Welcome to…RAIN

Welcome to…RAIN(the meeting formerly known as SPIN)

Presented by: the folks in RDA, with today’s emcee, Dana Director

Date: July 21, 2011

Agenda

• Intros

• Updates & timely information from the units:

Dana Director

TTBD RGC SPA Office of the VPR CRBCO

RFDS ORIO Research HR RATE

CTO

• Q & A

2RAIN: 07.21.2011

• RGC– Research Grants & Contracts

3RAIN: 07.21.2011

RGC: OHSU Research Grants & Contracts

NIH Updates• Mandating Use of the Commons to Submit No-Cost Extension

Notifications (NOT-OD-11-098) <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-098.html> National Institutes of Health

• Change in the NIH Continuous Submission Policy for Reviewers with Recent Substantial Service (NOT-OD-11-093) <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-093.html> National Institutes of Health

• NIH, AHRQ, CDC, FDA and NIOSH to Release Updated Electronic Application Forms ADOBE-FORMS-B2 (NOT-OD-11-096) <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-096.html> National Institutes of Health Agency for Healthcare Research and Quality Food and Drug Administration National Institute for Occupational Safety and Health

Deborah Golden-Eppelein

4RAIN: 07.21.2011

NIH Updates (cont’d)

Changes to these new form versions appear minor, but InfoEd is doing an analysis and we expect an update in the near future.

Just a reminder: eSNAP (electronic submission of Streamlined Non-Competing Award Procedures) is now mandatory. Paper progress reports may only be submitted for awards NOT subject to SNAP.

RAIN: 07.21.2011 5



NIH Reminder:

NIH staff and reviewers continue to find applicants trying to circumvent page limits by inserting information into inappropriate places in an application. Check out this cautionary statement from the latest policy reminder (NOT-OD-11-080 <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-080.html>) :

Yikes! Resist the temptation to overstuff your applications – you may actually be harming your chances for success.NIH may withdraw applications from review and funding consideration for egregious cases in which inappropriate material has been placed in a section or sections of an application without page limits, or in the Appendix.

RAIN: 07.21.2011 6



• SPA– Sponsored Projects Administration

7RAIN: 07.21.2011

SPA: OHSU Sponsored Projects Administration

• Effort Update– Jul10-Dec10 Period

• 4 Outstanding Effort Statements• Reminder: If a statement was returned to you, please make

the necessary changes and then send it back to SPA. • “Fun” Effort Stats

– 83% of statements were received by the April 18th deadline– 51% of statements were received during the week before the deadline.– 4% of statements required LD adjustments.

Amber Roberts

8RAIN: 07.21.2011

SPA: OHSU Sponsored Projects Administration

• Effort Update– Jan10-Jun10 Effort Period

• Patches fixing issues from Oracle upgrade will be installed before Effort Statements are ran in the system.

• Effort Period closes August 15th

• LCTA forms are due in August 12th

• Statements will be in the mail to campus by August 30th.• *Deadline to return statements is October 19th

*Individuals pulled for FY11 A-133 Audit will need to be returned significantly sooner!

Amber Roberts

9RAIN: 07.21.2011

SPA: OHSU Sponsored Projects AdministrationLaura Smith

10RAIN: 07.21.2011

• FY11 A-133 Audit– Auditors will be selecting test sample

beginning of August – SPA will notify the “chosen few”– Please respond timely to requests for

information/documents

SPA: OHSU Sponsored Projects AdministrationCharlie Resare

11RAIN: 07.21.2011

• Subrecipient Agreements– 2010 Pilot PO Project very successful!

• Led to easier tracking of Subaward budgets & expenditures

– PO’s to be attached on all subawards over the next 12 months.

• Implementation will be alphabetical by Department• Each department will be informed prior to

implementation

• CRBCO– Clinical Research Billing Compliance Office

RAIN: 07.21.2011 12

CRBCO: OHSU Clinical Research Billing Compliance

Epic Research Functionality Upgrade• August 4-6th, 2011 new research functionality will be

implemented with the Epic 2010 Upgrade

• Research subject will be “associated” with a study (replacing the FYI)

• No change from existing policy. Policy still applies only to research subjects receiving clinical services on a research study

• Conversion of all existing active research FYIs

Kristin Hackney

13RAIN: 07.21.2011


To view active research trials for a patient

- Click on Research Indicator in patient header

Kristin Hackney

14RAIN: 07.21.2011


To view inactive research trials for a patient

- Click on Research Indicator in patient header

Kristin Hackney

15RAIN: 07.21.2011


Identifying Research Subjects – In effect now• CRBO flagging research patients in Epic

• Coordinator to notify CRBO via email on the Research Subject Study Status Change Form within 3 days of a patient signing consent and when no longer receiving clinical services for the study

• CRBO will update Epic within 2 business days

• Study staff no longer has access to place research FYIs

Kristin Hackney

16RAIN: 07.21.2011


• Contact the CRBCO at [email protected] with questions or to schedule a department specific training on the Epic research upgrade.

• Find the Research Subject Status Change Form on the CRBCO website http://www.ohsu.edu/xd/research/about/integrity/irb/clinical-research-billing.cfm

Kristin Hackney

17RAIN: 07.21.2011

• Office of the VPR– Office of the Vice President for Research

18RAIN: 07.21.2011

• Where in the world is the VP’s Office??

(during the road closure)

RAIN: 07.21.2011 19

VPR: Office of the Vice President for ResearchDana Director

Pssst..

• OHSU/PSU Collaboration Efforts

RAIN: 07.21.2011 20

VPR: Office of the Vice President for ResearchDana Director

Portland State University, Vanguard Archives

• ORIO– OHSU Research Integrity Office

21RAIN: 07.21.2011

ORIO: OHSU Research Integrity Office

Don’t forget to schedule

your visit with Bill and Phil!Drs. Dale and Streeter want to talk to your department about

developing a program that:– assures the highest standards of animal care and use;

– is sensitive and responsive to the needs of OHSU’s scientific community;

– and encourages feedback from scientists.

Contact us to scheduleBill Dale: 4-9644; [email protected]

Phil Streeter: 4-1762; [email protected]

Amy Cline: 4-7842; [email protected]

Bill Dale

22RAIN: 07.21.2011


Institutional Gift accounting due August 1st • all schools, departments, divisions, and units

that receive gifts from industry– totaling greater than $100,000 in a fiscal year from any individual

Vendor– excluding industry funds provided for research or other sponsored

projects

• annual accounting of those funds on a form approved by the OIO

– http://www.ohsu.edu/xd/about/services/integrity/coi/gifts/index.cfm

Amy Cline

23RAIN: 07.21.2011


Not sure where to go for your biosafety and other research safety needs?

The Research Safety Program is now incorporated into the Research Integrity Office.

Amy Cline

24RAIN: 07.21.2011


Meet the new team Institutional Biosafety Committee (IBC) questions or any other

questions about the Research Safety Program– Kara Drolet, PhD, Associate Director, ORIO

Central Campus• Any biosafety or research chemical safety questions on the central or

waterfront campuses

– Debra Brickey, PhD, Central Campus Research Safety Manager

• Biosafety level 2 lab practices and containment questions

– Ben Smith, MS, Biosafety Specialist

For other central campus safety needs such as Radiation safety and hazardous waste,please contact EHRS

Amy Cline

25RAIN: 07.21.2011


West Campus• Any of your biosafety or other research safety questions on the west

campus.– Gwynn Daniels, PhD, West Campus Research Safety Manager

• Compliance with the Select Agent program– Sarah Byers, PhD, Biosafety Specialist

• Animal biosafety containment and practices at the primate center.– Susan Clary, MS, Biosafety Specialist

• General research safety– Daniel Toyooka, West Campus Safety Specialist

• Radiation safety– Vacant, Health & Safety Specialist

Amy Cline

26RAIN: 07.21.2011


IBC• IBC questions related to central campus IACUC

protocols– Leta Guptill, IBC/IACUC analyst

• All other IBC questions– Hilde Wette, PhD, IBC/CoIR senior analyst

Amy Cline

27RAIN: 07.21.2011


IRB reminder• Informed consent requirements for studies involving

human subjects:– Legally effective informed consent must be obtained before a

subject undergoes any research interventions – Legally effective informed consent requires that the basic elements of

informed consent 45 CFR 116, and additional elements when appropriate, are included in the consent form

– The consent document must be signed by the subject (or LAR) unless the IRB has approved a waiver of documentation of informed consent

• Informed consent is not required when:– The study is determined to be exempt by the IRB

– The IRB approves a waiver of consent

– Research is conducted in emergency settings

Mindy Roberts

28RAIN: 07.21.2011


IRB updates• We have a new IRB Co-Chair

– Kathryn Schuff, MD, MCR• Associate Professor of Medicine• Division of Endocrinonlogy, Diabetes and Clinical Nutrition• Clinical Research Compliance Manager, Clinical Research Center

Mindy Roberts

29RAIN: 07.21.2011


IRB updates• Our repository Policy Deadline is August 31st

• Next Repository Brown Bag– Thursday August 11th – 11:00 am to 12:30 pm– UHS 8B60

Mindy Roberts

30RAIN: 07.21.2011


IRB updates

• IRB Drop-in Sessions scheduled: – Every Friday from now until August 26th

– 1130am to 130pm– BRB 381

• Final session on Tuesday August 30th from 9am to noon.

Mindy Roberts

31RAIN: 07.21.2011


IRB updates• Changes to

Repository

forms

• Check our website and Research News blog

for updates on policies

Mindy Roberts

32RAIN: 07.21.2011


IRB updates

• Regular Brown Bag sessions beginning in the fall

• We’d love to hear about your ideas for topics

• Send all suggestions to Amy Cline

Mindy Roberts

33RAIN: 07.21.2011

• Research HR– Research Human Resources

34RAIN: 07.21.2011

New Research and Academic Staff Members of note:

Mark Peters, Export Compliance Officer

Andrew Chitty, MBA, Program Manager, OHSU Shared Resources

Kirsten Wall, MA, Senior Learning and OD Consultant for Diversity and Inclusion

RAIN: 07.21.2011 35

Research HR: Research Human ResourcesJennifer Crosby

Volunteer Services Update 500 active volunteers plus 100 more who are about to join our

program. Volunteer Services Office hours are Tuesday and Thursday (1-

5pm). Tuesdays are walk-ins; Thursdays are appointment only. We will be hosting an invitation-only Program Manager and

Department Volunteer Coordinator Luncheon this September (details forthcoming).

Research Outreach Project Update Communication plan NEO and Rewards and Recognition Program exploration

RAIN: 07.21.2011 36

Research HR: Research Human ResourcesJennifer Crosby

• RATE

– Research Administration Training & Education

37RAIN: 07.21.2011

RATE: Research Administration Training & EducationMargaret Gardner

RAIN Feedback Form

http://www.ohsu.edu/xd/research/administration/rain.cfm#Feedback

NEW

38RAIN: 07.21.2011

RDA 101 for Research AdministratorsLearn about Research Development and Administration (RDA)

departments as they apply to, and support, your role as an administrative staff member in a research unit.

introduction to RDA departments and representatives discussion of Roles & Responsibilities online tour of relevant resources, and more.

Save the date: First course scheduled for 9:30 a.m. Thursday, September 29, 2011 at Bancroft.

Registration opens late August. Grant Administration training (including pre- and post-

award topics) slated for October. Stay tuned!


39RAIN: 07.21.2011

Early terminations: • Only the PI can modify end date and change stipend amount.• TN amount must match amount paid from grant.• When prorating, list methodology in comment section. OHSU

recommends: (number of days worked) x 30• xTrain calculations need to be checked. If a change is needed, this

must be completed by PI.• Click ‘save’ button, and then click ‘save and route to BO’ button. • If Delegates face challenges coordinating with program managers

(PIs), contact Margaret Gardner at [email protected] or 4-8990.

RAIN: 07.21.2011 40


xTrain Update

Wrap Up

Q & A

Next Meeting:

September 22, 2011 9:30 AM

Send agenda item requests to: [email protected]

Or use the feedback form at:

http://www.ohsu.edu/xd/research/administration/rain.cfm

Everyone

41RAIN: 05.19.2011

Welcome to…RAIN

Documents

Transcript of Welcome to…RAIN