Research Matters

February 12, 2015

1

Devotional & PrayerChristina Jackson

2

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

3

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/

4

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

5

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

6

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 A m 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

7

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***

8

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 Timeline

Developing / Refining Polices/Procedures/IRB Forms• Septembe

r 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

10

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 vsContract 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 vsContract 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.

12

IC Subject Injury vsContract 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. 13

IC Subject Injury vsContract 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..

14

IC Subject Injury vsContract 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,…

15

IC Subject Injury vsContract 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….

16

IC Subject Injury vsContract 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. 

17

IC Subject Injury vsContract 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…..

18

IC Subject Injury vsContract 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…

19

Volunteers vs Students and the Delegation Log

20

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). 21

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.

22

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

23

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

24

Study Spotlight

25

FH Orthopedic Institute

26

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. 

27

Clinical Research Coordinator

Regulatory

Research Assistant

Manager/Supervisor/Director

Full-Time Investigator/Scientist Full-Time Physician , Part-Time Physician InvestigatorResident/GME Faculty

Volunteer

Full-Time Clinician, doing research part-time

Questions/Comments?

Thank you for your attendance at

Research Matters!

28