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Research Compliance Committee Annual Statement to the University’s Board of Governors 2016/17

 

Background

The University’s Research Compliance Committee (RCC) sets standards and ensures that the University meets its obligations to comply with the statutory, regulatory and policy requirements within its scope.  It reports to the University’s Planning and Resources Committee and is chaired by the Associate Vice President for Compliance, Risk and Research Integrity who reports directly to the President & Vice Chancellor and Registrar, Secretary and Chief Operating Officer. 

 

Assurance, Adverse Events and External Inspection Dashboard

 
Area of compliance
Current level of Compliance: Status in 2016/17

  Level 1 Level 2 Level 3

Adverse

Events

Audits
University Research Ethics Committees     *    

The Medicines for Human Use (Clinical Trials) Regulations 2004

         
EU Good Manufacturing Practice (GMP)          
The Human Tissue Act 2004 (and subsequent amendments)          
Animals (Scientific Procedures Act) 1986          
The Chemical Weapons Act 1996          
UUK Concordat to Support Research Integrity     *    
Clinical and Experimental Pharmacology: CRUK-MI          
Department of Health Information Governance Toolkit          

 * No formal external inspection by a regulator. External audits arranged through UNIAC.   

 

 

Assurance

Level 1

There is a clear governance structure, defined roles and responsibilities, appropriate training programmes, clear procedures to ensure compliance at local-level and quarterly reporting to the RCC.

Level 2

There is a programme of regular internal audits.

Level 3

The area of compliance is subject to external audits/inspections.

 

Green

Fully compliant, all requirements met at that level.

Amber

Processes in place, but not fully operational at that level.

Red

No processes in place at that level.


The University Research Ethics Committees are amber because they have not yet been externally audited.  This is scheduled with UNIAC for September 2017.

 

Adverse Events

Green

No minor or major adverse events as defined below. 

Amber

Minor Adverse Events only – Minor deviation from protocol or good practice or an unforeseen event relating directly to the research leading to minor harm or risk of harm to research subjects (human or animal), researchers’ reputation, and/or damage to premises/ facilities/equipment, with no serious disruption to activities.

Red

Major Adverse Event(s) - Significant deviation from protocol or good practice, or unforeseen event relating directly to the research leading to significant harm or risk of harm to research subjects (human or animal), researchers reputation, and/or significant damage to premises/facilities/ equipment with serious disruption to activities.

Clinical and Experimental Pharmacology: Cancer Research UK-Manchester Institute has a red rating because of the serious fire at the Paterson building of the CRUK-Manchester Institute (CRUK-MI). 

 

External Inspections

White

No inspection in 2016/17

Green

No significant findings or minor non compliances.

Amber

Major non compliances but no critical non compliances.

Red

Critical non compliances.

 

New Developments

  1. In 2015/16 we implemented an on-line ethical review process for the University’s ethics committees.  The Ethical Review Manager (ERM) provides a more efficient and user friendly experience for staff and students at the University of Manchester.  Since the implementation of the system the average time for processing a UREC application has been reduced from 51.5 days (2015/16) to 20 days (2016/17).  Further reductions are anticipated with the implementation in May 2017 of proportionate review for low-risk staff or student projects.
  1. We are supporting the transfer of the Manchester Academic Health Science Centre (MAHSC) Clinical Trials Unit from the Christie Hospital NHS Foundation Trust into the University of Manchester. Professor Thakkar has chaired a Research Governance Working Group responsible for creating an assurance and compliance framework for the CTU including defining clear roles and responsibilities.  He is now chairing a Transition Strategy Group which will ensure these are implemented.
  1. In order to support the University’s growing clinical trials portfolio, the University has entered into contractual arrangements with partner NHS Trusts to provide Sponsor Pharmacy support and support for monitoring clinical trials.
  1. The University purchased a Chemical Inventory System in February 2017 to provide a single, consolidated management system for records of chemicals and other harmful substances, lasers and X-ray machines as well as radiochemicals and those regulated materials which require reporting. The inventory will also facilitate compliance reporting which currently is done entirely manually. The implementation across the University is ongoing after a successful pilot phase, which identified over 120 litres/Kg of legacy hazardous substances (mostly corrosive and flammables) to be disposed of in one building, thereby reducing the ongoing risk to the organisation. Further reductions of legacy stocks would be expected in the rest of the buildings as the inventory rolls out.

 

Priorities for 2017/18

  1. To manage the transfer of the MAHSC CTU into the University of Manchester, making sure that the right governance and assurance arrangements are in place.
  2. Work with partner NHS Trusts to develop a Manchester-wide solution to the sponsorship of clinical trials.
  3. Updating and implementing changes to the University’s Code of Practice for Investigating Concerns about the Conduct of Research in response to lessons learnt from handling pervious cases.

 

Investigations into Allegations of Research Misconduct

In accordance with the UUK Concordat, the University has to provide a high-level statement on any formal investigations of research misconduct that have been undertaken.  The tables below details all the investigations that were initiated by the University between September 2016 and May 2017:

Staff/student

Faculty

Nature of complaint

Outcome

Hon Staff

BMH

Misrepresentation and breach of duty of care

Ongoing

Student

BMH

Piracy

Ongoing

Staff

BMH

Plagiarism and data misrepresentation

Ongoing