IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
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IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
\\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20esVersion 16OCT20191I.Authority and Institutional CommitmentThe Vice President for Research Administrations and Operations and the Assistant Dean for Regulatory Affairs and Research Integrity are the authority under which the Wake Forest Human Research Protection Program is established and overseen. IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20 These officials have sufficient standing, authority, and independence to ensure implementation and maintenance of the program.The Wake Forest IRB holIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
ds a Federalwide Assurance (FWA00001435), approved by the Office of Human Research Projections (OHRP). This assurance applies to non-exempt research i\\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20in biomedical and behavioral research, has in place a set of principles and guidelines that govern the institution, its faculty, staff, IRB members and staff, and the Institutional official in the discharge of its responsibilities for protecting the rights and welfare of human subjects taking part i IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20n research conducted at, or sponsored by the institution. Assurances applicable to federally supported or conducted research must, at a minimum, contaIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
in such a statement of principles, which may include an appropriate existing code, declaration, and/or statement of ethical principles as formulated b\\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20ocess for declaring the scope of the Common Rule has changed. The Common Rule will be applied to only federally- sponsored human subjects research studies.The Wake Forest Institutional Review Board has a number of organizations listed as components as part of the assurance. Each component is a wholl IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20y-owned subsidiary for which the Wake Forest Institutional Review Board will serve as the IRB of record and researchers will be subject to these policIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
ies and procedures.The mission of the IRB is to protect the safety, rights, and welfare of participants in "human research" defined in applicable fede\\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20ts, and welfare of research subjects is the most important consideration and prevails over interests of science and society.All human research activities and activities of the IRB, regardless of sponsorship, are guided by the ethical principles of The Belmont Report: Ethical Principles and Guideline IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20s for the Protection of Human Subjects Research. The IRB is also guided by the ethical principles for the protection of human research participants asIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
set forth in the Declaration of Helsinki. It operates in accordance with the requirements for human subjects research as set forth in the Code of Fed\\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20ed guidelines, as applicable. Relevant policies and procedures are mad available to sponsors, researchers, research staff, research participants, and the Institutional Review Board, as appropriate.When appropriate, all collaborating institutions and investigators engaged in non-exempt human subjects IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20 research, as defined at 45 CFR 46, will operate under an OHRP or other federally approved Assurance for the protection of human subjects.2When any reIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
search covered under this policy takes place in a foreign country, the procedures prescribed by the international institution, if any, will afford pro\\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20ocedures will occur.a.The IRB should obtain necessary information about the local research context through one or more of the following mechanisms:i.Personal knowledge of the local context by an IRB member, through direct experience with the research site, its population, and surrounding communityii IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20.Participation by one or more consultants at convened meetings or through written review. Such consultants should be appropriately qualified with locaIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
l knowledge of the research context, population, and its surrounding community.iii.Input from an IRB in the country where the research will take place\\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20he credentials and training of international collaborators and the plan for reporting events and to preserve the integrity of study data. The IRB must review all research conducted internationally by its faculty and staff. The investigator should also consult with researchers familiar with the cultu IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20re differences of international research and consider the different customs, habits, and practices of international study subjects with regard to theIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
process of obtaining informed consent.The IRB functions independently of other institutional entities regarding the protection of human subjects. IRB \\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20thority holds for all institutions designating the Wake Forest School of Medicine IRB as the IRB of record, and for all principal and co-investigators named in research protocols brought before the IRB, regardless of institutional affiliation or location in which the research will be conducted.The I IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20RB has the authority to take the actions listed below when appropriate.a.The IRB has the authority to approve, require modifications in order to securIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
e approval, disapprove, close or suspend any research study based upon its considerations tor the protection of human subjects. If the IRB disapproves\\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20b.The IRB has the authority to require progress reports from the investigators and oversee the conduct of any research study that is approved. The IRB may request a progress report at any time; however, progress reports will be reviewed at least annually depending on the IRB's assessment of the risk IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20 to subjects. The IRB has the authority to3have the consent process or any aspect of the research be observed by an IRB member or a third party whom tIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
he IRB determines is qualified and appropriate. The IRB has the authority to obtain all research records and documents associated with an approved stu\\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20s originally approved in which an unanticipated problem involving risk to the safety, rights, or welfare of human subjects or others has occurred. Similar action may be taken in the case of serious or continuing noncompliance with the requirements of any state or federal regulation or serious or con IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20tinuing noncompliance with the determinations of the IRB.d.Any suspension or termination shall be promptly reported in writing to the investigator, apIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
propriate Institutional official, and as appropriate to OHRP, the study sponsor, the FDA and other appropriate federal departments or agencies. Any re\\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20ve the authority to suspend research studies until a convened meeting of the IRB can evaluate the study and issues involved.e.The IRB has the authority to place restrictions (including but not limited to length of approval) on any study based upon its considerations for the protection of human subje IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20cts.f.Additional authority and responsibility may be permitted under institutional policy.The Vice President for Research Administration and OperationIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
s is the Institutional official. The Institutional official holds signature authority for all regulatory documents submitted to the Department of Heal\\x Wake Forest’School of MedicineWake Forest School of MedicineHuman Research Protection Program and Institutional Review BoardPolicies and Procedure IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20vestigator Agreements may be delegated to appropriate parties within the institution. The Institutional Official maintains ultimate responsibility for complaints or concerns about the human research practices.The IRB Director has been identified as the Human Protections Administrator (HPA) for the i IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20nstitutional FWA, and may serve as an additional point of contact to OHRP officials. All IRB staff, members, and Chairs report to the Director and thrIRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20
ough the Director to the administration and Institutional official.The IRB will report actions and findings to the Institutional official by making thGọi ngay
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