# Presentation: 185429

## Top 10 Methods to Prepare for an ORO Site Visit

- Presented by Deborah Collins
- Administrative Officer, Research
- Syracuse VA Medical Center

## #10 – Acknowledge that ORO will come!

- “For Cause” visit
- 		--not much lead time
- 		--conducted for a specific reason
- “Program Review” visit
- 		--conducted regularly to ensure 			program compliance

- 10/14/2007

## #9 – Prepare your staff

- Educate that site visits are normal & expected.
- Don’t wait until the site visit is announced-prepare in advance.
- 	--ORO will come every 3 years for Program Review
- 	--ORO will come every other year for BSL-3 	laboratories
- 	--ORO will come for data security review
- 	--AAHRPP, AAALAC, VA ITOC, VA Privacy Group?

- 10/14/2007

## #9 - continued

- Use the site visits as an opportunity to showcase what your program does well.
- View the visitors’ feedback as educational.
- (_**HINT**_: Findings & Recommendations from an ORO site visit report can be very helpful to focus resources on areas in need of improvement.)

- 10/14/2007

## #8 – Anticipate the visit

- Keep an updated list of names to contact.
- VAMC Director, Chief of Staff, ACOS/R, RIO, R&D Committee, IRB, IACUC, SRS Chairs.
- List of the major PIs and program areas.
- Know the Point of Contact/staff for each of the above.

- 10/14/2007

## #8 – Anticipation con’t.

- Determine the major elements of your site’s research program
- 		--Human Subjects?
- 		--Animals?
- 		--Data Security?
- 		--Select Agents/BSL-3 labs?
- 		--Lab Safety/Security?

- 10/14/2007

## #7 – ORO’s got a checklist for that!

- Animal Welfare
- HRPP
- IRB
- R&D Committee
- Research Data Security
- Research Privacy

- Research Safety
- Security for BSL-1 & BSL-2 Laboratories
- Security for BSL-3 Laboratories
- Developing an MOU

- 10/14/2007

## #7 - ORO Checklists (con’t.)

- Facility Director’s Research Oversight Checklist
- Completed annually, due July 1st to ORO.

- 10/14/2007

## Big HINT!Take advantage of the checklists!

- Use the checklists as an “open book” test.
- You’ve got the questions ahead of time, now use them to develop the answers for your specific site.

- 10/14/2007

## #6 - Participate in your program

- How does the IRB, IACUC, SRS, R&D Committee function?
- Attend meetings
- Review the protocols
- Attend walk-thru inspections
- Talk with the members and Chair

- 10/14/2007

## #6 - Participation (con’t.)

- When attending a meeting, jot down notes about what processes work well, as well as any problems.  Share with other subcommittees.
- Identify the members fluent with the regulations and local processes.
- (_HINT_: keep an updated list as potential interviewees for site visitors!)

- 10/14/2007

## #5 – Be open-minded to change

- Site visitors, as well as the staff at your site, will use different approaches to interpret regulations, implement processes, & solve issues.
- Use this as an asset to obtain a variety of perspectives on an issue.  View your research program as a ‘living entity’ that is constantly improving.
- (_**HINT**_: Don’t be afraid to question regulatory interpretations as it relates to your program.  Remember that you’re the expert on how your site operates – But always do this respectfully!)

- 10/14/2007

## #4 Compare your processes with your SOPs

- Sometimes good ideas evolve into great practices...
- But is it documented in your SOP?
- Review your SOPs regularly.

- 10/14/2007

## #4 - con’t.

- Regularly review your research program’s policies and procedures.
- Break it up – develop a schedule to target an area each month, quarterly, etc.
- Processes ‘morph’ over time, increases exponentially with more staff involved.  Ensure that what your site is doing continues to be reflected in your SOPs and forms.

- 10/14/2007

## #3 – Check ORO regularly

- _[http://vaww1.va.gov/oro/](http://vaww1.va.gov/oro/)_
- VA ORO Teleconference
- (_**HINT**_: If you miss it, read the minutes!)
- Get onto the ORO listserv
- 	Click “Get Connected” on the ORO homepage
- 		-RACO_RCO-L Discussion Group
- 		-ORO_Announcements-L Group

- 10/14/2007

## #2 – Elicit Feedback from Front Line Staff

- Regularly ask what is working, what is not functioning well.
- Get involved, remain active and visible with the R&D Committee and their subcommittees.  Also maintain a good relationship with the local Research Administration staff.
- 	(_**HINT**_: Most AO/Rs welcome a chance to talk shop over coffee!)

- 10/14/2007

## And finally, the #1 method I have to prepare for an ORO site visit....

## Locate your Research Program in an area averaging over 200 inches of snowfall each year...

- 10/14/2007