Free Consultations Available: Protocol Development, Statistical Plans, Data Management
Guidance for answering questions in protocol templates developed by Protocol Builder
Lay Terminology
Radiation Risk Language
- Protocol Elements
- Consent Form Elements
- Consent Background and Definitions
- Consent Considerations for Certain Types of Studies
- Research Exempt from Informed Consent
- Special Considerations for Projects Involving Vulnerable Populations
Free Consultations Available: Protocol Development, Statistical Plans, Data Management
Free consultations are available for protocol development, statistical plans and data management from Public Health and Sciences @ the Library
Protocol Builder Assistance
Protocol Builder is an online program that must be used by investigators who wish to submit a new study to the IRB-HSR that meets the criteria for review by any of the following review types: full board, expedited, exempt or non-engaged. For additional information on review types see: Submission Types. Protocol Builder will asks a series of questions which it uses to build the templates for the protocol and consent form that are specific to the study.
If you need additional assistance with the Protocol Builder Program, please contact IRB-HSR Staff
Guidance for answering questions in protocol templates developed by Protocol Builder
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: Waiver of Consent/HIPAA Authorization: Explain why the research could not practicably be conducted without a waiver of consent or waiver of HIPAA authorization.
Protocol Templates (non-oncology)
If you are writing a protocol that will serve as the protocol for a multi-site study, we strongly suggest you use one of the templates below to write the protocol. The template provided by Protocol Builder will not be accepted by the IRB-HSR.
- Protocol Templates for Clinical Trials | grants.nih.gov
- Expedited Protocol Template Example
- Full Board Protocol Template Example for protocols NOT involving an investigational drug, device or biologic
- Full Board Protocol Template Example for protocols involving an investigational drug, device or biologic
Protocol Templates (oncology)
If you will be the PI of an oncology protocol (single site or multi-site), please use one of the templates on the PRC website: https://med.virginia.edu/cancer-research/research-resources/office-of-clinical-research/protocol-review-committee/. If you are required to use an alternative template (e.g., by a funding source), please check with the Protocol Development Team (Protocol Development Team - UVA Comprehensive Cancer Center (virginia.edu)) before getting started.
The IRB protocol template provided by Protocol Builder does not address all of the sections that are required for PRC review and should not be used for oncology protocols.
Learning Shots
- Numerous learning shots are available that may help with writing your protocol and consent documents.
Lay 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 Risk Language
- If your study includes ionizing radiation, see the standard wording found on the Human Investigations Involving Radiation Exposure (HIRE)Website.