Tasha Osafo, CIP Assistant Director IRB Office Exempt Review.

Slides:



Advertisements
Similar presentations
Human Investigation Committee  Is It Research?  Is It Human Subjects Research?  Is It Human Subjects Research that requires IRB review?
Advertisements

QI project or research? Thomas F. Byrd M.D. HRRC Chair Subcommitees 2 and 4 December 3, 2013.
THE UW HEALTH SCIENCES IRB S OVERVIEW PRACTICAL REGULATORY ISSUES IN HUMAN SUBJECTS RESEARCH.
Exempt Research Mary Banks BS, BSN IRB Director CRC IRB and BUMC IRB.
 Federal regulations specify “engagement” at the institutional level  Cornell has a Federalwide Assurance specifying its commitment to comply with regulations.
CUMC IRB Investigator Meeting November 9, 2004 Research Use of Stored Data and Tissues.
Request For Exemption RFE. A Review of Penn’s Commitment to Research Research is a substantial and esteemed enterprise at Penn. The research community.
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.
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?
Quick Facts about Exempt Research No continuing review required IRB Reviewer makes Exempt determination 6 OHRP & 4 FDA categories(1 category overlaps)
Conducting Exempt Research An Overview of Human Subjects Protections Issues and the Review Process at ASU Office of Research Integrity and Assurance Institutional.
Institutional Review Board
Dana Evans 1 1 Exempt & Expedited Human Subjects Research.
Expedited vs Exempt by Richard R. Riker MD Vice-Chair, IRB Maine Medical Center.
BRI Institutional Review Board (IRB) Does your project require IRB oversight? By Chris Weir, CIP BRI IRB Manager April 18 th, 2011.
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.
ORAL HISTORIES AND HUMAN SUBJECTS RESEARCH PROTECTION REQUIREMENTS April 18, 2012.
INSTITUTIONAL REVIEW BOARD HISTORY AND ETHICS. 2 Ethical History : Holocaust : Nuremburg Trials 1964: Declaration of Helsinki :
HIPAA and Research Basics for IRB Tim Atkinson Director, Research and Sponsored Programs Director, Institutional Review Board Research Privacy Officer.
Research Ethics The Protection of Human Subjects.
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.
Stanley Estime, MSCI, CIP Senior QA/QI Specialist Lisa Gabel, CIP QA/QI Specialist IRB Determinations: What type of Review will your study receive?
1 Ethics of Working with Human Subjects (BIOL/CHEM 397 ) Header image designed by Michelle Jordan, UMBC Creative Services, 2009.
Conducting Exempt Research: An Overview of Human Subjects Protections Issues and the Review Process at ASU.
SLCL Human Subjects Review Committee. Who we are Four faculty from SLCL: – Melissa Bowles, Chair (SIP) – José Ignacio Hualde (Linguistics/SIP) – Jennifer.
Privacy and Confidentiality. Definitions n Privacy - having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally,
Office of Research Integrity and Compliance March 2011.
The Linguistics Department Institutional Review Board Committee Silvina Montrul, chair Fred Davidson Irene Koshik Ryan Shosted September 22, 2008.
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.
Institutional Review Board Procedures and Implications After the applied dissertation committee has approved the proposal and the IRB package, the student.
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,
UD IRB Guidelines for Applications for: Registrations of exempt research, Expedited IRB review, Full IRB review.
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.
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.
 Epidemiology -- Research – or Not Research? Medical Research Summit March Tom Puglisi, PhD.
Paul Hryvniak MS, CIP Alyssa Speier, MS, CIP September 30, 2014 Student Human Research Education Session Tel:
Human Subjects Research at Mines Colorado School of Mines New Faculty Orientation November 20, 2015.
Susan Loess-Perez, MS, CIP, CCRC Director of Research Compliance Office of Research Services Graduate Thesis and Dissertation Conference February 6, 2016.
Human Research Protection Program 101 March 20, 2007 Cincinnati, OH.
Created by Steve Martin, PA-C IRB Application Received Exempt Complete Yes No Mississippi College IRB Application Process Determine Review Category Expedited.
Presentation prepared for GCSU ENGAGE INSTITUTION REVIEW BOARD (IRB): FUNCTION AND SERVICE Tsu-Ming Chiang, Chair Whitney Heppner, Vice Chair Qiana Wilson,
What is exempt research? Angela Bain, IRB Administrator
Conditional IRB Approval
Submitting human subjects research
University of Central Florida Office of Research & Commercialization
Changes to Exempt Categories
University of Central Florida Office of Research & Commercialization
Introduction to the Institutional Review Board
IRB Educational Session - IRB Regulations and Types of Review
Submitting human subjects research
Alyssa Speier, MS, CIP QIP Student Education Session
Changes to Exempt Categories
This takes approximately 5 minutes or less from start to finish
Intro to Projects – Research with Human Subjects
What types of research are exempt and ohrp guidance on exemptions
Jeffrey M. Cohen, Ph.D. Associate Dean,
2018 Revised Common Rule: Exemptions
Common Rule Update: Exempt categories UT IRB
Common Rule Changes Effective date is January 21, 2019
IRB Educational Session - IRB Regulations on Expedited Review
Changes to Carthage College IRB processes and forms
What the IRB is looking for when reviewing your protocol
Human Participants Research
Current IRB at DMACC September 2018.
Research with Human Subjects
Presentation transcript:

Tasha Osafo, CIP Assistant Director IRB Office Exempt Review

OBJECTIVES 10/14/2011 IRB Retreat TKO  Review Basic IRB Concepts  Overview of Exempt Categories

10/14/2011 IRB Retreat TKO “I’m not interacting with humans. My project is exempt from the IRB.” “The PI is receiving de-identified data; her project is exempt.” “I’m doing a QI project; is my project exempt?” WHAT IS WRONG HERE? COMMON EXPRESSIONS

Misuse of the term “Exempt” when referring to “Non-human subjects research” From IRB perspective, the project is either Non-human subjects research or Human subjects research that meets Exempt, Expedited, or Full Board review criteria 10/14/2011 IRB Retreat TKO

Basic Decision Tree 10/14/2011 IRB Retreat TKO Step 1: Research? Yes No No IRB Step 2: Human Subjects? Yes No No IRB Step 3: Exempt, Expedited or Full Board? Step 4: Submit to IRB for final determination

Quick Facts about Exempt Research 10/14/2011 IRB Retreat TKO No continuing review required At NU, IRB Reviewer makes Exempt determination 6 OHRP & 4 FDA categories(1 category overlaps) No prisoners; pregnant women allowed; minors allowed, but restrictions apply (Subpart B & D determination not needed) HIPAA requirements apply if PHI used or disclosed

OVERVIEW OF EXEMPT CATEGORIES 10/14/2011 IRB Retreat TKO Review the Exempt Categories and overlapping Expedited Categories. Case Scenarios

Exempt Category 1 10/14/2011 IRB Retreat TKO Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Exempt Category 1 10/14/2011 IRB Retreat TKO Key Points: Research in established or commonly accepted educational settings, and Research of normal education practices Examples: Evaluating the use of accepted or revised standardized tests A program evaluation of pharmacy continuing education

Case Scenario Chicago public schools have offered SAT preparation workshops to its students for the last 10 years. The school tracks SAT results for its own purposes. Professor Kim from NU wishes to study the impact of these workshops on SAT scores in the schools. 10/14/2011 IRB Retreat TKO

Not Human Subjects Research Scenario The schools will give Dr. Kim de-identified SAT scores from 2006 to 2011 for her research. Neither Dr. Kim or the schools will be able to link the scores back to the students. She will collect basic demographics about the school from their websites. KEY POINTS: Dr. Kim is receiving a de-identified dataset that was not originally collected for her study. Human subjects are not involved; therefore, IRB review is not required. 10/14/2011 IRB Retreat TKO

Exempt Scenario Dr. Kim plans to administer a pre and post workshop survey to participating students to measure satisfaction and effectiveness of the workshop. Key Points: Dr. Kim is conducting research with human subjects due to administration of the survey. However, it meets Exempt category 1 as it is in a commonly accepted education setting (high school) and is studying the effectiveness of standard instruction techniques (the workshops). 10/14/2011 IRB Retreat TKO

Not Exempt Scenario Dr. Kim will assess if the workshops would be more effective if held outdoors by randomizing ½ the students to the normal workshop in the classroom; the other ½ are randomized to the woods. Key Points: While Dr. Kim is still studying a normal educational practice (the workshops), the setting in the woods is not considered a commonly accepted educational setting and the research does not qualify for Exempt status. Expedited review or Full Board review is required. 10/14/2011 IRB Retreat TKO

Exempt Category 2 10/14/2011 IRB Retreat TKO Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

Exempt Category 2 10/14/2011 IRB Retreat TKO Key Points: Minors cannot be surveyed or interviewed. Investigator may observe public behavior of children, but cannot participate in that behavior or activity. Identifiers can be recorded if disclosure of the subject’s responses will not place them at risk Examples: Survey of physicians regarding new pt. triage process Focus group to study impact of exercise on QOL

Exempt Category 2 v Expedited Category 7 Expedited Category 7 Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. 10/14/2011 IRB Retreat TKO

Exemption applies if Data is identifiable but not sensitive Data is sensitive but recorded without identifiers Children are only undergoing educational tests or observation of public behavior without interaction with the investigator Expedited applies if: Data is identifiable and sensitive but measures are in place to protect confidentiality Children are to be surveyed, interviewed, or observed with interaction by the investigator 10/14/2011 IRB Retreat TKO

CASE SCENARIO Dr. Jones, the Chair of the IRB, plans to survey researchers at his institution to assess satisfaction with the IRB review process. Approximately 50 researchers will be randomly selected to complete an online survey. 10/14/2011 IRB Retreat TKO

Not Human Subjects Research Scenario Dr. Jones does not plan to disseminate the results of his interviews. The results will be used within the IRB Office to assess what changes can be made to improve the review process. Key Points: While Dr. Jones is interacting with individuals, this is not research (a systematic investigation designed to develop or contribute to generalizable knowledge). It is a QI project and does not need IRB review. 10/14/2011 IRB Retreat TKO

Exempt Scenario Dr. Jones and his colleagues at other sites believe there is a correlation between satisfaction with the IRB and departmental support. Each site will send surveys to 50 researchers. The surveys will be anonymous. Key Points: Dr. Jones is engaged in research with human subjects and IRB review is required. Even though the survey may ask sensitive information, he meets Exempt Category 2 because results are recorded without identifiers. 10/14/2011 IRB Retreat TKO

Not Exempt Scenario Dr. Jones plans to retain identifiers on the surveys so that he can send out a second survey to those researchers who score extremely high on the dissatisfaction scale. Key Points: This project does not qualify for Exempt review due to retention of identifiers. Expedited Category 7 may apply if the IRB reviewer believes there are adequate measures in place to protect confidentiality and the risk is minimal. 10/14/2011 IRB Retreat TKO

Exempt Category 3 10/14/2011 IRB Retreat TKO Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or(b)(2) (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Exempt Category 3 Key Points: Research that otherwise doesn’t qualify for exemption under Category 2 due to collection of identifiable information that could place subjects at risk, qualifies under this category if the human subjects are elected or appointed public officials or candidates for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. 10/14/2011 IRB Retreat TKO

Exempt Category 4 10/14/2011 IRB Retreat TKO Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Exempt Category 4 10/14/2011 IRB Retreat TKO Key Points: Existing is defined as “on the shelf” at the time of initial IRB review. Information must be immediately recorded without identifiers & codes. Nobody should be able to link the data back to the subjects. Examples: Analysis of existing dataset in which the PI immediately removes MR#

Exempt Category 4 v Expedited Category 5 Expedited Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non- research purposes (such as medical treatment or diagnosis). 10/14/2011 IRB Retreat TKO

Exemption applies if: All data is existing, and Immediately recorded without identifiers or codes Expedited applies if: Data is existing but identifiers retained, and/or Data will be prospectively collected for non- research purposes (identifiers can be kept) 10/14/2011 IRB Retreat TKO

Case Scenario Dr. Adams has a freezer of blood samples that were originally collected for a research study which ended several years ago. Patient codes (which can be linked to the Medical Record) remain on the samples. The consent form originally signed by the subjects of Dr. Adams indicated whether or not their stored blood could be used for future research. 10/14/2011 IRB Retreat TKO

Not Human Subjects Research Scenario A researcher wishes to use the samples for his own study (non-FDA regulated). Dr. Adams removes the patient code from the samples before giving the samples to the researcher. Key Points: The researcher is conducting research. However, the samples were not originally collected for his project, and he is not receiving identifiable information. Therefore, he is not conducting human subjects research and does not need IRB review. 10/14/2011 IRB Retreat TKO

Exempt Scenario Dr. Adams gives the researcher the samples with the patient code. The researcher immediately removes the code upon receipt of the samples. Key Points: Because he is given samples with the patient code, the researcher is engaged in human subjects research. However, Exempt Category 4 applies as he is using existing samples and he plans to immediately remove the patient code. 10/14/2011 IRB Retreat TKO

Non-Exempt Scenario The researcher retains the patient code just in case he needs to contact the patient for follow-up information. Key Points: Exempt Category 4 does not apply as the researcher retains the patient code. The study may qualify for Expedited Category 5 (research involving materials that have been collected), as well as Expedited Category 7 if he eventually contacts subjects for follow-up information. 10/14/2011 IRB Retreat TKO

Exempt Category 5 10/14/2011 IRB Retreat TKO Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Exempt Category 5 requirements The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act). The research or demonstration project must be conducted pursuant to specific federal statutory authority. There must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB). The project must not involve significant physical invasions or intrusions upon the privacy of participants. 10/14/2011 IRB Retreat TKO

Exempt Category 6 (overlaps with FDA) 10/14/2011 IRB Retreat TKO Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Exempt Category 6 Examples 10/14/2011 IRB Retreat TKO Taste testing whole grain food products Comparing taste or smell of molasses, cheese or milk Sampling texture of ice cream

10/14/2011 IRB Retreat TKO Questions?

Contact Information 10/14/2011 IRB Retreat TKO Tasha K Osafo, BA, CIP Assistant Director Institutional Review Board Office Phone: Fax: