Policy Number: 6-4
Policy Name: Involvement of Human Subjects in Research and Research-Related Activities
Date: April 15, 1975
Revisions: June 5, 1989; March 1, 1996; September 1, 2005; January 18, 2008; February 28, 2008; March 16, 2010
To insure the protection of the rights and welfare of individuals used as subjects in research projects. A "Human subject" is a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
The University of Delaware bears full responsibility for the performance of all research involving human subjects, including complying with federal, state, and local laws as they may relate to such research. In meeting its obligations in this area, the University is guided by the ethical principles set forth in the report of the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report"), and adheres to the regulations of title 45, Part 46 of the code of Federal Regulations (45CFR46) and the University's Federalwide Assurance with the U.S. Department of Health and Human Services for the protection of human research subjects. Some research involving human subjects could require additional federal agency approvals (e.g.FDA, EPA).
The University requires that all projects involving human subjects are reviewed and approved by the Institutional Review Board (IRB), which is constituted according to the above-referenced regulations, to assure the following:
The benefit to the subject and the importance of the knowledge to be gained outweigh the risks to the subject to the extent that a decision to allow the subject to accept these risks is warranted;
The rights and welfare of subjects will be adequately protected;
Informed consent will be obtained by adequate and appropriate methods; and the activity will be reviewed at regular intervals.
The IRB will have responsibility for the final review and approval of projects involving human subjects.
This policy applies to all research if one or more of the following apply:
University investigators planning research projects involving the use of human subjects are required to (1) submit to the IRB the plans for anticipated research before beginning the projects and in sufficient time to allow the board to take action; (2) make clearly evident in the written research plan or through any further information that may be needed precisely how the rights and welfare of the research subjects are to be protected, how informed consent of human subjects is to be obtained, and whether written consent forms are to be used; and (3) during the course of the project make known to the committee any changes in protocol or any emerging problems of investigation that may significantly alter the original concept; (4) report to the IRB any instances of injuries or unexpected problems involving risks to subjects or others within one week of the occurrence; (5) make certain that all researchers working with human subjects have received formal training for human subject research protections; and (6) report on the progress of approved research to the IRB, as often as and in the manner prescribed by the IRB on the basis of risks to subjects, but no less than once per year; and (7) maintain research records in a manner consistent with the requirements of 45 CFR46 and the IRB.
Investigators who intend to involve human research subjects will not make for themselves the final determination of exemption from applicable regulations.
Specific procedures for submitting proposed research to the IRB and for operation of the IRB are available from the Research Office.
Submitted by: Research Office