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The UNC IRB has developed this SOP to describe a series of consistent, deliberate steps to mitigate fetal exposure to risk in clinical research studies among women of child-bearing potential (CBP).

Recognizing that a vital component of a comprehensive human research protection program is an education program for all individuals involved with research subjects, we are committed to providing training and an on-going educational process for IRB members, the staff of the IRB and HRPP Office, investigators and members of their research team, related to ethical concerns and regulatory and organizational requirements for the protection of human subjects.

This procedure describes the requirements for obtaining consent from human research subjects participating in research conducted under the auspices of UNC-Chapel Hill.

This policy outlines the responsibilities of IRB members for making known any potential or perceived conflicts of interest (COI) concerning protocols reviewed by the IRB. No IRB member may participate in the review of any research project in which they have a COI, except to provide information, as requested. It is the responsibility of each IRB member to disclose any COI related to a study submitted for review and to recuse him/herself from the deliberations and vote by leaving the room.

All activities involving the collection of human biological specimens for research purposes, as well as the research use of specimens collected for clinical care, must be conducted under the terms of an IRB approved research protocol. The collection and use of human biological specimens (either identifiable or de-identified) must comply with all applicable laws and regulations for research involving human biological specimens or superseding requirements.

FDA regulations apply to research that involves a FDA-regulated test article in a clinical investigation involving human subjects as defined by the FDA regulations. For FDA-regulated research, the IRB must apply the FDA regulations at 21 CFR 50 and 21 CFR 56. If required by organizational policy or a FWA, 45 CFR 46 must also be applied.

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) prepares and maintains adequate documentation of the IRB’s activities. All records are accessible for inspection and copying by authorized representatives of the FDA, OHRP, sponsors, and other authorized entities at reasonable times and in a reasonable manner.

The IRB will review and ensure that University of North Carolina at Chapel Hill (UNC-Chapel Hill) research involving human subjects meets all required ethical and regulatory criteria for initial and continuing review and any modifications of approved research. The IRB may conduct their review using the following review methods: Expedited Review and Review by Convened IRB.

A repository is a collection of data or biological specimens whose organizers: Receive data or specimens from multiple sources; Maintain the data or specimens over time; and Control access to and use of data or specimens by multiple individuals and/or for multiple purposes, which may evolve over time

This SOP establishes the process for identifying possible institutional conflicts of interests (ICOI) related to UNC-Chapel Hill human subjects research and the process for coordinating with the UNC-Chapel Hill Conflict of Interest Office. The goal of this SOP is to ensure timely, appropriate reviews of possible ICOI.

Consistent with the University of North Carolina at Chapel Hill’s research, teaching and public service missions, the University encourages faculty, staff and students to engage in appropriate outside relationships, including but not limited to private industry and the nonprofit sector.

When some or all of the participants in a research conducted under the auspices of the University of North Carolina at Chapel Hill (UNC-Chapel Hill) are likely to be vulnerable to coercion or undue influence or have diminished decision-making capacity, the research must include additional safeguards to protect the rights and welfare of these participants.

All research using human subjects must be approved by the University of North Carolina at Chapel Hill (UNC‐Chapel Hill). However, certain categories of human subject research are exempt from IRB approval. Exempt research is subject to review for determination of exemption status. At the UNC‐Chapel Hill exemptions are reviewed IRB Staff, and granted by an IRB Chair or designee.

This scenario arises when: UNC-Chapel Hill is the lead coordinating center responsible for overall study conduct; or A UNC-Chapel Hill employee serves as principal investigator for the entire multi-site study, (unless coordinating function located elsewhere as in some NIH-sponsored groups), or UNC-Chapel Hill is the sponsor (initiates contracts with and disburses funds to other sites).

Community based research (CBR) is research that is conducted as an equal partnership between academic investigators and members of a community. In CBR projects, the community participates fully in all aspects of the research process. Community is often self-defined, but general categories of community include geographic community, a community of individuals with a common problem or issue, or a community of individuals with a common interest or goal.