Informed Consent, Assent and Parental Permission

Informed consent is an essential part of ethical human subjects research.

Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve. Institutional Review Boards and investigators are responsible for ensuring that research participants provide informed consent prior to participating in research unless the requirement for informed consent is waived or altered (in non-exempt research) by the IRB.

Templates and Guidance

The following templates contain the basic elements of informed consent and are recommended for use to streamline IRB review and ensure that regulatory requirements are met. Study-specific information should be added to the templates using complete sentences in non-technical language. Additional consent template language has been reviewed and approved by the IRB Policy Committee. This language can be inserted in the designated sections of consent documents, as applicable.

Reading Level

When adding study-specific information to the templates, use simple lay language and an 8th-grade reading level throughout. Use the Flesch-Kincaid score tool in Word to measure the document's reading level.

• write short, simple, and direct sentences using lay language
• spell out all abbreviations and acronyms
• avoid scientific or technical terms

Formatting

• use 12-point font or larger based on your audience
• Times New Roman or Arial font is recommended
• line numbers have been added to aid in the review process and must be removed after the consent has been IRB approved
• update the template header:
  • IRB Protocol Number – the number assigned by ORRP (e.g., 2023H0156)
  • IRB Approval date – the date of IRB approval, which can be found on your approval letter
  • Version – personal tracking mechanism; dates (e.g., 11/20/2022) or numbers (e.g., 1.2)

  Informed Consent Templates

  • Informed Consent Template – Behavioral and Social Science Research (12/20/2021)
  • Informed Consent Template – Biomedical and Cancer Research (04/19/2021)
  • Combined Consent and HIPAA Authorization Template (04/19/2021)
  • Informed Consent Template – Exempt Research (12/20/2021)

  Instructions and Guidance

  • Informed Consent Guidance – Behavioral and Social Science Research (03/22/2019)
  • Informed Consent Guidance – Biomedical and Cancer Research (03/22/2019)
  • Combined Consent and Authorization Guidance (02/09/2021)
  • Informed Consent Guidance – Exempt Research (01/15/2019)

  Online Research Consent Templates

  For minimal risk research being conducted online (such as using an online survey host, conducting interviews via a video messaging platform, document collection via e-mail) consent may be obtained via participants reading a script and then agreeing to participate by clicking a link to a survey, a check box formatted by the survey host, etc. This is an example of a script to be read by participants to collect consent for participation in online research. The example provided either includes or prompts information for the required elements of consent as well as additional language specific to participant confidentiality when collecting data online. A consent script must be submitted for IRB review in conjunction with a request for a waiver of consent documentation.

  • Informed Consent Online Template – IRB Research (12/20/2021)
  • Informed Consent Online Template – Exempt Research (12/20/2021)

  Electronic Signatures for Informed Consent

  There are a variety of methods that can be used to obtain and document informed consent that meet the requirements of the university’s electronic signature policy. Some of the methods qualify as a legally valid electronic signature while others would only apply to minimal risk research and require a waiver of consent documentation. Information and guidance on obtaining and documenting electronic consent is provided by the Office of Technology and Digital Innovation.

  Verbal Consent and Contact Card Templates

  In some research studies, consent may be obtained verbally rather than by using a signed consent form. The consent script example includes all of the required elements of consent and can be tailored with information specific to the study. A verbal consent script must be submitted for IRB review in conjunction with a request for a waiver of consent documentation. The contact card with study-specific and ORRP contact information may be given to participants providing verbal consent.

  • Sample Contact Information Card (08/29/2023)
  • Verbal Consent Script Template (03/01/2024)

  Parental Permission Templates

  The permission of a parent(s) or guardian must be obtained and documented for children to participate in research unless these requirements are waived by the IRB. In instances where permission of two parents is required, edit the parental permission template to add lines to capture the printed name and signature of the second parent.

  • Parental Permission Template – Behavioral and Social Science Research (12/20/2021)
  • Parental Permission Template – Biomedical and Cancer Research (04/19/2021)
  • Combined Parental Permission and HIPAA Authorization Template (04/19/2021)