AUDIT AND RESEARCH: STUDIES OF MEXICAN RESEARCH ETHICS COMMITTEES

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AUDIT AND RESEARCH STUDIES OF MEXICAN RESEARCH
ETHICS COMMITTEES Dr Edith Valdez-Martinez Dr
John Porter IMSS, Mexico City and the London
School of Hygiene and Tropical Medicine
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Human Morality(Samuel Scheffler, 1992)

• .the ethical conversation of a culture like
  ours resembles a complex dance of moral
  judgement, psychological insight, and social
  analysis, requiring attention to motives as well
  as values, minds as well as morals, groups as
  well as individuals, causes as well as reasons,
  what is not said as well as what is said.

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Culture

• A culture (of a group of people) is made up of
  all the skills, feelings, values and beliefs that
  are learned, shared and taught by its members
  from one generation to the next
• (Bernard Lonergan Understanding Being an
  introduction and companion to insight. Edwin
  Mellen Press, USA, 1987)

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Where is trust? Audit as performance
indicator

• The new accountability has quite sharp teeth.
  Performance is monitored and subjected to quality
  control and quality assurance. The idea of audit
  has been exported from its original financial
  context to cover ever more detailed scrutiny and
  non-financial processes and systems. Performance
  indicators are used to measure adequate and
  inadequate performance with supposed precision.
  This audit explosion. has often displaced or
  marginalised older systems of accountability
  (Onora ONeill. A question of trust. Cambridge
  Univ Press 2002).

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Instituto Mexicano del Seguro Social (IMSS)

• Mexico Population 97.4 million. Health system
  Ministry of Health Social Security System
  (containing IMSS) and the Private Sector
• IMSS workers from formal private sector, civil
  servants, local government employees, armed
  forces and national oil company
• Research ethics committees being created. IMSS
  335 committees. Health Law section 5 states in
  health institutions the following will be
  created a research committee, an ethics
  committee and a bio-safety committee

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Research of IMSS Ethics Committees

• A national survey to identify the number,
  structure and productivity of local research
  ethics committees. (Results Few meetings poor
  lay representation dominated by male physicians)
• b) An audit to examine and verify organisational
  structure and work. A national audit of a sample
  of 60 LRECs of the IMSS was conducted to assess
  work conducted between January and December 2001.
• c) A qualitative study to explore how the
  committees apply ethics in the evaluation of
  research proposals.

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Auditoria/Audit

• Meaning of words Spanish/English
• Definition To what extent a situation, process
  or performance conforms to predetermined
  standards or criteria (Herk et al 2001) Aim
  educational and developmental

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Diagram of audit cycle
Stage 1 Information to identify strengths,
weaknesses, opportunities and threats
Stage 2 Formulation of strategies and plan of
action
Stage 3 Implementation of change
Audit
Stage 4 Monitoring the progress of changes
implemented
Stage 5 Handling resistance to change
Stage 6 Assessment of change by repeating cycle
Diagram adapted from NHS. Pharmacy audit
handbook. Available from URL http//www.npc.co.uk
/publications/auditHandbook/quality.htm The
elements that integrate the audit cycle are also
from Mintzberg H, Ahlstrand B, Lampel J,
editors. Strategy safary. A guide tour through
the wilds of strategic management. London
Prentice Hall 1998.
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Audit/Auditoria
Aim To determine to what extent the work of
LRECs conformed to the standards of the IMSS
regulation handbook by showing the frequency of
conformity to two key processes 1) assessment of
proposed research projects and 2) continuing
review of research previously authorised. Methods
The standard defined in the 2001 Medical
Research Handbook of the IMSS is based on Mexican
General Health Law on Health Research Matters,
the Declaration of Helsinki and on the specific
necessities of the Institution.
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Methods

• A standard letter sent to the directors of health
  care units and research units asking for their
  participation in the audit.
• Each committees secretary was informed
• 3. Confidentiality of committee members was
  assured.
• 4. Auditors perused committee documents and
  records the application form, decision form,
  specific procedures for protocols reviewing,
  evaluation forms for reviewing applications,
  agenda and minutes of meetings, decisions and
  advice provided to applicants, and interim and
  annual reports during follow-up.

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Results
Were projects sent to reviewers to be evaluated?
In 54/60 (90) the executive directors were the
sole reviewers of the protocols submitted for
approval. Do committees meet to evaluate
research projects? 43/60 (72) LRECs convened
plenary meetings 23 of these convened meetings
to analyse and discuss all the research proposals
submitted. The other committees only convened
meetings for specific situations eg evaluation of
clinical trials, disagreement among reviewers .
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Results
Do reviewers issue a report with the results of
their evaluation? In 38/60 (63) committees the
reviewers never issued a written report with the
results of their evaluation. Strategy was adopted
to lessen the workload of reviewers, to enable
them to focus their efforts on the objectives of
evaluating and counselling on the project,
and/or for being more practical. Did the
principal researcher participate in the
committees deliberation? In 27/43 (63) LRECs
the meetings were held in the presence of the
principal researcher of the project that was
being evaluated although authors did not
evaluate their own projects, they participated in
the discussions of the plenary committees.
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Results

• Continuing review process
• In 51/60 (85) LRECs, the follow-up of research
  was confined to six-monthly collection of verbal
  or written reports about the progress of research
  from the principal investigator.
• 9 (15) LRECs never conducted any follow-up. The
  causes of this appeared to be the lack of staff,
  large number of authorised projects and/or
  because the research projects were for
  dissertations of personnel in training.

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How should ethics committees be studied?

• What methodology should be used? social science
  methods (eg narratives, non participant
  observation) epidemiological methods
  demography, economics
• How should we deal with issues of relationship
  and culture?
• How should we deal with issues of power?
• Is it ethical to study ethics committees?

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Ways of supporting ethics committees

• Review and monitoring
• Audit (educational and developmental)
• Information on how to deal with problems
• Providing up to date information on ethics issues
• Helping to develop relationship/community within
  the committee

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