Office of Research Consent Documentation - Office of Research

Consent Documentation

Documenting informed consent occurs after explaining the research and assessing participant comprehension. Documentation of consent involves obtaining the signature of the participant (or LAR or parent(s), as applicable) as well as the person obtaining consent. In certain situations, an impartial witness or translator may also need to sign the consent document.

When certain requirements are met, the IRB can waive the requirement for documentation of consent. In these cases, the research subjects will be provided with information about the research but will not sign a consent document. Information is usually presented in an information sheet or an oral script.

In This Section 


 

What is the Requirement?

45 CFR 46.117 (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A written copy shall be given to the person signing the informed consent form.


 

Waiver of Documentation of Consent

46.117(c)(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following: 

(i) That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; 

(ii) 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; or 

(iii) If the subjects or legally authorized representatives 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. 

 When the requirement for a signature is waived, the individual obtaining consent must ensure that the participant receives the consent information, comprehends the information and voluntarily agrees to participate in the research.  Often the IRB will require the researcher to provide written information to potential participants in an Information Sheet, email invitation or as introductory language for a survey.  


 

How do I Comply with this Requirement?

Initial Review Application 

On the PI Attestation page, you will see links to the UC Davis standard operating procedures (SOPs) for consent process (HRP-090) and consent documentation (HRP-091). These SOPs are designed for use by researchers and provide the legal and ethical guidelines for consent process and consent documentation. As part of the attestation, you will confirm that you will follow HRP-090 and HRP091, as they apply to your research.

On the Consent page, you will be asked “Which of the following are involved? (Check all that apply)”

  • Signed Informed Consent: Research subjects will be informed about the research and will sign a consent document prior to enrolling in the research.
  • Information Sheet or Oral Consent: Research subjects will be informed about the research and will agree to participate but will not sign a consent document. Appropriate for some exempt research or with an IRB issued Waiver of Documentation of Consent.
  • No consent process: Research subjects will not be informed about research and will not have an opportunity to agree to participate. Appropriate for some exempt research or under an IRB issued Waiver of Consent.

Select “Signed Informed Consent” to indicate that potential research subjects (or their LAR) will be given information about the research and, after having an appropriate amount of time to decide, will sign a consent document if they choose to enroll in the research. This is appropriate for all greater than minimal risk research and for minimal risk research that does not qualify for a waiver of documentation.

Select “Information Sheet or Oral Consent” if potential research subjects (or their LAR) will be given information about the research and, after having appropriate time to decide, will chose whether to enroll in the research, but they will NOT sign a consent document. The information may be presented orally or in writing. This process is appropriate for some exempt research or when research qualifies for a waiver of documentation of consent. This is often used for research involving interviews, online surveys, or when anonymous sensitive information is collected, and you do not want any paperwork that links the subject to the research study. Note that this is not the same as electronic signature of consent. See additional guidance under “Documentation of Consent”.

 

If you select “Information Sheet or Oral Consent” you will be asked for the following study details.

  • Does this research involve any procedures for which written consent is usually required? For example, surgery, imaging, release of educational records, etc.
  • Is the consent document the only document linking the participant to the research?
  • Are the research subjects members of a distinct cultural group or community in which signing forms is not the norm?

 

Select “No consent process” to indicate that there is no consent process for your research. This means that research subjects (or their LAR) will not receive information about the research and will not decide whether to participate. Generally, this option is only used for secondary analysis of private identifiable data or specimens.

If you select “No consent process” you will be asked if any of the following are true. Select all that apply.

  • The research team will have no direct contact with potential research subjects.
  • Obtaining consent could pose a risk to subjects’ privacy, physical safety, or psychological wellbeing.
  • Failure to obtain a complete or representative data set would prevent this study from drawing reliable conclusions.
  • Other

Consent Documents and Information Sheets

The UC Davis IRB provides several template consent documents or your use. Download any template and customize the details to describe your specific research. The red and highlighted text in these templates is instructional and should be removed before submitting to the IRB. At the end of the templates, you will find pages titled “Signature Block” for various populations (Capable Adult, Adult Unable to Consent, Children). Include the signature block pages for the populations that will be recruited for your research; delete the other pages. When requesting a waiver of documentation of consent, delete all signature block pages. When there are no signature blocks the consent, document is often referred to as an Information Sheet.

 


 

Electronic Documentation of Consent vs. Waiver of Documentation Consent

It is important to understand the difference between using methods other than paper and pencil to document informed consent and waiving the requirement to document informed consent altogether. 

When providing consent online, there are a number of ways in which an e-signature might be documented. Some examples include: 

Attaching a scanned handwritten signature or using an e-signature service such as Adobe’s EchoSign; 

Typing one’s name with an accompanying check box and statement noting an intent to affix a legal signature (e.g., “By checking this box and typing my name below, I am electronically signing this consent form”); or 

Signing with a stylus in an electronic document. 

All constitute “signatures.” A waiver of documentation of informed consent is not required for these procedures. 

When a consent procedure will not include a written signature, it requires a waiver of documentation of informed consent. Common examples include online consent where participants are directed to begin a survey after reading an information sheet, or eligibility screening performed over the telephone with a potential subject. In these cases, the research team must request a waiver of documentation of informed consent from the IRB. 


 

Signature Requirements

Unless the IRB waives the requirement for a signed consent form, consent must be documented in one of the following manners, as approved by the IRB: 

Handwritten signature: 

  1. The participant (or the participant’s legally authorized representative (LAR)) personally signs and dates the consent form. 
  1. The individual obtaining consent personally signs and dates the consent form. 
  1. When necessary, the impartial witness personally signs and dates the consent form. 
  1. A copy of the signed and dated consent document is provided to the participant or the LAR. 
  1. The original signed and dated consent document must be maintained in the research files. 
  1. When applicable, place a copy of the signed and dated consent document in the participant’s EMR. 
  1. These statements should be included in the research record:  
  • A statement indicating that informed consent took place; 
  • The participant (or LAR) apparently understood the information and voluntarily agreed to participate; 
  • A copy of the signed and dated consent document was provided to the participant or LAR; 
  • The time and date the process took place. 

Electronic Signatures 

Federal regulations allow electronic signatures when the documentation process is approved by the IRB. UC Davis IRB will approve the use of a secure system for electronic or digital signature when the system provides an encrypted identifiable “signature” compliant with federal regulations. 

As with handwritten signatures, both the participant/LAR and the individual obtaining consent must provide an electronic signature. 

A paper or electronic copy of the consent must be provided to the participant. The electronic copy can be provided on an electronic storage device, through a document sharing program or via email.  However, only secure email should be used when the consent document includes identifiable health information or other sensitive information (e.g. subject diagnosis, use of illicit substances, etc.). 

If the electronic consent document includes one or more hyperlinks to information on the Internet, the hyperlinks should be maintained and information should be accessible to participants until study completion. If the hyperlinks or other web sites or podcasts convey information specifically related to the informed consent process, the information in these hyperlinks must be included in any printed paper copy, if one is provided. 

Whether using handwritten or electronic signatures, IRB Administration recommends that you document the steps completed during the consent process in the research record as outlined above. 

HIPAA and Electronic Signatures 

C Davis Health allows electronic signature for HIPAA Authorizations to be captured using only the UCD Health licensed DocuSign platform. To sign up for access to the UCD Health version of DocuSign, please put in a request through Service Now here. For further instructions on how to request DocuSign access, please see this webpage. Please note that currently there is no UCD Health approved platform for capturing electronic signatures on HIPAA Authorizations for studies subject to FDA Part 11.


 

Resources