Committee on Human Research Processes Clinical Translational Research Fellowship Program Curriculum Core.

Slides:



Advertisements
Similar presentations
Evaluation and Human Subjects Research Julie M. Aultman, Ph.D. Chair, Institutional Review Board Associate Professor, Family and Community Medicine Northeast.
Advertisements

IRB SUBMISSION PROCESS FOR SHB STUDIES Version 9/18/2013.
Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Human Subjects Research and the Marian University Institutional Review Board (IRB)
University Research Ethics Committee Workshop on procedure and data protection issues 30th May 2008.
Human Subjects Protections, Concepts, and Procedures Office of Research and Sponsored Programs Tom Lombardo, Ph.D., Director, Research Integrity & Compliance.
Protecting the Privacy of Family Members in Survey and Pedigree Research Jeffrey R. Botkin, MD, MPH University of Utah.
Jeopardy Rules Game show host will divide the room into two teams When you know the answer, raise your hand and wait to be called on Your answer must.
Pediatric Ethics Subcommittee of Pediatric Advisory Committee, September 10, 2004 Analysis of Research Protocols Involving Children: Combining Subparts.
DO NO HARM IRRB Presentation Purposes Responsibilities Processes NLU IRRB Home page.
 Daylene Meuschke, Ed.D Barry Gribbons, Ph.D RP Conference: April 2, 2013.
IRB 101: Introduction to Human Subject Research
Human Research Protection Program Training CHR Introductory Training: Protecting Human Research Subjects Melanie Mace, MA Education Coordinator, HRPP
IRB Basics Helen Panageas New York University School of Medicine Institutional Review Board Portion of slides courtesy of Suzanne M. Smith, University.
Human Investigation Committee  Is it research?  If yes, does it involve human subjects?  If yes, can it be exempt?  If no, will a Request for.
RESEARCH COMPLIANCE: Health Sciences Institutional Review Board.
Determinations of Research, Human Subjects Research, Exemptions, and Expedited Review Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst, Program for.
Is this Research? Exempt? Expedited?
Lisa Denney, MPH HRPP Assistant Director Melanie Mace, MA HRPP Education and Training Coordinator Bill Woods, PhD CAPS Policy and Ethics Core November.
Cornell Evaluation Network The Use of Human Participants in Research Office of Research Integrity and Assurance ~ May 14, 2007.
Avoiding the Pitfalls of an IRB Submission Chris Ayres Chair, Institutional Review Board Social & Behavioral Science & Chair, Department of Kinesiology,
April 2011 Conducting Research at SPC Approval Process and Procedures Center of Excellence for Teaching and Learning.
What you need to know about the Saint Leo IRB review process.
Research Involving Human Subjects All research involving the participation of human subjects must be submitted for review by the IRB (Institutional Review.
Submitting IRB Applications (or “Do I have to do an IRB?”) Linda A. Detman, Ph.D. Research Associate Lawton & Rhea Chiles Center for Healthy Mothers and.
Risk by Richard R. Riker MD Vice-Chair, IRB Maine Medical Center.
Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director.
Protecting Human Participants in Your Research and Classroom Projects NAU Institutional Review Board
RESPONSIBLE CONDUCT IN HUMAN SUBJECTS RESEARCH MARGARITA M. CARDONA DIRECTOR OF SPONSORED RESEARCH Institutional Review Board.
SUNY Oswego Human Subjects Committee Last Revised 10/28/2011.
The Institutional Review Board: A Community College Toolkit Dr. Geri J Anderson.
SUNY Oswego Human Subjects Committee Last Revised 10/28/2011.
Human Subjects Research at ASU An Overview. Overview Definitions Historical Framework Federal Guidelines Human Subjects Research at ASU.
Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Human Subjects Research and the Marian University Institutional Review Board (IRB)
Education Research and Social & Behavioral Science IRB.
Institutional Review Board Issues for Classroom Research Sharon McWhorter IRB Administrator, The University of Akron (With assistance from Phil Allen,
Is IRB Review or an OHSRP Determination Required?.
Determinations of Research, Human Subjects Research, Exemptions, and Expedited Review Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for.
NAVIGATING THE IRB PROCESS University Institutional Review Board California State University, Stanislaus.
CUNY Human Research Protection Program (HRPP) School of Professional Studies April 18, 2013
Case Studies: Puzzles in Human Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst, Program for Research Integrity Development and Education.
Regulations 201: Thorny Issues What is Research? Exempt and Expedited Reviews.
WELCOME to the TULANE UNIVERSITY HUMAN RESEARCH PROTECTION OFFICE WORKSHOP for SOCIAL/BEHAVIORAL RESEARCH (March 2, 2010) Tulane University HRPO Uptown.
When Do I Need Ethics Board Approval? George Schmid, M.D., M.Sc. World Health Organization/Centers for Disease Control and Prevention
Human Specimen Repositories Requirements of 21 CFR Parts 50 & 56 PRIM & R May 5, 2004 Sally A. Hojvat, Ph.D. Director of Microbiology Devices Office of.
Exempt Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more.
Human Research Protection Program 101 March 20, 2007 Cincinnati, OH.
Research Ethics Office of Research Compliance. Responsible Conduct of Research (RCR) Covers 9 content areas –Animal Subjects (IACUC) –Human Subjects (IRB)
0 Ethics Lecture Research. ACADEMY OF OPHTHALMOLOGY Disclosures  The speaker has no financial interest in the subject matter of this.
THE INSTITUTIONAL REVIEW BOARD. WHAT IS AN IRB? An IRB is committee set up by an institution to review, approve, and regulate research conducted under.
Protecting Human Subjects Overview of the Issues Applications to Educational Research The IRB Process.
Investigator Initiated Research Best Practices for IRB: SBER Corey Zolondek, Ph.D. IRB Operations Manager Wayne State University.
Protecting the rights, safety and welfare of human subjects March 2015.
Brief Overview of IRB and Human Subject Protections Issues at the University of Richmond Dr. R. Kirk Jonas Chair, University of Richmond Institutional.
COCE Institutional Review Board Academic Spotlight
Brief Overview of IRB and Human Subject Protections Issues at the University of Richmond Dr. R. Kirk Jonas Chair, University of Richmond Institutional.
University of Central Florida Office of Research & Commercialization
Introduction to IRB (Institutional Review Board)
Research with human participants at Carnegie Mellon University
SOU Institutional Review Board
IRB – Human subjects research incoming staff orientation 2017
shades of gray: When is IRB approval required?
University of Central Florida Office of Research & Commercialization
USC Institutional Review Boards
SOU Institutional Review Board
IRB – Human subjects research incoming staff orientation 2018
Human Participants Research
Demystifying the IRB Process: An Interactive Conversation with QIP
Valdosta State University
Research with Human Subjects
Research Compliance: Protections for Research Subjects
Presentation transcript:

Committee on Human Research Processes Clinical Translational Research Fellowship Program Curriculum Core

Objective Clarify Committee on Human Research (CHR) processes for your study. –Is it research? –Is it human subjects? –Type of review? –Resources

CHR Processes UCSF Human Research Protection Training and Education Resources – p#Basichttp:// p#Basic

Prior to moving forward with your study Determine –whether your study is a research study –whether your study involves a human subject –Type of CHR review

What is research? Research is the “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” – asphttp:// asp

Is my quality improvement project research? If you are collecting data to disseminate/apply to other populations, then generally CHR approval is required. If you are conducting a quality improvement project, CHR approval is not required. See website/decision algorithm for greater detail: – –

Definition of Human Subjects A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information [45 CFR (f)] If your study is a research study involving a human subject, your study requires a CHR approval.

Do students need to submit their proposal for CHR review and approval? The Committee on Human Research (CHR) must review all research that involve human subjects performed by UCSF faculty, staff, or students. – asphttp:// asp

Types of CHR Review Full committee, expedited, and exempt are three types of CHR review; the type of review is based on the level of risk in your study Minimal risk is the probability and magnitude of harm or discomfort anticipated in the research. Minimal risks are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Types of CHR Review Studies with greater than minimal risk → Full CHR review Examples: randomized studies, studies using an investigational drug Studies with no greater than minimal risk → Expedited or exempt CHR review For more details, see – mRevGI.asp#Typehttp:// mRevGI.asp#Type

Do you need to do the on-line Collaborative Institutional Training Initiative (CITI) Training? Yes, if you are “key personnel.” Key personnel are defined as: “…all individuals who contribute in a substantive way to the scientific development or execution of the study at or on behalf of UCSF or affiliated institutions. Typically, these individuals have doctoral or other professional degrees, although other individuals should be included if their involvement meets the definition of Key Personnel. In particular, investigators and staff involved in obtaining informed consent are considered Key Personnel.”

Prior to moving forward with your study If your research proposal is linked to an existing research study, ask your mentor to see their CHR documents. –Carefully review the sections on risks, benefits and vulnerable groups –Review the consent forms. Will your study pose any new risks? Will new tools be administered to subjects?

Prior to moving forward with your study Can a minor modification to an existing protocol be submitted? or, Do you need to submit a new application?

Where to go for help UCSF Human Research Protection Program – Your mentor CTSI Ethics Consultation –

Summary Research involving a human subject requires CHR approval Many resources are available at UCSF for the ethical conduct of research

CTRFP* Curriculum Core Rebecca Jackson MD, School of Medicine Barbara J. Burgel, RN, PhD, School of Nursing George Sawaya MD, School of Medicine Susan Hyde DDS, MPH, PhD, School of Dentistry Jaekyu Shin, PharmD, School of Pharmacy Joel Palefsky MD, School of Medicine * Clinical Translational Research Fellowship Program