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Research Administration Management System and eSubmission (RAMSeS) is used to create and manage the official University record for each sponsored project in a consistent, efficient manner. Each record contains both financial and compliance information necessary for proposal submission as well as award management once an award is funded.

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

This SOP establishes the processes and procedures for ensuring the rights, safety, and welfare of research participants are protected when UNC-Chapel Hill shares responsibility for research oversight with another organization.

Each separate human subjects research study requires IRB review and approval of the specific proposed study, regardless of whether the data set or research materials have been previously compiled.

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.

The purpose of this SOP is to ensure compliance with Department of Defense (DoD) requirements regarding the conduct of human subject research.

The purpose of this SOP is to establish written requirements to ensure compliance with U.S. Department of Energy (DOE) requirements regarding human subjects research.

The purpose of this SOP is to establish written requirements to ensure the University of North Carolina at Chapel Hill's compliance with U.S. Department of Education requirements regarding human subjects research.

All non‐exempt human subjects research must be reviewed by the IRB. The first step in determining whether research must be reviewed is to determine whether it meets the regulatory definition of human subject research.

Research conducted in established or commonly accepted educational settings that involve normal educational practices as well as research involving the use of educational tests, survey procedures, interview procedures, or the observation of public behavior is eligible for exemption from the Common Rule. However, such research sometimes raises special concerns to which the IRB must be especially attentive.

The IRB should pay particular attention to the following issues in survey research: Possibility of undue influence in administration of the survey; Possibility of deductive disclosure based on demographic information garnered from subjects (subject confidentiality and privacy must be protected); The setting of the survey and the issues raised by such a setting; and The mode of obtaining consent, especially when implied consent is to be used.

The purpose of this SOP to establish written requirements to ensure compliance with U.S. Environmental Protection Agency requirements regarding human subjects research.

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.

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) fosters a research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of the Organization.