Informed Consent/Assent

Policies/Guidance/Tools

Policies

  • Informed Consent SOP [C3.0050] [PDF]

Guidance

  • UK Informed Consent Template FAQs **NEW** 1/2/18 [PDF]
  • Waiver of Informed Consent/Assent Process and Documentation FastPass Video Training [YouTube Video]
  • Consent/Assent Checklist - Quality Improvement Review [O1.0000] [PDF]
  • OHRP Frequently Asked Questions on Informed Consent
  • Advice to Legally Authorized Representatives of Adult Participants in Medical Research [D87.0000] [PDF]
  • Advice to Legally Authorized Representatives of Adult Participants in Non-Medical Research [D88.0000] [PDF]
  • Would you ever need to re-consent a research participant? [D100.0000] [PDF]
  • FDA Communicating Risks and Benefits: Evidence-Based User's Guide
  • ORI Outline of FDA Guidance for Industry: Use of Electronic Informed Consent in Clinical Investigations [D120.0000] [PDF]
  • Waiver of Informed Consent (excerpt from IRB Overview) [T19.0000] [PDF]
  • Waiver of Documentation of Informed Consent (excerpt from IRB Overview) [T20.0000] [PDF]
  • Acute Care Waiver (excerpt from IRB Overview) [T28.0000] [PDF]
  • FDA Guide to Informed Consent (includes guidance on Non-English Speaking Subjects and Illiterate English Speaking Subjects) [HTML]
  • UK Guidance on Unique Informed Consent Circumstances [D135.0000] [PDF]
  • Common Rule Informed Consent Requirements (DHHS 45 CFR 46 & FDA 21 CFR 50) [PDF]

Tools for Developing Informed Consent Documents

Templates/Samples/Forms

Informed Consent Templates

Medical Informed Consent/HIPAA Combined Template

Nonmedical Informed Consent Template

  • English [F2.0150] [WORD]
  • Spanish [F2.0155] [WORD]

Sample Repository/Registry/Bank Consent

  • English [F1.0170] [WORD]

Assent Form Templates

Medical

  • English [F1.0200][WORD]
  • Spanish [F1.0210] [WORD]

Nonmedical

  • English [F2.0200] [WORD]
  • Spanish [F2.0210] [WORD]

Request for Waiver of Informed Consent Process

Waiver of Informed Consent (excerpt from IRB Overview) [T19.0000] [PDF]

Request for Waiver of Documentation of Informed Consent Process

Waiver of Documentation of Informed Consent (excerpt from IRB Overview) [T20.0000] [PDF]

Samples

Sample Applications and Protocol Development Resources

The following are examples of Key Information pages created for education purposes only. They are not exact representations of actual studies. Study topics and subject matter was chosen to illustrate concepts that may be key for participant consideration. The IRB has not reviewed or endorsed the examples. The examples do not include the entire consent document.

Key Information Page Examples for Simulated Studies:

  • Comparative Effectiveness Research [PDF]
  • Placebo-Controlled Clinical Trial [PDF
  • Research Biobank [PDF
  • Clinical Outcomes [PDF]
  • Healthy Volunteer Medical [PDF
  • Healthy Volunteer Nonmedical [PDF
  • Nonmedical testing and survey [PDF

Instructions

Proposed Informed Consent Document

  • Instructions for Informed Consent Document - Medical & Nonmedical IRB [F1.0175] [HTML]

Assent Form

  • Instructions for Proposed Assent Form - Medical & Nonmedical IRB [F1.0225] [HTML]

IRB Application Instructions for Request for Waiver of Informed Consent Process

The IRB may waive the requirement or approve alteration of elements of informed consent if it finds and documents that the research meets certain conditions. For example, if you are conducting research involving deception, or conducting medical record reviews, your research may meet the conditions for this waiver. For certain research, the IRB may approve waiver of the requirement for informed consent when consent to participate is assumed in the absence of an objection (passive consent). To request this waiver, check mark the box for "Request for Waiver of Informed Consent Process" under the Informed Consent section of the E-IRB application, and answer the questions as prompted.

Request for Waiver of Documentation of Informed Consent Process

The IRB may waive the requirement to obtain a signed consent document for some or all of the subjects if certain conditions are met. For example, your research may meet the conditions for this waiver if you are conducting a mail survey, telephone survey, internet research, or international research where recruitment of subjects would be inhibited based on cultural beliefs. In order for the IRB to consider approval for waiving this requirement, check mark the box for "Request for Waiver of Documentation of Informed Consent Process" under the Informed Consent section of the E-IRB application, and answer the questions as prompted.

Even if a waiver from the requirement to obtain a signed consent document applies to your research, you may still need to provide information to individuals about the research so they have the knowledge and opportunity to consider whether or not to participate. To help ensure required elements are included in your consent document, please use the Cover Letter Template.

Note: The cover letter template was developed specifically for survey/questionnaire research; however, it may be useful as a guide for developing a consent document for other types of research as well. 

Tissue/Specimen Repositories or Individual Studies Banking Material for Future Use

  • University of Kentucky (UK) Office of Research Integrity (ORI) Research Biospecimen Bank Guidance [D129.0000] [PDF]
  • University of Kentucky (UK) Office of Research Integrity Research (ORI) Registry Guidance [D130.0000] [PDF]
  • Sample Repository/Registry/Bank Consent [F1.0170] [PDF]
  • University of Kentucky Issues to be Addressed and Sample Consent Language for Tissue/Specimen Repositories or Individual Studies Banking Material for Future Use [D58.0000] [PDF]