research misconduct and fraud policy …€¦ · research misconduct and fraud policy version 2...

Research Misconduct and Fraud Policy Version 2 September 2010

RESEARCH MISCONDUCT AND FRAUD POLICY AND PROCEDURES

Reference GG/CG/004

Date approved October 2009

Approving Body Trust Board

Implementation date September 2010

Version 2

Supersedes NUH Version 1 (Identification and Management of Research Misconduct and Fraud) July 2006

Consultation undertaken Directors‟ Group

Date of Completion of Equality Impact Assessment

3 August 2010

Target audience All Staff

Supporting Procedure(s) -

Review Date October 2012

Lead Executive Medical Director

Author/Lead Manager Director Of R&D

Further Guidance/Information R&D Department, QMC Campus: Extension 62112


CONTENTS

Paragraph

Title

Page

1. Purpose 3

2. Policy Statement 3

3. Scope of policy 3

4. Definitions 4

5. Staff Obligations 5

6. Assignment of Responsibilities 5

7. Reporting Arrangements 6

8. Process of Investigation 6

9. Outcomes of Investigation 8

10. Equality and Diversity 9

11. References 9

Appendix 1 Equality Impact Assessment 10

Appendix 2 We are Here for You Assessment 14

Appendix 2 Employee Record of Having Read the Policy

17


RESEARCH FRAUD AND MISCONDUCT POLICY 1. Purpose The aim of this policy is to set out clearly what constitutes research

misconduct and fraud and the processes to be followed when failure

to comply with the relevant legislative and regulatory frameworks is

suspected and identified.

2. Policy Statement The Trust Policy is to encourage, promote and facilitate employees to participate in research. The policy adheres to principles and process described in the NUH Disciplinary Policy, and is intended to be read in conjunction with the NUH Disciplinary Investigation Procedure and Disciplinary Hearing Procedure.

3. Scope of Policy This policy applies to the following categories of staff:- a) All full time or part time staff whose substantive employer is the Trust whether holding permanent, temporary or fixed term Contracts of Employment with Nottingham University Hospitals NHS Trust b) All full time or part time staff engaged in Trust activities who do not necessarily hold Contracts of Employment with the Trust themselves but who are employed for purposes of carrying out Trust functions and/or activities. This category applies to staff recruited via employment agencies, c) Staff who hold Trust Contracts of Employment but have additional duties and/or obligations to another Employer(s) and/or who are self-employed or undertake additional duties on a consultant-led basis.


d) Staff holding Trust contracts of employment whose payroll costs are met either partially or wholly by another party (e.g. a university, medical charity, a government department or commercial sponsor).

e) All Trust employees who hold honorary contracts with other organisations (e.g. a university) which recognises the research status of an employee.

f) Trainee professionals hosted by the Trust who conduct research during the course of their training. 4. Definitions

According to the MRC Policy and Procedure for Inquiring into

Allegations of Scientific Misconduct (1997), research fraud and

misconduct are defined as: “The fabrication, falsification, plagiarism

or deception in proposing, carrying out or reporting results of

research or deliberate, dangerous or negligent deviations from

accepted practices in carrying out research. It includes failure to

follow established protocols if this failure results in unreasonable risk

or harm to humans, other vertebrates or the environment and

facilitating of misconduct in research by collusion in, or concealment

of, such actions by others. It also includes intentional, unauthorized

use, disclosure or removal, or damage to, research related property

of another, including apparatus, materials, writings or devices used in

or produced by the conduct of research. It does not include honest

error or honest differences in the design, execution, interpretation or

judgment in evaluating research methods or results or misconduct

unrelated to the research process. Similarly, it does not include poor

research unless it encompasses the “intention to deceive”.”

Examples of research misconduct/fraud include but are not limited to:


● failure to obtain all necessary permissions (e.g. Ethics, MHRA,

ARSAC, Trust approval) to undertake a research project

● failure to document consent appropriately

● fabrication of research participants, results or analysis.

● abuse of research funds or equipment.

5. Staff Obligations

All staff should conduct research according to

The Medicines for Human Use (clinical trials) regulations 2004

The Human Tissue Act 2004

The Mental Capacity Act 2004

The Data Protection Act 1998

6. Assignment of Responsibilities

The Trust Director of R&D will be responsible for the initial

assessment of the allegation of research fraud and/or misconduct

and will decide the likely complexity of the investigation.

Where the researcher involved is not an NUH employee but holds an

honorary contract or a letter of access with the Trust, the researcher‟s

substantial employer will be informed.

Where the study is hosted but not sponsored by NUH, then the

research Sponsor will be informed. Under the Research Governance


Framework, it is the Sponsor‟s responsibility to ensure that adequate

arrangements are in place for the detection, investigation and

management of research fraud and misconduct. It is therefore

essential that research partnership agreements specify arrangements

for the detection, reporting and investigation of research misconduct.

7. Reporting Arrangements

All allegations of misconduct in research will be treated seriously and

fairly and their merit investigated with integrity and sensitivity, in order

to observe the principle of no-detriment, such that neither the

Complainant nor the Respondent should suffer solely as a

consequence of the fact that a good faith allegation has been made.

Suspected research fraud and misconduct should be reported to the

Director of R&D. Where necessary the R&D Director will seek more

senior, expert or independent advice and make an early decision

whether or not to suspend temporarily Trust approval of the research

project concerned. Care will be taken to balance the risks to the

safety and benefit to research participants.

The Medicines and Healthcare Regulatory Agency (MHRA) has the

power of inspection of sites involved in the conduct of clinical trials of

investigational medicinal products, and may identify research fraud or

misconduct.

8. Process of investigation

The process of investigation will follow the procedure outlined in the

NUH Disciplinary Investigation Procedure, with minor modification:


The Director of R&D Director will identify a suitable „Case

Investigator‟ with responsibility for conducting the investigation.

In view of the limited number of individuals in the Trust qualified

to investigate cases of alleged research misconduct or fraud,

the Case Investigator may also be the Director of R&D, or

nominated deputy.

If a minor issue is raised, a more informal approach will be

adopted and the R&D director will call a meeting to discuss the

case with all involved.

For those cases which the Director of R&D considers may lead

to serious outcome, as defined in 6. v) – vii), and NUH retains

responsibility, either as the employing organisation, or by

mutual agreement with the researches employers, a full

investigation will be conducted by a panel constituted for the

purpose. The panel will be selected at the discretion of the

Director of R&D, but will include representatives of HR from the

organisation employing the researcher and may include a

senior Disciplinary Manager, i.e the Medical Director, and

expertise in the field under investigation. Rarely the

investigation will be chaired by an independent party. Members

should have no direct involvement in the activity under

investigation.

Any Hearing which takes place will be conducted in accordance

with the Trust Disciplinary Hearing Procedure (2009).

The Trust undertakes to conduct such investigation in a timely

manner, bearing in mind the MRC Guidelines (1997), but

cannot commit to specific deadlines in any individual case.

Comprehensive notes will be taken at each stage of the review

and investigative process. All notes should be stored in a safe


and secure environment during the process and filed within the

R&D Office once the matter is concluded. All documentation will

be handled in accordance with the provisions of the Data

Protection Act 1998.

9. Outcomes of an Investigation

If the investigation concludes that research misconduct or fraud has

taken place one or more sanctions may be appropriate at the

discretion of the Director of R&D or, in event of full investigation, the

Disciplinary Manager with the support of R&D and HR:

i) withdrawal of NUH R&D approval for the specific research project

ii) withdrawal of Trust or other funding

iii) withdrawal or correction of pending or published abstracts and

papers emanating form the research project in question

iv) increase of the Risk Index for the research project in question,

resulting in frequent auditing/monitoring and closer attention to future

work originating from the researcher.

v) barring of the researcher from applying for future research funding

or conducting any research within NUH.

vi) revoking an honorary contract/letter of access

vii) report researchers to ethics committees and professional bodies.


10. Equality and Diversity

All patients, employees and members of the public should be treated fairly and with respect, regardless of age, disability, gender, marital status, membership or non-membership of a trade union, race, religion, domestic circumstances, sexual orientation, ethnic or national origin, social & employment status, HIV status, or gender reassignment.

Equality Impact Assessment

NUH is committed to ensuring that none of its policies, procedures, services, projects or functions discriminate unlawfully. In order to ensure this commitment all policies, procedures, services, projects or functions will undergo an Equality Impact Assessment.

Reviews of Equality Impact Assessments will be conducted in line with the review of the policy, procedure, service, project or function 11. References

Research Governance Framework for Health and Social Care, 2nd ed,

April 2005.

NUH Disciplinary Policy, Disciplinary Investigation Procedure and

Disciplinary Hearing Procedure

Code of practice for Research, UK Research Integrity office,

September 2009


Appendix 1 EQUALITY IMPACT ASSESSMENT TEMPLATES / FORMS 1. Name of Policy or Service

Research Fraud and Misconduct Policy 2. Name of Responsible Manager

Maria Koufali

3. Name of person completing assessment Helen Jones 4. Date EIA Completed

03 August 2010

5. Description and Aims of Policy/Service (including relevance to equalities) The aim of this policy is to set out clearly what constitutes research misconduct and fraud and the processes to be followed when failure to comply with the relevant legislative and regulatory frameworks is suspected and identified

6. Results of Initial Screening or Full Equality Impact Assessment:

Equality Group Assessment of Impact

Age N/A

Gender N/A


Race N/A

Sexual Orientation N/A

Religion or belief N/A

Disability N/A

Dignity and Human Rights N/A

Working Patterns N/A

Social Deprivation N/A

7. Decisions and/or Recommendations (including supporting rationale) None

Equality Area

Key Equalities

Legislation / Policy (See

summary sheet)

Is this policy or service

RELEVANT to this equality area?

YES / NO

Assessment of Potential Impact:

HIGH MEDIUM

LOW NOT KNOWN

Reasons for

Assessment

positive (+)

negative (-)

Gender Sex Discrimination Act 1975 Equal Pay Act 1970 Equalities Act 2006 Gender Recognition Act 2004

NO

Race Race Relations Act 1976

NO


Race Relations (Amendment) Act 2000

Disability Disability Discrimination Act 1995 and 2005

NO

Age Age Regulations 2006

NO

Sexual orientation

Equalities Act 2006 Relevant employment legislation

NO

Religion and beliefs

Equalities Act 2006 Relevant employment legislation

NO

Social Deprivation

Neighbourhood Renewal Strategy Tackling Health Inequalities Local Area Agreement

NO

Dignity and Human Rights

Human Rights Act 1998 (relevant

NO


articles)

Working Patterns

The Part-time Workers (Prevention of Less Favourable Treatment) Regulations 2000

NO

8. Monitoring and Review Arrangements Review to be carried out October 2012


Appendix 2 WE ARE HERE FOR YOU ASSESSMENT To what extent is your Policy or Trust-wide Procedure affected by the following We Are Here For You values? Please rate each value from 1 – 3 (1 being not at all, 2 being affected and 3 being very affected)

1. Polite and Respectful

Whatever our role we are polite, welcoming and positive in the face of adversity, and are always respectful of people‟s individuality, privacy and dignity.

1

2. Communicate and Listen We take the time to listen, asking open questions, to hear what people say; and keep people informed of what‟s happening; providing smooth handovers.

1

3. Helpful and Kind All of us keep our „eyes open‟ for (and don‟t „avoid‟) people who need help; we take ownership of delivering the help and can be relied on.

1

4. Vigilant (patients are safe) Every one of us is vigilant across all aspects of safety, practices hand hygiene and demonstrates attention to detail for a clean and tidy environment everywhere.

1

5. On Stage (patients feel safe)

We imagine anywhere that patients could see or hear us as a „stage‟. Whenever we are „on stage‟ we look and behave professionally, acting as an ambassador for the Trust, so patients, families and carers feel safe, and are

1


never unduly worried.

6. Speak Up (patients stay safe) We are confident to speak up if colleagues don‟t meet these standards, we are appreciative when they do, and are open to „positive challenge‟ by colleagues.

1

7. Informative We involve people as partners in their own care, helping them to be clear about their condition, choices, care plan and how they might feel. We answer their questions without jargon. We do the same when delivering services to colleagues.

1

8. Timely We appreciate that other people‟s time is valuable, and offer a responsive service, to keep waiting to a minimum, with convenient appointments, helping patients get better quicker and spend only appropriate time in hospital.

1

9. Compassionate We understand the important role that patients‟ and family‟s feelings play in helping them feel better. We are considerate of patients‟ pain, and compassionate, gentle and reassuring with patients and colleagues.

1

10. Accountable Take responsibility for our own actions and results

1

11. Best Use of Time and Resources Simplify processes and eliminate waste, while improving quality

1


12. Improve Our best gets better. Working in teams to innovate and to solve patient frustrations

1

TOTAL

12


Appendix 3

EMPLOYEE RECORD OF HAVING READ THE POLICY

RESEARCH MISCONDUCT AND FRAUD POLICY AND PROCEDURES

I have read and understand the principles contained in the named policy.

PRINT FULL NAME

SIGNATURE

DATE

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