Protocol & Consent Writing Assistance

Background Information

• Basic Elements of Protocol
• Subject Selection
• Special Considerations for Projects Involving Vulnerable Populations
• Elements of Consent Form
• Informed Consent Considerations for Certain Types of Studies
• Altering or Waiving Elements of Informed Consent/ Waiver of Consent
• Waiver of Documentation of Informed Consent
• Consenting Subjects Who Do Not Read, Speak or Understand English
• Research Exempt from Informed Consent

Protocol Builder

Protocol Builder is an online program that must be used by investigators who wish to submit a protocol to the IRB-HSR.  The program asks a series of questions which the program then uses to build the template for the protocol and consent form that are specific to your project. A Protocol Builder User's Manual is available to provide additional instruction.

If you need additional assistance with the Protocol Builder Program please contact Margaret Ball at 243-0639 or mnw2h@virginia.edu.

Protocol Builder Questions- Help Files

When may consent be waived? 

Protocol & Consent Writing Assistance

Non UVa-IRB Protocol (e.g. Sponsor's protocol, Investigator Initiated Protocol Templates)

If you are writing a protocol that will serve as a Sponsor's protocol (e.g.you will be the PI of a multi-site trial, you will be the PI of an oncology protocol for which the Cancer Center PRC requires a protocol written in CTEP format etc) we strongly suggest you use the templates below to write your Sponsor's protocol.

• Expedited Sponsor's Protocol Template Example
• Full Board Sponsor's Protocol Template Example for protocols NOT involving an investigational drug, device or biologic
• Full Board Sponsor's Protocol Template Example for protocols involving an investigational drug, device or biologic
• NCI CTEP Template and Information

UVa-IRB Protocol Assistance

Examples of how to answer the following questions may be found by clicking on the question below.

• Section: Recruitment: Question: How will the consenting process take place?
• Section: Waiver of Documentation of Consent: Question: Provide a short paragraph describing the study which will be given to the potential subject either verbally or in writing.
• Section:  HIPAA Criteria:  Question F.  Explain why the research could not practicably be conducted without a waiver of consent.

Additional references are available to you to assist you once your templates are developed in Protocol Builder.

Learning Shots

Numerous learning shots are available that will help with writing your protocol

Medical Terminology

You may refer to MedTerms.com or the UVa Glossary of Suggested Lab Wording for help writing your consent form in lay language.

Radiation

If your study includes ionizing radiation, see the standard wording found in the Radiation Safety Document.