All human subject research and research-related activities involving human subjects conducted within or under the auspices of Lynn University by any faculty, employees or students, is subject to the Institutional Review Board for the Protection of Human Subjects in Research (IRB) review, recommendations if warranted, and final approval.
The purpose of the IRB is to safeguard the safety, privacy, health and welfare of the human subjects involved in research and research-related activities. The IRB reviews three categories of research: new projects periodic review on a continuing project and procedural revision to a previously approved project. IRB members are selected for their experience, expertise, diversity and breadth in backgrounds and represent individuals with primary concerns in both scientific and non-scientific areas. Under no conditions can proposed research begin prior to IRB review and written approval.
Investigators have many obligations, including designing the study so that the incidence of risk and stress are minimized to the greatest degree possible and that these risks are accurately described in the protocol. Moreover, the investigator bears responsibility for terminating the study when hazards or risks to the subjects become apparent or may be incompatible with the study’s benefits; further, investigators must report any adverse reactions associated with the study to the IRB.
Information regarding the IRB Policies is available in the appropriate college and the IRB Web site (contact the IRB for the URL to this site). These procedures are briefly summarized as follows:
- The investigator and the advisor of the project must take and complete the National Institutes of Health "Human Participants [Subjects] Protection Education for Research Teams" online course. The course can be found at phrp.nihtraining.com. Certificates of completion must be provided to the IRB prior to in the initiation of data collection.
- Prior to submission to the IRB, a research proposal must be approved by an advisor in the case of student research or by the supervisory vice president in the case of a university employee.
- Completed IRB application including the research protocol, certifications and signatures, and curriculum vitae of principal investigator is submitted to the IRB. Reviews may be by convened full board review, expedited review, or request for exempt status.
- Submission of material is done electronically and is rolling. Information regarding submission can be found at the IRB blackboard site. If the IRB has any special concerns or questions, the researcher may be asked to attend the meeting.
- The IRB notifies the investigator and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and provide the investigator an opportunity to respond in person or in writing. Institutional notification for employees is sent to the investigator’s supervisory vice president and to the research advisor in the case of students. For students, once approved, a copy of the approval letter is sent to the Office of the Registrar for the student’s permanent file.
- Currently approved protocols must be reviewed annually.