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Table 5 Overview of ethical considerations: potential risks of participation and planned strategies for risk mitigation

From: The “Family Health = Family Wealth” intervention: study protocol for a pilot quasi-experimental controlled trial of a multi-level, community-based family planning intervention for couples in rural Uganda

Risks

Safeguards for risk mitigation

Potential for breaches in confidentiality related to collected data

(1) The use of unique identifiers instead of medical identification/record numbers or participant names

(2) The storing of the lists that link the participants to their unique identifiers in locked, secure locations

(3) The use password protection for all data collected and/or stored electronically

(4) Training all study staff in the importance of and procedures for protecting participants’ confidentiality

Potential to experience discomfort while discussing sensitive information during interviewer administered computerized questionnaires and group intervention sessions

(1) IRB-approved consent forms to convey that the survey portion of the research project and group sessions involve sensitive topics

(2) The ability to skip any questions that makes one uncomfortable and to withdraw from the study any time

(3) Training all study staff in the importance of procedures for protecting participants’ confidentiality

(4) Training of study staff to approach sensitive topics in a culturally appropriate and non-judgmental way

Potential unintended negative consequences on participants in the intervention (e.g., conflict between partners)

(1) Inform participants of potential risks in the informed consent process and discourage participation among individuals who fear participation could increase their risk for violence victimization.

(2) Ask participants to inform study staff throughout the study if they feel they are experiencing an increased risk of violence so that they can be linked to resources and removed from the study if deemed necessary

(3) Monitor increased risk of violence through the post-intervention interview

(4) Monitor increased risk of violence through the 3-month and 6-month questionnaires

(5) Training of group facilitators to recognize disagreement between couples and will provide counseling to couples to minimize discordance, and the occurrence of conflict

(6) Training of group facilitators to guide couples’ in selecting action plan items that are appropriate for their circumstances