Manager Tufts CTSI Welcome and Introduction Tufts CTSIs Mission amp Purpose Stimulate and expedite innovative clinical and translational research with the goal of improving the publics health ID: 934878
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Slide1
Marcia S. Izzi, MPHBusiness Finance ManagerTufts CTSI
Welcome and Introduction
Slide2Tufts CTSI’s Mission & Purpose
Stimulate and expedite innovative clinical and translational research, with the goal of improving the public’s health
Entire spectrum
of clinical and translational research is critical to meeting the promise and the public’s needs of biomedical
science
Established in 2008 to translate research into better health
Slide3Spectrum of Translational ResearchBench and animal research
Clinical
testing and trials
Testing in practice settings
Healthcare system delivery
Public health
and health policy
T1 T2 T3 T
4
Bench to Bedside…
...to Clinical Practice…
…to
Widespread Care Delivery
…
…to Health Policy
Slide4Tufts Clinical and Translational Science Institute (CTSI)
Research ServiceOrganizations
Study Design & Analysis
Clinical Study & Regulatory Support
Informatics
Conveners &
Connectors
Team Science
Collaboration
Multidisciplinary
Stakeholder & Community-Engaged
Change Agents
Innovation &
TransformationScience of Science
Process ImprovementAddressing Roadblocks
Educator and TrainersGraduate Certificate, Masters, and PhD ProgramsProfessional Development
Fellowship and Career Development Programs
Slide5Tufts CTSI Partners & Collaborators
Tufts Schools & Centers
Cummings School of Veterinary Medicine
Fletcher School of Law & Diplomacy
Friedman School of Nutrition Science & Policy
Institute for Clinical Research & Health Policy Studies at Tufts Medical Center
Jean Mayer USDA Human Nutrition Research Center on Aging
Sackler School of Graduate Biomedical Sciences
Schools of Arts & Sciences
School of Dental Medicine
School of Engineering
School of Medicine
Tisch College of Civic Life
Tufts Center for the Study of Drug Development
T
ufts-Affiliated Hospitals
Baystate Medical Center
Lahey
Hospital & Medical Center
Maine Medical Center
New England Baptist Hospital
Newton-Wellesley Hospital
St. Elizabeth’s Medical Center
Tufts Medical Center
Academic Partners
Brandeis University
Massachusetts Institute of Technology Northeastern University
RAND Corporation
Industry/Non-Profit
Partners
Baim Institute for Clinical Research
Blue Cross Blue Shield of MA
Eli Lilly and Company
The Jackson Laboratory
Pfizer, Inc.
Tufts Health Plan
Community-Based Partners
Action for Boston Community Development (ABCD)
Asian Community Development Corporation
Asian Task Force Against Domestic Violence
Asian Women for Health
Boston Chinatown Neighborhood Center
Center for Information and Study on Clinical Research Participation (CISCRP)
Greater Boston Chinese Golden Age Center
Health Resources in Action
Museum of Science, Boston
New England Quality Care Alliance (NEQCA)
Slide6How Does Tufts CTSI Help Researchers?Consultations
Connections to collaborators & research
projects
Research
design
&
analysisRegulatory support Clinical studies & trials support
Informatics tools
Pilot
Studies Awards
Training &
education
opportunitiesCTS Graduate Program
TL1 Fellowship ProgramKL2 Scholarship ProgramProfessional Education
Slide7For more information: www.tuftsctsi.org
Slide8Get Connected: CTSI HappeningsWeekly e-newsletter with news, professional development and funding opportunities, resources, and success stories.Issued every Monday at 8AMSign up on our website or
at http://eepurl.com/C4d9X
Slide9About Tufts Health Sciences Institutional Review Board (IRB)IRB serves Tufts
Medical Center and Tufts University Health SciencesE-mail IRBOffice@tuftsmedicalcenter.org
to be added to the Tufts Health Sciences IRB e-mail distribution list – to receive the Quarterly IRB Newsletter
Call the IRB Office ext. 6-7512 with any questions!
Slide10Today’s Tufts Expert PanelAndreas Klein
, MDDirector, Regulatory Affairs, Tufts CTSI;
Chair, Tufts Health Sciences Institutional Review
Board
Kathleen Benoit
Senior Research
Administrator, Office of the Vice Provost for Research (OVPR
),
Tufts University
Frederick M. Frankhauser
, JD, MBA,
RPh
Director
, Grants & Contracts, Tufts Medical Center
Meghan Coughlin, MSResearch Administrator, Office of Research Administration,Tufts Medical Center
Slide11New Requirements at a Glance
This
seminar’s PowerPoint has been adapted from the original slide decks created by NIH as training and outreach resources
https://grants.nih.gov/policy/clinical-trials/training-resources.htm
Slide12Doing Human Subjects Research?
Slide13Changes at a GlanceAll Research Involving Human Participants
New forms to collect human subjects information
Use of a single Institutional Review Board (IRB) for multi-site studies
Certificates of confidentiality for all research that uses “identifiable, sensitive information”
Research that Meets the NIH Definition of a Clinical Trial
Training in Good Clinical Practice (GCP)
Clinical trial-specific Funding Opportunity Announcements (FOAs)
New review criteria
Expanded registration and results reporting in ClinicalTrials.gov
Slide14Why Changes to Clinical Trial Policies?
Efficiency
Enhance the efficiency of how research studies involving human participants are conducted
Transparency
Promote a culture of transparency in research in order to advance public health
Accountability
Ensure that NIH can appropriately identify and report on their clinical trials portfolio to ensure proper stewardship
Timely Reporting
Decrease the time it takes investigators to publicly report study results
Slide15Seminar Learning ObjectivesIdentify tools and resources for determining if your study is a clinical trial and what actions are required for an NIH grant proposal, IRB applications, and study reportingOutline financial and administrative prerequisites needed to collaborate with other institutions under the single IRB requirement
Describe the importance of engaging Tufts IRB in the early stage of proposal development
Slide16Seminar TopicsClinical Trials – DefinitionClinical Trials – Administrative ChangesSingle IRB RequirementsClinicialtrials.gov and other
Slide171. How Do I Determine
If My
S
tudy is a Clinical
T
rial?
Andreas Klein
, MD
Director, Regulatory Affairs, Tufts CTSI;
Chair, Tufts Health Sciences Institutional Review Board
Slide18New NIH Definition of a Clinical Trial is Broad: Your Human Subjects Research Might Meet the Definition of a Clinical TrialDefinition was clarified and broadened in October 2014Encompasses a wide range of types of trials, including:
MechanisticExploratoryPilot/Feasibility
Behavioral
With
this new broader
definition, many more studies are classified as clinical trials
Slide19Why Identifying Whether NIH Considers Your Study to Be
a Clinical Trial is Crucial
Select and apply
through
a
clinical trial-specific
Funding Opportunity Announcement (
FOA
) and human subjects information required in the new application form, “
Form-E
”
Address additional
review criteria
specific for clinical trials in the Research Strategy and human subjects sections of your application
Get trained in Good Clinical Practice (GCP)
Register and report your clinical trial in ClinicalTrials.gov
to comply with appropriate policies and
regulations
Slide20How Does NIH Define a Clinical Trial?A research study in which one or more
human subjects are prospectively assigned
to one or more
interventions
(which may include placebo or other control) to evaluate the effects of those interventions on
health-related biomedical or behavioral outcomes
.
Learn more at
https://grants.nih.gov/policy/clinical-trials/definition.htm
Slide21Unpacking the Definition
Prospectively Assigned
: a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial
.
Intervention
:
a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.
Health-related
Biomedical or Behavioral Outcome
: the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.
Slide22Is Your Study a Clinical Trial?
Ask Yourself
Does your study…
Involve one or more
human subjects
?
Prospectively assign
human subject(s) to intervention(s)?
Evaluate the
effect of intervention(s)
on the human subject(s)?
Have a health-related biomedical or behavioral outcome?
If “yes” to ALL of these questions, your study is considered a clinical trial
Slide23Learn more at: https://grants.nih.gov/policy/clinical-trials/definition.htm Decision Tree and Tools
Slide24Question: Is This Study a Clinical Trial?
Test Your Knowledge!
Slide25Case #1. The study involves the recruitment of research participants who are randomized to receive one of two approved drugs. It is designed to compare the effects of the drugs on the blood level of a protein.
Slide26Case #1. The study involves the recruitment of research participants who are randomized to receive one of two approved drugs. It is designed to compare the effects of the drugs on the blood level of a protein. This study is a clinical trial.
Slide27Case #2. The study involves the recruitment of research participants with disease X. It is designed to compare the diagnostic performance of approved devices A and B, both of which are used in clinical practice, to measure disease markers. Device A will be used in half of the patients; device B will be used in the other half.
Slide28Case #2. The study involves the recruitment of research participants with disease X. It is designed to compare the diagnostic performance of approved devices A and B, both of which are used in clinical practice, to measure disease markers. Device A will be used in half of the patients; device B will be used in the other half.X This study is not a clinical trial.
Slide29Case #3. The study involves the recruitment of research participants suspected to have disease X. It is designed to compare the ability of approved devices A and B to diagnose the disease and inform the clinical management of disease X. Device A will be used in half of the patients; device B will be used in the other half.
Slide30Case #3. The study involves the recruitment of research participants suspected to have disease X. It is designed to compare the ability of approved devices A and B to diagnose the disease and inform the clinical management of disease X. Device A will be used in half of the patients; device B will be used in the other half. This study is a clinical trial.
Slide31Case #4. The study involves the analysis of de-identified, stored blood samples and de-identified medical records of patients with disease X who were treated with an approved drug. The study is designed to evaluate the level of a protein in the blood of patients that is associated with therapeutic effects of the drug.
Slide32Case #4. The study involves the analysis of de-identified, stored blood samples and de-identified medical records of patients with disease X who were treated with an approved drug. The study is designed to evaluate the level of a protein in the blood of patients that is associated with therapeutic effects of the drug.X This study is not a clinical trial.
Slide33Case #5. The study involves the analysis of identifiable, stored blood samples and identified medical records of patients with disease X who were treated with an approved drug. The study is designed to evaluate the level of a protein in the blood of patients that is associated with therapeutic effects of the drug.
Slide34Case #5. The study involves the analysis of identifiable, stored blood samples and identified medical records of patients with disease X who were treated with an approved drug. The study is designed to evaluate the level of a protein in the blood of patients that is associated with therapeutic effects of the drug.X This study is not a clinical trial.
Slide35Additional Information & ResourcesDecision Tool
Case StudiesFAQs
Decision Tree
When in doubt, contact your Program
Official
In addition, refer to the optional NIH-FDA Clinical Trials Protocol Template (for phase 2 or 3 drug or device clinical trials)
Learn more at:
https://grants.nih.gov/policy/clinical-trials/definition.htm
Slide36Recap:
Clinical Trials Definition
Panel and Q&A
Slide372. What Should I Do
Once I Have Determined
My Study is a Clinical Trial?
Marcia S.
Izzi
, MPH
Business Finance
Manager, Tufts CTSI
Slide38Effective for due dates on/after January 25, 2018 – all FOAs will be designated as one of the following in Section II of the FOA:Clinical Trial Required
Clinical Trial Not AllowedClinical Trial Optional
No Independent Clinical Trials: *only for Career Development (K) & Fellowship (F)
1) Identify and Submit Your Grant Application
to an FOA or Request for Proposal (RFP)
S
pecifically
D
esignated for Clinical
T
rials
Important:
Adding a clinical trial to a non-clinical trial application is no longer permitted via the prior approval process. Grantees must submit competitive renewal
.Contact your Program Official or the Scientific/Research contact listed in Section VII of the FOA to ensure you are submitting to the correct
announcement.
Slide39How to Determine if an FOA Accepts Clinical Trials?
FOA Title (new FOAs only)
FOA Section II. Award Information
Tip:
Check your FOA at least 30 days before the due date for any updates
Slide402) Address Clinical Trial-Specific Review Criteria in the Research Strategy Section FOAs that accept clinical trials will include new review criteria
Scored Review CriteriaSignificance
Investigator
Innovation
Approach
Environment
Additional Review Criteria
Study Timeline & Milestones
Tip:
Read the FOA carefully and be sure your application addresses the review criteria appropriately
Slide413) Study the New Application Packages (FORMS-E) Early On and Prepare for Detailed Human Subjects InformationPHS Human Subjects and Clinical Trials Information Form
Consolidates information from multiple formsIncorporates structured data fields
Collects information at the study-level
Use the Research Strategy section to discuss the overall strategy, methodology, and analyses of proposed research, but
do not duplicate
information collected in the PHS Human Subjects and Clinical Trials Information
form:
https
://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm
Slide42Changes to the Appendix Policy
Effective for due dates on/after January 25, 2018
– Since the new Human Subjects and Clinical Trials Information form collects key elements from the protocol, the optional protocol submission will be removed from the Appendix Policy.
Parent FOAs
Will
NOT
allow inclusion of
the
protocol in the application
If the protocol is included, the application will be sent back
IC issued FOAs
Protocols and other materials allowed only when specified as required in the FOA
Learn more at
https://
grants.nih.gov/grants/guide/notice-files/NOT-OD-17-098.html
Slide43NIH policy:GCP training can be achieved through several ways:class or course (such as the online CITI course)academic training programcertification from a recognized clinical research professional organization
Training should be refreshed every 3 years to stay up to date with regulations, standards, and guidelinesRecipients of GCP training are expected to retain documentation of their training and make it available to NIH upon request
Learn more at
https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm
4) Get Trained in Good Clinical Practice
(GCP) and Retain Documentation
Slide44Institution-Specific Good Clinical Practice (GCP) Training PolicyTufts GCP training policy Currently, GCP training is required for all NIH funded studies that meet the NIH definition of clinical trialAs of January 1, 2018, GCP training will be required for all clinical trials, regardless of funding source
Acceptable GCP training courses include CITI or any other GCP training approved by “TransCelerate”, a mutual recognition program for GCP trainingNon-Tufts: Check with your institution
Make sure what GCP training courses are acceptable at
your
institution.
Slide45Recap:
Clinical Trials Administrative Changes
Forms, Review Criteria, GCP, and Other Changes
Panel and Q&A
Slide463. How Do I
M
anage Single IRB (
sIRB
) for
My Multi-Site Study?
Andreas Klein
, MD
Director, Regulatory Affairs, Tufts CTSI;
Chair, Tufts Health Sciences Institutional Review Board
Slide47Single Institutional Review Board (sIRB) Requirement for Multi-site ResearchsIRB policy aims to:
Streamline the ethical review required for the protection of human subjects to enhance research efficiency
Reduce unnecessary administrative burdens and inefficiencies
Learn more at
https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm
Slide48What Does the sIRB Policy Apply To?Domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research Includes research supported through:GrantsCooperative agreements
Contracts
NIH Intramural Research Program
sIRB policy does
not
apply to career development, research training, or fellowship awards
Slide49Address your sIRB Plan in Your Application or ProposalDescribe the use of an sIRB that will be selected to serve as the IRB of record for all study sites
Confirm that participating sites will adhere to the sIRB Policy and describes how communications between sites and sIRB will be handled
Tip:
sIRB Plan attachment will be included in the new
Human
Subjects & Clinical Trials Information form
Slide50Why is This Such a Big Deal?Funding of research by HHS is contingent upon an agreement between HHS and Tufts by which the Tufts IRB will:Conduct initial and continuing review of the researchEnsure the IRB reviews all changes in researchEnsure prompt review and reporting of unanticipated problems and non-compliance with Federal policy
Slide51Tufts sIRB Use CaseTufts researcher proposes multi-site clinical trial involving a new treatment for psoriasis for NIH funding.
sIRB requirement applies to this studyPI has three options:
Engage services of a commercial IRB
Pro: multi-site experience, familiarity
Con: $$$
Slide52Tufts sIRB Use CaseAssign oversight to one of the collaborating study sites Pro: probably less expensive than commercial
Con: contend with another IRB system
Tufts serves as
sIRB
Pro
: likely least expensive option
Con: limited local capability at current time, PI / study will need to assume on- the-ground oversight
Slide53Tufts sIRB RecommendationsConsult IRB and Research Administration / OVPR during your “proposal development” stage toDetermine who should or will assume the role of IRB of record and what such decisions entail
Assess the feasibility of your study plan and potential IRB cost; evaluate various models and options
Build in the potential IRB cost for your application
Understand the relationship with consortium partners
Qualification
Bandwidth
Letter of Intent (LOI) to be initiated by Tufts
sIRB
application
Slide54Recap:
Single IRB (
sIRB
) Requirement for
Multi-Site Research
Panel and Q&A
Slide554. What are My
R
esponsibilities with
ClinicalTrials.Gov
Reporting?
Meghan Coughlin
, MS
Research
Administrator
Office
of
Research Administration, Tufts
Medical Center
Slide56NIH Policy on Dissemination of NIH-Funded Clinical Trial InformationEffective for applications due on/after January 18, 2017 – All clinical trial applications requesting support for a trial that will be initiated on/after January 18, 2017 must register and report the results in ClinicalTrials.govNIH dissemination policy:
Extends previous HHS laws and regulations to apply to all NIH-funded clinical trials, including the defined subset of “applicable clinical trials”
Increases the availability of information to the public about clinical trials
Learn more at
https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Slide57To Comply with the NIH Policy on Clinical Trial Dissemination, Awardees Must:
Submit a plan in the application that outlines compliance with the expectations of the policy
Register the clinical trial no later than 21 days after enrolling the first participant
Submit summary results no later than one year after primary completion date
Slide58More Information on Registering & Reporting in ClinicalTrials.govDecision tree for ensuring complianceFAQs
Learn more at https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Slide59Other Changes to
Note,
Discussion
, and Closing Remarks
Andreas Klein
, MD
Director, Regulatory Affairs, Tufts CTSI;
Chair, Tufts Health Sciences Institutional Review Board
Slide60Updated Certificates of Confidentiality (CoC) PolicyCoCs will be issued automatically for any NIH-funded project using identifiable, sensitive information that was on-going on/after December 13, 2016
Applies to all human subjects research that uses identifiers (biomedical, behavioral, clinical, or other research)
Eliminates
the need for NIH funded investigators to apply for a
CoC
Enhances the privacy protections of individuals participating in NIH-funded research
Requires investigators to only disclose information under specific circumstancesApplies to NIH awards funded wholly, or in part, by NIH
Disclosure restrictions also apply to anyone who receives a copy of identifiable sensitive information protected by the policy, even if they are not funded by NIH
CoC
is issued as a term and condition of award (no physical certificate
)
For studies with an informed consent form, include NIH template
CoC
language in the consentLearn more at
https://humansubjects.nih.gov/coc/index
Slide61Some Requirements PendingIn addition to the NIH initiatives, Final Revisions to the Common Rule (the set of federal regulations for ethical conduct of human subjects research) are set to take effect on January 19, 2018 HHS has proposed a 1 year delayIf a one year delay is granted, the proposal is to allow implementation of 3 burden-reducing changes on January 19, 2018:Conduct a yearly administrative check in on minimal risk studies at the time of continuing review (eliminating the requirement for a full continuing review)
New exempt categories of researchGeneral certifications of overarching grants with no human subjects research will no longer need IRB review & approval
Slide62Recap:
Clinicaltrials.gov &
Other Requirements
Panel and Q&A
Slide63Questions?
Thank you!
Slide64ResourcesWebsite on Clinical Trial Requirements for Grants and Contracts:
https://grants.nih.gov/policy/clinical-trials.htm
Training Resources:
https://grants.nih.gov/policy/clinical-trials/training-resources.htm
SlidesHuman Subjects/Clinical Trials Questionnaire
Videos
Training opportunities
Help spread the word!