Forms, Policies & Procedures
Here you will find a repository of forms, policies and procedures related to research at the University of Delaware. This repository draws on sources throughout campus to provide quick and easy access to these resources in a variety of formats, such as html, MSWord and Adobe PDF. We encourage you to explore and use the tools provided to narrow your search by word, resource type or category in order to learn more about the content that governs research at UD.
*NOTE: As of October 2020 Google Chrome changed how it handles file downloads. If you encounter difficulties, right click on the “Download” button/link and select “save link as.” Once selected the file download will be executed and can be saved to the desktop. A second method is to use a different browser.
Animal Subjects in Research
For Forms, Policies and Procedures pertaining to Animal Subjects in Research and other resources
Compliance
Conflict of Interest
Contracts and Grant Management
Effort Certification
Export Regulations (ITAR/EAR/OFAC)
Human Subjects in Research
Intellectual Property
Internal Funding
Material Transfer
Reporting Misconduct
Research Administration
Research Agreement Templates
Safety
Students
Templates
University
Form: Human Subjects in Research, Templates, University
Documentation Consent Process Form and Log
Documentation Consent Process Form and Log
Informed consent is a process and involves providing a potential subject with adequate information about the research to allow for an informed decision about the subject’s voluntary participation in a research study. Informed consent is a process. Documenting informed consent occurs after explaining the research, addressing any questions, and assessing participant comprehension.
- Documentation of informed consent requires the signature of informed consent by the research participant (or their legally authorized representative or parent(s), as applicable) unless a waiver of that signature has been approved by the IRB.
- The forms here are two different suggested templates that can be used so that the person obtaining consent notates the following: current and IRB-approved informed consent forms were used, that he/she explained the research to the participant, ensured that the participant understood the research and that the participant freely agreed to enroll.
- These forms should be utilized at the beginning of the study and throughout the study, when updates and revisions to the consent form(s) require re-consent.
- The templates herein provide a framework for documenting the consent discussion and process with each potential study participant and should be customized to different studies as applicable.
- Modify the form as needed/desired to add or remove any additional consent information, such as:
- If a legally authorized representative is present
Information related to signatures as applicable
Form Details:
OWNER: UD Research Regulatory Affairs
RESPONSIBLE OFFICE: Research Office
ORIGINATION DATE: January 5, 2022
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Form: Human Subjects in Research
Exempt Determination Tool
Exempt Determination Tool
A tool to help determine if research is eligible for exempt status under the Common Rule.
Form Details:
OWNER: Maria Palazuelos
RESPONSIBLE OFFICE: UD IRB
ORIGINATION DATE: January 21, 2019
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Form: Human Subjects in Research
IRBNet New User Registration
IRBNet New User Registration
The University of Delaware uses the IRBNet system to manage its IRB Protocols with research concerning human subjects. If you are not already registered with IRBNet, it is necessary that you do so in order to produce the documentation that will be reviewed by the University of Delaware’s IRB. After review, the IRB office will communicate with the principal investigator and request any clarifications or edits that need to be completed before approval can be issued.
Once a review has been completed, decision letters are uploaded in IRBNet and are always accessible to the investigator(s). Informed consent documents from projects approved via an expedited or full board review will be stamped with the IRB approval and expiration date and also uploaded in IRBNet. Informed consent must be obtained using the stamped version of the approved documents, (i.e., participants signatures need to be collected in a copy of the stamped informed consent.) No IRB stamp is added to informed consent documents associated to projects deemed exempt.
Form Details:
OWNER: Research Office
RESPONSIBLE OFFICE: Research Office
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