AUDIT AND RESEARCH: STUDIES OF MEXICAN RESEARCH ETHICS COMMITTEES Dr Edith Valdez-Martinez

1. 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

2. 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.’

3. 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)

4. 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 O’Neill. A question of trust. Cambridge Univ Press 2002).

5. 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

7. 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.

8. ‘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

9. 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 6 Assessment of change by repeating cycle Stage 5 Handling resistance to change 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.

10. 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.

11. Methods • A standard letter sent to the directors of health care units and research units asking for their participation in the audit. • Each committee’s 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.

12. 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 ….

13. 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 committee’s 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.

14. 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.

15. 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?

16. 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

17. Power equalization Ethical decision making Democratic dialogue Reflection on ethics Reconciliation between personal interest and values Figure adapted from Prilleltensky I, et al. Applied ethics in mental health in Cuba: part II –power differentials, dilemmas, resources, and limitations. Ethics and behaviour 2002; 12: 243-260.