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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.

This policy establishes the Human Research Protection Program (HRPP) as the body responsible for ensuring UNC-Chapel Hill conducts human subjects research that is ethical and that complies with all relevant laws and regulations.

The Intermediate Investment Pool is open to all participants that are eligible for the UNC- Chapel Hill Temporary Investment Pool.

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.

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.

When some or all of the participants in a research conducted under the auspices of the University of North Carolina at Chapel Hill (UNC-Chapel Hill) are likely to be vulnerable to coercion or undue influence or have diminished decision-making capacity, the research must include additional safeguards to protect the rights and welfare of these participants.

The Investment Fund's distribution policy attempts to accomplish two objectives: (1) Provide participants with a stable source of spending support at a rate which is sustainable over the long term. (2) Provide spendable funds for the annual budget of each participant in a stable stream.

During the performance of clinical practice/research activities, students may interact with clients/research participants with tuberculosis (TB), hepatitis B (HBV), HIV/AIDS, and other infections. This contact may expose the student to infectious agents and may result in the student transmitting an infectious disease to other students, faculty, clients, family members, and research participants.

This document establishes a uniform policy for billing of procedures, items, or tests provided to participants who participate in clinical research studies to ensure compliance with federal, state, and institutional guidelines. This policy supplements existing policies related to the conduct of clinical research studies. This policy is applicable to medical items or services provided as part of a clinical research study; however, it does not apply to studies that do not involve human subjects.

Accidents or sickness which occurs while traveling internationally pose unique challenges. Participants may be unfamiliar with the medical services and locations of their host country. Language barriers and different billing requirements may affect prompt medical services. In addition, serious injuries may require the need for medical evacuation or repatriation services.

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.

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.

This document sets forth procedures for reporting and responding to Discrimination, Harassment (including Sexual or Gender-Based Harassment and Sexual Violence), Interpersonal Violence, Stalking, Complicity, and Retaliation (hereinafter collectively referred to as “Prohibited Conduct”) involving a Visitor, Program Participant, Contractor, or other Third Party as the Responding Party.

This SOP establishes written procedures for ensuring prompt review and reporting of any Unanticipated Problems Involving Risks to Subjects or Others, Serious Noncompliance, Continuing Noncompliance, Suspension or Termination of IRB approval.

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.