# Presentation: 890588

## 
Office of Research and Development
Local Accountability Meeting

January 2009

**Office of Research and Development**
**Local Accountability Meeting**
**January 2009**

## 
Mission and Challenges

VHA Handbook 1058.01: Reporting Research Events

- Mission and Challenges
- VHA Handbook 1058.01: Reporting Research Events

##  Advise Under Secretary for Health 
 Monitor / Review / Investigate Compliance
Protection of Human Subjects
Laboratory Animal Welfare
Research Safety & Research Security
Research Information Security
Research Misconduct

*** ******Monitor / Review / Investigate Compliance***
*Protection of Human Subjects*
*Laboratory Animal Welfare*
*Research Safety & Research Security*
*Research Information Security*
*Research Misconduct*

*Regional Offices*

- Northeastern
*Bedford, MA*
*VISNs 1, 2, 3*

- Midwestern
*Hines, IL*
*VISNs 11, 12, 15, 19, 23*

- Western
*Loma Linda, CA*
*VISNs 18, 20, 21, 22*

- Southern
*Atlanta, GA*
*VISNs 7, 8, 16, 17*

- Mid-Atlantic
*Washington, DC*
*VISNs 4, 5, 6, 9, 10*

## Trends in Research Compliance

- Increasing Challenges for Program Oversight (CY2006  Present)
- Facility Director Leadership
- Facility-Level Program Oversight
- Auditing and Monitoring to Enhance Compliance
- Aging Infrastructure
- Relationships with Academic Affiliates

## Action Plans: Meeting Current Challenges

- Facility Director Leadership
-  Leadership & Accountability Training (ORD)
-      –  Mandatory Attendance (January 2009)
-  Annual Certification of Research Oversight (ORO)
-      –  Began July 1, 2007 (ORO)

## Action Plans:  Meeting Current Challenges

*Facility-Level Program Oversight**	*
***  **Research Administrative Review (ORD)*
*    **–  **Define Roles & Accountability for ACOS/R,*
*        **AO/R, R&D Committee*
*	*
***  **Leadership & Accountability Training (ORD)*
*    **–**  **Mandatory Attendance (January 2009)*
***  **Facility Investigator Training Program Required** *

## Action Plans: Meeting Current Challenges

- Auditing & Monitoring
-   Facility Research Compliance Officer Required
-      –  Effective December 31. 2008 (detailed or permanent)
-      –  Must Report to Facility Director (Mandatory)
-      –  Direct Reporting of Non-Compliance to ORO
-   Annual 100% Audit of Informed Consent
-   Tri-Annual Regulatory Audit of all Protocols
-   Audit Results Reported to ORO
-   Add Audit Monitoring to ORO On-Site Reviews
-   Research Compliance Officer Training (ORO)

## Aging Infrastructure

- Infrastructure Review (ORD)
- Research Allocation Review (ORD, Finance, 10N)
- ORD Research Administration IT Solution Work Group

*Action Plans:  Meeting Current Challenges*

## Action Plans: Meeting Current Challenges

*Relationships with Academic Affiliates*
*	*
*  **AAMC – VA Working Group *
*  **VHA – OGC – OI&T Working Group*
*     –   **Use of Oversight Committees*
*     –   **Research Service Responsibilities*
*     –   **Data Ownership*
*     –   **Data Storage and Use*

## 
ORO On-Site Program Reviews
(Human, Animal, Safety, Info Sec, etc)

*ORO On-Site Program Reviews*
*(Human, Animal, Safety, Info Sec, etc)*

- CY03   CY04   CY05   CY06   CY07   CY08

- 100
- 75
- 50
- 25

**19**

**22**

**45**

**33**

**95**

** ****97**

## Facility-Identified Noncompliance

-  CY03   CY04   CY05   CY06   CY07   CY08

- 200
- 150
- 100
- 50

**68**

**90**

**49**

**177**

**66**

**201**

## Replaces All Previous ORO Reporting Requirements
Human Research
Animal Research
Research Safety
Research Laboratory Security
Research Information Protection
Includes Reporting:
Within the Facility
To ORO
New Definitions and Reporting for Human Research
Unanticipated Problems / Serious Adverse Events
Serious of Continuing Noncompliance

*Human Research*
*Animal Research*
*Research Safety*
*Research Laboratory Security*
*Research Information Protection*
*Includes Reporting:*
*Within the Facility*
*To ORO*
*New Definitions and Reporting for Human Research*
*Unanticipated Problems / Serious Adverse Events*
*Serious of Continuing Noncompliance*

*VHA Handbook 1058.01: Reporting Research Events*

## New Definitions
Administrative Hold.
A voluntary interruption of research enrollments and/or ongoing research activities.
Does not apply to interruptions of research related to concerns regarding:
The safety, rights, or welfare of human research subjects, research investigators, research staff, or others; or
The safety or welfare of laboratory animals.

***Administrative Hold.***
*A voluntary interruption of research enrollments and/or ongoing research activities.*
*Does *_*not*_* apply to interruptions of research related to concerns regarding:*
*The safety, rights, or welfare of human research subjects, research investigators, research staff, or others; or*
*The safety or welfare of laboratory animals.*

*VHA Handbook 1058.01: Reporting Research Events*

## New Definitions
Serious Noncompliance. 
Failure to adhere to the laws, regulations, or policies governing VA research that:
Results in substantive harm or damage (or risk of substantive harm or damage) to the safety, rights, or welfare of human subjects, research staff or others; or
Results in substantive harm or damage (or risk of substantive harm or damage) to the safety or welfare of laboratory animals; or
Substantively compromises the integrity or effectiveness of research protections, either systemically or relative to a particular protocol or project.

***Serious Noncompliance.**** *
*Failure to adhere to the laws, regulations, or policies governing VA research that:*
*Results in substantive harm or damage (or risk of substantive harm or damage) to the safety, rights, or welfare of human subjects, research staff or others; or*
*Results in substantive harm or damage (or risk of substantive harm or damage) to the safety or welfare of laboratory animals; or*
*Substantively compromises the integrity or effectiveness of research protections, either systemically or relative to a particular protocol or project.*

*VHA Handbook 1058.01: Reporting Research Events*

## New Definitions
Serious AE (SAE) / Serious Problem. 
An AE or problem that involves or results in:
Death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect; or
Substantive harm or damage (or risk of substantive harm or damage) to the safety, rights, or welfare of research subjects, research staff; or
Substantive harm or damage (or risk of substantive harm or damage) to the safety or welfare of laboratory animals; or
The need for medical, surgical, behavioral, social, or other intervention to prevent any of the above.

***Serious AE (SAE) / Serious Problem. ***
*An AE or problem that involves or results in:*
*Death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect; or*
*Substantive harm or damage (or risk of substantive harm or damage) to the safety, rights, or welfare of research subjects, research staff; or*
*Substantive harm or damage (or risk of substantive harm or damage) to the safety or welfare of laboratory animals; or*
*The need for medical, surgical, behavioral, social, or other intervention to prevent any of the above.*

*VHA Handbook 1058.01: Reporting Research Events*

## New Definitions
Continuing Noncompliance. 
Persistent or repeated failure to satisfy VA or other federal research requirements,
Either in the past or extending into the present.
Unanticipated Problem in Research.
Any problem in research that is not expected
In terms of nature, severity, or frequency of occurrence
As documented in the protocol or other materials approved by the R&DC, IRB, IACUC, etc.
For human research, may include the informed consent document, clinical investigators’ brochure, product labeling, etc. 

***Continuing Noncompliance. ***
*Persistent or repeated failure to satisfy VA or other federal research requirements,*
*Either in the past or extending into the present****.***
***Unanticipated Problem in Research.***
*Any problem in research that is not expected*
*In terms of nature, severity, or frequency of occurrence*
*As documented in the protocol or other materials approved by the R&DC, IRB, IACUC, etc.*
*For human research, may include the informed consent document, clinical investigators’ brochure, product labeling, etc.** *

*VHA Handbook 1058.01: Reporting Research Events*

## General Requirements

Facility Director must report to ORO:
Within 5 business days of being informed of a reportable event
Report must be in writing and signed
Report required whether or not event has  been resolved
Followup reports as required by ORO 

***Facility Director must report to ORO:***
*Within 5 business days of being informed of a reportable event*
*Report must be in writing and signed*
*Report required whether or not event has  been resolved*
*Followup reports as required by ORO *

*VHA Handbook 1058.01: Reporting Research Events*

## Human Research

Unanticipated Problems Involving Risks (Subjects/Others):
Must be reported to the IRB and ACOS/R within
	5 business days of discovery
Unanticipated problems include:
Interruptions of research due to concerns about safety, rights, or welfare of subjects, research personnel, or others
Work-related injuries requiring more than minor medical intervention or lead to serious injury or death
Any PBM Alerts related to a facility research project
All Unanticipated Serious Adverse Events

***Unanticipated Problems Involving Risks (Subjects/Others):***
*Must be reported to the IRB and ACOS/R within*
*	**5 business days of discovery*
*Unanticipated problems include:*
*Interruptions of research due to concerns about safety, rights, or welfare of subjects, research personnel, or others*
*Work-related injuries requiring more than minor medical intervention or lead to serious injury or death*
*Any PBM Alerts related to a facility research project*
*All Unanticipated Serious Adverse Events*

*VHA Handbook 1058.01: Reporting Research Events*

## IRB Review of Unanticipated Problems and SAEs:

Within 5 business days of report, a designated voting IRB Member/Reviewer (or the convened IRB) must:
Determine and document whether event is related, possibly related, or unrelated to the research.
If related or possibly related, must determine that event is:
Not Serious, No Action Required
Not Serious, But Minor Changes Needed via Expedited Review.
Serious, Immediate Action Needed to Prevent Harm, Report to Facility Director within 5 business days, Refer to Convened IRB Review for Resolution
Serious, but Immediate Action Not Needed to Prevent Harm, Report to Facility Director within 5 business days, Refer to Convened IRB Review for Resolution

*Within 5 business days of report, a designated voting IRB Member/Reviewer (or the convened IRB) must:*
*Determine and document whether event is related, possibly related, or unrelated to the research.*
*If related or possibly related, must determine that event is:*
*Not Serious, No Action Required*
*Not Serious, But Minor Changes Needed via Expedited Review.*
*Serious, Immediate Action Needed to Prevent Harm, Report to Facility Director within 5 business days, Refer to Convened IRB Review for Resolution*
*Serious, but Immediate Action Not Needed to Prevent Harm, Report to Facility Director within 5 business days, Refer to Convened IRB Review for Resolution*

*VHA Handbook 1058.01: Reporting Research Events*

## Serious or Continuing Noncompliance

Must be reported to the IRB and ACOS/R within
	5 business days of discovery
If IRB determines serious or continuing noncompliance occurred, must be reported to Facility Director within 5 business days. 
If discovered during an RCO informed consent or regulatory audit, must be reported with 5 business days to:
Facility Director
ACOS/R
IRB for Review and Resolution
R&D Committee

*Must be reported to the IRB and ACOS/R within*
*	**5 business days of discovery*
*If IRB determines serious or continuing noncompliance occurred, must be reported to Facility Director within 5 business days. *
*If discovered during an RCO informed consent or regulatory audit, must be reported with 5 business days to:*
*Facility Director*
*ACOS/R*
*IRB for Review and Resolution*
*R&D Committee*

*VHA Handbook 1058.01: Reporting Research Events*

## Report to ORO Regional Office

Problems (including AEs) Involving Risks to Subjects or Other that are
Serious and Unanticipated and Related (or Possibly Related) to the Research
Serious or Continuing Noncompliance
If identified by an RCO informed consent or regulatory audit, must also be reported to VISN Director and CRADO
Suspensions or Terminations of IRB approval

*Problems (including AEs) Involving Risks to Subjects or Other that are*
***Serious ***_***and***_*** Unanticipated ***_***and***_*** Related (or Possibly Related)**** to the Research*
*Serious or Continuing Noncompliance*
*If identified by an RCO informed consent or regulatory audit, must also be reported to VISN Director and CRADO*
*Suspensions or Terminations of IRB approval*

*VHA Handbook 1058.01: Reporting Research Events*

## Report to ORO Central Office
(Copy to ORO Regional Office)

Assurance Changes
IRB Changes
MOU Changes
Accreditation Problems

***(Copy to ORO Regional Office)***
*Assurance Changes*
*IRB Changes*
*MOU Changes*
*Accreditation Problems*

*VHA Handbook 1058.01: Reporting Research Events*

## 
Comparable Reporting Required for:
Animal Welfare
Research Safety
Research Laboratory Security
Research Information Protection
Alleged Research Misconduct
Handbook Includes Summary Tables and Decision Charts to aid in facility decision making
Local SOPs Required for All Required Internal and External Reporting

*Comparable Reporting Required for:*
*Animal Welfare*
*Research Safety*
*Research Laboratory Security*
*Research Information Protection*
*Alleged Research Misconduct*
*Handbook Includes Summary Tables and Decision Charts to aid in facility decision making*
*Local SOPs Required for All Required Internal and External Reporting*

*VHA Handbook 1058.01: Reporting Research Events*

## http://www.1.va.gov/oro/ 

1717 H Street, NW, Suite 500 (10R)
Washington, D.C.  20420
PHONE: (202) 266-4577

*1717 H Street, NW, Suite 500 (10R)*
*Washington, D.C.  20420*
*PHONE: (202) 266-4577*