Risk-Benefit Ratio and Determinations. Sarah Mumford, Ammon Pate, Annie Risenmay IRB Operations Managers University of Utah
|
|
- Gerard Bond
- 6 years ago
- Views:
Transcription
1 Risk-Benefit Ratio and Determinations Sarah Mumford, Ammon Pate, Annie Risenmay IRB Operations Managers University of Utah
2 Risk-Benefit Ratio and Determinations Nuances of Risk Determinations Direct Benefit Radiation Risks for Research Purposes Biopsy Risks for Research Purposes Exception From Informed Consent Nuances of Compliance/UP Determinations
3 Nuances of Risk Determinations Criteria for Approval Subpart D Children (Both DHHS and FDA) The IRB may approve studies involving children only if the research falls into one of the three following categories: 1. No greater than minimal risk 2. Greater than minimal risk but offers the prospect of direct benefit or may contribute to the well-being of the individual child 3. Minor increase over minimal risk and no prospect of direct benefit to individual children but likely to yield generalizable knowledge about child s disorder or condition
4 Nuances of Risk Determinations Considering Children in Research Placebos Breaking Out Segments of Research Two Categories Research Procedures Minor Increase Over Minimal Risk Two Parent vs One Parent Permission
5 Direct Benefit Additional Monitoring OHRP does not permit additional monitoring or more frequent follow-up to be considered direct benefit for research participation. The OHRP guidance reads: Relative to monitoring procedures: any benefit of monitoring listed in a application must be an objective of the study and for approval under ; the monitoring procedure must have the intended, not incidental, potential benefit of influencing the management of the individual child s disease. * refers to Children s Category 2 OHRP Discussion: Any benefit of monitoring must be a stated objective of the protocol. The monitoring procedure must have the intended, not incidental, potential benefit of influencing the management of the child s diseases or condition. Not acceptable to piggy back additional procedures of greater than minimal risk in a protocol under the guise of it being a monitoring procedure necessary for the child s care. Cannot justify non-clinically indicated biopsy that it might demonstrate some undetected problem Cannot justify MRI to study brain activity in children with ADHD by stating that the MRI could potentially provide benefit to the child by
6 Radiation Risks for Research Procedures Old Practice: Any radiation for research-only procedures is greater than minimal risk Does not account for type, amount, or location Working with Radiation Safety and Jeff Botkin to develop new more nuanced practice Additional guidance from Radiation Safety Committee for board consideration
7 Biopsy Risks for Research Purposes - Link to Board Member Guidance Guidelines apply to adults and children Extra consideration given for children Participant s underlying condition may impact determination (e.g. hemophilia, etc.) IRB can apply different guidelines a on case-by-case basis Skin Minimal Risk: Single <2mm, do not routine require sutures Minor Increase Over Minimal: Require sutures, usually includes punch biopsies Greater than Minimal: Any size biopsy on face due to motor nerves and arteries close to skin GI Tract, Transbrochial Lung, Brochial Wall May be Minimal Risk if during clinical endoscopy Addt l criteria (Number, Pt status, Frequency) Greater Than Minimal Risk If extra biopsy when others are taken for standard diagnostics Liver and Kidney Greater Than Minimal Risk
8 Slide 7 AR1 SlideGenius and ask for these graphics in red; right now they look very pixelated (difficult to manipulate color when they were white to begin with) Annie Risenmay, 1/26/2017
9 Exception From Informed Consent (EFIC)
10 What it is, and what it isn t Research "in a setting where the emergency circumstances require prompt action and generally provide insufficient time and opportunity to locate and obtain consent from each subject's legally authorized representative. (FDA 2013). It is not the same as emergency use of an investigational drug or device in a single patient. Emergency Use of a Test Article is when an investigational drug or device is used to treat a single patient outside a research study.
11 What should the IRB application materials include? 1. Justification for Study Design (EFIC Waiver) 2. Consent Process and ICF 3. Community Consultation and Public Disclosure Plan 4. Data & Safety Monitoring Board 5. IND and/or IDE from FDA
12 Justification for Study Design (EFIC Waiver) Patients in life threatening situation Available treatments unproven/unsatisfactory Collection of scientific evidence necessary to determine safety & efficacy
13 Justification for Study Design continued Obtaining consent is not feasible because: Patient medical condition prevents effective consent Intervention must be administered before LAR consent can be obtained No reasonable way to prospectively identify individuals who may be eligible Participation holds prospect of direct benefit because: Patients facing life threatening situation requiring intervention Appropriate animal/preclinical show evidence supporting the potential for direct benefit Appropriate risk/benefit ratio
14 Consent Process and ICF Must be performed as soon as is reasonable ICF must include all usual elements Researcher describes plan to attempt to obtain consent from LAR within therapeutic window (described in Protocol) when feasible If LAR consent is not feasible, researchers attempt to contact family members, and ask if they would object to participant s participation If participant condition improves, inform participant as soon as feasible If participant dies after enrollment (without LAR), LAR/family member(s) informed when feasible
15 Community Consultation & Public Disclosure Community Consultation Two way communication Goals are to show respect for individuals and community by listening to and acting on feedback
16 Public Disclosure Public Disclosure Plan for public disclosure to communities in which the investigation is conducted before study initiation. Plan for public disclosure after completion of the study to inform the community and researchers of study results, including demographic characteristics of participants
17 Data & Safety Monitoring Board Must be Independent, and must include all the usual elements of a Data & Safety Monitoring Board
18 Obtain an IND for IDE Planned Emergency Research Required even if the drug or device is already FDA approved for a specific indication
19 Board Review Key elements to focus on at board: Is the justification for the EFIC Waiver adequate? Is the Community Consultation and Public Disclosure plan specific enough?
20 IRB Approval Initial IRB approval is granted for a period of time (generally 6 months) to allow Community Consultation and Public Disclosure to take place. After which, PI submits Continuing Review with results of Consultation and Disclosure. At this point, the board can approve enrollment. At annual Continuing Reviews, the board should review PI s summary of efforts to contact LARs/family member(s) during the previous year.
21 Additional Guidance requirements/planned emergencyresearch.php
22 Planned Emergency Use Non-FDA Regulated studies
23 When does this situation arise? Study does not include investigational use of a drug or device, and is therefore not subject to FDA regulation Example: Emergency Department study randomizing to either: Cardiac Cath Lab or, Initial ICU admission
24 Justification for Study Design (EFIC Waiver) Patients in life threatening situation Available treatments unproven/unsatisfactory Collection of scientific evidence necessary to determine safety & efficacy Obtaining consent is not feasible Participation holds prospect of direct benefit because
25 IRB Requirements OHRP has not issued guidance for planned emergency research.
26 What should the IRB application materials include? 1. Justification for Study Design (EFIC Waiver) 2. Consent Process and ICF 3. Community Consultation and Public Disclosure Plan 4. Data & Safety Monitoring Board 5. IND and/or IDE from FDA
27 IRB Approval Initial IRB approval is granted for a period of time (generally 6 months) to allow Community Consultation and Public Disclosure to take place. After which, PI submits Continuing Review with results of Consultation and Disclosure. At this point, the board can approve enrollment. At annual Continuing Reviews, the board should review PI s summary of efforts to contact LARs/family member(s) during the previous year.
28 Board Review Key elements to focus on at board: Is the justification for the Waiver adequate? Is the Community Consultation and Public Disclosure plan specific enough?
29 Nuances of Compliance/UP Determinations
30 Report Forms Report forms are reviewed at the administrative level first o Not an unanticipated problem; o Not non compliance; or o Non compliance but not serious nor continuing non compliance. If the administrative reviewer or subcommittee reviewer believe the report is a possible UP or possible S/C NC, they forward it to the convened board to determine if the report represents: o An unanticipated problem o Non compliance, not serious or continuing o Serious and/or continuing non compliance
31 Deviations Serious Non Compliance An act or omission to act that resulted in significant harm (physical, psychological, safety, or privacy) or significantly increased the possibility of harm to the rights and welfare of research participants. Continuing Non Compliance A pattern of repeated actions or omissions to act that suggests a future likelihood of reoccurrence and that indicates a deficiency in the ability or willingness to comply with Federal regulations, VHA Handbooks or the policy, requirements, and determinations of the IRB governing human subject research.
32 Report Forms: Consideration Determinations may involve more than just black and white consideration.
33 Report Forms: Consideration Was the deviation reported promptly? Did the deviation harm any participants? Could it potentially have harmed participants? Were there any mitigating factors (e.g., something was not documented but was later found out to have taken place)?
34 Report Forms: Consideration Is the study still open? Status of the currently enrolled participants? Has the investigator had previous issues with non compliance, possibly in other studies/instances? (IRB staff has institutional knowledge.) What if the investigator does not agree with IRB determination?
35 Report Forms: Consideration How does the study team propose to correct the issue and prevent the deviation from occurring again? Corrective actions other than those proposed by the study team? Is suspension or termination of the study necessary?
36 Case 1: Description An investigator initiated study (with oversight by industry sponsors) is looking at a study drug treatment in participants with moderate, severe, and very severe aplastic anemia. Thirteen participants are enrolled at our local site, but the study is closed to enrollment with all study procedures completed. During a review of research records, it was noted there were several compliance issues, including: Various consenting and documentation errors including four participants who were seen and/or followed by physicians not listed on the 1572 and not having documented training on the protocol; Review of adverse events and assessment of blood smears were not consistently documented by the study investigators; Insufficient source documentation to determine proper drug accountability and participant adherence to dose escalation; Eligibility criteria had not been followed correctly; and Documentation of medical oversight and safety monitoring appeared to be lacking.
37 Case 1: Determination It was determined that the deviations described in the report constituted serious non compliance because: o Inclusion and exclusion criteria not followed; o SAE reporting guidelines not observed; and o Consent process (including documentation) not maintained. These deviations suggested the possibility of increased risk of harm to participants as a result of non protocol compliant enrollment procedures, inadequate drug accountability and documentation, and compromised data integrity.
38 Case 1: Corrective Actions The study was closed, so corrective actions were issued for future studies conducted by this investigator. o o o o o Follow SOP on Clinical Trial Participant Screening and Eligibility Review Assess toxicities for study drug discontinuation, dose modification, adverse events, and study stopping rules Document and verify accurate recording of data Required independent audit after the first two participants are enrolled Data cannot be used to submit to the FDA
39 Case 1: Follow-Up What if study had been open? If study personnel had not been listed in 1572 but had appropriate training? PI appealed to ask if he could still use data (publishing with better documented cases or noting data integrity issues in publication), board determined data was too compromised.
40 Case 2: Description Study testing memantine in stroke participants to see if it increases recovery during first three months post stroke. Nurse read instructions from EPIC stating participants should receive two 7mg tablets, but IDS issued bottles with 14mg tablets, and the nurse ended up giving two 14mg tablets to a participant. No adverse effects attributable to double dose; participant was not given medication the following day in order to titrate appropriate following this incident.
41 Case 2: Determination The board determined that this Report Form did represent non compliance but not serious or continuing non compliance. The issue lies in the level of the possibility of risk, since overdosing on any medication can produce detrimental effects. It is assumed the participants were informed of the risks on this study and that the risks of taking more of the medicine would fall within the already described risks of taking the drug, so it does not appear the rights of the participant were not compromised. Drug information from the protocol stated that the largest known ingestion of memantine worldwide was 2.0g, and the patient who took this dose experienced coma, diplopia, and agitation, but subsequently recovered; the participant here was given only 28 mg, much less than the highest overdose. Package insert states that the recommended target dose is 20 mg/day; no evidence that this amount of memantine increased risk to this participant.
42 Case 2: Corrective Actions o Update the EPIC instructions to more clearly reflect dosing instructions. o Create a plan/sop to reinforce that the nurse administering medication must double check the strength and the regimen prior to medication administration.
43 Case 2: Follow-Up What if participant had received more than the double dose? Would a similar type of deviation always be considered not serious non compliance?
44 Case 3: Description Study protocol requires that female participants receive a urine pregnancy test for screening and immediately prior to any vaccine inoculations, implying that the test must be negative. A female study participant received a urine pregnancy test prior to receiving a vaccine, but that vaccine was administered to her before the results of her pregnancy test had been processed. The study coordinator didn t realize that the pregnancy portion of the test results was absent until after inoculating the participant. The original urine test turned out to be compromised, so a second sample was collected, and proved to be negative.
45 Case 3: Determination It was determined that this event represents serious non compliance; while the board recognizes that no actual harm occurred in this specific event, there was the potential for significant harm if the pregnancy test had in fact been positive.
46 Case 3: Corrective Actions Study coordinator counseled and retrained on the importance of following protocol requirements with an emphasis on pregnancy testing, patient safety, and GCP. Study team instructed not to administer future inoculations until a negative pregnancy test result can be verified.
47 Case 3: Follow-Up Would we have handled this differently if participant had been pregnant? Could there have been any mitigating factors that would have changed the serious non compliance determination?
University of South Carolina. Unanticipated Problems and Adverse Events Guidelines
University of South Carolina Unanticipated Problems and Adverse Events Guidelines These guidelines define the procedures of USC for addressing unanticipated problems involving risks to research participants
More informationThe SOP applies to all human subject research falling under the purview of the University of Missouri Institutional Review Board.
Institutional Review Board.... University of Missouri-Columbia.. Standard Operating Procedure Informed Consent Types and Elements Informed Consent Types and Elements Effective Date: December 12, 2005 Original
More informationBiomedical IRB MS #
Department for Human Research Protections Institutional Review Boards Biomedical IRB MS # 1035 419-383-6796 IRB.Biomed@utoledo.edu Social, Behavioral and Educational IRB MS # 944 419-530-6167 IRB.SBE@utoledo.edu
More informationI. Scope This policy defines unanticipated problems and adverse events and establishes the reporting process and timeline.
Human Research Protection Program Policies & Procedures Unanticipated Problems and Adverse Events Version 3.0 Date Effective: 11.9.2012 Research Integrity Office Mail code L106-RI Portland, Oregon 97239-3098
More informationUNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD REPORTING UNANTICIPATED PROBLEMS INCLUDING ADVERSE EVENTS
UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD REPORTING UNANTICIPATED PROBLEMS INCLUDING ADVERSE EVENTS I. PURPOSE To specify the procedures for reporting unanticipated problems,
More informationResearch Audits PGR. Effective: 12/04/2013 Reviewed: 12/04/2015. Name of Associated Policy: Palmetto Health Administrative Research Review
Effective: 12/04/2013 Reviewed: 12/04/2015 Name of Associated Policy: Palmetto Health Administrative Research Review Definitions Responsible Positions Equipment Needed Procedure Steps, Guidelines, Rules,
More informationIRB Federal Regulations Comparison Table 4/24/01 as updated through 10/31/01
Legal Authority 45 CFR Part 46 21 USC 321-392; 21 CFR, Parts 50 and 56 Coverage All research involving human subjects conducted, All clinical investigations regulated by the FDA, including supported or
More informationPROMPTLY REPORTABLE EVENTS
PROMPTLY REPORTABLE EVENTS PURPOSE AND SCOPE To define the structure and responsibility for reporting unanticipated problems that occurs during the conduct of research. APPLICABLE REGULATIONS Policy II.02
More informationPublic Input for Changes to Reportable Events Policy
Public Input for Changes to Reportable Events Policy May 23, 2017 Richard Guido, MD, IRB Chair Jamie Zelazny, PhD, RN, Regulatory Affairs Specialist Outline Regulatory basis for reporting policies Importance
More informationClinical Research Seminar
Clinical Research Seminar HOW TO DEVELOP A CORRECTIVE AND PREVENTIVE ACTION PLAN (THAT EVEN THE IRB AND FDA WILL LOVE) April 11, 2018 Fiona Rice, MPH Human Research Quality Manager fionar@bu.edu Mary-Tara
More informationGood Clinical Practice: A Ground Level View
Good Clinical Practice: A Ground Level View Jeanna Julo, BA, BA, CCRP Assistant Director, Clinical Data Management & Quality Controls, Auditing & Training Clinical Research Administration Research Institute,
More informationGuidance for Institutional Review Boards, Clinical Investigators, and Sponsors. Exception from Informed Consent Requirements for Emergency Research
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors Exception from Informed Consent Requirements for Emergency Research U.S. Department of Health and Human Services Food and
More informationKBEMS Pilot Programs- Adverse Event Notification
KBEMS Pilot Programs- Adverse Event tification Emergencies and Reporting of Adverse Events The responsible project coordinator must promptly notify the Kentucky Board of EMS & the KCTCS HSRB of any problems
More information1. Department of Defense (DoD) Human Subjects Protection Regulatory Requirements
Information for Investigators: Headquarters, U.S. Special Operations Command Human Research Protection Office (HRPO) Human Research Protections Regulatory Requirements 1. Department of Defense (DoD) Human
More informationGood Documentation Practices. Human Subject Research. for
Good Documentation Practices for Human Subject Research Bridget M. Psicihulis, RHIA, CCRC Quality Improvement Unit Coordinator Human Research Protection Program Wheaton Franciscan Healthcare (last updated
More informationHuman Research Protection Program Institutional Review Board
Human Research Protection Program Institutional Review Board Policies and Procedures Guidebook TABLE OF CONTENTS Federal, State and University Regulations Related to the IRB... Section 1.0 Definition of
More information12.0 Investigator Responsibilities
12.0 Investigator Responsibilities 12.1 Policy Investigators are ultimately responsible for the conduct of research. Research must be conducted according to the signed Investigator statement, the investigational
More informationDEPARTMENT OF HEALTH & HUMAN SERVICES WARNING LETTER. (b) (4) clinical investigation (Protocol entitled A Phase II, Multicenter,
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 WARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUESTED Ronald Bukowski, M.D. 28099 Gates Mills
More informationETHICAL AND REGULATORY CONSIDERATIONS
CONSIDERATIONS Office for Office for Human Research Protections The Office for Office for Human Research Protections (OHRP) is an administrative subdivision within the U.S. Department of Health and Human
More informationBIMO SITE AUDIT CHECKLIST
Item AUTHORITY AND ADMINISTRATION FOR STUDIES INVOLVING HUMAN DRUGS, BIOLOGICS AND DEVICES 1. Compare the Investigator Agreement with the information provided by the assigning Center. Auditor will check
More informationUniversity of Colorado Denver Human Research Protection Program Investigator Responsibilities for the Protection of Human Subjects
Institutional Guidelines The Colorado Multiple Institutional Review Board (COMIRB) recently reviewed and approved your research. The COMIRB reviews research to ensure that the federal regulations for protecting
More informationHIC Standard Operating Procedure. For-Cause Audits of Human Research Studies
HIC Standard Operating Procedure For-Cause Audits of Human Research Studies Background As part of the Wayne State University (WSU) Human Investigation Committee s (HIC) Human Research Protection Program,
More informationGood Clinical Practice. Lisa de Blieck MPA CCRC Clinical Trials Coordination Center
Good Clinical Practice Lisa de Blieck MPA CCRC Clinical Trials Coordination Center Good Clinical Practice (GCP) An international standard for the design, conduct, performance, monitoring, auditing, recording,
More informationReporting to the IRB How to Report the Essentials and Improve the Protection of Human Subjects
Webinar Series Reporting to the IRB How to Report the Essentials and Improve the Protection of Human Subjects April 10, 2013 Presented by: James MacFarlane Director of Board Operations About the Webinar
More informationOffice of Human Research Office of Human Research Policy and Procedure Manual. Version: 4/4/18
Version: 4/4/18 Signatures on File for the Approval of Revisions to the Policy and Procedures Table of Contents 100 General Administration (GA)... 5 Policy GA 101: The Authority and Purpose of the Institutional
More informationI. HSC Review and Approval of Research Involving Children
9.0 Vulnerable Populations 9.1 Research Involving Children I. HSC Review and Approval of Research Involving Children A. The special vulnerability of children makes consideration of involving them as research
More informationTitle: Investigator Responsibilities. SOP Number: 1501 Effective Date: June 2, 2017
Previous Version Dates: Title: Investigator Responsibilities SOP Number: 1501 Effective Date: June 2, 2017 1 Purpose Investigators are ultimately responsible for the conduct of research. Investigators
More informationStudy Management SM STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting
Study Management SM 306.00 STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval: Frederick M. Schnell, MD,
More informationETHICS COMMITTEE: ROLE, RESPONSIBILITIES AND FUNCTIONS K.R.CHANDRAMOHANAN NAIR DEPARTMENT OF ANATOMY, MEDICAL COLLEGE, THIRUVANANTHAPURAM
ETHICS COMMITTEE: ROLE, RESPONSIBILITIES AND FUNCTIONS K.R.CHANDRAMOHANAN NAIR DEPARTMENT OF ANATOMY, MEDICAL COLLEGE, THIRUVANANTHAPURAM Outline Introduction Composition Responsibilities of IEC Responsibilities
More informationThe GCP Perspective on Study Monitoring
The GCP Perspective on Study Monitoring Heidi Judge, CCRP Sr. Clinical Trials Project Manager Clinical Trials Network and Institute Massachusetts General Hospital 1 Overview Monitoring Basics Who, What,
More informationGeneral Administration GA STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility
General Administration GA 102.01 STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility Approval: Nancy Paris, MS, FACHE President and CEO (17 July 2014) (Signature and
More informationQUALITY ASSURANCE PROGRAM
QUALITY ASSURANCE PROGRAM Elaine Armstrong, MS Quality Assurance Manager PURPOSE Verify accuracy of submitted data Verify compliance with protocol and regulatory requirements Provide educational support
More information(Type inside gray boxes, cells will expand) A. EIGHT POINT CRITERIA for IRB Review
Page 1 of 5 IRB Reviewers 8-Point Analysis Form Based on Federal Policy for the Protection of Human Subjects, Criteria for IRB Approval of Research (45 CFR 46.111) Protocol ID #/Title: Date of Review:
More informationNOVA SOUTHEASTERN UNIVERSITY
NOVA SOUTHEASTERN UNIVERSITY DIVISION OF RESPONSIBILITIES FOR RESEARCH AND SPONSORED PROGRAMS Vice President of Research & Technology Transfer: The responsibilities of the Vice President of Research &
More informationRESEARCH SUPPORTED BY A DEPARTMENT OF DEFENSE (DOD) COMPONENT
DUKE UNIVERSITY HEALTH SYSTEM Human Research Protection Program RESEARCH SUPPORTED BY A DEPARTMENT OF DEFENSE (DOD) COMPONENT 2/19/2016 The following special considerations apply to research involving
More informationDr. R. Sathianathan. Role & Responsibilities of Principal Investigators in Clinical Trials. 18 August 2015
18 August 2015 Role & Responsibilities of Principal Dr. R. Sathianathan Professor of Psychiatry, SRMC, Porur & Former Director, Institute of Mental Health, Chennai Principal Investigators & GOOD CLINICAL
More informationSOP Problems and Adverse Events, Record and Report
Office of Research Integrity - Human Subjects SOP #: ORI(HS)- 1.0 Page #: Page 1 of 5 Approved By: ORI Executive Director *Signature on file Date: Date First Effective: 11/18/2013 Approved by: Biomedical
More informationUNC Lineberger Comprehensive Cancer Center. Data and Safety Monitoring Plan
UNC Lineberger Comprehensive Cancer Center Data and Safety Monitoring Plan Norman E. Sharpless, MD, Director P30CA-16086 Approved: September 29, 2014 Table of Contents Monitoring Progress of Trials and
More informationWIRBinar. How to Survive an FDA Inspection. Upcoming Trainings: Contact Us: (360)
WIRBinar How to Survive an FDA Inspection 10-26-2011 Brought to you by WIRB Education and Consulting Services. Improve your ability to maintain compliance and protect human subjects with guidance from
More informationIssues of. Informed Consent. Mitchell E. Parrish, JD, RAC, CIP Regulatory Attorney
Issues of Informed Consent Mitchell E. Parrish, JD, RAC, CIP Regulatory Attorney Part I Part II Regulatory Requirements Key Considerations Part III Elements of Consent Part IV Summary 2 PART I 3 Informed
More informationLaverne Estañol, M.S., CHRC, CIP, CCRP Assistant Director Human Research Protections
Laverne Estañol, M.S., CHRC, CIP, CCRP Assistant Director Human Research Protections Quality Improvement Activities and Human Subjects Research September 7, 2016 TOPICS What is Quality Improvement (QI)?
More informationDO I NEED TO SUBMIT FOR THIS?... & OTHER FREQUENTLY ASKED QUESTIONS. March 2015 IRB Forum
DO I NEED TO SUBMIT FOR THIS?... & OTHER FREQUENTLY ASKED QUESTIONS March 2015 IRB Forum Topics Quality Assurance/Quality Improvement Projects Informed Consent- when is a waiver appropriate? Retrospective/Prospective
More informationUConn Health Office of Clinical & Translational Research Standard Operating Procedures
Purpose and Applicability: To ensure that a Medicare Coverage Analysis is done by staff in OCTR for all research clinical trials that produce r routine clinical services (RC) to be billed to Medicare and
More informationNN SS 401 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR SITE SELECTION AND QUALIFICATION
NN SS 401 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR SITE SELECTION AND QUALIFICATION SOP: NN SS 401 Version No.: 2.0 Effective Date: 21Oct2016 SITE SELECTION AND QUALIFICATION Supercedes Document:
More informationFDA Medical Device Regulations vs. ISO 14155
Vol. 11, No. 9, September 2015 Happy Trials to You FDA Medical Device Regulations vs. ISO 14155 By Shawn Kennedy Medical device clinical trials must comply with 21 CFR Parts 11 (Electronic Records), 50
More informationResearch Compliance Oversight in the Department of Veterans Affairs
Research Compliance Oversight in the Department of Veterans Affairs Karen M. Smith, PhD Director, Midwestern Regional Office Office of Research Oversight Department of Veterans Affairs Health Care Compliance
More informationGenesis Health System. Institutional Review Board. Standard Operating Procedures
Genesis Health System Institutional Review Board Table of Contents 1. INSTITUTIONAL AUTHORITY... 6 2. PURPOSE... 6 3. THE SCOPE & AUTHORITY OF THE IRB... 7 Scope...7 Authority of the GHS-IRB...7 Authority
More information"Getting Your Protocol Through the IRB"
"Getting Your Protocol Through the IRB" Human Participant Research at University of Maryland, Baltimore Jon Mark Hirshon, MD, MPH, PhD Senior IRB Vice-Chair Nuremberg Code (1947) First Codification of
More informationSECNAVINST E ONR Dec 2017 SECNAV INSTRUCTION E. From: Secretary of the Navy. Subj: HUMAN RESEARCH PROTECTION PROGRAM
ONR 343 SECNAV INSTRUCTION 3900.39E From: Secretary of the Navy Subj: HUMAN RESEARCH PROTECTION PROGRAM Encl: (1) Changes (2) References (3) Responsibilities (4) Procedures (5) Definitions (6) Reports
More informationUtilizing the NCI CIRB
Policy P15 Written By: B. Laurel Elder, Ph.D. Created: September 2, 2011 Edited Version P15.1 Utilizing the NCI CIRB PURPOSE - The purpose of this Standard Operating Procedure (SOP) is to outline the procedures
More informationTITLE: Reporting Adverse Events SOP #: RCO-204 Page: 1 of 5 Effective Date: 01/31/18
SOP #: RCO-204 Page: 1 of 5 1. POLICY STATEMENT: The research team is responsible for recognizing changes in subject health that may qualify as adverse events, classifying those results as defined in the
More informationCLOSE OUT VISIT REPORT (NO CRF TO MONITOR)
Date: Page: 1 of 8 CLOSE OUT VISIT REPORT (NO CRF TO MONITOR) Protocol: PI Name: PI Address: Date of Visit: Monitor(s): Other Sponsor Personnel Present: Site Personnel Present at Visit (include names and
More informationRequest to Use an External IRB as an IRB of Record
This form is to be used by investigators requesting use of an external IRB. Please submit this completed form, along with the required attachments, to the MHC IRB at hrpp@mclaren.org. (Please see SOP:
More informationRESEARCH SUPPORTED BY A DEPARTMENT OF DEFENSE (DOD) COMPONENT
DUKE UNIVERSITY HEALTH SYSTEM Human Research Protection Program RESEARCH SUPPORTED BY A DEPARTMENT OF DEFENSE (DOD) COMPONENT 5/23/2011 The following special considerations apply to research involving
More informationLifeBridge Health HIPAA Policy 4. Uses of Protected Health Information for Research
LifeBridge Health HIPAA Policy 4 Uses of Protected Health Information for Research This Policy contains the following Sections: I. Policy II. III. IV. Definitions Applicability Procedures A. Individual
More informationTheradex Audit 2013: Findings & Corrective Action
Theradex Audit 2013: Findings & Corrective Action Overview Discuss Findings and CAP for: Informed Consent Content IRB Informed Consent Eligibility Treatment Serious Adverse Events Response General Data
More informationINDIANA STATE UNIVERSITY POLICIES AND PROCEDURES FOR THE REVIEW OF RESEARCH INVOLVING HUMAN SUBJECTS
INDIANA STATE UNIVERSITY POLICIES AND PROCEDURES FOR THE REVIEW OF RESEARCH INVOLVING HUMAN SUBJECTS This manual is believed to be in full compliance with all applicable Federal and state laws and regulations.
More informationVCU Clinical Research Quality Assurance Assessment
VCU Clinical Research Quality Assurance Assessment Principal Investigator Protocol Title Protocol IRB Number Name of Person Completing Assessment Date Assessment was Completed The goal of this assessment
More informationNational Cancer Institute. Central Institutional Review Board. Standard Operating Procedures
National Cancer Institute Central Institutional Review Board Standard Operating Procedures CIRB Standard Operating Procedures Additional copies are available from the CIRB website (http://www.ncicirb.org)
More informationmanaging or activities.
STANDARD OPERATING PROCEDURE Clinical Research Monitoring TITLE: Site Initiation Visit TITLE: Site Initiation Visit 1. PURPOSE SOP Number: Version: 1.0 MICHR CRM MON 002 Effective Date: 19Dec2013 1.1 This
More informationClinical Trial Quality Assurance Common Findings
Clinical Trial Quality Assurance Common Findings Objectives Identify common findings found in research study reviews conducted by the CTQA Program Understand what findings require an action plan vs. a
More informationStandard Operating Procedure IRB Review of Research Subject to the Revised Common Rule
HRP Consulting is providing this sample SOP addendum to assist organizations in the event that the revised Common Rule goes into effect on January 19, 2018. This sample SOP addendum does not address every
More informationWashington University Institutional Review Board Policies and Procedures. April 20, 2015
Washington University Institutional Review Board Policies and Procedures April 20, 2015 Table of Contents I. AUTHORITY AND INSTITUTIONAL COMMITMENT... 2 II. APPLICABILITY: ACTIVITIES SUBJECT TO IRB JURISDICTION...
More informationSECNAVINST D BUMED-M00R 6 November 2006
SECNAV INSTRUCTION 3900.39D From: Secretary of the Navy DEPARTMENT OF THE NAVY OFFICE OF THE SECRETARY 1000 NAVY PENTAGON WASHINGTON DC 20350-1000 Subj: HUMAN RESEARCH PROTECTION PROGRAM SECNAVINST 3900.39D
More informationUniversity of Illinois at Chicago Human Subjects Protection Program Plan
Office for the Protection of Research Subjects (OPRS) Institutional Review Board FWA# 00000083 University of Illinois at Chicago Human Subjects Protection Program Plan 203 AOB (MC 672) 1737 West Polk Street
More informationLegally Authorized Representatives in Clinical Trials
Vol. 7, No. 3, March 2011 Can You Handle the Truth? Legally Authorized Representatives in Clinical Trials By Judy Katzen The sickest patients need the best medical care, which might involve participation
More informationRoles of Investigators in the Managements of Clinical Trials
Roles of Investigators in the Managements of Clinical Trials Chii-Min Hwu, M.D. Section of General Medicine Department of Medicine Taipei Veterans General Hospital Learning Objectives PI Outlines How to
More informationINVESTIGATOR GUIDANCE:
INVESTIGATOR GUIDANCE: Investigator Obligations HRP-800 002 28 Sep 2013 Page 1 of 2 1. PURPOSE 1.1. This guidance describes the obligations of investigators conducting overseen by CGIRB
More informationAnnex VIIIA Guideline for correct preparation of a model patient information sheet and informed consent form (PIS/ICF)
DEPARTMENT OF MEDICINAL PRODUCTS FOR HUMAN USE Annex VIIIA Guideline for correct preparation of a model patient information sheet and informed consent form (PIS/ICF) Version 10 th November 2016 Date of
More informationGuide to Completing Medical University of South Carolina s Institutional Review Board (IRB) Continuing Review Application
Guide to Completing Medical University of South Carolina s Institutional Review Board (IRB) Continuing Review Application This guide has been developed to help researchers complete IRB continuing review
More informationEMA & FDA Inspections: Site perspective. Shandukani Research Centre
EMA & FDA Inspections: Site perspective Shandukani Research Centre Why were we inspected? Pharmaceutical company applied for registration of the study drug (Phase I/II dosing studies in paediatrics) Large
More informationSTUDY TEAM RESPONSIBILITIES ORIENTATION FOR NEW CLINICAL RESEARCH PERSONNEL MODULE 2
ORIENTATION FOR NEW CLINICAL RESEARCH PERSONNEL MODULE 2 Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network for Research Professionals Overall Agenda for Orientation Module 1: Introduction
More informationCentral Michigan University Standard Operating Procedures Human Research Protection Program
Central Michigan University Standard Operating Procedures Human Research Protection Program Additional Guidance for Federal Agencies: ED, DoD, DoJ August 2010 September 2016 Edited for AAHRPP Response
More informationNew Study Submissions to the IRB
New Study Submissions to the IRB Tufts-New England Medical Center Tufts University Health Sciences IRB Education Series 2006 Presentation may only be reused or reprinted with written permission from the
More informationUSING SMART IRB AND SINGLE IRB REVIEW
USING SMART IRB AND SINGLE IRB REVIEW Jeannie Barone Director, HRPO ATTRIBUTES Special thanks to Nichelle Cobb, PhD from University of Wisconsin-Madison for her permission to utilize her slides on SMART
More informationUniversity of Virginia Standard Operating Procedures for the Human Research Protection Program
University of Virginia Standard Operating Procedures for the Human Research Protection Program University of Virginia IRB SOP Version Date: July 11, 2017 Table of Contents 1 Human Research Protection Program...
More informationComprehensive Protocol Feasibility Questionnaire
Protocol Title: Potential Principal Investigator: Regulatory Coordinators: Department Chair: PROJECT FEASIBILITY PI and Study Team: YOUR RESPONSES TO THIS SURVEY CONSTITUTE A BEST ESTIMATE OF RESOURCES
More informationMARKEY CANCER CENTER CLINICAL RESEARCH ORGANIZATION STANDARD OPERATING PROCEDURES SOP No.: MCCCRO-D
Page 1 of 8 MARKEY CANCER CENTER CLINICAL RESEARCH ORGANIZATION STANDARD OPERATING PROCEDURES SOP No.: Title: Data Safety and Monitoring Committee Administrative and Revision: N/A Revision Date: N/A Functional
More informationExempt & Expedited Reviews. February 2017 IRB Member Training
Exempt & Expedited Reviews February 2017 IRB Member Training Introduction Studies that are minimal risk Meet certain criteria ( categories ) Extensive screening by ORA staff Reviewed by a designated member
More informationOffice of the Vice Chancellor for Research Supervisory Responsibilities of Clinical Investigators
Office of the Vice Chancellor for Research Supervisory Responsibilities of Clinical Investigators Patricia Fischer, RN, CCRP Investigator Responsibilities FDA Draft Guidance May 2007 Clarifies FDA s expectations,
More informationDANA-FARBER / HARVARD CANCER CENTER STANDARD OPERATING PROCEDURES FOR HUMAN SUBJECT RESEARCH
SOP #: CON-100 Page: 1 of 9 Effective Date: 2/28/17 1. POLICY STATEMENT: The research team is responsible for obtaining and documenting the informed consent of each subject who participates in research.
More informationRoles & Responsibilities of Investigator & IRB
Roles & Responsibilities of Investigator & IRB Jaranit Kaewkungwal Mahidol University Regulatory & Guidelines Regulatory & Guidelines GCP & Computer / Database Management Systems International Conference
More informationIRB 04. Research Supported by the Department of Defense
IRB 04 Research Supported by the Department of Defense Presented by IRB Compliance Program, Human Subjects Office May 9, 2016 1 Why a New IRB? Department of the Navy (DoN) research previously sent to WIRB
More informationPatient Case Records Review
Patient Case Records Review Debra Herzan, RN, BSN, OCN, CCRP Alliance for Clinical Trials in Oncology Audit Prep Workshop - Alliance Group Meeting November, 2014 6 Categories l Informed Consent l Eligibility
More informationCan Improvement Cause Harm: Ethical Issues in QI. William Nelson, PhD Greg Ogrinc, MD, MS Daisy Goodman, CNM. DNP, MPH
Session Code A4, B4 The presenters have nothing to disclose Can Improvement Cause Harm: Ethical Issues in QI William Nelson, PhD Greg Ogrinc, MD, MS Daisy Goodman, CNM. DNP, MPH December 6, 2016 #IHIFORUM
More informationMedicare Billing and Reimbursement Essentials for Research
Medicare Billing and Reimbursement Essentials for Research Medical Research Summit Grand Hyatt Hotel, Washington, DC Session 103: Monday, March 19, 2001 Agenda Why is Medicare Billing Compliance Important?
More informationUniversity of Michigan Policy On Investigating Noncompliance and Animal Welfare Concerns
Background Information The University of Michigan s Animal Care and Use Program (ACUP) adheres to the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy), the federal
More informationStrategies for Achieving Regulatory Compliance and Economies in DoD-Supported Research
Strategies for Achieving Regulatory Compliance and Economies in DoD-Supported Research University of Pittsburgh Pittsburgh, Pennsylvania 30 June 2016 Laura Ruse Brosch, RN, PhD Director, Office of Research
More informationTufts Medical Center (Tufts MC) and Tufts University Health Sciences (TUHS) IRB Western IRB (WIRB) Submission Policy
Tufts Medical Center (Tufts MC) and Tufts University Health Sciences (TUHS) IRB Western IRB (WIRB) Submission Policy Policy/Procedure Phase II (IIa, IIb, or II), III, or IV protocols undertaken at Tufts
More informationDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 3%3&4
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 3%3&4 JUL 1 3 2CG3 WARNING LETTER Food and Drug Administration Center for Devices and Radiological Health 2098 Gaither Road Rockville, MD 20850
More informationFINANCIAL CONFLICT OF INTEREST POLICY Public Health Services SECTION 1 OVERVIEW, APPLICABILITY AND RESPONSIBILITIES
FINANCIAL CONFLICT OF INTEREST POLICY Public Health Services SECTION 1 OVERVIEW, APPLICABILITY AND RESPONSIBILITIES 1.1 Statement of Background and Purposes The United States Department of Health and Human
More informationThe United States Army Combined Arms Center Education (CAC-E) BULLETIN 940. Research Review and Approval
Bulletin 940 Research Review and Approval The United States Army Combined Arms Center Education (CAC-E) BULLETIN 940 Research Review and Approval Institutions covered by this bulletin include: Command
More informationDANA-FARBER / HARVARD CANCER CENTER POLICIES FOR HUMAN SUBJECT RESEARCH TITLE:
POLICY #: EDU-100 Page: 1 of 5 1. POLICY STATEMENT: Individuals who participate in research activities overseen by DF/HCC must satisfy specific training requirements in order to conduct human subject research.
More informationINSPIRing Changes to the IRB Process: New templates and more
INSPIRing Changes to the IRB Process: New templates and more John F. Ennever, MD, PhD, CIP Director, Human Research Protection Program Office of Human Research Affairs Boston Medical Center and Boston
More informationWHAT IS AN IRB? WHAT IS AN IRB? 3/25/2015. Presentation Outline
Education &Training WHAT IS AN IRB? Introduction to the UofL Institutional Review Boards & Human Subjects Protection Program IRB Review Process Post Approval Monitoring March 2015 1 Presentation Outline
More informationA Principal Investigator s Guide to Responsibilities, Qualifications, Records and Documentation of Human Research University of Kentucky
A Principal Investigator s Guide to Responsibilities, Qualifications, Records and Documentation of Human Research University of Kentucky I. Compliance with IRB and Applicable Federal Requirements A. Investigators
More informationUniversity of Colorado Denver Colorado Multiple Institutional Review Board (COMIRB) Policies and Procedures for the Protection of Human Subjects
University of Colorado Denver Colorado Multiple Institutional Review Board (COMIRB) Policies and Procedures for the Protection of Human Subjects Revised March 2015 Effective Date: March 2015 Approved by
More informationInitially Submitted on 11/24/2009 Final Submission By Test6 CA on 11/24/2009 1:51 PM Approval By student13 student13 on 11/24/2009 1:52 PM Attendees
Location: Los Angeles Research Institute: Los Angeles, CA Investigation Product/Test Article: Laftr Visit Mechanism: On-site Initially Submitted on 11/24/2009 Final Submission By Test6 CA on 11/24/2009
More informationHow to Prepare for Federal Inspections and What to Expect
How to Prepare for Federal Inspections and What to Expect Jennifer A. Graf Tufts Medical Center Tufts University Health Sciences Director of IRB Operations Originally presented at the February 2011 Society
More informationVENCLEXTA PATIENT SUPPORT SERVICES
VENCLEXTA PATIENT SUPPORT SERVICES Models shown are not actual patients or health care professionals. Indication VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL)
More information