Research Support Information Network (RESIN)

Presented by: Office of the Vice Chancellor for Research Date: May 3, 2016

Agenda

Updates & Timely Information from Research Support:

Office of the VCR Travel URC ORSP

IRB Research Compliance Contract Administration Office of Finance IACUC Office of Global Health ORRA Compliance - Export Control OGSP TRI BioVentures Winthrop Rockefeller Cancer

Institute 2 5/6/2016

5/6/2016 3

exportcontrol.uams.edu Philip Principe, Director, Export Control, Institutional Compliance

exportcontrol.uams.edu

5/6/2016 4

exportcontrol.uams.edu Philip Principe, Director, Export Control, Institutional Compliance

Contact Information Philip Principe

501-686-6168

PPrincipe@uams.edu

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

Complete transformation of grants.nih.gov website Simplified Interface

Streamlines how to find information Provides context for information

Forms Library (grants.nih.gov/grants/forms) A comprehensive inventory of forms, instructions, and

format pages for each stage of the grant life cycle.

5/6/2016 5

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

Reorganization of Application Guides General Instructions

Comprehensive guidance for all NIH grant applications

Separate Guides for Specific Grant Programs

5/6/2016 6

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

Complete transformation of grants.nih.gov

7

8

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

9

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

10

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

11

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

12

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

13

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

14

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

15

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

16

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

17

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

18

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

19

Changes to the NIH Website and Forms Instructions DeAnn Hubberd, Associate Director, OGSP

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

NIH FORMS-D

For due dates on or after

May 25, 2016

5/6/2016 20

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

New PA Numbers

Parent R01 PA-16-160 Parent R21 PA-16-161 Parent R03 PA-16-162

5/6/2016 21

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

5/6/2016 22

PHS 398 Cover Page Supplement • New Vertebrate Animals section added

• New questions Are animals euthanized? Yes/No If Yes, is method consistent with AVMA guidelines? Yes/No

If No to AVMA guidelines, describe method/provide scientific justification

• Ability to add Program Income information for 10 budget periods (previously 5)

• Field order and label changes

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

5/6/2016 23

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

PHS Assignment Request Form

New, optional form Used to provide structured information to NIH referral staff

regarding: funding component assignment preference, study section preference, individuals who should not review your application due to conflicts, and scientific areas of expertise needed to review your application

Complements existing “Cover Letter Attachment” on SF424 (R&R) form

5/6/2016 24

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

5/6/2016 25

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

5/6/2016 26

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

5/6/2016 27

PHS 398 Research Plan New “Data Safety Monitoring Plan” attachment – required if answer to Clinical Trial Question on PHS Cover Page Supplemental Form is “Yes”

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

5/6/2016 28

PHS 398 Research Plan New “Authentication of Key Biological and/or Chemical Resources” attachment

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

PHS Inclusion Enrollment Report Combines Planned Enrollment Report and Cumulative Inclusion Enrollment

Report forms into a single form Questions used to identify type of report:

Delayed onset study? Yes/No Enrollment Type? Planned/Cumulative (Actual) Using an Existing Dataset or Resource? Yes/No Enrollment Location? Domestic/Foreign Clinical Trial? Yes/No

NIH-Defined Phase II Clinical Trial? Yes/No

5/6/2016 29

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

PHS Inclusion Enrollment Report

5/6/2016 30

NIH FORMS-D Suzanne Alstadt, Director Office of Research and Sponsored Programs

New Application Guide

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.100-how-to-use-the-application-instructions.htm

5/6/2016 31

ARresearch.org Jean McSweeney, Ph.D., R.N. Assoc. Dean for Research, College of Nursing

5/6/2016 32

5/6/2016 33

ARresearch.org Jean McSweeney, Ph.D., R.N. Assoc. Dean for Research, College of Nursing

5/6/2016 34

ARresearch.org Jean McSweeney, Ph.D., R.N. Assoc. Dean for Research, College of Nursing

5/6/2016 35

ARresearch.org Jean McSweeney, Ph.D., R.N. Assoc. Dean for Research, College of Nursing

5/6/2016 36

ARresearch.org Jean McSweeney, Ph.D., R.N. Assoc. Dean for Research, College of Nursing

UAMS-Office of Global Health Nick Zaller, Ph.D. Director, Office of Global Health Associate Professor, College of Public Health

Introduction Goals of OGH

To facilitate and coordinate global health efforts across campus; To develop and sustain partnerships to provide students and faculty

with global health experiences.

Your Role & Involvement Your international research, education and clinical experiences and

activities Data re ongoing global health efforts—UAMS policy Global Health Certificate Program Travel resources, networking, & opportunities

5/6/2016 37

UAMS-Office of Global Health Nick Zaller, Ph.D. Director, Office of Global Health Associate Professor, College of Public Health

Contact: Nick Zaller, Ph.D. Director, Office of Global Health Associate Professor, College of Public Health ndzaller@uams.edu 686-8366 Brittney Roy Project Coordinator, Office of Global Health bmroy@uams.edu 526-7199

5/6/2016 38

What to Expect When You’re Expecting…AAHRPP Jennifer Holland, JD - IRB Director

The AAHRPP Reaccreditation Site Visit

will be May 23-25. Initial accreditation was in October 2005

with reaccreditation in 2008 and 2011. AAHRPP now reaccredits every 5 years.

What to Expect When You’re Expecting…AAHRPP Jennifer Holland, JD - IRB Director

AAHRPP focuses on the entire UAMS

Human Research Protection Program. This includes the IRB but also biosafety, COI, general counsel, research contracts, ACHRI, ORC, research pharmacy, IRB Reviewers, Principal Investigators and Study Staff.

What to Expect When You’re Expecting…AAHRPP Jennifer Holland, JD - IRB Director

Representatives from Research and Institutional Administration are each interviewed in separate sessions.

IRB Reviewers, Principal Investigators, and Study Coordinators are randomly selected by AAHRPP for interviews.

AAHRPP also reviews the IRB files for studies they select.

What to Expect When You’re Expecting…AAHRPP Jennifer Holland, JD - IRB Director

Once the site visit is completed, UAMS will be

provided with an initial report outlining any requirements that must be met before the AAHRPP Council meeting in September.

IRB Policies and Procedures may need to be modified based upon the Site Visit findings.

What to Expect When You’re Expecting…AAHRPP Jennifer Holland, JD - IRB Director

UAMS first accredited in 2005; one of the first 25

institutions worldwide to earn accreditation AAHRPP accreditation becoming a standard,

with more than 60 percent of U.S. research universities and medical schools now accredited or in the accreditation process

Accreditation can encourage trust among collaborators and provide an edge when attracting study sponsors

Next RESIN

Next RESIN June 7, 2016 @ 12:00 p.m. Location - Walton Auditorium, Winthrop P.

Rockefeller Cancer Institute, 10th floor All RESIN presentations archived on the UAMS

Research website http://www.uams.edu/research/RESIN_Achive.asp

5/6/2016 44