Research-compliance.umich.edu
Research Ethics & Compliance University of Michigan
WEBOur Campus Partners. Effective research compliance relies on cooperative oversight and action from multiple units. UMOR works with the schools and colleges and other U-M central offices to facilitate research compliance and related business processes (e.g., laboratory inspections and technology transfers).
Actived: 8 days ago
IRB Application Process Research Ethics & Compliance
WEBThe IRB application is an online questionnaire/form that any member of the study team can initiate within U-M's eResearch Regulatory Management (eRRM) system. It's designed to gather all the information and materials necessary for the IRB-HSBS, along with applicable research review units , to evaluate and approve the research in accordance with
IRB Review Process Research Ethics & Compliance
WEBIRB-HSBS Turnaround Times. "Turnaround" is the estimated time it takes to complete the IRB review and determination process. Full-board: 4 - 8 weeks. Expedited: 2 - 4 weeks. Exempt: < 1 week. The U-M Institutional Review Boards (IRBs) fulfill their goals to protect human research participants and support the design and conduct of sound research
IRB-HSBS Education Research Ethics & Compliance
WEBFor scheduling or questions, contact: IRB Health Sciences and Behavioral Sciences. Phone: (734) 936-0933. [email protected]. Lists the training and educational opportunities offered by the U-M IRB-HSBS to apply for IRB approval, conduct human subjects research, and navigate through the federal regulations, state laws, and …
Single IRB-of-Record (sIRB) Process Research Ethics & Compliance
WEBFederally-funded cooperative (i.e, "multi-site") human research studies are required per the Common Rule (45 CFR 46.114) to utilize a single IRB-of-Record (sIRB) to streamline the review process for human participant protections and to avoid duplicate review by an institutional review board at each site.. Under the sIRB model, an IRB at …
Research Safety Research Ethics & Compliance
WEBFor more information about U-M research safety programs or for policy matters, call 734-936-3934 or send e-mail to [email protected]. For more information about research safety practices and procedures or to report safety concerns, call the Department of Environment, Health & Safety (EHS) at 734-647-1143.
Human Research Protection Program (HRPP)
WEBFor UMHS Clinical Engineering services or consultation regarding the use (e.g., selection, safety, maintenance) of investigational devices in human subjects research, call 734-615-3502. Describes the University of Michigan's Human Research Protections Program (HRPP) for research involving human participants and provides resources for investigators.
PEERRS: Human Subjects Research Protections Course Details
WEBThe PEERRS Human Subjects Research Protections (HSP) course defines human subjects research, identifies the federal regulations that govern the research activity, explains why compliance with the regulations is important, and provides information on the common methods used to apply these regulations, including: risk evaluation, study population …
PEERRS Portal Research Ethics & Compliance
WEBMy LINC help (e.g., registration, navigation): Contact the ITS Service Center at (734)-764-HELP [734-764-4357] or email [email protected]. PEERRS program questions: Email the PEERRS training group at [email protected]. PEERRS is the University of Michigan's online program for certain regulatory compliance and responsible conduct of research …
Human Subjects Protections Glossary Research Ethics
WEB"Human Subjects Protections" is a collective term for the federal, state, and university policies, procedures, and ethical considerations that protect the rights and welfare of human beings who participate in research as the subjects of that research. The Human Research Protections Program (HRPP) provides the institutional guidelines for human subjects …
International Human Subject Research Resources
WEBThe external informational resources linked below address important areas for the development, approval, training for and conduct of international human subjects research. Investigators and IRB members may find these resources helpful when considering the multitude of unique and complex issues related to international human subjects research.
eResearch NextGen: Human Research Application
WEBeResearch NextGen uses an iterative design and review process with multiple working groups that focus on a regulatory requirement, application type or data component, or business process. The working groups are composed of representatives from U-M study teams, U-M IRB offices and boards, ancillary units, the HRPP, and ITS eResearch.
IRB Health Sciences and Behavioral Sciences (HSBS)
WEBThe Health Sciences and Behavioral Sciences Institutional Review Board (IRB-HSBS) is responsible for protecting the rights and welfare of human participants in research conducted by faculty, staff and students affiliated with the University of Michigan – Ann Arbor Campus as well as the Dearborn and Flint Campuses (see list of supported units ).
Institutional Review Board
WEBIRB Health Sciences and Behavioral Sciences Standard Operating Procedures May 2020 1 PART 1 – INTRODUCTION, PURPOSE, AND ETHICAL PRINCIPLES I. The Human Research Protection Program (HRPP) The purpose of the HRPP is to protect the rights and welfare of human participants in
Collaborative Research: IRB-HSBS sIRB Process
WEBThe Common Rule (45 CFR 46.114) requires that a single IRB-of-Record (sIRB) be designated to review and ongoing oversight of federally sponsored non-exempt cooperative or multi-site human research studies. If a U-M study team wishes the IRB-HSBS to serve as the sIRB for a proposed project, the Principal Investigator (PI) or a …
International Human Subjects Research Risks
WEBInternational research risks extend beyond the boundaries of the university’s research oversight infrastructure. Mitigation must rely on thoughtful, informed judgments or investigators may drop promising lines of research or may not be able to rise to ethical challenges in protecting human research participants.
IRB-HSBS General Informed Consent Template Research Ethics
WEBDescription: (Word) Blank template with 2018 revised Common Rule key information and other required informed consent elements represented as section headers; includes instructions and recommended language. It is strongly advised that you modify this template to draft a project-specific informed consent document for your study for IRB …
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