Informed Consent

Participants who do not speak English should be presented with a consent document written in a language understandable to them and that includes all required elements of consent. A consent form fully translated into the participant’s language should be used whenever possible. An interpreter should also be used to communicate with the participant during the consent discussion and throughout the study as needed.

For more information about consent form translations, contact:

• Stanford Medicine Health Care Medical Interpretation and Translation Services
  • See: Language Access Protocol for Research, Clinical Trials, QI, etc.
  • Questions: DL-MIT-Supervisors@stanfordhealthcare.org
• Interpreter Services at Stanford Medicine Children’s Health:
  • For translation or interpretation inquiries, contact the Clinical Research Support Office at crso@stanfordchildrens.org or (650) 497-8371

Federal regulations do permit use of a Short Form Consent Process under certain circumstances, when approved by the IRB.

Federal regulations require that consent for research be obtained from the participant’s “legally authorized representative (LAR),” if the participant lacks the capacity to consent. The California Health and Safety Code addresses surrogate decision making in most research situations. This state law specifies the LAR of the participant in most research situations.

Surrogate decision makers may be used, when:

1. Informed consent has not been waived by the IRB; 
2. The individual is “unable to consent and does not express dissent or resistance to participation;” 
3. The individual is not an inpatient on a psychiatric unit or in a mental health facility or a patient on a psychiatric hold; 
4. The research involves a “medical experiment” as defined under CA HSC § 24174; and
5. The medical experiments “relate to the cognitive impairment, lack of capacity or serious or life-threatening diseases and conditions of research participants.”

If the above criteria are satisfied, the following surrogate decision makers may give informed consent for the individual to participate in the research.

For a Non-Emergency Room Environment:

Informed consent may be obtained from a surrogate decision maker with reasonable knowledge of the participant, who shall include any of the following persons, in the following descending order of priority:

1. Agent pursuant to an advance health care directive,
2. The conservator or guardian having the authority to make health care decisions for the person,
3. The spouse,
4. The domestic partner (as defined in Section 297 of the Family Code),
5. An adult son or daughter,
6. A custodial parent of the person,
7. Any adult brother or sister,
8. Any adult grandchild,
9. An available adult relative with the closest degree of kinship to the person.

Notes: 

• When there are two or more available persons who are in the same order of priority, if any of those persons expresses dissent as to the participation of the person in the medical experiment, consent shall not be considered as having been given.
• When there are two or more available persons who are in different orders of priority, refusal to consent by a person who is a higher priority surrogate shall not be superseded by the consent of a person who is a lower priority surrogate.

For an Emergency Room Environment:

Informed consent may be obtained from a surrogate decision maker who is any of the following persons:

1. Agent pursuant to an advance health care directive,
2. The conservator or guardian having the authority to make health care decisions for the person,
3. The spouse,
4. The domestic partner (as defined in Section 297 of the Family Code),
5. An adult son or daughter,
6. A custodial parent of the person, or
7. Any adult brother or sister.

Notes:

• When there are two or more available persons, refusal to consent by one person shall not be superseded by any other of those persons.

If you have questions about these legal requirements, contact the Stanford Office of the General Counsel.

eConsent is the method for obtaining and documenting informed consent using an electronic system. eConsent can be used to supplement or replace paper-based informed consent documentation. The consent process and investigator responsibilities remain the same regardless of the method used to obtain consent. The eConsent process must be reviewed and approved by the IRB before use. The eProtocol application should describe the electronic system to be employed, the process to facilitate the participant’s comprehension of the information provided, and how participants will be given the opportunity to ask questions.

The requirements for the study dictate whether eConsent is appropriate and what electronic system can be utilized.  For research that requires documentation of signed consent, the electronic system used must be able to document legally valid signatures. For research that qualifies for a waiver of documentation of signed consent, an electronic system that is able to document legally valid signatures is not required. Research that is FDA regulated (studying the safety and/or efficacy of a drug or medical device) requires use of an electronic system that is Part 11 compliant (21 CFR Part 11). 

Adobe Sign is the recommended eConsent platform for FDA regulated research. See information and instructions for using AdobeSign.

The IRB recommends the following process for obtaining informed consent from individuals who are visually impaired or unable to read, write or speak:

• The investigator should provide an oral presentation of the consent materials (this may include a pre-recorded video or audio recording);
• An impartial witness should be present for the consent discussion in accordance with the short-form consent process;
• When possible, the participant may sign or mark an X to indicate consent. If this is done, the witness should still sign the consent form; and
• The person obtaining consent should sign the consent form and document the details of the consent process in the research records.

Note that the Protocol Director and person obtaining consent must ensure that the participant understands the information provided and has agreed to participate.

For each clinical trial conducted or supported by a federal department or agency, one IRB-approved consent form used to enroll subjects must be posted on a publicly available Federal website. 

See additional guidance from Spectrum on Informed Consent Form Disclosure.

According to federal guidelines, consent form language should be suitable for the general public, written at the 8th grade level. The resources below translate commonly used scientific words into lay language that may be more easily understood:

• Lay Language Glossary
• Clinical Trials Terms

Suggested language can also be found in the National Comprehensive Cancer Network (NCCN) Informed Consent Language Database.