Search89 Results

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 document establishes the definitions followed by the University of North Carolina at Chapel Hill (UNC-Chapel Hill) Human Research Protection Program. This is a non-exhaustive list. Regulations and other documents (e.g. guidance documents issued by federal regulatory agencies) should be referenced when applicable.

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

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

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.

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).

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

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.

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.

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.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required the creation of a Privacy Rule for identifiable health information. Except as otherwise permitted, the Privacy Rule requires that a human research subject “authorize” the use or disclosure of the human research subject's "protected health information" to be used in research.

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) is committed to ensuring that educational opportunities are offered to research participants, prospective research participants, and community members which will enhance their understanding of research involving human participants at UNC-Chapel Hill and provide them the opportunity to provide input and express concerns. This procedure describes how UNC-Chapel Hill fulfills that responsibility.

It is the University of North Carolina at Chapel Hill policy that any sponsored research conducted under the auspices of UNC-Chapel Hill is conducted in accordance with federal guidelines and ethical standards. This SOP describes the procedures required to ensure that all sponsored research meets University requirements.