April 2011 Conducting Research at SPC Approval Process and Procedures Center of Excellence for Teaching and Learning.

Slides:



Advertisements
Similar presentations
The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.
Advertisements

QI project or research? Thomas F. Byrd M.D. HRRC Chair Subcommitees 2 and 4 December 3, 2013.
Is it Research?. Is It Research? 2 Elements –The project involves a systematic investigation –The design (meaning goal, purpose, or intent) of the investigation.
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.
THE UW HEALTH SCIENCES IRB S OVERVIEW PRACTICAL REGULATORY ISSUES IN HUMAN SUBJECTS RESEARCH.
Evaluating Risk 1 IRB CELT Presentation Colleen Donaldson – IRB Administrator Julie Wilkens – IRB Coordinator.
Exempt Research Mary Banks BS, BSN IRB Director CRC IRB and BUMC IRB.
IRB 101: Introduction to Human Subject Research
 Federal regulations specify “engagement” at the institutional level  Cornell has a Federalwide Assurance specifying its commitment to comply with regulations.
Cooperative Research IRB Brownbag, 3/4/08. ISU Policy Cooperative research projects are those projects which involve more than one institution. The official.
CUMC IRB Investigator Meeting November 9, 2004 Research Use of Stored Data and Tissues.
IRB Basics Helen Panageas New York University School of Medicine Institutional Review Board Portion of slides courtesy of Suzanne M. Smith, University.
RESEARCH COMPLIANCE: Health Sciences Institutional Review Board.
Is this Research? Exempt? Expedited?
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,
1 NJ Dept. of Health Decision Tree for eIRB Submission Revised: 06/18/2015 Is this research defined as: A systematic investigation which includes research.
Institutional Review Board (IRB) Human Subject Dr. John N. Austin, Director and Ms. Renee S. Jones, Associate Director Delaware State University Office.
What is your Acronym IQ? ASC DOC DOS FYS SACS NEH NIH OSHA IRB TGIF.
Michelle Groy Johnson Quality Improvement Officer Research Integrity Office Tough Love: Understanding the Purpose and Processes of Quality Assurance.
INSTITUTIONAL REVIEW BOARD HISTORY AND ETHICS. 2 Ethical History : Holocaust : Nuremburg Trials 1964: Declaration of Helsinki :
What is your Acronym IQ? ASC DOC DOS FYS SACS NEH NIH OSHA IRB TGIF.
Risk by Richard R. Riker MD Vice-Chair, IRB Maine Medical Center.
Committee on Human Research Processes Clinical Translational Research Fellowship Program Curriculum Core.
Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director.
RESPONSIBLE CONDUCT IN HUMAN SUBJECTS RESEARCH MARGARITA M. CARDONA DIRECTOR OF SPONSORED RESEARCH Institutional Review Board.
The Institutional Review Board: A Community College Toolkit Dr. Geri J Anderson.
How to Successfully Apply to the IRB Richard Gordin, IRB Chair True Rubal, Administrator / Director For the Protection of Human Participants in Research.
The Linguistics Department Institutional Review Board Committee Silvina Montrul, chair Fred Davidson Irene Koshik Ryan Shosted September 22, 2008.
Investigators’ Responsibilities in Conducting Human Subjects Research Dept. of Regulatory Affairs April 18, 2012.
A step-by-step guide to help you determine if your research protocol is required to be reviewed by the Lindenwood University IRB INSTITUTIONAL REVIEW BOARD.
Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Human Subjects Research and the Marian University Institutional Review Board (IRB)
Dustin Yocum, MA Institutional Review Board University of Illinois HUMAN SUBJECTS RESEARCH.
Institutional Review Board Issues for Classroom Research Sharon McWhorter IRB Administrator, The University of Akron (With assistance from Phil Allen,
Human Subjects Review: Policies and Procedures. Why A Human Subjects Review? It is the policy of this University that all researchers undertaking studies.
NAVIGATING THE IRB PROCESS University Institutional Review Board California State University, Stanislaus.
IRB Process Overview Ling Wang IRB Representative Graduate School of Computer and Information Sciences.
What Institutional Researchers Should Know about the IRB Susan Thompson Senior Research Analyst Office of Institutional Research Presented at the Texas.
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.
Human Subjects Protection Program Office of Research Compliance Navigating through the current HSPP and IRB Presented by: Danielle Griffin, M.S. Research.
Paul Hryvniak MS, CIP Alyssa Speier, MS, CIP September 30, 2014 Student Human Research Education Session Tel:
© 2015 Marketo, Inc. Marketo Proprietary and Confidential Page 1 Investigators’ Responsibilities in Conducting Human Subjects Research Office of the Vice.
Human Research Protection Program 101 March 20, 2007 Cincinnati, OH.
HUMAN SUBJECTS QUIZ! TRUE OR FALSE?
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.
COCE Institutional Review Board Academic Spotlight
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
University of Central Florida Office of Research & Commercialization
USC Institutional Review Boards
SOU Institutional Review Board
This takes approximately 5 minutes or less from start to finish
What types of research are exempt and ohrp guidance on exemptions
Jeffrey M. Cohen, Ph.D. Associate Dean,
CUNY Human Research Protection Program (HRPP)
Human Participants Research
Demystifying the IRB Process: An Interactive Conversation with QIP
Valdosta State University
Research with Human Subjects
Presentation transcript:

April 2011 Conducting Research at SPC Approval Process and Procedures Center of Excellence for Teaching and Learning

St. Petersburg College Conducting Research  All research conducted at SPC involving human participants must be approved.  In lieu of a formal Institutional Research Board (IRB), SPC has a Research Review Committee (RRC).  Committee was started in 2007 and is composed of faculty, program administrators, and other college staff. April 29, 2011 Conducting Research at SPC2

St. Petersburg College Purpose of the Committee  “To review, approve, and monitor research studies conducted by employees or others outside the College involving students, faculty, staff, alumni, or other College resources for purposes of protecting human rights and supporting the interests of the College.”  Board of Trustee Rule 6H , Conducting Educational Research Board of Trustee Rule 6H , Conducting Educational Research April 29, 2011 Conducting Research at SPC3

St. Petersburg College Website April 29, 2011 Conducting Research at SPC4 

St. Petersburg College Research Review Committee  DeeDee Watts, Faculty, Co-Chair  Jesse Coraggio, AE, Co-Chair  Beth Carlson, Faculty  Carol Weideman, Faculty  Richard Flora, Dean  Conferlete Carney, Tarpon Springs Provost  Suzanne Gardner, General Counsel Anne Cooper, Leadership Sponsor April 29, 2011 Conducting Research at SPC5

St. Petersburg College Definitions  Research study is defined as “research” (See Code of Federal Regulations, 45 CFR (d)) that involves “human subjects” (See Code of Federal Regulations, 45 CFR (f)).  Research is defined as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" according to the Code of Federal Regulations, 45 CFR (d). April 29, 2011 Conducting Research at SPC6

St. Petersburg College Definitions  Human subject is defined as an “individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information” according to the Code of Federal Regulations, 45 CFR (f). April 29, 2011 Conducting Research at SPC7

St. Petersburg College Definitions  Minimal risk is defined as the “probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests,” according to the Code of Federal Regulations, 45 CFR (i). April 29, 2011 Conducting Research at SPC8

St. Petersburg College Forms Application for Research Study April 29, 2011 Conducting Research at SPC9

St. Petersburg College Application for Research Study  Researcher Information  Sponsor Information  Type of Proposed Research  Research Proposal and Design  Assurances April 29, 2011 Conducting Research at SPC10

St. Petersburg College Assurances  Request to conduct research that is governed by Board of Trustees Rules of St. Petersburg College, as well as state and federal law concerning educational research, privacy and confidentiality.  Agree to follow all guidelines and regulations of this institution, and will maintain the confidential nature of records and the privacy rights of all participants.  Agree that St. Petersburg College will be provided a copy of the completed research study product.  Agree that under no circumstances can research proceed until given notification of approval of this Application by the Research Review Committee, and have executed the “Access to Confidential Data Researcher Agreement.” April 29, 2011 Conducting Research at SPC11

St. Petersburg College Forms Access to Confidential Data April 29, 2011 Conducting Research at SPC12

St. Petersburg College Access to Confidential Data Form  Unauthorized disclosure of confidential information is illegal  Data, data sets or output reports are confidential and the information is to be protected  Final reports may only report on students in aggregate summaries and not individually. April 29, 2011 Conducting Research at SPC13

St. Petersburg College Forms Research Review Committee Checklist April 29, 2011 Conducting Research at SPC14

St. Petersburg College Research Review Process All requests must be filed with the AEA Department with a signed Application for Research Study along with the following:  Signed Access to Confidential Information agreement;  Copy of the research proposal;  Copies of any consent forms;  Copies of any assessment instruments (tests, surveys, questionnaires, or interview scripts);  Copy of the Institutional Research Board (IRB) application, if any, submitted to another institution;  Copy of the IRB approval letter, if applicable; and  Evidence of Human Participant Training. April 29, 2011 Conducting Research at SPC15

St. Petersburg College Research Review Process  RRC will convene to assess completed application packets and will determine whether the application will be approved or denied based on the level of risk to participants and the best interests of the college.  RRC will review to ensure that the research shall not violate any state or federal law pertaining to the protection of privacy and present only a minimal risk to participants. April 29, 2011 Conducting Research at SPC16

St. Petersburg College Research Review Process  Co-chairs of the RRC (or designee) will notify the applicant(s) of the approval or rejection of the application.  If further participation in the project is considered to be not in the best interest of the college, the researcher will be notified of the rejection immediately.  The researcher(s) submitting the application will be required to supply the AEA department with a complete, final version of the research report for placement in the central research files. April 29, 2011 Conducting Research at SPC17

St. Petersburg College Research Review Process  An Annual Update Form will be required to be filed by the research applicant with the AEA Department.  Where the research has not been completed within the allotted twelve months, the applicant(s) may request an extension of time. April 29, 2011 Conducting Research at SPC18

St. Petersburg College Timeline  Due to the involvement of many participants in the process, application review make take up to a month or longer to complete.  Frequently, applicants are asked follow-up questions by the RCC to ensure a thorough understanding of the research April 29, 2011 Conducting Research at SPC19

St. Petersburg College Exceptions…  Student course assignments are generally not considered “research” under the federal definition as these course assignments are not “systematic data collection” efforts intended to “develop or contribute to generalizable knowledge.”  Therefore, student course assignments generally do not require the RRC review, approval, and monitoring. April 29, 2011 Conducting Research at SPC20

St. Petersburg College Exceptions…  However, when student course assignments are in fact systematic data collection efforts intended to “develop or contribute to generalizable knowledge,” they are considered a research study and are subject to RRC review, approval, and monitoring. April 29, 2011 Conducting Research at SPC21

St. Petersburg College Research Intent  One clear example that the activity is a research study is the intent to publish or otherwise disseminate the results of the research activity.  Faculty and/or students intending to publish such course assignments must complete an Application for Research Study and submit it to the RRC for review and approval prior to beginning the assignment. April 29, 2011 Conducting Research at SPC22

St. Petersburg College Institutional Research  Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:  research on regular and special education instructional strategies, or  research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods April 29, 2011 Conducting Research at SPC23

St. Petersburg College Moratorium  Due to the amount of research applications and the limited resources, a moratorium exists on all research conducted at SPC by outside parties April 29, 2011 Conducting Research at SPC24

St. Petersburg College Related Web Resources Compliance and Integrity Links  The Office of Human Research Protections The Office of Human Research Protections  The Office of Research Integrity (ORI) The Office of Research Integrity (ORI)  The Belmont Report The Belmont Report  Nuremberg Code Nuremberg Code  Protecting Human Subjects Training Protecting Human Subjects Training  University of South Florida IRB University of South Florida IRB April 29, 2011 Conducting Research at SPC25

St. Petersburg College Related Web Resources Federal Documents  Title 21 CFR - Part 50 - FDA Policy on Informed Consent Title 21 CFR - Part 50 - FDA Policy on Informed Consent  Title 21 CFR - Part 50D - FDA: Additional Safeguards for Children Title 21 CFR - Part 50D - FDA: Additional Safeguards for Children  Title 21 CFR Part 56 - FDA Policy on IRBs Title 21 CFR Part 56 - FDA Policy on IRBs  Title 45 Public Welfare, Part 46, Protection of Human Subjects Title 45 Public Welfare, Part 46, Protection of Human Subjects April 29, 2011 Conducting Research at SPC26

St. Petersburg College Next Steps  Designing a standardized rubric to evaluate research  Creating a ‘expedited’ process for research that constitutes only a ‘very’ minimal risk to participants (e.g., survey with no identifiable participant information)  Establishing Program Administrator assurance of research rigor April 29, 2011 Conducting Research at SPC27

St. Petersburg College April 29, 2011 Conducting Research at SPC28 Questions

April 2011 Conducting Research at SPC Approval Process and Procedures Center of Excellence for Teaching and Learning