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Decisional Capacity and Surrogate Consent 

Decisional Capacity Assessment

It is universally agreed that persons signing valid research consent forms must have adequate decision-making capacity to do so. Investigators can use several procedures to enable persons with decisional capacity impairment 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, audio/video-recording of consent interviews, or involvement and/or concurrent consent of a trusted family member or friend in the disclosure and decision-making process.

A sample Decisional Capacity Assessment tool is available for use. This tool elicits a response from potential subjects to a series of questions that demonstrates the subject's capacity to understand the study's goals, risks/benefits, and choice to participate.

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Surrogate Consent

If a decisional capacity assessment determines that an individual is unable to give thoroughly informed consent, surrogate consent must be obtained from the subject's LAR such as a parent, guardian, or conservator. The investigator 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. 

Investigators must determine whether use of surrogate consent is appropriate. Consistent with state law, the IRB uses the following criteria when determining whether to permit the use of surrogate consent for participation in a research study:

  • Surrogate consent may be permitted by the IRB only in research studies relating to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of the subjects.
  • The investigator must include a rationale for the use of surrogate consent.
  • There must be a protocol-specific plan for the sequence of steps that will be employed by the investigators to acquire and document surrogate consent provided by a LAR. The investigators must include a description of this plan and provide details of how the decision making capacity of subjects will be assessed and by whom.

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Obtaining Surrogate Consent 

Investigators shall describe to potential surrogates the nature of ongoing decisions during the study regarding the subject's participation, decision to participate in certain procedures, changes to the study, etc., in order to ensure that the surrogate will be willing to undertake these on-going responsibilities. 

The Self-Certification of Surrogate Decision Makers for Participation in Research form is completed by the surrogate as an attachment to the informed consent document. It verifies the willingness of the person to serve as a surrogate, details the relationship of the surrogate to the subject and the surrogate's qualifications demonstrating "reasonable knowledge" of the subject. Investigators must give a copy of the form, along with a copy of the consent, to the surrogate and keep the signed forms in the study records. 

Potential surrogates must be advised that if a higher-ranking surrogate is identified at any time, the investigator will defer to the higher-ranking surrogate's decision regarding the subject's participation in the research. If the potential surrogate identifies a person of a higher degree of surrogacy, the investigator is responsible to contact such individuals to determine if they want to serve as surrogate.

Surrogates are prohibited from receiving any financial compensation for providing consent. This does not prohibit the surrogate from being reimbursed for expenses the surrogate may incur related to the surrogate's participation in the research.

Important Notes:

  • When the IRB approves surrogate consent for a protocol, it is with the understanding that, whenever possible, investigators will attempt to obtain informed consent directly from the subjects and that a re-consenting process may be necessary for those with fluctuating decision making capacity or those with decreasing capacity to give consent. 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.
  • Surrogate consent to participate is not permitted for persons in a State of California mental health facility inpatient psychiatric ward, or persons on psychiatric hold.
  • Modification requests to add cognitively impaired or medically incapacitated populations and/or surrogate consent is considered a significant change to the protocol.

For more information see the UC Office of the President (UCOP) Guidance on Surrogate Consent for Research.