University Park IRB
University Park Institutional Review Board (UPIRB) is a committee of faculty, staff, students and members of the community charged with review and oversight of primarily socio-behavioral research projects submitted by students, faculty, or staff of University Park Campus.
The review process is designed to protect the rights and welfare of human subjects by ensuring
- equitable subject selection
- adequate informed consent
- assessment and minimization of risks
- privacy and confidentiality
UPIRB reviews all human research protocols in accordance with federal regulation, state law, and university policy.
Frequently Asked Questions:
What is the typical turn around time?
All iStar applications are reviewed in the order received. Applications should be submitted at least 1 month prior to the intended research start date. Review time is dependent on the number of studies in queue. The IRB strives to initiate review of all submissions with 5-10 working days. Full-Board studies are reviewed, per the IRB meeting schedules.
What is the difference between Expedited and Exempt?
IRB Review/approvals will be determined with consideration to research procedures, potential risks, and other factors that may affect the research subjects.
Studies that qualify for one of the exemption categories (as determined by the IRB during initial review) are exempt from further IRB review for the life of the study unless there is a change in the research procedures, recruitment, consent documents, etc. Prior to initiating a change, the investigator must submit a study amendment for IRB review and approval.
Exempt research must uphold protection of research subjects and the basic ethical principles of The Belmont Report (Respect for Persons, Beneficence, and Justice).
Studies that qualify for expedited review will be reviewed by the IRB Chair or by a designated IRB reviewer. Expedited studies and studies approved by Full Board review have a maximum approval period of 365 days or less as appropriate for the degree of risk.
The IRB will conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109 (e)).
What is Not Human Subjects Research (NHSR)?
Not Human Subjects Research is an activity that does not meet the federal definition of “Human Subjects” or “Research”. A human subject is defined as a “living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information”.
Research is defined as a “systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”.
NHSR activities are not subject to IRB review.
- Types of IRB Review
- Is Your Project Human Subjects Research?
- Are You Conducting Research Using Human Subjects?
When does my submission need Full Board Review?
Submissions with one or more of the following criteria usually go to the Full Board:
- studies using vulnerable populations
- studies taking place internationally (especially those with little or no provisions for protection of human subjects)
- studies where information may be disclosed that could require mandatory legal reporting (e.g., child/elder abuse, drugs, etc.)
- studies involving deception that raises the level risk for subjects
- studies the IRB staff, chair, member, or designee determines to be greater than minimal risk (minimal risk is federally defined as: the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests)
- clinical procedures involving drugs and devices
What do I do if my study has expired? Can I continue collecting data?
Stop collecting data and stop enrolling subjects. Submit a Continuing Review Application via iStar. Investigators may only continue research beyond the approval period if discontinuing research procedures exposes subjects to potential harm or discomfort – (e.g. subjects receiving medical or psychological treatments). Procedures must be conducted according to the approved protocol.
What if I just found out if I am suppose to have IRB approval before starting research and I already started?
Stop all research activities and contact the IRB office immediately for further instruction.