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The University has established disciplinary and behavioral assessment policies and procedures designed to address matters of alleged Student misconduct. From time to time, the University is faced with situations where the alleged conduct of a Student or Student Organization poses a risk of ongoing danger or disruption requiring immediate action to mitigate such risk. This policy addresses these situations and to fulfill the University’s obligation to promote a safe campus environment.
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- Human Research Ethics and IRB
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.
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- Research
- Human Research Ethics and IRB
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.
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- Human Research Ethics and IRB
A decision whether oral history or other activities solely consisting of open ended qualitative type interviews are subject to the policies and regulations outlined in an institution's FWA and DHHS regulations for the protection of human research subjects (45 CFR 46) is based on the prospective intent of the investigator and the definition of "research" under DHHS regulations at 45 CFR 46.102(d)
- Knowledge Base
- Research
- Human Research Ethics and IRB
While any person may make a report if they have reasonable cause to believe that a child or elder was abused or neglected, North Carolina law mandates that certain persons who suspect child or elder abuse or neglect report this.
- Knowledge Base
- Research
- Human Research Ethics and IRB
The vast amount of social and behavioral information potentially available on the Internet has made it an important tool for researchers wishing to study the dynamics of human interactions and their consequences in this virtual medium. Researchers can potentially collect data from widely dispersed populations at relatively low cost and in less time than similar efforts in the physical world.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.
- Knowledge Base
- Research
- Human Research Ethics and IRB
Genetic research studies may create special risks to human subjects and their relatives. These involve medical, psychosocial, legal and economic risks, such as the possible loss of privacy, insurability, and employability, change in immigration status and limits on education options, and may create a social stigma. Knowledge of one's genetic make-up may also affect one's knowledge of the disease risk status of family members.
- Knowledge Base
- Research
- Human Research Ethics and IRB
Family research typically involves obtaining information from one family member (called a proband) about other family members (third parties). For a detailed description of family history research, see SOP 2901
- Knowledge Base
- Research
- Human Research Ethics and IRB
In general, an anecdotal report on one or a series of patients seen in one’s own practice and a comparison of these patients to existing reports in the literature is not research and does not require IRB approval. Going beyond one’s own practice to seek out and report cases seen by other clinicians creates the appearance of a systematic investigation with the intent to contribute to generalizable knowledge and therefore is considered research and would require IRB approval.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.
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- Research
- Human Research Ethics and IRB
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.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.