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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.

The purpose of this SOP is to establish written requirements to ensure compliance with U.S. Department of Justice requirements regarding human subjects research. This SOP specifies requirements for research supported by the National Institute of Justice and/or conducted within the Bureau of Prisons.

This SOP establishes written procedures for initiating a response to an emergency impacting the UNC-Chapel Hill Human Research Protection Program (HRPP) or HRPP operations.

This SOP discusses rules governing investigator self-experimentation and experimentation on family members of investigators.

There is the inherent risk that incidental findings (IF) may be discovered on research- directed imaging procedures. These IFs may or may not be of clinical significance. The incidence of detected abnormalities when imaging varies depending on a number of factors including age of subjects, health status, the technology used and the expertise of the individual reviewing the image.

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).

The University of North Carolina at Chapel Hill Institutional Review Board (IRB) will review all transnational research involving human participants to assure adequate provisions are in place to protect the rights and welfare of the participants. Approval of research is permitted if the procedures prescribed by the foreign institution afford protections that are at least equivalent to those provided in 45 CFR 46.

Federal regulations and University of North Carolina at Chapel Hill (UNC-Chapel Hill) policies require Institutional Review Board (IRB) approval for research with human subjects. This applies whether the research is conducted by faculty or students, by individuals, or a group. Failure to obtain proper approval in advance may jeopardize your data, prevent you from publishing the results, and place you and UNC-Chapel Hill in violation of federal regulations.

If researchers wish to utilize data from voice, video, digital or image recordings, they must take a variety of special precautions. First, the researcher must obtain appropriate permissions from subjects who will not have their anonymity protected due to the very nature of the data being collected.

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.

Studies involving the use of radiation, such as those requiring patients to be X-rayed, are not eligible for expedited review, even if all of the other procedures in the study have been deemed to pose no more than minimal risk.

With respect to cigarettes and alcoholic beverages, IRBs and researchers should be aware that under North Carolina state law these substances may not be distributed to or used by minors.

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.

Qualitative studies, which may involve such methods as participant observation, case studies, unstructured interviews, focus groups and various other descriptive techniques, raise special issues for the IRB. Qualitative research investigators usually have a well-articulated plan for their research, often have one or more reasonably specific hypotheses to be tested, and can describe in general terms the techniques they intend to employ.

A pilot study is typically defined as an initial or smaller-scale investigation or a study to either test out new experimental designs (including survey or instrument development) or methods of treatment. Pilot studies are synonymous with feasibility studies, where the investigation proposed is planned to identify various issues to determine that the larger study of the same subject matter has the greatest potential to successfully test the intended research hypotheses.