Risk Based Research Management

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					Risk Based Research
Management
Sarah Corcoran RGN, DPSN, BA Hons
Head of Risk Management at Central
Manchester and Manchester Children’s
NHS Trust
                        STANDARD

Healthcare organisations which either lead or
participate in research activities adhere to, and apply
consistently, the principles and requirements of the
Research Governance Framework.

                            OVERVIEW

Research is essential to the successful promotion and protection of
health and well-being and to modern and effective health and
social care services. At the same time, research can involve
an element of risk, both in terms of return on investment
and sometimes for the safety and well-being of the
research participants. Proper governance of research is
therefore essential to ensure that the public can have confidence in,
and benefit from, quality research in health and social care. The
public has a right to expect high scientific, ethical, and financial
standards, transparent decision-making processes, clear allocation
of responsibilities and robust monitoring arrangements.
Risk - definitions
   hazard: a source of danger; a possibility of incurring loss or
    misfortune; "drinking alcohol is a health hazard"
   a venture undertaken without regard to possible loss or
    injury; "he saw the rewards but not the risks of crime"; "there
    was a danger he would do the wrong thing"
   expose to a chance of loss or damage; "We risked losing a lot
    of money in this venture"; "Why risk your life?"
   the probability of becoming infected given that exposure to an
    infectious agent has occurred
   gamble: take a risk in the hope of a favorable outcome;
    "When you buy these stocks you are gambling"
    www.cogsci.princeton.edu/cgi-bin/webwn
   The uncertainty of an event occurring
    that could have an impact on the
    achievement of objectives. Risk is
    measured in terms of consequences
    and likelihood.
    www.mcgill.ca/internalaudit/tools/defi
    nitions/
   Risk is an album by the metal band
    Megadeth released in 1999.
    en.wikipedia.org/wiki/Risk_(album)
   “ , the rational model of the traditional
    research methods textbook, which
    presents the research process as an
    idealized, neat series of logically
    directed steps, does not of course
    provide a description of the way in
    which research is actually conducted.
Cont….
Rather like the managerial process, which until
  recently was idealized by textbooks an a
  logical orderly one of planning [………] ,
  there is now widespread recognition of the
  view that ‘idiosyncrasies of the person and
  circumstance are at the heart, not the
  periphery of scientific enterprise’ (Bell and
  Newby, 1977)
      in, Gill,J and Johnson,P. Research
  Methods for Managers . Paul Chapman
  Publishing 1997
Risk Assessment

   The overall process of risk analysis
    and evaluation.
Risk Acceptance

   An informed decision to accept the
    consequences and likelihood of a
    particular risk.
Risk Control

   That part of risk management which
    involves the implementation of
    policies, standards, procedures,
    physical changes etc to eliminate or
    minimise risks.
                         Identify Broad Area    May be
                                                identified by risk
                                                assessment
    May be
    identified by risk     Select Topic
    assessment
                                               Risk assessing
                                               the approach
                                               may alert Team
                         Decide Approach
                                               to potential
                                               problems in the
                                               future.
  Circulation and
  risk assessment          Formulate Plan
  by team may
  alert to problems
  with the plan.
                         Collect Information    Risk assessment
                                                of data
Do the findings
                                                collection and
pose different
                            Analyse Data        analysis
risks or have
                                                processes could
they identified
                                                prevent
risks?
                                                methodology
                         Present Findings       errors.
    Benefits for R&D
                         R&D Process
                         RA’s can support
                         R&D staff in their
                         every day work
                         and protect
                         projects from
                         process errors
              RA’s can lead to     RA’s can ensure
              decisions about      R&D
              which R&D            recommendations
              projects to          are robustly
              undertake and        examined and new
              directly influence   risks introduced
              decisions on         are properly
R&D Opportunities
              funding etc          evaluated.       R&D Outcomes
Risk management process
AS/NZS 4360:1999 - Risk management
      Risk Register
         Communicate and Consult                  Establish Context



                                                    Identify Risks




                                                                      Monitor and review
                                   ASSESS RISKS


                                                   Analyse Risks


                                                    Evaluate and
                                                     Rank Risks



                                                     Treat Risks
                The Risk Register

        Ris k are a or
No.                       Ris k de s cription    Action de s cription   Im pact   Lik e lihood   Ris k   Start date   Due date   Cos t       Re s pons ibility
          s tandard



                         Responsibilities       Clearly document                                                                            Risk
   Health and            for Health and         and define                                                                                  Advisor/Healt
 1                                                                        3            5         15      01.07.02     31.12.02           £0
   Safety                Safety are not         responsibilities                                                                            h and Safety
                         clearly defined.       across the Trust.                                                                           Advisor

                                                The bulk of these
                         Staff cannont
                                                documents
                         read the
                                                should be                                                                                   Risk
                         amount of
      Health and                                reduced and                                                                                 Advisor/Healt
 2                       information                                      4            3         12      01.07.02     31.03.03   £1,500
      Safety                                    information                                                                                 h and Safety
                         currently
                                                produced that is                                                                            Advisor
                         available to
                                                standardised and
                         them.
                                                clear.
Management of Risk
Registers
     Monitor the management of identified
     Risks and make decisions on retention
         Of any high level residual risk


          Monitor the management of
        The risks identified at the team
        Level – identify any outstanding
       strategic risks. Manage these risks
       And feedback to monitoring level


                Identify Risks
     Manage these risks at a local level and
         feedback to monitoring level
For Example……
                                                Each of these groups
       Trust Board                              asks questions of one
                                                another – an
                                                Assurance
     Trust Wide Risk
                                                Framework is
      Management
                                                developed in order to
        Committee
                                                maintain the ongoing
                                                process and ensure
Divisional Risk Management                      responsibilities are
         Committee                              correctly defined and
                                                executed.

                             Local Risk Forum
Risk Assessment
   facilitates communication between decision-makers,
    technical experts, and other interested parties, by
    providing explicit data which is amenable to review
    and describes shortfalls, such as the nature and
    extent of uncertainties attached to the data.

   identifies the role and impact of policy
    considerations (eg. social, political or economic) in
    the evaluation of information which is essentially
    scientific in nature;
   provides a framework for examining explicitly the
    potential adverse consequences of alternative risk
    management policies or actions;

   helps to identify research needs and research
    priorities;

   assists the UK in its efforts to foster the adoption of
    a goal-setting approach to legislation during the
    negotiation of international or European Union (EU)
    legislation, agreements or standards.

   http://www.hse.gov.uk/aboutus/meetings/ilgra/min
    rpt1c.htm
But……many of you have
been doing this for a long
time…….
   You've carefully thought out all the angles.


   You've done it a thousand times.


   It comes naturally to you.


   You know what you're doing, its what you've
    been trained to do your whole life.


   Nothing could possibly go wrong, right ?
Wrong….!
            Incidents By Division April 2005



      20%                      15%


                                       5%
3%                                               Childrens Services
                                            5%
                                                 Clinical Scientific Services
                                                 Dental Hospital
                                                 Division Of Medicine
                                                 Division Of Surgery
                                                 Manchester Royal Eye Hospital
15%                                              St Mary's Hospital



                              37%
    Stages of Development of Organisational
    Accident : James Reason
                     Contributory
                     Factors
                     Influencing
 Organisational &    Clinical Practice      Task      Defence
 Corporate Culture                                    Barriers
                       Error
                     Producing                                   Accident
                                                                 /Incident
                     Conditions
Management                                Errors
Decisions and
Organisational        Violation
                                         Violations
  Processes          Producing
                     Conditions
RISK IDENTIFICATION AND ASSESSMENT                                                                                        Page              of
Area                                                    Risk                                           Date                       Date of
                                                        Assessor                                                                  Review

 Ref       DESCRIPTION OF RISK – describe the         EXISTING CONTROLS – physical controls           RISK ASSESSMENT                RISK        RISK
           potential problem.                         and/or systems currently in place to reduce     Severity       Likelihood     RATING       RANK
                                                      the risk of adverse incidents?                       (S)           (L)         (SxL)




Senior Manager Validating Assessment                                                                Date
RISK TREATMENT / ACTION PLANNING
        ADDITIONAL CONTROLS REQUIRED               SUBSEQUENT       COST     PRIORITY        PERSON               TIME             PROGRESS
        – What action needs to be taken to        RISK RATING IF     (£)                   RESPONSIBLE           SCALE
        eliminate or reduce the risk so far as      ADDITIONAL
        is reasonably practicable?               CONTROLS ARE
                                                    INSTITUTED
 Ref                                             S    L    (SxL)
    Risk Grading Matrix
                    1         2             3              4              5



    Likelihood     Rare   Unlikely      Moderate         Likely        Certain

    Severity
1   Low            Low       Low           Low            Low            Low
2   Slight         Low       Low        Significant    Significant      High
3   Moderate       Low    Significant      High        Very High      Very High
4   Major          Low    Significant   Very high      Very high     Unacceptable
5   Catastrophic   Low       High       Very high     Unacceptable   Unacceptable
“Here is Edward Bear,coming
downstairs now, bump, bump, bump,
on the back of his head, behind
Christopher Robin. It is, as far as
he knows, the only way of coming
downstairs, but sometimes he feels
that there really is another way, if only
he could stop bumping for a moment
and think of it”


                                  A.A. Milne 1926

                   Illustration E.H.Shepard 192614
Any Questions?



   Sarah Corcoran, Head of Risk
    Management
    – sarah.corcoran@cmmc.nhs.uk
    – 0161 276 6179