Research, Sponsored Program, Technology Transfer and Intellectual Property

Human Subjects in Research and Research-Related Activities

Section: Research, Sponsored Program, Technology Transfer & Intellectual Property Policies
Policy Name: Human Subjects in Research and Research-Related Activities
Policy Owner: Vice President for Research, Scholarship & Innovation
Responsible University Office: Research Office
Origination Date: April 15, 1975
Revisions: June 5, 1989; March 1, 1996; September 1, 2005; January 18, 2008; February 28, 2008; March 16, 2010; July 21, 2015
Legacy Policy Number: 6-04
  1. SCOPE OF POLICYThis policy addresses the University of Delaware (“UD” or “University”) obligation to ensure the protection of the rights and welfare of individuals used as subjects in research-related activities and applies to all University departments, units, faculty, staff and students.
    1. “Human Subjects” are living individuals about whom a University researcher conducting research-related activities obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
    2. A Principal Investigator (“PI”) is the individual designated in a grant or contract to be responsible for ensuring compliance with the academic, scientific, technical, financial and administrative aspects and for day-to-day management of the Sponsored Project (grant or contract) including programmatic reporting.
    3. The Institutional Official (“IO”) is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the University’s Federal Wide Assurance (“FWA”).
    UD 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, 45 CFR 46, and the University’s FWA with the U.S. Department of Health and Human Services (and all other requirements from governmental entities with legal jurisdiction oversight) for the protection of Human Subjects in research.
    The UD Provost appoints the Deputy Provost for Research & Scholarship as IO for research involving Human Subjects. The Deputy Provost for Research & Scholarship may appoint the Associate Deputy Provost for Research & Regulatory Affairs to act in the capacity of IO.
    1. The University requires that all projects involving Human Subjects be reviewed and approved by the University’s Institutional Review Board (“IRB”), which is constituted according to the above-referenced regulations, to assure the following:
      1. The risks to Human Subjects are minimized and reasonable in relation to the anticipated benefits to subjects, and the importance of the knowledge that may be reasonably be expected to result;
      2. The rights and welfare of Human Subjects be adequately protected;
      3. The selection of Human Subjects is equitable;
      4. Informed consent be sought and appropriately documented; and
      5. The activity be reviewed at regular intervals.
    2. The IRB has responsibility for the final review and approval of projects involving Human Subjects.
    3. This policy applies to all research involving Human Subjects if one or more of the following apply:
      1. The research is a University-research activity performed under the auspices of a UD agreement, or
      2. The research is conducted by or under the direction of any employee or agent of this University in connection with his or her institutional responsibilities, or
      3. The research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
      4. The research involves access to University’s private identifiable information.
    4. University PIs planning research projects involving the use of Human Subjects are required to:
      1. Submit to the IRB the plans for anticipated research protocol before beginning the projects and in sufficient time to allow the board to review;
      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 Human Subjects are to be protected, how informed consent of Human Subjects is to be obtained, and whether written consent forms are to be used;
      3. During the course of the project, seek IRB approval of any changes to the research protocol prior to their implementation and/or any problems that may significantly alter the original plan;
      4. Report to the IRB any instances of unexpected problems or adverse events involving risks to Human Subjects according to the IRB standard operating procedures;
      5. Ensure all members of the research team complete formal training addressing Human Subject research protections;
      6. Report progress of approved research to the IRB, as often as and in the manner prescribed by the IRB, but no less than once per year; and
      7. Maintain research records in a manner consistent with the requirements of 45 CFR 46 and IRB direction.

      All matters pertaining to research involving Human Subjects must be submitted to the Research Office, which will facilitate obtaining IRB review and concurrence.

      Specific procedures for submitting proposed research to the IRB and for operation of the IRB are available from the Research Office.