Table 7 Overview of ethical considerations: potential risks of participation and planned strategies 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

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

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

(3) Training all study staff in the importance of and procedures for protecting participants’ confidentiality, including the use of a signed confidentiality agreement

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

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

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

(3) Training of study staff to approach sensitive topics in a culturally appropriate and nonjudgmental way

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

(1) Inform participants of potential risks in the informed consent process

(2) Training of group facilitators to create a safe space for open discussion at the start of each session

(3) Training of group facilitators in strategies to approach discussions that challenge gender norms carefully