Module 1 About University Research Responsibilities of PI and Research Staff Research at the University of Michigan PI and Research Staff Responsibilities.

Slides:

Advertisements

Similar presentations

IRB Application Process Deb Schneider IRB Administrator Office of Research & Sponsored Programs 1055 AB (313)

Advertisements

Introduction to Human Subjects Research at the University of Michigan – Dearborn. Debra Schneider IRB Administrator (313)

Spring  Welcome ◦ Amanda Athey, Assistant Dean, Graduate School  Student Experience  Funding Opportunities ◦ Rebecca Drake, Research Administrator,

Institutional Review Board Guidance.  Independent Ethics Committee  Ethical Review Board  Research Ethics Committee 2.

1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.

Recently Issued OHRP Documents: Guidance on Subject Withdrawal and Draft Revised FWA Secretary’s Advisory Committee on Human Research Protections October.

POST APPROVAL MONITORING AND EDUCATION PROGRAM Jane Lehmbeck 1, Sarah Blackman 1, Karen Davenport 2, Karen Parks 1 Office of the Vice President for Research.

February 8, 2007 Research Administration: University of Michigan Business & Finance Forum Marvin G. Parnes Associate Vice President for Research & Executive.

Ethical Issues in Human Experimentation The Role of the IRB The IRB is an administrative body established to protect the rights and welfare of human subjects.

SPS Round Table The Use of Human Participants in Research Office of Research Integrity and Assurance (ORIA) April 17, 2007.

Capturing IRB Protocol-Proposal Congruency For NIH research involving human subjects at Just-In-Time (JIT) Cynthia Kane, Associate Director Laura Kozma,

February 8, 2007 eResearch: University of Michigan Business & Finance Forum Marvin G. Parnes Associate Vice President for Research & Executive Director.

Office of Research Integrity Office of Research Integrity Orientation Session November 8, 2012 ECSS

Working with DRDA NSF Career Development Workshop Division of Research Development and Administration Dave Plawchan Managing Project Representative, DRDA.

Institutional Review Board (IRB) Human Subject Research Office (HSRO) University of Miami and Affiliated Institutions.

Basic Research Administration Principles Presented by Ronald Kiguba Research Coordinator, Makerere Medical School.

Federalwide Assurance Presentation for IRB Members.

Research and AWC Faculty Seminar, February 19, 2009, Mary Schaal, M.Ed.

International Research & Research Involving Children K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development.

The proper protocol for grant approval at LCSC GRANT-WRITING 101: INTERNAL PROCEDURES.

Retha Britz Copyright 2013 All rights reserved for this presentation 1 Establishment and functioning of a REC Retha Britz.

ORO Reviews: Frequent Findings Related to IRBs Bob Brooks Associate Director Research Compliance Education and Policy VHA Office of Research Oversight.

Responsible Conduct of Research (RCR) What is RCR? New Requirements for RCR Who Does it Affect? When? Data Management What is the Institutional Plan? What.

Managing Your Grant Award August 23, 2012 Janet Stoeckert Director, Research Administration Sr. Administrator, Basic Sciences Keck School of Medicine 1.

10/16/2015 Roles and Responsibilities of Principal Investigators/ Program Directors/ Project Directors.

© 2009 Cengage Learning. All Rights Reserved. Clinical Research.

Office of the Vice President for Research Research, Scholarship, and Creative Expression R. Timothy Mulcahy Vice President for Research.

The Institutional Review Board: A Community College Toolkit Dr. Geri J Anderson.

IRB BASICS: Issues in Ethics and Human Subject Protections Prepared by Ed Merrill Department of Psychology November 12, 2009.

UC DAVIS OFFICE OF RESEARCH Overview of Good Clinical Practices (GCP) Investigator and Study Team Responsibilities Miles McFann IRB Administration Training.

6/7/041 Seeking To Improve Human Research Protections through Accreditation John H. Mather MD Director, ORCR, OVPR.

Rebecca Nickleson, MS, CRA Assistant Director Office of Research & Sponsored Programs.

NCURA April 25, 2006 Compliance Coordination and Research Administrators: Opening the Lines of Communication Judy Harris, Assistant Director, Arizona State.

LETTER OF INTENT FOR INDUSTRY SPONSORED RESEARCH Signe Denmark, SCTR Research Opportunities & Collaborations Ryan Mulligan, SCTR Grants & Contracts Navigator.

Office of Sponsored Projects The Funding Life Cycle.

AAHRPP ACCREDITATION (Association for the Accreditation of Human Protection Programs)

CUNY Human Research Protection Program (HRPP) School of Professional Studies April 18, 2013

WELCOME to the TULANE UNIVERSITY HUMAN RESEARCH PROTECTION OFFICE WORKSHOP for SOCIAL/BEHAVIORAL RESEARCH (March 2, 2010) Tulane University HRPO Uptown.

 Welcome ◦ Amanda Athey, Director, Graduate School  Student Experience  Funding Opportunities ◦ Rebecca Drake, Research Administrator, Office of Research.

Conducting Research at Lincoln IRB/HRPP Policies, Procedures & Good Clinical Practices B Kanna MD, MPH, FACP Associate Program Director of Internal Medicine.

Human Subjects Protection Program Office of Research Compliance Navigating through the current HSPP and IRB Presented by: Danielle Griffin, M.S. Research.

Office of Sponsored Projects The Funding Life Cycle.

Non-compliance with Human Subjects Research Regulations J. Bruce Smith, MD, CIP November 2014 Continuing Education for IRB Members.

 What is an IRB and why do we need one at Western?  Who needs to submit proposals to the IRB?  If approved, how long is your proposal good for?  Is.

1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.

Institutional Review Board (IRB) 101 Oleg Kisselev, Administrative IRB Chair *This presentation was prepared/presented.

Introduction to the HRPP and IRB Human Research Protection Program (HRPP) Office.

Business Operations Pre-Award. Confidential Disclosure Agreements (CDA)/ Non-Disclosure Agreements (NDA)

 The purpose of IRB is to ensure the rights of research subjects are protected  In accordance with the ethical standards of the U.S. Department of Health.

Current Challenges & Opportunities in Clinical Research Compliance.

To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.

Research Compliance and Institutional Review Boards

New Faculty Orientation

Jeffrey M. Cohen, Ph.D. CIP President HRP Associates, Inc.

New Faculty Orientation

HUMAN RESEARCH PROTECTION PROGRAM or

AAHRPP Accreditation Welcome to the University of Georgia’s presentation for accreditation of the human research protection program (HRPP). This presentation.

To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.

Sponsored Programs at Penn

AAHRPP + IRB Update Michael Mahoney

To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.

Submitting a Proposal.

Randolph Hall Vice President of Research

GSBM Presentation Updated

Proposal Processing Wake Forest University Health Sciences

Proposal Routing in Cayuse SP

Overview of Process for GSEP Students

Change to Commercial IRB Fees

Human Participants Research

GPS IRB SIX STEPS Updated

Presentation transcript:

Module 1 About University Research Responsibilities of PI and Research Staff Research at the University of Michigan PI and Research Staff Responsibilities

General Information about Research at the University of Michigan Departments that oversee research involving Human Subjects: OVPR (Office of the Vice President for Research) DRDA (Division of Research Development Administration) HRPP (Human Research Protection Program Office) The UM IRB’s IRB Application Process Possible interview questions about UM Research Information about your responsibilities as a researcher

University Research Office of Vice President for Research oversees all aspects of research at the University of Michigan. Vice President for Research: Stephen Forrest Division of Research Development and Administration: Helps submit proposals Reviews Contracts Processes Grant Awards Makes sure that all sponsored research involving human subjects are submitted for IRB Review

HRPP : Human Research Protection Program Purpose: Protect the rights and welfare of human subjects participating in research at the university Promotes compliance with relevant legal requirements and ethical standards. Supports investigators in their research activities

4 University IRB’s IRB Med IRB Health Sciences & Behavioral Sciences Dearborn IRB Flint IRB

IRB Application Process PI submits application via eResearch PI completes PEERRS Human Subjects training eResearch application goes to Reviewer If necessary reviewer requires changes to protocol to ensure adequate Human Subjects Protections are in place. When adequate protections are in place Reviewer approves the study. Reviewer may also determine that PI may not proceed with study.

Who has primary responsibility for protecting the rights & welfare of human subjects? The PI and Research team Safeguarding the subjects takes precedence over the goals and requirements of any research. The PI and research team are expected to know about and comply with the requirements of the ethical requirements of the Belmont Report and the Common Rule.Belmont Report Common Rule

Human Subjects Training & Support Resources All University of Michigan researchers must complete the relevant PEERRS Human Subjects module. Director of Research & Sponsored Programs is available to answer questions. IRB Administrator is available to answer basic questions. ORSP Human Subjects webpage HRPP Webpage

Resources Dearborn Office of Research & Sponsored Programs PEERRS DRDA OVPR / HRPP

This is the end of module 1. This is the end of Module 1. Module 2 will discuss general vocabulary and principles related to Human Subjects Research.