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No investigator conducting research under the auspices of the University of North Carolina at Chapel Hill (UNC-Chapel Hill) may involve a human being as a subject in research without obtaining the legally effective informed consent of the subject or the subject’s legally authorized representative unless a waiver of consent has been approved by the IRB in accordance with Section 2.9 of these procedures.

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

Environmental Protection Agency (EPA) policy requires that researchers submit IRB determinations and approval to the EPA human subjects research review official for final review and approval before the research can begin. For research not conducted or supported by any federal agency that has requirements for protecting human research subjects and for which the intention of the research is submission to the EPA, the EPA requirements for protecting human research subjects apply.

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.

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.

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.

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

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.

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) has established standards and safeguards to protect patient’s information and to ensure compliance with federal and state information security regulations.

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 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.”

Learning how to conduct ethical human subject research is an important part of a student’s educational experience. Research activities that are designed as part of a course requirement for purposes of learning experience only and are not “designed to develop or contribute to generalizable knowledge” may not require IRB review and approval if all of the following conditions are true...

Generally, researchers at UNC-Chapel Hill may not solicit by direct appeal to students, employees or trainees in that researcher’s department or class in an effort to recruit subjects for a study. Such direct and targeted solicitation (which should be distinguished from the dissemination of information such as is done in mass distribution emails) takes place within a power dynamic that could be construed as coercive by the potential subjects being solicited.