Building on Lessons from the WHO Publication Putting Women First: Ethical and Safety Recommendations for Research on Domestic Violence against Women

Publication Date
2016

Developed in conjunction with a global network of researchers, scientists, and practitioners on violence against women (VAW), these World Health Organization (WHO) recommendations offer guidance on how to address questions specific to conducting research on health-based interventions to prevent and respond to VAW. The focus is on ethical and safety considerations for various stages of research - from design and development of interventions to evaluation of outcomes and impacts, and, finally, to obligations upon study completion. The specific emphasis is on issues associated with conducting longitudinal research (quantitative and/or qualitative) on VAW interventions, including randomised controlled trials (RCTs), quasi-experimental studies, and prospective programme evaluations. The recommendations are intended to support research teams to design ethical and safe studies and discuss these issues with research ethics review boards, and ultimately to protect the safety of those implementing and participating in such research.

The new recommendations reflect the ethical concerns on VAW research, expressed in numerous articles and publications, that have come to light since WHO published Putting Women First: Ethical and Safety Recommendations for Research on Domestic Violence Against Women in 2001. As the evidence base on the magnitude, context, and consequences of VAW has grown, research efforts and attention have begun to focus on decreasing the knowledge gap on effective responses through intervention research. Some of the questions to be explored include, for example, how can researchers safely approach selection, recruitment, and follow-up of participants in a study to evaluate the outcomes and impacts of an intervention to prevent violence? How do researchers address randomisation of participants into control or intervention arms? How do researchers monitor and manage risk of violence from participation in the intervention? And what additional protections should be put in place when the research involves populations requiring special considerations, such as pregnant women?

A graphic in the report provides an overview of the recommendations in the original WHO publication; it is highly recommended that researchers closely review that document (click here [PDF]). They include:

  1. The safety of respondents and the research team is paramount and should guide all project decisions.
  2. Prevalence studies need to be methodologically sound and to build upon current research experience about how to minimise the under-reporting of violence.
  3. Protecting confidentiality is essential to ensure both women's safety and data quality.
  4. All research team members should be carefully selected and receive specialised training and ongoing support.
  5. The study design must include actions aimed at reducing any possible distress caused to the participants by the research.
  6. Fieldworkers should be trained to refer women requesting assistance to available local services and sources of support. Where few resources exist, it may be necessary for the study to create short-term support mechanisms.
  7. Researchers and donors have an ethical obligation to help ensure that their findings are properly interpreted and used to advance policy and intervention development.
  8. Violence questions should only be incorporated into surveys designed for other purposes when ethical and methodological requirements can be met.

For 5 of the above original recommendations, the report outlines additional considerations.

  • With regard to #1 above (on safety), there are several additional issues, particularly related to confidentiality of the research topic and the consent process, to consider in the context of intervention research. For example, studies that have successfully involved other household or community members in VAW intervention research while maintaining the confidentiality of the study's primary focus on violence indicate that the following actions can assist in this effort:
    • Give careful consideration to the title of the study or intervention and how it is described to other team members, the public, participating agencies, and potential participants.
    • Pay attention to the questions asked of each type of participant. For example, when engaging both victims and perpetrators of violence in interventions where violence is being indirectly assessed (e.g., the focus on violence has not been disclosed to the perpetrators of violence), it is advisable to avoid focusing on the perpetrators; questions about both perpetration and experience of violence should be posed to both groups.
    • Develop standardised scripts that both staff and participants can use comfortably to answer questions about the study posed by uninvolved family and community members and that avoid disclosing violence as the primary focus. Use standardised scripts during community-based data collection or participant follow-up when research teams may interact with, or be interrupted by, uninvolved family and community members.
    • Actively monitor how the research is discussed within the community, which may include monitoring of rumours by community advisors or interviews with community members to assess their awareness of the study's focus on violence.

    Other concrete guidance is shared, for instance with regard to minimising power hierarchies. In addition to not overstating the therapeutic benefit of the study, researchers should be sensitive to the potential influence of social hierarchies on voluntary informed participation. For example, in many settings, health-care providers are treated with respect and deference, and individuals, particularly those who are experiencing violence, may be disinclined to refuse their requests. Research study staff obtaining informed consent should be trained to pay attention to standards of behaviour or appearance, such as dress, jewellery, or mode of transportation, that can reduce social differences. Another strategy that may mitigate these power hierarchies is to recruit staff of a similar sociodemographic background to the study population.

  • With regard to #3 above (on confidentiality), there are additional considerations such as the fact that studies conducted in a health-care setting offer several advantages in terms of confidentiality protection. Researchers may be able to use health centre telephones and/or staff to follow up with participants in the apparent context of a routine health-care follow-up, reducing the chance that the phone number or individual making the contact is viewed suspiciously by participants' partners or others in their social network. However, other risks remain. The health centre staff may be known to the woman in her personal life (e.g., friends, family members, neighbours), which can raise issues of confidentiality. Staff should be prepared ahead of time as to how to handle these circumstances (e.g., with the use of scripts and code words). Women should always be prepared by the study team to respond to questions from family members or others regarding where they are going and why they are going with a certain frequency, and should be consulted regarding safe practices for contact (as described).
  • With regard to #4 above (regarding the research team), topics explored here include: division of counselling and research roles; additional areas of training (e.g., role-playing during training using a variety of scenarios that may arise in group settings); and assessing and addressing need for staff support.
  • With regard to #6 above (on referrals), it is noted that, because of the potentially longitudinal nature of intervention research, the responsibility of the research team, as well as the opportunity, to refer women to additional services and sources of support may be increased and may necessitate additional actions to keep the research team's knowledge of resources and relationships with referral service providers up to date.
  • With regard to #7 above (on communication of findings), WHO stresses that dissemination of results to participants, researchers, service providers, and the general public should avoid stigmatising or exacerbating risks faced by participants and the vulnerable populations they represent. The following strategies are suggested:
    • Consult with local stakeholders at the study outset to discuss the health, social, and economic circumstances that may influence expectations and the future provision of interventions.
    • Discuss sustainability/scale-up of effective interventions with study sponsors prior to study launch. Issues include the strength of evidence and what additional data may be needed to determine decisions regarding the availability of effective interventions to the study population or the broader community (city, state, country).
    • Clarify actions needed to advance adoption and implementation of efficacious interventions such as establishing links with advocacy groups, strengthening human resources or providing training.
    • Maintain transparency with all consultations and resulting decisions, taking care to minimise any unequal power hierarchies between the research team, community members, and participants.

The document also outlines new recommendations for intervention research, describing each in detail. In short:

  1. Intervention studies need to be methodologically sound and build on the current evidence base of interventions and intervention research experience.
  2. Processes and criteria for participant recruitment should be carefully considered to avoid excluding women who may not initially disclose experience of violence.
  3. Participant randomisation should be transparent and described in a way that can be easily understood by those involved in the research.
  4. The provision of services to comparison-arm participants should maintain a minimum standard of care.
  5. Measuring and monitoring harm related to the research should be incorporated into safety protocols (includes special consideration for research in antenatal care settings and special considerations related to mandatory reporting requirements).

The concluding section of the document stresses that, as with all recommendations, research teams will need to interpret the information provided here in the context of their own research questions and settings. Given the relatively new focus on intervention research, WHO recognises that these recommendations will need to be updated as additional experience is gained. "We hope this will be a growing resource for future research teams." An annex includes sample language and is followed by a glossary of relevant terms.

Source: 

Posting from Ados May to the IBP Global community, December 1 2016; and WHO website, December 1 2016.