Informed Consent

• Definition:
  Participants give informed consent, but they do not sign a form. Instead, researchers follow a consent script or provide participants with an information sheet summarizing the conversation.
• When Used:
  Minimal risk research not occurring face-to-face, such as surveys sent by mail or completed online, telephone interviews, or the collection of sensitive information without a written record which could identify participants.
• Related Guidance:
  • Waiver of Signed Consent

• Definition:
  Participants give informed consent, using a consent script or document using a consent script or document that omits some or alters some or all elements of informed consent.
• When Used:
  Minimal risk research such as surveys or telephone interviews.
• Related Guidance:
  Waiver of Informed Consent

• Definition:
  The research is conducted without obtaining consent from participants.
• When Used:
  Medical chart reviews or analysis of existing data. In rare cases where secondary participants may be involved and it would either be prohibitive or potentially dangerous to obtain consent.  
• Related Guidance:
  Waiver of Informed Consent

• Definition:
  Children indicate their willingness to participate in research, verbally or by signing an assent form. In most cases, parent/guardian permission for the child’s participation must also be documented via standard written consent.
• When Used:
  Research involving prospective enrollment of children (in Wisconsin, those under age 18).
• Templates:
  • Assent - therapeutic study
  • Assent - non-therapeutic study

• Related Guidance:
  • Assent by Children
  • Model language for assent and parent / guardian permission
  • Model language for signature sections

Special consent processes are needed with some subject populations to ensure that information about study participation is communicated effectively and that their rights and welfare are protected. Certain situations may also require special consent processes. The documents below provide population- and situation-specific guidance for conducting the consent process.

• Documenting Consent Electronically or for Remote Subjects Guidance
• Illiterate Research Participants
• Legally Blind Research Participants or Legally Authorized Representatives
• Non-English or Limited English Speaking Research Participants
• Adult Research Participants Lacking Capacity to Consent
• Advance Directive for Research
• Power of Attorney for Research
• Consent Processes for Exempt Studies
• Re-Consenting Subjects Guidance
• Guidance Regarding Self-Experimentation of Researchers as Study Subjects

• Electronic Code of Federal Regulations: This page lists the federally required elements of consent. All applicable elements should be included in consent documents.
• HS IRBs Informed Consent Checklist: HS IRBs staff use this checklist to confirm that consent documents and consent processes comply with regulatory and institutional requirements. Researchers may find this a helpful tool when preparing consent documents to submit for IRB review.

• Guidance from Federal Agencies:
  • Informed Consent FAQs from the Office of Human Research Protections
  • FDA Guide to Informed Consent
  • Children’s Assent Guidance from the National Cancer Institute

• Readability: Helpful tools for making consent and assent documents easier for research participants to understand.
• The Federal Plain Language Guidelines and NIH Plain Language site provide concrete advice for presenting technical information in an understandable way.
• The CDC’s Simply Put: A Guide for Creating Easy-to-Understand Materials (PDF) recommends techniques that can be applied to consent documents.
• UW-Madison's Cultural and Linguistics Services offers Plain Language Workshops on writing and designing clear, readable documents.
• The CDC's Clear Communication Index can help you evaluate the effectiveness of your consent documents.
• Readability-Score.com uses several calculators (e.g. Flesch-Kincaid) to assess readability and grade level of text.
• Tools for simplifying medical and research-related terminology:
  • National Patient Safety Foundation’s Words to Watch – Fact Sheet (PDF)
  • The University of Iowa: Medical Terms in Lay Language
  • National Comprehensive Cancer Network (NCCN) Informed Consent Language Database
  • CDC Plain Language Thesaurus
  • University of Michigan’s Plain Language Medical Dictionary

Use these templates for studies involving physical intervention with any level of risk. Examples: research blood draws, exercise, imaging, dietary restrictions or supplements, drugs or devices administered for research purposes.

• Physical Risk Template plus HIPAA: For studies to which the HIPAA Privacy Rule applies. Study teams are encouraged to use this combined consent and authorization form, rather than a separate HIPAA authorization, whenever possible.
• Template with instructions (use for guidance and reference)
• Template without instructions (use to create consent forms)
• Physical Risk Template: For studies to which HIPAA either does not apply or that must use a separate HIPAA authorization form.

• Template with instructions (use for guidance and reference)
• Template without instructions (use to create consent forms)

• Physical Risk plus Summary: For studies to which HIPAA either does not apply or that must use a separate HIPAA authorization form. Use this template for consent forms more than 10 pages long (not counting illustrations, tables, or signature pages). This template begins with a Study Summary designed to serve as the concise and focused presentation of key information for lengthy consent forms.

  • Template with instructions (use for guidance and reference)
  • Template without instructions (use to create consent forms)

Use a separate Study Summary as a supplement if your consent form:

• Is based on a consent form template other than one of those posted above;
• Does not begin with a concise presentation of key information;
• AND Is more than 5 pages long.
  

This is most likely to happen with studies that are not federally funded and use a consent template provided by a study sponsor.

• Study Summary Template

Use these templates for non-exempt studies whose procedures involve no physical risks. Examples: data or biospecimen repositories, recruitment registries, telephone or mobile app-based interventions, surveys, interviews.

• Non-physical Risk Template plus HIPAA: For studies to which the HIPAA Privacy Rule applies. Study teams are encouraged to use this combined consent and authorization form, rather than a separate HIPAA authorization, whenever possible.
• Template with instructions (use for guidance and reference)
• Template without instructions (use to create consent forms)
• Non-physical Risk Template: For studies to which HIPAA does not apply or that must use a separate HIPAA authorization form.
  • Template with instructions (use for guidance and reference)
  • Template without instructions (use to create consent forms)

See this page for template consent form language to describe reproductive risks to subjects, conflicts of interest within the study team, long-term banking of data or specimens for future use, certificates of confidentiality, and other situations.

• Consent Addendum Template: For communicating significant new information to study participants.
• Additional Model Language: Standardized language to describe reproductive risks to subjects, conflicts of interest within the study team, long-term banking of data or specimens for future use, certificates of confidentiality, and other situations.
• Short Form Template: Used to document a consent process for research participants who cannot read the standard consent form.
• Exemption Consent Template: For studies that qualify for exemption under Category 1 (educational practices) and Category 2 (interviews, surveys, focus groups, observations of public behavior).
• VA Consent Template: For studies that fall within the purview of the Madison VA Hospital.
• Emergency/One-Time Use Consent Template: For the use of an unapproved drug, biologic or device outside of its FDA-approved indications in "emergency use" situations which meet specific federal regulatory criteria.
• Humanitarian Use Device (HUD) Consent Template : For the use of a humanitarian use device outside of its FDA-approved indications in "emergency use" situations which meet specific federal regulatory criteria.
• Investigator as a Participant in Human Subjects Research: Experimentation on Self Consent Form Template: For documentation of informed consent for participation in human subjects research when the experimentation involves the researcher.