Making Life Easier for Researchers Managing Research Bureaucracy

1
Making Life Easier for Researchers Managing
Research Bureaucracy Mary Cubitt CSP
Development Lead NIHR CRN CC
2
What makes research bureaucratic?

• Legislation
• Ethics
• NHS Permission
• Honorary Contracts
• Contracts and agreements

3
Legislation

• Clinical Trials Regulations
• Medical Devices Regulations
• Human Tissue Act
• Mental Capacity Act
• Data Protection Act
• Access to prisoners

4
Pathways through the legislation

• Ask for advice at an early stage in study design
• NIHR Research Design Service
• CLRN funded RD managers in NHS organisations
• University RD managers sponsors of research
• Complex queries from RD Managers to UKCRC
  Regulatory and Governance Advice Service
• On line resources
• IRAS online help

5
Ethics

• Research involving NHS patients, data or
  facilities needs Ethics approval
• NHS Research Ethics Committees (NRES)
• Social Care Research Ethics Committee
• Gene Therapy Advisory Committee
• Changes for research involving only NHS staff

6
Improving the Ethics Process

• Big changes over last 5 years
• IRAS Integrated Research Application System
• Review dependent on study type
• Specialist RECs
• Site Specific Assessment now in of NHS permission

7
NHS Permission

• Need permission from NHS organisation otherwise
  not covered by NHS indemnity
• Not one NHS approx 400 NHS organisations
• All different application systems
• All undertake different reviews
• NIHR Centralised System for gaining NHS
  permission (NIHR CSP)

8
NIHR CSP

• Currently available to NIHR Portfolio studies
• Commercial and academic
• Gateway to NIHR Portfolio
• One place to submit applications IRAS
• Allocated a Lead CLRN to assist
• Norfolk Suffolk CLRN RD staff dispersed in
  NHS organisations

9
NIHR CSP

• Study wide checks shared over all sites
• Supporting documents shared with all sites
• Local checks based on Site Specific Information
  Forms for each site
• Automatically sent to each site
• NHS permission at each site facilitated

10
NIHR CSP

• Most benefit to multi centre studies
• First implementation 18 Nov 2008
• Massive change for NHS RD
• Ongoing development to improve RD services to
  researchers

11
Honorary Research Contracts

• National guidance regarding research honorary
  contracts
• Who needs what and when
• Non NHS staff who will have an impact on patient
  care
• Research Passport
• Honorary contract or Letter of Access

12
Arrangements for NHS staff

• NHS staff do not need honorary contracts to work
  across NHS organisations
• Do need a letter of access
• Host NHS organisation knows they are there
• Employer knows they are there

13
Contracts and agreements

• Model agreements endorsed by DH and UKCRC
• Used unaltered will speed things up as no need
  for legal review
• mCTA
• CRO mCTA
• mCIA and CRO mCIA
• mNCA

14
NIHR Information Systems

• A unified set of web-based systems will hold the
  information required to manage health and social
  care research in England. The integrated system
  is being designed and built to make the processes
  of information input, retrieval and dissemination
  faster and easier for everyone involved.

15
RDMIS

• Research and Development Management Information
  System
• Life cycle of research project from funding to
  dissemination
• Includes funding applications, RD submissions,
  accrual upload to NIHR Portfolio database
• Small scale piloting towards end 2009

16
RDMIS screen cast

• http//www.nihr.ac.uk/systems/Pages/systems_resear
  ch_information_systems.aspx

17
Summary

• Commitment from Department of Health to reduce
  research bureaucracy in NHS
• Best Research for Best Health 2006
• Implementation largely through the CLRNs
• Department of Health further committed to
  improving support for researchers to help
  facilitate research

18
Useful links

• http//www.east-of-england-rdsu.org.uk/default.asp
  
• https//www.myresearchproject.org.uk/
• http//www.crncc.nihr.ac.uk/index/clinical/csp.htm
  l
• http//www.ukcrc-rgadvice.org
• http//www.ct-toolkit.ac.uk/
• http//www.dt-toolkit.ac.uk/home.cfm
• http//www.nihr.ac.uk/systems/Pages/systems_resear
  ch_passports.aspx
• http//www.ukcrc.org/regulationgovernance/modelagr
  eements.aspx