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.


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RO Forms, Policies, and Procedures Search 2019

Animal Subjects in Research

For Forms, Policies and Procedures pertaining to Animal Subjects in Research and other resources

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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
RO Forms, Policies, and Procedures Search 2019

Form: Human Subjects in Research, Templates, University

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

Download Form Email https://research.udel.edu/forms-policies-procedures/?entry=94367

ASSISTANCE

Compliance Hotline
Phone: (302) 831-2792

UD Research Office
210 Hullihen Hall
Newark, DE 19716
Phone: (302) 831-2136
Fax: (302) 831-2828
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