# Presentation: 498963

## RESULTS OF ORO RCO/RACO QUESTIONNAIRE, 2008

**Paula Squire Waterman**
**Office of Research Oversight**
- October 10, 2008

## ORO RCO/RACO QUESTIONNAIRE, 2008

- Developed by ORO Central Office
- 24 questions in an on-line survey to learn more about the status and work activities of RCOs/RACOs
- Put online 7/31/08
- Used “The Survey Monkey” to capture and record answers
- Response rate approximately 50%
- Closed 8/22/08

## 2. How long have you functioned as a RCO/RACO?

## 3. What is your GS level?

## Looking at the answers to the Questionnaire as an example of past practices, what was found when looking at who or what affected the allocation of time for an RCO’s various tasks?

- QUESTIONNAIRE RESULTS #1

## Who was an RCO’s “official supervisor” ?

- Question #5. In your role as RCO/RACO, please indicate the title of your official supervisor (please check one):
- 38 out of 50 indicated one of five people:  medical center director (10), chief of staff (10), ACOS/R (12), and AO (6), with 12 miscellaneous others indicated.

## Others who directed RCO activities

- Question 6. In your role as RCO/RACO, please indicate all of those who direct your day-to-day activities (check all that apply):
- 49 (out of 51) indicated additional people controlled their day-to-day activities.   The 6 most common were -  medical center director (19), chief of staff (12), ACOS/R (31), AO (27), R&D committee chair (11), and IRB chair (10).  In all, there were 145 answers to the question, indicating many RCOs had more than one person (average 2.9) who could direct their “day-to-day” activities.

## Others influenced RCO “day-to-day activities”

- Question 7. Excluding those persons that you previously indicated direct your day-to-day activities, who else significantly influences the work that you perform as a RCO/RACO? (Check all that apply.)
- 45 (out of 51) indicated that additional people influenced their day-to-day activities.   The 7 most common were -  R&D committee chair (24), IRB chair (20), ACOS/R (17), IRB administrator (15), medical center director (12), chief of staff (11), and AO (10).  In all, there were 149 answers to the question, indicating many RCOs had more than one person (average 3.3) who could influence their “day-to-day” activities.

## So, previously, it appeared that many RCOs, in addition to their direct supervisors, could have additional people who might direct their day-to-day activities, and other people who could influence what they did.

## Slide 10

## Again, when looking at the Questionnaire as an example of past practices, what was found when looking at the sorts of tasks assigned to RCO’s?

- QUESTIONNAIRE RESULTS #2

## Activities – research committees

- Let’s look at activities related to research committees -
- 12. Which tasks do you perform in regard to the HRPP/R&D Committee? (Check all that apply.)
- 13. Which tasks do you perform in regard to the IRB? (Check all that apply.)
- 14. Which tasks do you perform in regard to the IACUC/ACUP? (Check all that apply.)
- 15. Which tasks do you perform in regard to Bio/Radiation safety? (Check all that apply.)

## Results of activities – research committees

| All columns 
n = 51 | HRPP/R&D | IRB | IACUC/
ACUP | BIO-RADIATION SAFETY |
| --- | --- | --- | --- | --- |
| No tasks related to committee | 2 | 5 | 22 | 23 |
| Administrator | 7 | 4 | 2 | 3 |
| Write SOPs | 38 | 25 | 14 | 15 |
| Design forms | 33 | 21 | 11 | 13 |
| Prepare minutes | 6 | 2 | 2 | 4 |
| Prepare correspondence | 17 | 8 | 3 | 7 |
| Prepare reports | 31 | 19 | 8 | 8 |

## Results of activities – research committees  (continued) ......

| All columns 
n = 51 | HRPP/R&D | IRB | IACUC/
ACUP | BIO-RADIATION SAFETY |
| --- | --- | --- | --- | --- |
| Perform audits | 41 | 31 | 15 | 13 |
| Develop/conduct QA/AI activities | 36 | 25 | 10 | 12 |
| Evaluate compliance | 42 | 34 | 21 | 19 |
| Do compliance audits | 42 | 32 | 15 | 15 |
| Assist PIs with applications | 26 | 24 | 5 | 6 |
| Coordinate with affiliate | 17 | 16 | 5 | 4 |
| Tasks differ with committee.... | Do annual program evaluation - 28 | Write consent – 3 | Perform inspections – 13 | Perform inspections - 11 |

## Results of research activities – administrative tasks

**Let’s start looking at the variety of tasks that RCOs performed –**
- 16. In your role as a RCO/RACO, which of the following administrative tasks do you perform? (Check all that apply.)
- All but 5 indicated they performed administrative tasks.   The most common was “compiling special reports (n=42),” which could involve compliance reports. The next 5 most common were -  write/update investigator handbooks (30), draft medical center memos (29), assist in staffing oversight committees (22), credentialing (13), and conducting performance evaluations of direct reports (10).  In all, there were 168 answers to the question, indicating many RCOs performed more than one administrative task (average 3.3).

## Results of research activities – regulatory tasks

**Let’s continue looking at the variety of tasks RCO/RACOs performed –**
- 17. In your role as a RCO/RACO, which of the following regulatory tasks do you perform? (Check all that apply.)
- All but 4 indicated they performed regulatory tasks (n=49).   The most common was “answer study-specific regulatory questions (n=41),” which could involve compliance issues. The other 3 tasks include - coordinate efforts with outside auditors/monitors (25), assist with IND/IDE/HUD applications (10), and other assorted regulatory tasks (7).  The total of 87 answers to the question indicated some RCOs performed more than one regulatory task (average 1.8).  Added to the numerous other tasks assigned to RCOs, a picture of a substantial work load begins to emerge.

## Results of research activities – additional tasks

**There were additional tasks given of RCOs –**
- 18. In your role as RCO/RACO, what additional tasks do you perform? (Check all that apply.)
- All but 1 indicated they performed additional tasks (n=48).   The most common was “coordinate facility accreditation efforts (n=36),” a time-consuming effort while it is occurring. The other 3 tasks included – coordinating with pharmacy (24), assisting with other facilities’ accreditation efforts (18), and performing IT evaluations (11).  The total of 83 answers to the question indicated some RCOs perform more than one additional task (average 1.8).  In light of the multitude of various tasks  previously assigned to RCOs, a review of what they are assigned to do might be needed to ensure RCOs have adequate time to perform the mandatory auditing duties assigned to them.

## Questionnaire results - RCO activities 

- Previously, it appeared that many RCOs were assigned quite a few tasks, some of which were not related to compliance.  In light of the now-mandatory auditing requirements assigned to RCOs, the time available to them for performing such tasks might be limited.

## Questions?

**Comments****?**

**Discussion****!!**

## Paula Squire Waterman
Program Analyst
Office  of  Research  Oversight

http://www.1.va.gov/oro
810 Vermont Avenue, NW (10R)
Washington, DC  20420
Phone:  (202) 266-4581
Fax:  (202) 266-4560

**Program Analyst**
**Office  of  Research  Oversight**
***http://www.1.va.gov/oro***
**810 Vermont Avenue, NW (10R)**
**Washington, DC  20420**
**Phone:  (202) 266-4581**
**Fax:  (202) 266-4560**

## Slides 22 – 31 show the data for questions 5-7 on who supervises and influences a RCO’s day-to-day activities.

Slides 32 – 46 show the data for questions 12-18 on the various roles RCOs play in doing their jobs , and the sorts of tasks assigned to them.

_**Slides 32 – 46**_** show the data for questions 12-18 on the various roles RCOs play in doing their jobs , and the sorts of tasks assigned to them.**

**THE “RAW” QUESTIONNAIRE DATA**

## 5a. In your role as RCO/RACO, please indicate the title of your official supervisor (please check one):

## 5b. In your role as RCO/RACO, please indicate the title of your official supervisor (please check one):

- 2 - Hospital/facility compliance officer
- 1 - Compliance officer
- 1 - Chief compliance officer
- 1 - Compliance & Business Integrity Officer
- 1 - Performance manager
- 1 - Chief, performance improvement
- 1 - V/P R&D (also known as AO)
- 1 - Both ACOS and AO
- 1 - Network director
- (2 answers not applicable)

## 6a. In your role as RCO/RACO, please indicate all of those who direct your day-to-day activities (check all that apply):

## 6b. In your role as RCO/RACO, please indicate all of those who direct your day-to-day activities (check all that apply):

## 6c. In your role as RCO/RACO, please indicate all of those who direct your day-to-day activities (check all that apply):

## 6d. In your role as RCO/RACO, please indicate all of those who direct your day-to-day activities (check all that apply):

- 3 – Self directing/work independently
- 1 – R&D AO
- 1 – Safety Committee Chair
- 1 – Chief, Performance Improvement
- 1 – Coordinator, R&D (no ACOS/R)
- 1 – AA/COS
- 1 – activities sometimes set by issues involving MCD, COS, or committee chairs
- 1 – VISN compliance
- 1 – Network Director & network CMO
- (one not applicable)

## 7a. Excluding those persons that you previously indicated direct your day-to-day activities, who else significantly influences the work that you perform as a RCO/RACO? (Check all that apply.)

## 7b. Excluding those persons that you previously indicated direct your day-to-day activities, who else significantly influences the work that you perform as a RCO/RACO? (Check all that apply.)

## 7c. Excluding those persons that you previously indicated direct your day-to-day activities, who else significantly influences the work that you perform as a RCO/RACO? (Check all that apply.)

## 7d. Excluding those persons that you previously indicated direct your day-to-day activities, who else significantly influences the work that you perform as a RCO/RACO? (Check all that apply.)

- 1 – Research personnel from all areas (laboratory, subject care, etc.)
- 1 – Research pharmacy, biosafety chair, RSO
- 1 – Biosafety/biosecurity chair
- 1 – Research coordinator
- 1 – IRB staff
- 1 – Affiliate university IRB/ORI
- (one not applicable)

## 12a. Which tasks do you perform in regard to the HRPP/R&D Committee? (Check all that apply.)

## 12b. Which tasks do you perform in regard to the HRPP/R&D Committee? (Check all that apply.)

## 13a. Which tasks do you perform in regard to the IRB? (Check all that apply.)

## 13b. Which tasks do you perform in regard to the IRB? (Check all that apply.)

## 14a. Which tasks do you perform in regard to the IACUC/ACUP? (Check all that apply.)

## 14b. Which tasks do you perform in regard to the IACUC/ACUP? (Check all that apply.)

## 15a. Which tasks do you perform in regard to Bio/Radiation safety? (Check all that apply.)

## 15b. Which tasks do you perform in regard to Bio/Radiation safety? (Check all that apply.)

## 16a. In your role as a RCO/RACO, which of the following administrative tasks do you perform? (Check all that apply.)

## 16b. In your role as a RCO/RACO, which of the following administrative tasks do you perform? (Check all that apply.)

- 1 – Write/modify SOP and policies to comply with ORO
- 1 – Serve on hospital credentials committee, wrote draft research credentialing SOP
- 1- Quality assurance and training
- 1 – Various-prep for research week activities, recruit speakers for research lecture series, etc.
- 1 – Update FWA, chair FCOI/HAPP committees, coordinate AAHRPP submission
- 1 – Work with non-profit personnel on compliance and contract issues
- 1 – Write SOPs, MOUs, etc.
- 1 – Research liaison on numerous hospital committees

## 16c. In your role as a RCO/RACO, which of the following administrative tasks do you perform? (Check all that apply.)

- 1 – Administrative tasks
- 1 – Attend all IACUC, biosafety, affiliate & VA IRB, R&D meetings.  Develop standardized forms for regulatory compliance for investigator-initiated studies
- 1 – Develop agendas for human research compliance meetings with ACOS/R&D, AO, & IRB staff; maintain notes/action items from those meetings; meet regularly with IRB staff; assist ACOS/AO as needed & requested on other human research-related reports/mandates
- 1 – Ensure all research personnel complete required VA training
- 1 - Assist Research Office as necessary with administrative duties
- 1 – Everything from making copies to drafting SOPs

## 17a. In your role as a RCO/RACO, which of the following regulatory tasks do you perform? (Check all that apply.)

## 17b. In your role as a RCO/RACO, which of the following regulatory tasks do you perform? (Check all that apply.)

- 2 – AAHRPP preparation/submission
- 2 – Coordinate/participate visits by regulatory agencies, follow recommendations to conclusion, prepare correspondence
- 1 – Quality assurance and training
- 1 – Anything related to OSHA, EPA, USDA, NIH guidelines
- 1 – Evaluate compliance with regulations

## 18a. In your role as RCO/RACO, what additional tasks do you perform? (Check all that apply.)

## 18b. In your role as RCO/RACO, what additional tasks do you perform? (Check all that apply.)

- 1 – Assist with facility accreditation, perform limited data security audits as part of study audits
- 1 – Performance improvement tasks
- 1 – Coordinator with lab, medical media, nursing
- 1 – Serve on IED council, preventive ethics committee, VISN compliance council, nursing research council, conflict of interest committee; train PIs, subcommittees, R&D committee
- 1 – COI administrator
- 1 – Liaison with affiliate for studies open at both places; assist PIs meet and understand regulatory requirements
- 1 – Assist research accreditation efforts
- (one not applicable)