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Informed Consent

Version Date: 06/05/17

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.


Health Sciences IRBs: Introduction to New Consent Form Templates Workshop

The Health Sciences IRBs Office is excited to announce that newly developed Informed Consent Templates and Additional Model Language are now available on our updated Informed Consent Knowledge Base (KB) page. The HS IRBs Office will be holding workshops to provide an overview of the new materials, including when and how researchers submitting to the HS IRBs can use the documents.  The workshops dates are:

  • Thursday, July 27 – 3-4 PM – Click here to register


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

Additional Model Language
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.

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 of the Requirements for Informed Consent
  • Definition:

    Participants give informed consent, using a consent script or document that does not include, or that alters, standard elements of informed consent.
  • When Used:

    Primarily for screening taking place by telephone.
  • Related Guidance:

    Telephone Recruitment and Screening

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. Also required to access medical records to pre-screen for eligible patients prior to recruitment.
  • 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

Non-Physical Risk Templates

Other Templates

 

 

 

See Also:




Keywords:informed consent, IC, form, written, oral, waiver, elements, templates, readability, information sheet, info sheet, consent   Doc ID:72899
Owner:Tesha Z.Group:Health Sciences IRBs
Created:2017-04-25 15:44 CDTUpdated:2017-07-18 15:14 CDT
Sites:Health Sciences IRBs
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