Post on 27-Mar-2018
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New Biographical Sketch Format
The National Institutes of Health (NIH) have introduced changes
to the Biographical Sketch format (NOT-OD-15-032 ) required for
applications submitted for due dates on or after May 25, 2015.
Key Changes:• Increases page limit from four (4) to five (5)
• Allow researchers to describe up to five (5) of their most
significant contributions to science including up to four (4) peer-
reviewed publications or other non-publication research
products that are relevant to the described contribution
• A URL to the applicant’s publicly available bibliography may be
provided (SciENcv or My Bibliography)
Grants
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SciENcv (Science Experts Network Curriculum Vitae)
• An interagency system designed to create biosketches for multiple federal agencies (Working group: DOD, DOE, EPA, NIH, NSF, USDA)
• Pulls information from available resources making it easy to develop a repository of information
Grants
http://www.ncbi.nlm.nih.gov/sciencv/tutorials/
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NIH Salary Cap
NOT-OD-15-049 provides information regarding the new NIH Salary Cap on Grants, Cooperative Agreements, and Contracts.
Effective January 11, 2015, the new NIH Salary cap was increased from $181,500 to $183,300.
* Cost Sharing is the financial support contributed by FH to externally funded projects. (Refer to Memo dated August 12, 2014 and Research Matters 10-07-14)
Grants
Proposed Budget
Personnel Role % Effort NIH Cap Base Salary Amount Fringe
Benefits
Fringe Benefits
Amount Total
Smith, John, PhD Principal Investigator 20% 183,300 36,660 30% 10,998 47,658
Actual Cost
Personnel Role % Effort Actual Base Salary Amount Fringe
Benefits
Fringe Benefits
Amount Total
Smith, John, PhD Principal Investigator 20% 300,000 60,000 30% 18,000 78,000
Cost Share
Personnel Role % Effort Salary Variance Salary Amount Fringe
Benefits
Fringe Benefits
Amount Total
Smith, John, PhD Principal Investigator 20% 116,700 23,340 30% 7,002 30,342
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Biographical Sketch
• For the NIH announcement about the new biosketch:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-032.html
• For the general Biographical Sketch Format Page Template:
http://grants.nih.gov/grants/funding/424/SF424R-R_biosketch_VerC.docx
• For the general Biographical Sketch Format Page Instructions and sample:
http://grants.nih.gov/grants/funding/424/SF424R-R_biosketchsample_VerC.docx
• For more information about SciENcv:
http://www.ncbi.nlm.nih.gov/sciencv/
• For a brief instruction on how to use SciENcv:
https://www.youtube.com/watch?v=PRWy-3GXhtU&feature=youtu.be
NIH Salary Cap
• For the NIH announcement about the new salary cap:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-049.html
Grants
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Effective March 1
A one-time fee will be applied to submissions requesting to rely
upon a central IRB.
IRB Fees – Update
S u b m i s s i o n Ty p e Am o u n t
Internally Funded Studies†*
Initial – New Study $ 500
Late Submission Fee $ 500
Rely Upon Central IRB $ 500
Externally Funded Studies
Initial - New Study $2000
Late Submission Fee $ 500
Renewal (Full board and Expedited) $ 750
Full Board Protocol Amendment/ Revisions†† $ 500
Expedited Protocol Amendment/Revisions†† $ 300
IRB FEE SCHEDULEEffective March 1, 2015
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Investigator Forum 2015
Well attended
Huge thanks for assistance from department directors /
teams
263 attended, with 234 completing evaluations 42% January 19th evening - Orlando
44% January 20th morning - Orlando
12% January 20th evening - Celebration
“Share the Knowledge” Barker B February 16 from 12 p.m. – 1 p.m.
February 18 from 2 p.m. – 3 p.m.
February 20 from 10 a.m. – 11 a.m.
***Non-Attendee Update***
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AAHRPP Accreditation Update
• Final stages prior to submitting Step 1 Application • Finishing touches to new Policies, Forms, etc
• Reaching out to department directors to have Forms
tested
• Aiming for March 2015 submission date
• Final stages prior to roll out of new policies • Face-to-face meetings with departments
• Aiming for April 1, 2015 roll out of new Policies, Forms,
etc
• Ongoing Education - Provide small group sessions to
learn more
FH HRPP Accreditation
TimelineDeveloping / Refining Polices/Procedures/IRB Forms
•September 2014-present
Educate Research Personnel
•January 2015 Investigator Forum
•February-March 2015 – Research Department Outreach
Prepare / Submit Step 1 Application
•March 2015
Roll out New Policies/SOP’s/IRB Forms
•April 2015
AAHRPP Site Visit
• TBD
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Investigator Manual & Guidance
Guidance distributed and discussed at Investigator Forum
Short and to the point
New Forms (Adobe Acrobat Preferred)
No Signatures Required
Slightly Revised Protocol Template (Investigator Initiated studies)
Protocol “supplement” for industry sponsored studies (information
previously requested in Application)
Revised Consent Form templates
More than minimal risk, minimal risk
External IRB’s
Reportable New Information required to be reported locally
Letters – New Look
IRB Process ImprovementsWhat changes can you expect?
IC Subject Injury vs
Contract Language
AAHRPP Element I.8.A
The Organization has a written
agreement with the Sponsor that
addresses medical care for research
participants with a research related
injury, when appropriate.
The organization has a process to
confirm the terms specified in the
contract or agreement and in the
consent document are consistent. 11
IC Subject Injury vs
Contract Language
Informed Consent
You and/or your health
plan will be charged for
this treatment. The
study sponsor or doctor
will not pay for this
medical treatment, and
you will not receive any
other kind of payment.
Contract
The sponsor will
reimburse Study Center
for the reasonable costs
of immediate treatment
of any adverse reaction
or physical injury…but
only if such expenses
are not paid for by the
Subject's medical
insurance.
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IC Subject Injury vs
Contract Language
Informed Consent
Medical care will be provided to
you if you are injured as a direct
result of participation in this
study. You will be responsible for
the costs of this care if it is not
paid by your health insurance
carrier or other third party payer.
Some insurance companies and
third party payers may not pay for
treatment of injuries that result
from participation in a research
study, including hospitalization
costs. If your insurance company
or third party payer does not pay
for these costs, you will be
responsible for them.
Contract/LOI The sponsor agrees to assume
responsibility for the direct,
reasonable and necessary costs
of medical care incurred by
Institution for the care and
treatment of the immediate
effects of any bodily or
personal injury sustained by a
Study subject that is the direct
result (a) of administration of
the Study Drug in accordance
with the Site Clinical Trial
Agreement, the Protocol and
any other written instructions
of the sponsor.
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IC Subject Injury vs
Contract Language
Informed Consent
The sponsor will not pay
any money to you or pay
any of your medical bills
Contract
The sponsor will provide
payment to the institution
for reasonable,
unreimbursed medical
expenses, including
hospitalization, which the
institution may incur as a
direct result from the
study drug, or its
administration, etc..
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IC Subject Injury vs
Contract Language
Informed Consent “If you suffer any
physical injury as a
direct result of the
devices provided in this
study, you will be
reimbursed for the
reasonable costs of
additional medical
treatment….”
Contract If any injury occurs to
the subject as a direct
result of the Study
Device or a Study
procedure, SPONSOR
agrees to reimburse
INSTITUTION all
reasonable medical
expenses necessary to
treat such injury,…
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IC Subject Injury vs
Contract Language Informed Consent If you become sick or injured
following the study procedures, Florida Hospital will provide you with medical treatment. The Sponsor will reimburse you or Florida Hospital for the reasonable and necessary costs of such medical treatment, provided that you have followed the instructions of the Study Doctor. No other form of reimbursement for study-related injury or illness is offered by the Sponsor.
Contract Institution will provide
medical treatment to
Trial subjects who suffer
an adverse reaction or
injury during the trial.
The sponsor will
reimburse Institution for
the reasonable and
necessary costs of
providing such care….
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IC Subject Injury vs
Contract Language
Informed Consent
In the event of research-related injury or illness, medical treatment and hospitalization are available. This medical treatment and/or hospitalization are not free of charge.The sponsor will be responsible for reimbursement of reasonable and necessary costs if these study-related expenses are not covered by your medical insurance and are not attributable to:
Failure by you or the institution to adhere to the protocol.
Negligence or wilful misconduct by you or the institution
Contract
The sponsor agrees to assume responsibility and shall reimburse Institution for the reasonable and necessary costs of medical treatment of any Subject Injury experienced by a Subject enrolled in the Study to the extent that such expenses are not attributable to Subject’s pre-existing medical condition or underlying disease, except for such costs that arise from:
(i) a failure to adhere to the terms of the Protocol by Institution, except medically necessary deviations, or
(ii) negligence or willful misconduct on the part of the Institution.
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IC Subject Injury vs
Contract Language
Informed Consent
The Sponsor and the
research site will not
compensate you for
injury or for expenses
incurred because of this
research study.
Contract In the event of an
unanticipated adverse effect, directly resulting from the Study Device, the sponsor shall reimburse Institution and/or Investigator, as the case may be, for reasonable and necessary medical expenses incurred by study subjects as a direct result of the treatment of adverse reactions resulting from the administration of the Study Device…..
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IC Subject Injury vs
Contract Language
Informed Consent The sponsor of the study
agreed to reimburse the reasonable and necessary medical expenses not routinely covered by insurance for tests and treatments required to evaluate and treat an injury directly caused by the proper use of the study drug or a properly performed procedures required only by the study.
Contract Sponsor shall pay as
applicable for the reasonable and necessary costs incurred for expenses not routinely covered by insurance for tests and treatments required to evaluate and treat an injury to the subject if it determined that the adverse event was directly related to administration of the study drug or a procedure required solely for the purpose of the conduct of the protocol…
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What Students May
and May Not Do STUDENTS PARTICIPATING IN RESEARCH AT FH MAY:
Assist research department employees.
Complete assigned tasks for which they have appropriate background, experience, training, education, and/or on-the-job training.
Have access to patient records if applicable and necessary in order to complete assigned tasks, and as indicated in FH Institutional Review Board (IRB) application materials and subsequent IRB approval
Obtain informed consent if approved by the FH IRB.
Serve as a Sub-Investigator on a research project.
If the student is also a FH employee, s/he may serve as the PI of a research project with the condition that at least one other FH employee must be on the research project team.
STUDENTS PARTICIPATING IN RESEARCH AT FH MAY NOT:
Take the place of an employee, (i.e., their absence should not adversely affect the daily operations of a department).
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Students on the Delegation Log
Please check the Yes box if a student is using this study to complete an educational requirement.
• Complete information on bottom of page to provide specifics. This triggers the ORA to verify appropriate Legal documents are in place for this student to obtain course credit or meet educational requirements.
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Team Member
Add Responsibility Code(s)
and
Describe Other Roles
Contact or Communication
with participants OR
Access to identifiable
information
Y / N
Involved in the
Consent Process
Y / N
Using study to
complete education
requirement*
Yes No Yes No Yes No
*Name of student(s): Name of educational facility:
Degree, certification, or program to be completed:
Name of school Advisor: Name of Florida Hospital (FH) Mentor:
Guidance Documents on
Students Updates include:
General guidance on conducting research at FH is available for student projects, however this is limited and does not include statistical analysis.
Notification to Nursing Research at FH.Nursing.Research@flhosp.org for projects completed for an advanced degree in the field of nursing
REMINDER: Students (both FH and non-FH employees) can only conduct research at FH if there is a fully executed affiliation or research collaboration agreement on file with the educational institution that includes the specific academic program.
Current institutions include: UCF, FSU, Adventist University Health Sciences (ADU), FAMU, University of Phoenix, University of South Alabama, Barry University, Embry Riddle, and Western Governors
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Observers ≠ Research Team Member Time may be limited based on nature of
experience and may not exceed 30 days
Observer must be
processed/credentialed.
If Observer is international, then
additional processing is required -
contact Sanjay John (HR)
Patients must be informed of the
presence of observers and observe only
if permission is granted by the patient
Must always be accompanied by FH
person who has been designated as the
observers “Sponsor”
Will not provide medical care, conduct a patient
interview, take medical history, examine a patient,
provide medical advice to a patient or assist in any
procedure.
Will not make entries into or make copies of
patient medical records
Will not write or make verbal orders for patients
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Research Enterprise
Update from Leadership
Steven SmithChief Scientific Officer
Rob HerzogVice President
ORA Announcements Notice of NIH Requirement for Federal Recognition of Same-Sex/Marriages
by Grant and Research and Development Contract Recipients
The ORA is soliciting feedback on our new educational platform. We
would like to hear from representatives from all of these groups:
Please contact Amy Hinton through the ORA mailbox if you would be willing to
attend a 30 minute session in early March at South to review our new materials
and share your thoughts.
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Clinical Research Coordinator
Regulatory
Research Assistant
Manager/Supervisor/Director
Full-Time Investigator/Scientist
Full-Time Physician , Part-Time Physician Investigator
Resident/GME Faculty
Volunteer
Full-Time Clinician, doing research part-time