Table 1 Ten guiding questions

What are the objectives of the initiative? How are they linked to potential improvements in public health?

− A clear link must be provided between the initiative and potential public health improvements; potential benefits may be immediate or future. Collection of data where public health value is more speculative may be permissible with justification.

− This question serves as an anchor for review, as many of the questions below relate back to the original objectives.

Can the objectives be achieved using the proposed methods?

− Initiatives lacking sufficient methodological rigour may lead to data that is of poor quality or invalid, wasting resources and potentially causing potential harm through misinformation.

− Requirements for scientific rigour must be balanced with sensitivity to the context in which an activity is implemented.

− Judgment regarding the design of an initiative requires relevant methodological expertise as well as some knowledge about the participating populations and other contextual details, as relevant.

Who are the expected beneficiaries of the knowledge gained or other benefits?

− Beneficiaries may include individuals and/or communities, whether or not they are directly participating in the proposed initiative.

− Individual and collective interests may be shared or competing, or both, depending on the circumstance.

What are the burdens and potential harms associated with the proposed initiative? Who bears them?

− Harms associated with evidence generation in public health frequently arise from collection, use or disclosure of information; potential consequences include stigmatization, discrimination, psychological distress or economic loss. Other harms, such as threats to health, may also occur.

− Burdens generally are borne by those participating in an initiative. Harms may affect individuals and/or communities, whether or not they are directly participating in the proposed initiative.

− Potential harm to relationships should be considered.

− Where possible, an effort must be made to mitigate or minimize risks and burdens, balancing against any loss in potential benefit.

Are burdens and potential harms justified in light of the potential benefits to participants and/or to society?

− Burdens and potential harms should be weighed against not only potential benefit from conducting an inquiry, but the harm in not carrying out that inquiry.

− Burdens or harms may accrue to different individuals/groups than those receiving the benefit but, where this is the case, there should be some justification.

− “Fair procedures” such as transparency and stakeholder participation should be used to guide decision making regarding balancing of burdens, harms and benefits.

Is selection of participants fair and appropriate?

− Fair distribution of burdens, risks and potential benefits includes paying special attention to vulnerable or disadvantaged populations, to be included where there is potential benefit, excluded where certain groups face greater burden or risk, or preferentially

− Included because of increased probability or magnitude of benefit.

− The principle of reciprocity requires finding ways to give back to individuals or communities that bear a disproportionate share of burden or risk for the benefit of others.

Is individual informed consent warranted? Is it feasible? Is it appropriate? Is it sufficient?

− While important, individual autonomy does not always take priority over other ethical concerns, such as welfare of populations.

− For many public health initiatives, obtaining individual consent may not be required, feasible or appropriate. Where departure from individual informed consent is proposed, consider alternatives such as broad consent, notice with opt out, and consultation with a representative sample of the population of interest.

− In certain cases, such as examination of illegal behaviour, alternative approaches such as use of verbal consent or pseudonyms may be appropriate.

Is community engagement warranted? Is it feasible? What level of engagement is appropriate?

− Community engagement is encouraged where feasible and might be used in lieu of, or in addition to individual consent.

− Engagement may range from informing to consultation, collaboration and empowerment.

− Community engagement may include some form of collective consent or consensus process authorizing the initiative in the community.

− Challenges include determining what level of engagement is appropriate, what counts as a community, and who the appropriate representatives are.

What are the social justice implications of this initiative?

− Projects that reinforce existing inequities should be avoided and opportunities to promote social justice should be considered where possible.

− Extra resources or special measures may be needed to promote social justice, for example to ensure that disadvantaged groups are appropriately considered in the development of project objectives, or to remove barriers to their participation in public health initiatives.

What are the potential longer-term consequences?

− Where possible, potential negative long-term consequences of an initiative should be considered and plans for mitigating these risks should be developed prior to implementation.

− Community engagement can be helpful both in identifying potential long term harms, and in devising methods to address them.