Office of Research and Sponsored Programs
The Office of Research and Sponsored Programs (ORSP) is responsible for assisting the faculty in the preparation of proposals, and in the preparation and administration of sponsored contracts, grants, and agreements. It serves as a liaison between faculty and contracting federal, state and local agencies and industry sponsors; reviews and negotiates funding agreements; monitors all sponsored contracts / grants / agreements received by the University for fiscal integrity; and checks for institutional compliance with the sponsor and university policies and procedures. Each University department or center is served by a Contract and Grant Specialist from the ORSP. To find out who to contact, see the ORSP website at: https://research.cc.lehigh.edu/office-research-and-sponsored-programs.
Office of Research Integrity
The office of Research Integrity is charged with overseeing ethical aspects of research, as outlined in the sections below.
Protection of Human Subjects in Research
All research and experimental activities in which people participate as subjects must be approved by Lehigh’s University Institutional Review Board (IRB) prior to the involvement of the subjects. This applies to all sponsored and unsponsored research, continuing education courses, thesis/dissertation projects, and certain instructional projects and activities involving human subjects research conducted by University students, staff, and faculty.
The University’s basic policy places the primary responsibility for the protection of the welfare and the right of privacy of the individual subject on the principal investigator. The responsibility is shared by the University as an institution and, where outside support is provided, by the sponsoring agency.
There are three types of human subjects research review: Exempt, Expedited, and Full committee review. If investigators have any questions about which type of review their proposal is eligible for, they should contact the Office of Research Integrity.
Each researcher involved in the study who will be interacting with the subjects must complete an online training course on the protection of human subjects. The link to the online course can be found at the Office of Research Integrity Human Subjects in Research website: http://research.cc.lehigh.edu/irb.
To begin the review process, investigators should first visit the Human Subjects in Research website for information. IRB applications are submitted through the web-based system IRBNet. Information on IRBNet and a tutorial for getting started are available on the website. The completed Human Subjects Application (available at IRBNet.org), the consent form, any instruments to be used, a copy of the funding proposal or thesis proposal (if applicable), and a copy of the completion certificate from the online human subjects protection training course must be included in the IRBNet package. The review process will not begin until the committee has all the required information.
The IRB recommends submitting applications at least six weeks in advance of the anticipated research start date, to allow adequate time for committee review and researcher response to committee questions. Studies which meet the criteria for Exempt or Expedited review are reviewed on an ongoing basis throughout the year. Studies requiring Full committee review must be voted on at convened IRB meetings. The IRB meets on the second Tuesday of each month. Full review studies should be submitted at least 30 days in advance of the next scheduled IRB meeting. Investigators will receive notification of the IRB’s actions, comments, and recommendations through IRBNet.
For research protocols requiring Full committee review and certain Expedited protocols, approvals are granted for a maximum of one year. For these projects, annual renewals are mandatory in order to keep studies greater than 12 months in length active. For all projects, interim progress reports may be requested by the IRB. For renewals, the investigator should submit a continuing review form, a copy of all instruments to be used with any changes noted, consent form(s), and a written explanation of the study with a complete description of any changes to the study procedures. Changes to a previously-approved study or consent procedures must be reviewed and approved by the IRB before they can be implemented. Continuing Review and Amendment/Modification applications are processed via IRBNet. All adverse events and unanticipated problems must also be reported immediately through IRBNet.
A copy of an Informed Consent form and written explanation of the study must be given to each subject. This explanation may be incorporated at the beginning of the consent form or on the back of the form. In some studies, such as mailed questionnaires or on-line questionnaires, signed informed consent may be waived. However, the investigator must provide an informed consent document and an explanation of the study as before. A statement should be included that clearly states that by responding or participating, the subject is granting consent for use of their data. This can be provided in a cover letter that the subject may retain.
Contact the Office of Research Integrity with any questions regarding human subjects or IRB policies and procedures.
Humane Care and Treatment of Laboratory Animals
Before ordering or beginning any research, research training, experimentation or biological testing involving live, vertebrate animal(s), the investigator must submit and have received approval on an animal use protocol. Allow four weeks for protocol review and approval.
Completed protocol forms should be sent to the Institutional Animal Care and Use Committee (IACUC) via the web-based IRBNet system (available at IRBNet.org). The protocol form provides specific data concerning the species to be used, detailed information related to the use of the animals and justification for the use of the animals. Other procedures which need to be addressed in the form are surgery, procedures to minimize pain, use of anesthetics, animal housing and methods of euthanasia.
Any anticipated changes made to an approved protocol must be promptly reported through a modification form and requires IACUC approval.
Annual renewals are mandatory. Forms and tutorials can be found at http://research.cc.lehigh.edu/animals.
Access to the Central Animal Facility is restricted to investigators and the staff designated in the approved protocols on file and only after appropriate training and exams are successfully completed. Contact the Office of Research Integrity with any questions regarding IACUC policies and procedures.
Office of Technology Transfer
The Office of Technology Transfer (OTT) assists with finding paths to widespread use of research results, especially through commercialization. OTT will help to determine when protection of intellectual property is likely to enable development of results for widespread practice through commercialization, manages Lehigh intellectual property, and assists in finding grant support for transitioning research results into commercial use.
Any member of the University faculty, staff, or student body who develops or conceives of a patentable, copyrightable or other intellectual property while employed at Lehigh as a direct result of regular university duties, or significant use of university facilities, must disclose that property to the University through the OTT using an Invention Disclosure Form which can be found on the OTT website. The OTT website, found at: http://research.cc.lehigh.edu/ott provides guidance, contact information, and forms that will help navigate the process of protecting intellectual property, fulfilling governmental reporting requirements and assisting in the commercialization of intellectual property. In addition, the University Policy on Intellectual Property can be found at: http://www.lehigh.edu/~policy/university/ip.htm.