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Informed Consent

Version Date: 02/15/2019

Informed consent is the process through which researchers provide the information potential participants need to make a knowledgeable decision about taking part in a research study. This page provides guidance and tools to help researchers develop processes and documents that are effective and meet regulatory requirements.

Informed consent for studies conducted at the Madison VA must meet VA requirements. See the VA Research Overview page for guidance and VA consent templates.

Check this page regularly for updates to guidance, templates, and model language. The Informed Consent and Revised Common Rule presentation is available here


Types of Informed Consent

Standard Written Consent

  • Definition:

    Participants sign a document that includes all required elements of informed consent to indicate that they agree to participate in a study.
  • When Used:

    Research involving prospective enrollment of participants. This could include face-to-face interactions, physical interventions with participants, using medical or student records, or collecting sensitive information about people.
  • Templates:

    Consent Templates

Short Form for Consent
  • Definition:

    Participants sign a shortened consent form to document that information contained in a standard written consent form has been presented to them in a verbal consent process. A witness to the consent process also signs the short consent form.
  • When Used:

    Research involving prospective enrollment of participants who cannot read the standard consent form. Most often, this includes people who are illiterate or have limited literacy, or who are not fluent in written English.
  • Templates:

    Short Form Template

Waiver of Signed 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:

Alteration or Omission of Elements of Informed 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

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

Assent and Parent/Guardian Permission for Children

Guidance

Informed Consent Processes

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.

Informed Consent Documents

Consent Templates

Templates with instructions provide important guidance on how to use the template, what is needed or required in each section of the consent form, and when additional model language may be required.

Physical Risk Templates

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 plus HIPAA plus Summary: For studies to which the HIPAA Privacy Rule applies. 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.
  • Study Summary

    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.
    Non-Physical Risk Templates

    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.
    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.

    Other Templates

     

     

     

    See Also:




    Keywords:informed consent, IC, form, written, oral, waiver, elements, templates, readability, information sheet, info sheet, consent   Doc ID:72899
    Owner:Sherry H.Group:Health Sciences IRBs
    Created:2017-04-25 14:44 CSTUpdated:2019-12-06 16:43 CST
    Sites:Health Sciences IRBs
    Feedback:  0   0