Informed Consent

• Informed consent should be obtained from the subject or the subject’s legally authorized representative (LAR) prior to involvement in research.
• Subjects should be given appropriate time to consider and discuss their involvement research before making a decision. 
• Investigators should minimize the possibility of coercion or undue influence on a subject’s choice of participation. 
• Information given to the subject must be in a language they understand. 
• The information given to the subject should include information that a reasonable person would want to have in order to make an informed decision. 
• Informed consent must begin with a concise and focused presentation of the key information, presented in a way that is easy to understand.
• Informed consent may not include language indicating that the subject is waiving their legal rights or language that in any way releases the investigator, sponsor, institution or other involved agents from liability or negligence.

• A statement that the study involves research.
• Explanation of the study purpose.
• Study duration.
• Description of procedures.
• Indication whether any procedures are experimental.
• Foreseeable risks or discomforts.
• Benefits.
• Appropriate alternative procedures or courses of treatment, if any.
• How confidentiality of records will be maintained.
• For research involving more than minimal risk, an explanation as to whether any medical treatments are available if injury occurs.
• Contact information in case there are questions.
• Contact information in the event of a research-related injury.
• A statement that participation is voluntary.
• A statement that deciding to not participate will involve no penalty or loss of benefits to which the subject is otherwise entitled.
• A statement that the subject may stop participation at any time.
• One of the following statements:
  • Once identifiers are removed, data may be used for future research studies or distributed to another investigator for future research studies without additional informed consent.
  • That the subject’s data collected as part of the research will not be used or distributed for future research studies, even if identifiers are removed.

The following statements should be used when appropriate: 

• A particular treatment or procedure may involve risks to the subject that are unforeseeable.
• Reasons why the subject’s participation may be terminated by the investigator.
• Additional costs to the subject.
• The consequences of a subject’s decision to withdraw. 
• A statement that significant new findings may affect the subject’s willingness to continue. 
• Whether the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will share in this commercial profit.
• Whether clinically relevant research results will be disclosed to subjects.
• Whether the research will or might include whole genome sequencing.

For human subjects research that includes minors as subjects, permission from parent(s) or legal guardian(s) should be addressed. The IRB may determine that permission from just one guardian is sufficient. 

For human subjects research that includes minors as subjects, “consent” cannot be obtained since these individuals are not of age to provide consent. Instead, child or adolescent agreement to participate (child or adolescent assent) should be addressed. Investigators should focus on describing the consent requirements in a way that minors fully understand. This is especially relevant in studies that may cause discomfort or are unlikely to provide direct benefit to subjects, since it may be challenging for minors to weigh possible societal benefits of research.

Suggested guidelines:

Age 6-7

A short verbal description of the research (in simple terms) is given to the child, with a focus on what participation will include.  The child can then indicate their verbal agreement or disagreement. This procedure may be documented on the informed consent form by the presence of an adult witness.

Age 8-12

A more complete verbal description of the research (in simple terms) is given to the child.  The child can then indicate their verbal agreement or disagreement.This procedure may be documented on the informed consent form by the presence of an adult witness. 

Age 13 – 17

Written agreement should be requested from the minor, using age-appropriate language.

Consent form templates can be found on Human Subjects Research Forms and Templates.

Informed consent should be documented using an IRB-approved consent form. This documentation can be signed by the subject or their LAR with wet ink or electronically using a UC Santa Cruz DocuSign account. A copy must 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.

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds that:

• The research presents no more than minimal risk and involves no procedures for which written consent is normally required outside the research context.
• Consent document would be the only record linking the subject to the research and the principal risk to the subject is the potential harm resulting from a breach of confidentiality.
• The study subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects and 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 or LARs with a written statement regarding the research. 

The IRB may waive the requirements to obtain informed consent altogether or may approve a consent procedure which does not include all of the elements of informed consent. To do so, all of the following must be true and indicated explicitly in the IRB submission: 

• 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 or LARs will be provided with additional pertinent information after participation.

Although not usually applicable at UC Santa Cruz, for research involving public benefit and service programs conducted by or subject to the approval of state or local officials, the IRB may grant a waiver if:

• 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.

Federal regulations require that informed consent information be presented in language understandable to the subject. Consent language should include only layperson language, and should be at or lower than an eighth grade reading level. Exceptions can be made if appropriate, based on subject populations (e.g. a study involving only interviews with university faculty). In addition, researchers are required to provide consent language appropriately translated if subjects are not fluent in English. For studies that involve greater than minimal risk (typically those requiring full committee review), a professional or certified translation may be required.