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Introduction

  1. Top of page
  2. Introduction
  3. Emotional cost of VA
  4. Access to information
  5. Consenting process and ethical clearance
  6. Way forward
  7. References

Age, sex and cause of death are registered for only a third of all deaths globally, and the vast majority of these deaths occur in developed countries (Lopez et al. 2000). In rural Africa, ≥80% of childhood deaths occur at home and are not registered in any routine mortality reporting system (Mung'ala and Snow 1994). Data on levels and causes of adult deaths in developing countries are extremely deficient in comparison with the information available for children (Feacham et al. 1992). Increasing investments in controlling acquired immunodeficiency syndrome (AIDS), tuberculosis and malaria, and the renewed focus on health indicators by the United Nations Millennium Declaration emphasize the need for new tools and methods to generate robust regional, national and sub-national estimates of cause-specific mortality levels and patterns (Murray et al. 2004). Verbal autopsy (VA) is a method of ascertaining causes of death from information on illness and circumstances preceding death obtained from bereaved caregivers. VA has the potential to generate cause-specific mortality data, and its application in sample or sentinel mortality surveillance systems is proposed as an interim strategy to close the mortality information gap in developing countries (Setel et al. 2005). Issues relating to the standardization and validation of VA tools and procedures have been discussed at several international workshops by experts in this field (Gray & Barss 1990; Chandramohan 1993, 1996; Ronsmans & Campbell 1994; Anker et al. 1996; WHO 2005); but surprisingly, the ethical dimension has never been raised. We want to increase awareness regarding the sensitive nature of this method of data collection and of the ethical issues that need to be considered to implement VA appropriately within mortality surveillance systems.

Emotional cost of VA

  1. Top of page
  2. Introduction
  3. Emotional cost of VA
  4. Access to information
  5. Consenting process and ethical clearance
  6. Way forward
  7. References

Verbal autopsy interviews, which rekindle the circumstances that led to the death of a close relative, can cause emotional distress. The degree of distress triggered by this process depends on various factors such as the age and relationship of the deceased, the circumstance of death, the culture of bereavement, time interval since death, and the counselling skills of the interviewer. For instance, interviewing a young woman who has lost her husband or child a few months earlier ‘can end in tears’1. The puerperium is also a very sensitive time for mothers and the effects of a VA interview during this period have not been recorded or reported. VAs during the puerperium conducted by an interviewer who has little or no training in counselling have the potential to cause psychological distress, particularly in young mothers.2 It can be argued that bereaved families would prefer to forget the events leading to the death of a relative. Recalling such events after a long period would cause emotional distress. However, currently, it is suggested that for assessing causes of still birth and neonatal death, VAs be conducted ‘soon’ after the event in order to obtain reliable information from mothers (WHO 2005). We suggest that, until there is more information and a better understanding of the effects of VA on the mother during this vulnerable period, VA interviews not be conducted during the 6–8 weeks following a stillbirth or neonatal death. We propose studies by independent investigators to evaluate the psychological effects of VAs in a number of sites routinely conducting them and to introduce a minimum mandatory level of training in counselling techniques to VA interviewers.

The advantages of using lay VA interviewers over medically qualified ones have been debated without any consensus (Chandramohan 1996). However, most mortality surveillance systems presently employ non-medical graduates for conducting VAs (WHO 2005). Typically, interviewers have had 2 weeks VA training but little or no instruction in counselling. VA training manuals focus on eliciting symptoms, signs and circumstances preceding a death (University of Toronto 2004). To improve the process of VAs and to prevent aggravating grief and emotional distress to families and communities, standards and norms for VA interviewers need to be established, including training in the techniques of counselling.

Access to information

  1. Top of page
  2. Introduction
  3. Emotional cost of VA
  4. Access to information
  5. Consenting process and ethical clearance
  6. Way forward
  7. References

Mortality surveillance systems using verbal autopsy are justified on the grounds that the benefits of readily available robust cause-specific mortality data outweigh the emotional cost of VA borne by few individuals. So what data are readily available in the public domain from demographic sentinel surveillance (DSS) sites using VA? The INDEPTH-network reported model life tables for Africa using data from 19 DSS sites (INDEPTH 2004). The causes of death estimated by VA in 15 INDEPTH sites were collated and cause-specific mortality data comparable between sites are expected to be published very soon. Clearly these data will be extremely useful in determining disease control activities and research agendas. The VA data from the Adult Mortality and Morbidity Project (AMMP) in Tanzania has been widely disseminated and used for estimating the global burden of disease (http://www.ncl.ac.uk/ammp/project_outputs/nationalmortality.html). The availability of age- and cause-specific mortality data from DSS sites has improved since the INDEPTH-network has been operational. However, some issues on access to information need to be agreed upon. What is the maximum time lag permissible from the time of collection of primary data to reporting summary estimates to public health authorities in a given country? How soon can or should access to the primary data be given to researchers and public health practitioners from national and international organizations? The United Kingdom Freedom of Information Act (http://www.hmso.gov.uk/acts/acts2000/20000036.htmaofs) stipulates that any person has the right to make a request for information held by a public authority, including academic and research organizations. Exemptions include information relating to a deceased person, the disclosure of which might endanger the mental health of surviving relatives or have an adverse effect on public health. Publicizing the cause of death of a relative may cause emotional distress and therefore should be treated confidentially. However, aggregated data on causes of death that are needed for public health planning are not exempted from disclosure. Clearly the UK Freedom of Information Act is not applicable everywhere. However, certain norms in the degree of access to data retained by DSS sites need to be agreed upon. We suggest that age- and cause-specific mortality data should be collated and reported annually. Access to primary data in accordance with the freedom of information act would be desirable since these data are essential for promoting public health. A debate on the feasibility and implications of using the Freedom of Information Act in mortality surveillance systems is needed to build consensus and to develop guidelines for providing access to primary data.

Consenting process and ethical clearance

  1. Top of page
  2. Introduction
  3. Emotional cost of VA
  4. Access to information
  5. Consenting process and ethical clearance
  6. Way forward
  7. References

At present, 36 sentinel DSS and two large-sample vital registration systems (India and China) are using verbal autopsy to assess causes of more than 100 000 deaths annually (http://www.indepth-network.net/dss_site_profiles/dss_sites.htm). From the information available on the websites and reports of the DSS and sample vital registration systems it is unclear whether consent is obtained from families before conducting VA interviews. We analysed the operating procedures of 36 field sites that routinely conduct VA. Only 17 sites reported their consenting procedures, refusal rate of VA interviews, and ethical clearance requirement. All 17 sites obtain verbal consent for conducting VA interviews. Nine of these sites reported that they rarely encounter refusals and six sites encountered no refusals at all. This is perhaps surprising, as the interview includes questions on alcohol use, smoking, illnesses such as HIV/AIDS or TB, and abortion. Furthermore, it is not clear how confidentiality of the information obtained from VA is maintained, as the interviews are often conducted by a person living in the neighbourhood of the deceased.

Informed consent is meant to ensure that study participants are treated with respect and safeguarded against coercion. The process and documentation of obtaining informed consent for clinical trials is rigorously regulated and monitored by ethics committees and trial monitors (CIOMS 2002). Although informed consent is a prerequisite for any qualitative research (http://www.codex.uu.se/texts/international.html), the regulatory requirements and monitoring of the consenting process of VA are not as rigorous as for clinical trials. Often community consent is obtained from village chiefs when the DSS is initiated and then verbal consent is obtained at the beginning of the VA interview (http://www.indepth-network.net/dss_site_profiles/dss_sites.htm). However, there is no clear requirement of information to be given to potential respondents. As the mortality data collection systems using VA are becoming the norm in many countries and there is a trend to position these systems in the office of the Registrar General of vital events (http://www.censusindia.net/srs21.html), VA is seen synonymous to registration of death, which is mandatory in many countries. If VA is considered mandatory for vital registration purposes, then the informal verbal consenting process may become less formal. The current process of informed consent to VA appears to be informal and inadequate. Arguably, written consent should be obtained before conducting any sensitive interview; thus we suggest introducing written consent from prospective respondents in accordance with the ethical principles of research and auditing the consenting process.

Most of the 17 sites that responded to our enquiry reported that the ethical clearance for conducting VA is embedded in the ethical approval for the overall DSS project and this approval is for an indefinite period. We assume that the sites that did not respond would also have obtained ethical clearance from the respective ethical committees when VA studies were initiated. However, it seems that there is no standard set for renewal of ethical clearance for conducting VA for extended periods. Mortality surveillance systems using VA that aim to provide data on mortality trends have to run for prolonged periods. Before setting up such systems for extended periods, the following questions have to be addressed: (i) How frequently should investigators renew the ethical clearance? (ii) If community consent is obtained, how often should it be repeated? (iii) What criteria should be used for assessing the ethical standards of the VA procedures? (iv) By whom and how often should mortality surveillance systems using VA be monitored and evaluated for adherence to ethical standards?

Way forward

  1. Top of page
  2. Introduction
  3. Emotional cost of VA
  4. Access to information
  5. Consenting process and ethical clearance
  6. Way forward
  7. References

There is a move to increase the coverage of mortality surveillance system using VA in order to create more robust estimates of causes of death globally (Setel et al. 2005). Quality standards for ethical conduct of VA need to be established and monitored. We suggest that the World Health Organization, and the institutions involved in running VA-based mortality surveillance systems, should make an effort to develop guidelines and mechanisms to regulate and monitor the ethical standards of these systems.

References

  1. Top of page
  2. Introduction
  3. Emotional cost of VA
  4. Access to information
  5. Consenting process and ethical clearance
  6. Way forward
  7. References
  • Anker M, Black RE, Coldham C, et al. (1996) A Standard Verbal Autopsy Method for Investigating Causes of Death in Infants and Children. WHO, Geneva, Switzerland.
  • Chandramohan D (1993) Verbal tools for adults deaths, Workshop Report. London School of Hygiene and Tropical Medicine, London.
  • Chandramohan D (1996) Verbal Autopsy Tools for Adult Death, Workshop Report. London School of Hygiene and Tropical Medicine, London.
  • Chandramohan D, Maude G, Rodrigues L, Hayes R (1998) Verbal autopsies for adult deaths: their development and validation in a multicentre study. Tropical Medicine and International Health 3, 346446.
  • Feacham R, Phillips M, Bulatao A (1992) Introducing adult health. In: The Health of Adults in the Developing World. (eds AFeacham, TKjellstrom, RMurray, MOver, MPhillips), Oxford University Press, New York, pp. 121.
  • Gray RSG, Barss P (1990) The Use of Verbal Autopsy Methods to Determine Selected Causes of Death in Children. Institute for International Programs, School of Hygiene and Public Health, The John Hopkins University, Baltimore, Maryland, Occasional paper 10.
  • INDEPTH (2004) INDEPTH Model Life Tables for Sub-Saharan Africa, INDEPTH (also available online at http://www.ashgate.com).
  • Lopez A, Ahmed O, Guillot M et al. (2000) World Mortality in Life Tables for 191 Countries. World Health Organization, Geneva.
  • Mung'ala V, Snow R (1994) Death registration on the Kenyan coast. East African Medical Journal 71, 747750.
  • Murray C, Lopez A, Wibulpolprasert S (2004) Monitoring global health: time for new solutions. British Medical Journal 329, 10961100.
  • Ronsmans A, Campbell O (1994) Verbal Autopsies for Maternal Deaths, Report of a WHO Workshop. London School of Hygiene and Tropical Medicine, London.
  • Setel P, Sankoh O, Mathers C, Velkoff V, Rao C, Gonghuan Y et al. (2005) Sample registration of vital events with verbal autopsy: a new commitment to measuring and monitoring vital statistics. Bulletin of the World Health Organization 83, 611617.
  • University of Toronto (2004) Sample Registration System: Verbal Autopsy Manual of Instructions of Supervisors. Registrar General of India and Centre for Global Health Research Perspective Study of Six Million Indians. Technical Report No 1. University of Toronto (available at http://www.cghr.org).
  • CIOMS (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International Organisations of Medical Sciences in Collaboration with WHO. CIOMS.
  • WHO (2005) WHO Technical Consultation on Verbal Autopsy Tools, Talloires, France, 2–3 November 2004, Workshop Report, WHO, Geneva, Switzerland.