The guidelines below were developed following a Working Group on Disaster Research and Ethics (WGDRE) meeting in 2007 with the aim of developing ethical guidelines which would be applicable to post-disaster research, partiuclarly that performed in the developing world. We welcome any feedback from members.

The Draft Statement/Guidelines for Disaster Research

In addition to the accepted national and international ethical guidelines for the conduct of research, we urge researchers to pay particular attention to the following ethical principles when conducting research in disaster-affected situations. These guidelines are meant to supplement the relevant existing national and international documents and not to replace them. The areas which these guidelines address include the potential for harm resulting from the research process and its socio-political implications, and the potential for the exploitation of the research participants as well as the affected community. They also look at conflicts of the researchers’ interests with that of the community being studied, and the process of recruitment of survivors as participants with a particular emphasis on obtaining valid and truly informed consent. These guidelines also emphasise gender and cultural sensitivity, and the need for research to contribute to the healing and empowerment of the disaster-affected community.

  1. Relevance to disaster situations
    a) Research planned to be conducted after a disaster should be essential and is not possible in non-disaster situations.
    b) The objectives of all potential research in disasters should be weighed very carefully for their potential contribution to the survivors, and for their value in future disaster situations.
    c) All phases of the research must be culturally sensitive and should involve those familiar with the community’s situation and their cultural beliefs and practices.
  2. Informed consent and voluntariness
    a. Any research is only to be carried out with the prior, free and informed consent of the person concerned based on adequate information.
    b. The research team must identify factors that serve as a barrier to the freedom of individual members of the participant population to give consent, and provide effective mechanisms to address them.
    c. Survivors of disaster situations are particularly vulnerable and should not be subjected to inducement.
    d. Research should not be disguised as treatment, relief or humanitarian aid. Every effort must be made in the informed consent process to make research participants aware of the difference between participating in a study and receiving humanitarian aid. The different roles of the researchers, caregivers, and volunteer workers must always be clarified, and the potential conflicts of interest declared.
    e. In cases of collection and storage of human biological materials during a disaster, the purposes of such collection and storage should be explicitly stated in the informed consent process and also that these materials gathered would not be used for any other purpose.
    f. The requirement for research on children affected by disasters cannot be ruled out. However, due to their greater vulnerability, the researcher will have to justify the need to use children as research participants. The informed consent process will have to incorporate mechanisms of proxy consent by their parents or guardians and include provision from permission by the child whenever applicable. The reviewers will look very carefully at the process of consent involving children who have lost one or both parents in the disaster. 
  3. Community consultation and participation
    a. Community participation before and during the research is essential in disaster-affected communities.
    b. The researchers and review process need to identify the communities that may be affected by the research and consult with them. The research team must describe a preliminary community mapping/scoping exercise to ensure familiarity with the community as well as identify local resources who will support ethical execution of the research.
    c. A community representative or advocate must be identified by a process which is acceptable to the study population.
    d. Community representatives or advocates should be involved in conceptualisation, review, research and dissemination of research involving disaster-affected populations.
    e. In no case should a collective community agreement or the consent of the community leader or other authority or advocate substitute for an individual’s informed consent.
  4. Non-exploitation
    a. The selection of research participants must be made on scientific reasons and not based on accessibility, cost, gender or malleability.
    b. The research should not impose additional burdens on people who are already traumatised, and on the local infrastructure.
  5. Dignity, privacy and confidentiality
    a. Given the circumstances that survivors of a disaster face, extra care must be taken to protect the privacy and confidentiality of individuals and communities.
    b. In the collection of data and human biological material, human dignity must be respected for both survivors and the deceased.
    c. Similarly, stringent standards must be maintained for the storage and possible sharing of human biological material and data.
    d. Utmost attention must be paid to prevent stigmatisation, ostracisation, and other harm to individuals and communities at all stages in the research process.
  6. Risk minimisation
    a. Since disaster-affected populations are particularly vulnerable, it must be ensured that the conduct of research imposes the absolutely minimal risk.
    b. Risks that are acceptable under ordinary circumstances may not necessarily be acceptable in disaster situations.
    c. The research team must demonstrate the ability to anticipate adverse reactions and facilitate appropriate interventions.
  7. Institutional arrangements
    a. Institutions that sponsor and conduct research should recognise that a stronger ethical obligation is required in disaster-related research.
    b. Research in disasters should be coordinated with other disaster relief activities.
    c. Research should not disrupt or further burden the existing infrastructure.
  8. Professional Competence
    a. Ensure professional competence of all members of the research team for their specific tasks.
    b. The highest standards of scientific research and peer review should be maintained through the entire process.
  9. Public interest and distributive justice
    a. The research undertaken should provide direct or indirect benefits to the researched group, the disaster-affected community or future disasteraffected populations.
    b. Prior agreement should be reached, whenever possible, between the community and the researcher on what benefits could arise from the research, and how they would be shared.
    c. The actual benefits arising from research should be shared with society as a whole and with the international community with due consideration to the potential negative effects upon the participants and the communities involved, in consultation with the community.
  10. Dissemination of results
    a. Transparency in the dissemination of results should be a prior condition for the conduct of research in disasters.
    b. Research published in open access journals will ensure the widest dissemination of findings.
    c. Efforts should be made to use the results of research to influence the formulation and modification of policy.
    d. The presentation of the results of research to the community who participated in the research, and to the public, should be after a process of peer review has validated the conclusion reached.
    e. The relevant results need to be presented in understandable language to research participants and the participating community.
  11. Ethics review
    a. Independent, multidisciplinary and pluralist ethics committees should assess all the relevant ethical, cultural, legal, scientific and social issues related to research projects. These should include representation or advocates from the disaster-affected community.
    b. All research should be subject to local ethics review that includes regular feedback from the researchers and community representatives.
    c. In addition, there should be a centralised mechanism (such as a national ethics review committee) for review and coordination of all research in the disaster-affected area to ensure a wide perspective on all the research and to prevent unjustified repetitive work.
    d. A central/national “clearing house” on an open website would be more effective in preventing duplication, as well as letting everyone know what topics have been covered, are currently being researched, and which ones are being planned.
    e. Prior ethics review and approval may be taken before initiating research in an expected disaster situation of periodic or recurrent nature. However, the research may commence only after consultation with the actual disaster-affected community.
    f. Expedited review may be necessary in exceptional situations, but should be conducted with extreme caution. This expeditious review must follow the standard procedure considering the guidelines mentioned above, with a quorum agreed beforehand.
    g. In the case of research projects that commenced before a disaster, the investigators must go back to the ethics review board to consider
    — in consultation with the community, wherever or whenever possible
    — whether the research may continue or stop.
    h. Where applicable, the protocol should include provisions for aftercare, including appropriate mechanisms for continuation of essential services that were associated with the research protocol, and a proper referral mechanism to deal with the needs of participants and members of the
    research team.
  12. International collaborative research
    a. All research in the disaster-affected area needs to be done with a local partner(s).
    b. Such collaborations should be based on mutual respect and partnership. Collaboration needs to be undertaken between national researchers, policymaker and the community, to share responsibility for determining the importance of the problem, assessing the value of the research, planning, conducting, and monitoring the research, and integrating that research into the social system.
    c. Contribute to developing the capacity for researchers, policy makers, and the community to become full and equal partners in the international research enterprise.
    d. Permission taken from local authorities does not exclude the requirement for ethics review at local and national levels.
    e. Special consideration should be given to the transfer of biological material, ownership of data and intellectual property rights issues. The export of biological materials from a disaster-affected area should be strictly regulated through a central mechanism.
    f. Benefits of the research, if any, financial or non-financial, should be shared fairly with the community and decided a priori.

References
Berg, J. and N. King (2006) Strange Bedfellows? Reflections on Bioethics’ Role in Disaster Response Planning, The American Journal of Bioethics, 6 (5), 3–5.


Inter-Agency Standing Committee (IASC) (2007) IASC Guidelines on mental health and psychosocial support in emergency settings, IASC, Geneva.


International Committee of Medical Journal Editors (ICMJE) (1982) Uniform requirements
for manuscripts submitted to biomedical journals, Ann Intern Med, 96, 766–7.

(1991) Statements from the International Committee of Medical Journal
Editors, JAMA, 265 (20), 2697–8.


Patel, V., and A. Sumathipala (2006) Psychological approaches to somatisation in developing countries, Advances in Psychiatric Treatment, 12, 54–62.

Rose S., J. Bisson, R. Churchill, and S. Wessely (2002) Psychological debriefing for preventing post traumatic stress disorder, Cochrane Database Syst Rev, 2002 (2), art. no.: CD00560, doi: 10.1002/14651858.CD000560.


Samaraweera, S., S.H. Siribaddana, S. Sivayogan, A. Sumathipala, and D. Bhugra (2008) Psychological autopsy on completed suicides of Sinhalese in Ratnapura, Suicide and Life Threatening Behaviour, 38 (2), 221–8.

Samaraweera, S., S.H. Siribaddana, A. Sumathipala, and D. Bhugra (2007) RCT of Cognitive Behaviour Therapy in active suicidal ideation — a feasibility study in Sri Lanka, European Journal of Psychiatry, 21 (3), 175–8.

(2008) Prevalence of Suicidal ideations from Sri Lanka, Crisis (in press).


Simpson, B. (2001) Ethics regulation and the new reproductive technologies in Sri Lanka, The Ceylon Medical Journal, 46 (2), 54–7.


Siribaddana, S., H. Ball, Z. Hewage, N. Glozier, Y. Kovas, D.A.R.K. Dayaratne, A. Sumathipala, P. McGuffin, and M. Hotopf (2008) Colombo Twin and Singleton Study (CoTASS): A description of a population based twin study of mental disorders in Sri Lanka, BMC Psychiatry, 8, 49–54.


Siribaddana, S., S. Hewege, D. Siriwardena, M. Athukorale, A. Sumathipala, and M. Hotopf (2006) Update from Sri Lankan twin registry; establishment of population based register and ongoing project on common mental illness, alcohol and suicidal ideation. Invited data based article in the special issue on twin registers, Twin
Research and Human Genetics, 9 (6), 868–74.


Siriwardhana C. (2007) Disaster Research Ethics — A Luxury or a Necessity for Developing Countries? Available at http://www.asiantribune.com/index.php?q=node/4524. Sumathipala, A., S. Hewege, R. Hanwella, and A.H. Mann (2000a) Randomised controlled trial of cognitive behaviour therapy for repeated consultations for medically unexplained complaints: a feasibility study in Sri Lanka, Psychological Medicine, 30 (4), 747–57.


Sumathipala, A., and J. Murray (2000) New approach to translating instruments for cross-cultural research: a combined qualitative and quantitative approach for translation and consensus generation, International Journal of Methods in Psychiatric Research, 9 (2), 87–95.


Sumathipala, A., D.J.S. Fernando, S.H. Siribaddana, M.R.N. Abeysingha, R.W. Jayasekare, V.H.W. Dissanayake, and N. De Silva (2000b) Establishing a twin register in Sri Lanka, Twin Research, 3 (4), 202–4.

Sumathipala, A., S.H. Siribaddana, N. De Silva, D.J.S. Fernando, M.R.N. Abeysinghe, R. Dayaratne, D. De Silva, N. Warnasuriya, and M. Hotopf (2002) Sri Lankan Twin Registry — Supplement on twin registries, Twin Research, 5 (5), 424–6.


Sumathipala, A., S. Siribaddana, S. Samaraweera, and D.A.R.K. Dayaratne (2003a) Capacity building through multi-disciplinary research: a report from Sri Lanka, British Journal of Psychiatry, 183, 457–8.


Sumathipala, A., S. Siribaddana, and N. De Silva, (2003b) Qualitative research, a review, Ceylon Medical Journal, 48 (4), 136–9.

Sumathipala, A., S.H. Siribaddana, M.R.N. Abeysinghe, N. De Silva, D.J.S. Fernando, D.A.R.K. Dayaratne, D. De Silva, N.D. Warnasuriya, and M. Hotopf (2003) Challenges in Recruiting Older Twins for the Sri Lankan Twin Registry, Twin Research, 6 (1), 67–71.


Sumathipala, A., and S. Siribaddana (2003) Research ethics from a developing world perspective, Vijitha Yapa Publishers, Colombo.


Sumathipala, A. (2004) Cognitive behaviour therapy for medically unexplained symptoms, PhD thesis, University of London.


Sumathipala, A, Siribaddana S, Samaraweera S. (2004) Do patients’ volunteer their life weariness and suicidal ideations? A Sri Lankan Study, Crisis, 25 (3), 103–7.

Sumathipala, A., S. Siribaddana and V. Patel (2004) Under-representation of developing countries in the research literature: ethical issues arising from a survey of five leading medical journals, BMC Med Ethics, 5, 5.


Sumathipala, A., S. Siribaddana, S. Mangava and P. De Silva (2006c) Cognitive Behavioural therapy for Medically Unexplained symptoms, Forum for Research and Development Publication, Colombo.


Sumathipala, A., S. Siribaddana and C. Perera (2006d) Identification and management of dead bodies as a component of psychosocial interventions after the Tsunami: a view from Sri Lanka, International Review in Psychiatry, 18 (3), 249–57.


Sumathipala, A., S. Siribaddana, M.R.N. Abeysingha, P. De Silva, M. Dewey, M. Prince, and A.H. Mann (2008a) A randomised controlled trial of cognitive behavioural therapy versus structured care for medically unexplained symptoms in a primary care setting in Sri Lanka, British Journal of Psychiatry, 193, 51–9.


Sumathipala, A., S. Siribaddana, S. Hewege, M. Lekamwattage, M. Athukorale, C. Sisirawadena, J.A. Murray, and M. Prince (2008b) Informed consent in Sri Lanka: views of ethics committee members: A qualitative study, BMC Medical Ethics, 20, 9–10.


Sumathipala, A., S. Siribaddana, S. Hewege, M. Lekamwattage, M. Athukorale, C. Sisriwardene, J.A. Murray and M. Prince (2008c) Ethical approval and informed consent: analysis of biomedical publications originating from Sri Lanka, BMC Medical Ethics, 9, 3.


Sumathipala, A., S. Siribaddana, M. Prince, and A.H. Mann (2008e) Understanding the cognitive representation of medically unexplained symptoms and its implication on treatment development research: A Sri Lanka study, BMC Psychiatry, 8, 54.

Van Emmerik, A.A., J.H. Kamphuis, A.M. Hulsbosch, and P.M. Emmelkamp (2002) Single session debriefing after psychological trauma: a meta-analysis, Lancet, 360, 766–71.


WHO (2003) Mental and social aspects of health of populations exposed to extreme stressors, World Health Organization. Available at http://www.who.int.

WHO EM-DAT Collaborating Centre for Research on Epidemiology Disasters Emergency event data base. Available at http://www.emdat.be.

Also By

Arthula Sumathipala, Aamir Jafarey, Leonardo de Castro, Aasim Ahmad, Darryl Marcer, Sandya Srinivasan, Nandini K. Kumar, Slemen Sutaryo, Anant Bhan, Dananyaja Wadeyaratne, Sriyakanthi Beneragama, Chandrani Jayasekera, Sarath Edirisingha, Chesmal Siriwardhana, Sisira Siribaddana

Reply

Please Sign in (or Register) to view further.