# Presentation: 494315

## VHA Handbook 1058.2

- Research Misconduct

- VHA Updates in Research Regulatory Compliance
- [Workshop 28]

- Society of Research Administrators International
- Sunday, October 16, 2005
- 1:30 to 5:00 pm
- Peter Poon

## Applies to all federally-funded research
Uniform definition of research misconduct
fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results
Procedural requirements and guidelines
e.g., clear separation of Inquiry/Investigation, Adjudication, and Appeal phases

- Uniform definition of research misconduct
- _fabrication_, _falsification_, or _plagiarism_ in proposing, performing, or reviewing research, or in reporting research results
- Procedural requirements and guidelines
- e.g., clear separation of Inquiry/Investigation, Adjudication, and Appeal phases

**Federal Policy on Research Misconduct (2000)**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Effective May 4, 2005
VHA Manual M-3, Part I, Chapter 15 rescinded
All VHA facilities are required to follow the new Handbook for research misconduct allegations

- Effective May 4, 2005
- VHA Manual M-3, Part I, Chapter 15 rescinded
- All VHA facilities are required to follow the new Handbook for research misconduct allegations

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Fabrication, Falsification, or Plagiarism in proposing, performing, or reviewing research, or in reporting research results

Fabrication:  making up data or results and recording or reporting them
Falsification:  manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record
Plagiarism:  the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit

**Fabrication**, **Falsification**, or **Plagiarism** in proposing, performing, or reviewing research, or in reporting research results
**Fabrication**:  making up data or results and recording or reporting them
**Falsification**:  manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record
**Plagiarism**:  the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Research misconduct does not include honest error or differences of opinion
To constitute research misconduct, the behavior must:
represent a significant departure from accepted practices of the relevant research community; and
be committed intentionally, knowingly, or with reckless disregard for the integrity of the research
The allegation must be proven by a preponderance of the evidence (i.e., more likely than not to be true)

- Research misconduct does *not *include honest error or differences of opinion
- To constitute research misconduct, the behavior must:
- represent a _significant departure_ from accepted practices of the relevant research community; and
- be committed _intentionally_, _knowingly_, or _with reckless disregard_ for the integrity of the research
- The allegation must be proven by a **preponderance of the evidence** (i.e., more likely than not to be true)

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Allegations of research misconduct must be made in good faith and must be reasonable:
The informant must believe in the substance of his/her allegation; and
The allegation must be one which a person in the Informant’s situation could reasonably make.
An allegation is not made in good faith nor reasonable if made with reckless disregard for or willful ignorance of facts that would negate the allegation.

- Allegations of research misconduct must be made in **good faith** and must be **reasonable**:
- The informant must **believe** in the substance of his/her allegation; and
- The allegation must be one which a person in the Informant’s situation could **reasonably** make.
- An allegation is not made in good faith nor reasonable if made with reckless disregard for or willful ignorance of facts that would negate the allegation.

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Informants are not required to prove good faith in order for an Inquiry to be opened.
However, an allegation that is not made in good faith may result in the waiver of certain protection privileges (i.e., protection from retaliation).

- However, an allegation that is not made in good faith may result in the waiver of certain protection privileges (i.e., protection from retaliation).

**Allegations**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Before an Inquiry is opened, the RIO must determine that the allegation meets all of the following requirements:

The allegation involves VA research
The allegation is of research misconduct
The allegation on its face contains the elements of a finding of research misconduct:
Significant departure from accepted practices
Committed intentionally, knowingly, or with reckless disregard

Deficient Allegations
Notify Informant of the particular threshold requirement(s) that the allegation fails to meet

- The allegation involves VA research
- The allegation is of research misconduct
- The allegation *on its face* contains the elements of a finding of research misconduct:
- Significant departure from accepted practices
- Committed intentionally, knowingly, or with reckless disregard
- Deficient Allegations
- Notify Informant of the particular threshold requirement(s) that the allegation fails to meet

**Required Threshold**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Other non-VA entities (e.g., academic affiliates) may have concurrent jurisdiction over the same research project
Perform joint Inquiry/Investigation with representatives from both institutions
Negotiate which entity will take the lead
Single set of recommendations
Each entity follows own procedures for adjudication and appeals

- Perform joint Inquiry/Investigation with representatives from both institutions
- Negotiate which entity will take the lead
- Single set of recommendations
- Each entity follows own procedures for adjudication and appeals

**Joint Jurisdiction**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## 	Sole purpose:  to determine whether sufficient evidence exists to open a formal Investigation.

**Inquiry**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Sequestration of physical evidence
Inquiry conducted by RIO or an Inquiry Committee
Interview Respondent and Informant
Written transcripts
Inquiry Report (summary format)
Determine whether sufficient evidence exists to open Investigation
Complete within 30 days

- Inquiry conducted by RIO or an Inquiry Committee
- Interview Respondent and Informant
- Written transcripts
- Inquiry Report (summary format)
- _Determine whether sufficient evidence exists to open Investigation_
- Complete within 30 days

**Inquiry**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Evidence that would raise a significant suspicion of research misconduct to a reasonable person is sufficient to justify opening a formal Investigation

Termination of VA Case
Available evidence is insufficient to justify opening an Investigation
Retain case file for authorized retention period
Forward Inquiry Report VISN, ORO CO
If VAMC Director disagrees, must open an Investigation

- Termination of VA Case
- Available evidence is insufficient to justify opening an Investigation
- Retain case file for authorized retention period
- Forward Inquiry Report VISN, ORO CO
- If VAMC Director disagrees, must open an Investigation

**Opening an Investigation**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## 	Purpose:  to determine 
whether and to what extent research misconduct has occurred;
who is responsible; and
what corrective actions are appropriate.

*whether and to what* *extent* research misconduct has occurred;
*who* is responsible; and
- what *corrective actions* are appropriate.

**Investigation**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## May be a standing or ad hoc Committee
Composed of 3 to 5 individuals
Representative of agency/entity with concurrent jurisdiction
No actual or apparent conflict of interest
Respondent and Informant may submit objections to Committee membership based on COI, but Director makes final decision

- Composed of 3 to 5 individuals
- Representative of agency/entity with concurrent jurisdiction
- No actual or apparent conflict of interest
- Respondent and Informant may submit objections to Committee membership based on COI, but Director makes final decision

**Investigation Committee**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Sequestration of physical evidence
Administrative Investigation Board procedures (VA Handbook 0700)  
		*Except where Handbook 1058.2 has contrary provision
Interview Respondent and Informant, other witnesses
Written transcripts
Determine whether, what extent research misconduct has occurred, who is responsible, and what corrective actions are appropriate
VAMC Director sends Investigation Report to Network Director, with any added recommendations and proposed disciplinary actions
Complete within 90 days

- Administrative Investigation Board procedures (VA Handbook 0700)
- 		*Except where Handbook 1058.2 has contrary provision
- Interview Respondent and Informant, other witnesses
- Written transcripts
- _Determine whether, what extent research misconduct has occurred, who is responsible, and what corrective actions are appropriate_
- VAMC Director sends Investigation Report to Network Director, with any added recommendations and proposed disciplinary actions
- Complete within 90 days

**Investigation**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Investigation Report summarizes
the allegation
the evidence reviewed
Recommendation about whether research misconduct occurred, the type/extent of misconduct, who is responsible, corrective actions
Draft reviewed and commented on by
Respondent
Informant (only the portion related to Informant’s role and testimony)

- the allegation
- the evidence reviewed
- Recommendation about whether research misconduct occurred, the type/extent of misconduct, who is responsible, corrective actions
- Draft reviewed and commented on by
- Respondent
- Informant (only the portion related to Informant’s role and testimony)

**Investigation Report**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Conducted in lieu of a VAMC investigation in exceptional circumstances
as determined by ORO CO within its discretion

Exceptional circumstances:
the VAMC is not prepared to handle the allegation in a manner consistent with Handbook 1058.2
the VAMC cannot complete an investigation for any reason
ORO involvement is needed to protect the public interest

- as determined by ORO CO within its discretion
*Exceptional circumstances:*
- the VAMC is not prepared to handle the allegation in a manner consistent with Handbook 1058.2
- the VAMC cannot complete an investigation for any reason
- ORO involvement is needed to protect the public interest

**ORO Investigation**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Examples:
Government-wide debarment
Removal from a particular project or suspension/ termination of an active award
Restitution of funds or civil penalties
Prohibition from receiving VA research funds for a period of time
Correction or retraction of published article
Monitoring or supervision of future work
Required certification of data or sources
Remedial education and/or mentoring

- Government-wide debarment
- Removal from a particular project or suspension/ termination of an active award
- Restitution of funds or civil penalties
- Prohibition from receiving VA research funds for a period of time
- Correction or retraction of published article
- Monitoring or supervision of future work
- Required certification of data or sources
- Remedial education and/or mentoring

**Corrective Actions**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Considerations:
Extent of the misconduct (amount, duration, scope)
Degree to which misconduct was knowing, intentional, or reckless
Presence or absence of pattern of misconduct
Consequences of the research misconduct
Respondent’s position and responsibility
Cooperation of Respondent
Likelihood of rehabilitation
Type of corrective actions imposed in past cases

- Extent of the misconduct (amount, duration, scope)
- Degree to which misconduct was knowing, intentional, or reckless
- Presence or absence of pattern of misconduct
- Consequences of the research misconduct
- Respondent’s position and responsibility
- Cooperation of Respondent
- Likelihood of rehabilitation
- Type of corrective actions imposed in past cases

**Corrective Actions**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## VA determination based on recommendations from the Investigation
Adjudication by the Network Director
review of Investigation Report and all supporting documents
may consult with ORO, ORD, OGC
May adopt all, some, or none of the Investigation’s recommendations

- Adjudication by the Network Director
- review of Investigation Report and all supporting documents
- may consult with ORO, ORD, OGC
- May adopt all, some, or none of the Investigation’s recommendations

**Adjudication**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## ORO CO reviews each case for procedural conformance:
Timeliness
Objectivity
Preservation of safeguards
Thoroughness
Competence

- Timeliness
- Objectivity
- Preservation of safeguards
- Thoroughness
- Competence

**Departmental Review**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance

## Inquiry/Investigation and adjudication substantially adhered to procedures

- Uphold Network Director’s decision

- Inquiry/Investigation **did not substantially adhere** to procedures *so as to materially affect outcome* of the case

- Reopen VAMC Investigation, _or_ open *ad hoc* ORO Investigation

*ORO Disposition:*

**Departmental Review**

## All final research misconduct findings and proposed corrective actions may be appealed
Only named Respondents may appeal
Reviewed by the Under Secretary for Health
Must appeal within 30 days of receiving notice
Document review only
Exception:  Debarment hearing (38 CFR 44, Subpart H)
Final decision:  uphold, reverse, or modify

- Only named Respondents may appeal
- Reviewed by the Under Secretary for Health
- Must appeal within 30 days of receiving notice
- Document review only
- Exception:  Debarment hearing (38 CFR 44, Subpart H)
- Final decision:  uphold, reverse, or modify

**Appeals**

**Notes:**
Met from October 1999 to December 2002.
Members from ORO, ORD, OGC, IG, field
Number of contentious issues, including one which had to be resolved at the Under Secretary’s level
-------------------------------------------------------------
Handbook 1058.2 currently being reviewed for final clearance