University of Delaware
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Human Subjects in Research

University policy and federal law (45 CFR 46) require that all research involving human subjects, bio specimens and/or tissue samples from humans, and/or private identifiable data must be reviewed by an Institutional Review Board (IRB).

Educational Activities that are not Human Subjects Research: All human subjects research requires prior institutional approval, but not all data gathering by students constitutes human subjects research. The definition of research below establishes that an activity must be designed with the intent to develop or contribute to "generalizable knowledge." Classroom activities designed to teach research techniques or allow students to practice those techniques are not considered research with human subjects.

Simulations of human experimentation and course-assigned data collection do not constitute human subjects research if the activities are designed for educational purposes only; and


Educational Activities that are Human Subjects Research: If an instructor determines that there is a possibility that a student's proposed research project may result in a formal presentation or publication, he/she should recommend that the student submit the project for IRB review before beginning the study.



Definitions

Research: means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subject: means a living individual about whom an investigator (whether professional or student) conducting research obtains:

  • Data through intervention or interaction with the individual, or
  • Identifiable private information

Intervention: includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

Interaction: includes communication or interpersonal contact between investigator and subject.

Private information: : includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Minimal Risk: : means that the probability and magnitude of of harms and comfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Clinical Trial: : exact definition of what type of studies constitute a clinical trial are different depending on the applicable oversight agency. More details on clinical trials can be found here.


For questions please contact the UD IRB Office by email: hsrb-research@udel.edu or by phone: (302) 831-2137.

FWA

The University of Delaware has a Federalwide Assurance FWA (#00004379) on file with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). Through this document the University commits itself to upholding the Code of Federal Regulations and the ethical principles of the Belmont Report for all research involving human subjects conducted by University faculty, staff, and students. The UD Vice President for Research, Scholarship and Innovation is the Signatory Official of the UD FWA.


For questions please contact the UD IRB Office by email: hsrb-research@udel.edu or by phone: (302) 831-2137.

IRB

An Institutional Review Board (IRB) is a committee charged with the protection of the rights and welfare of human subjects recruited to participate in biomedical, behavioral, or social science research. The IRB has the regulatory authority to approve, modify or disapprove research, and suspend or terminate approval of research involving human subjects that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.

The University of Delaware has one IRB registered with DHHS (IORG #0000279). UD IRB membership is in accordance with the applicable regulatory requirements in 45 CFR 46.107 and 21 CFR 56.107. IRB membership includes diverse backgrounds and expertise to promote adequate review of research commonly conducted by UD researchers. Membership shall include both scientists and non-scientists as well as outside community members. Members from the UD faculty and staff are to be nominated by their respective dean, department chair, or supervisor, in concurrence with the IRB Chair and the UD Vice President for Research, Scholarship, and Innovation. Outside community members (not affiliated with the UD community) will be nominated by the IRB Chair. The UD IRB members, including the IRB Chair, are appointed by the UD Vice President for Research, Scholarship and Innovation.

Members shall serve for terms of three years, renewable with concurrence of their respective dean, department chair, or supervisor, the IRB Chair and the UD Vice President for Research, Scholarship, and Innovation. All members will complete human subjects protections and IRB training prior to starting each term. Members are expected to attend regularly scheduled IRB meetings.

IRB members may have designated alternate(s) members. An alternate is an individual appointed to the IRB to serve in the same capacity as the specific IRB member(s) for whom the alternate is named. Alternate members must meet the same training requirements as the full member for which they serve.

The UD IRB Office supports the functions of the IRB and its Chair, Dr. Jean-Philippe Laurenceau . The IRB can be contacted at:

University of Delaware IRB
210 Hullihen Hall (Research Office)
Phone: 302-831-2137
Email: hsrb-research@udel.edu



For questions please contact the UD IRB Office by email: hsrb-research@udel.edu or by phone: (302) 831-2137.

IRB Meetings

UD IRB meetings are held monthly. Generally, meetings will be at noon on the third Wednesday of each month. Meeting dates and times are posted on the Research Office calendar of events.

For convened IRB meetings the required quorum is defined as more than half of the current full membership. At least one member whose primary concerns are in non-scientific areas, and one member whose primary concerns are in scientific areas must be in attendance to satisfy quorum requirements. In addition, if research involving prisoners is to be reviewed, the member designated as the prisoner advocate must also attend.

IRB members must avoid potential conflicts of interest when conducting protocol review. A potential conflict of interest occurs when a reasonable outside observer might perceive the circumstances as creating an apparent conflict of interest. Examples of such potential conflicts include an IRB member having a close personal relationship with a researcher submitting a proposal, an IRB member serving as a researcher on the proposed project, or an IRB member serving as a consultant to the project. IRB members with potential conflict of interest must recuse themselves and not be present for the discussion, except as to provide information requested by the IRB, and vote on the research. Recused members will not be counted towards the quorum requirements in the review and voting of the research for which they recused.

Quorum will be determined and verified by the IRB office staff member(s) attending the meeting before the discussion and vote for each item reviewed. IRB decisions will be made based on the vote of the majority of the eligible members present at the meeting

Participation in a convened meeting via tele or video conference is acceptable to meet quorum requirements provided the member(s) have received the materials to be reviewed prior to the meeting and can actively participate in the discussion.


For questions please contact the UD IRB Office by email: hsrb-research@udel.edu or by phone: (302) 831-2137.

Additional Resources

UD Policy & Procedure Manual
Involvement of Human Subjects in Research and Research-Related Activities

Faculty Handbook
Human and Animal Subjects in Research

UD Nurse Managed Health Center (NMHC)
The NMHC can partner with UD researchers providing medical testing and monitoring of research participants

Office of Human Research
Protections (OHRP)

This information is provided by the United States Department of Health & Human Services

Belmont Report
Ethical principles for the protection of human subjects in research.

Definitions
Applicable to human subject research provided by the United States Department of Health & Human Services


For questions please contact the UD IRB Office by email: hsrb-research@udel.edu or by phone: (302) 831-2137.