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 Agreements
Safety
Students
Templates
University
Exemptions
There are five defined categories of research exempt from the regulatory requirements imposed by the “Common Rule.” Exempt review determinations MUST be made by the IRB office and require the submission of a research protocol to the IRB.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, AND (b) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability or reputation.
Exemption 2 does not apply to children except for research involving observations of public behavior when the investigator does not participate in the activities being observed. - Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior that is not exempt under category 2, if (a) the human subjects are elected or appointed public officials or candidates for public office, or (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects that are conducted by or subject to the approval of department or agency heads and that are designed to study, evaluate or otherwise examine (a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs, (c) possible changes in or alternatives to those programs or procedures, or (d) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Research conducted in established or commonly accepted educational settings involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.
Exempt reviews are conducted as projects are submitted. Review times may vary depending on the overall volume of projects to be reviewed by the IRB at any given time. In most cases, exempt reviews are completed within two weeks from the submission date. A project determined exempt does not require annual continuing reviews. Informed consent forms of projects determined to be exempt will not be stamped by the IRB. The IRB office should be consulted about proposed changes that could affect the exempt classification.
Procedure Details:
OWNER: UD Research Regulatory Affairs
RESPONSIBLE OFFICE: Research Office
Procedure Source
Email