To the Institutional Review Board,
This document outlines the procedures that will be implemented to protect human subjects participating in our qualitative research study utilizing two focus groups, each with 12 participants, for a total of 24 participants. We are committed to upholding the highest ethical standards and ensuring the well-being of all participants.
1) Informed Consent:
Prior to participation, each potential participant will receive a detailed informed consent form. This form will clearly explain the study’s purpose, procedures (including the focus group format and estimated duration), potential risks and benefits of participation, and the voluntary nature of their involvement. Participants will be given ample time to review the form and ask questions. Written informed consent will be obtained from each participant before they are allowed to participate in the focus group. For participants who may have limited literacy, the consent form will be read aloud and explained verbally, with their verbal consent documented in the presence of a witness.
2) Voluntary Participation:
Participation in this study is entirely voluntary. The informed consent form will explicitly state that participants are free to decline to participate or to withdraw from the study at any time without penalty or loss of benefits to which they are otherwise entitled. Participants will be reassured that their decision to participate or not will not affect their relationship with the research team or the institution.
3) Confidentiality:
All data collected during the study will be treated as confidential. Participants will be assigned pseudonyms or identification numbers to protect their anonymity. No identifying information, such as names or other personal details, will be included in any reports or publications resulting from this study. Data will be stored securely (see section 5) and accessed only by authorized research team members. Participants will be informed that while they are encouraged to respect the confidentiality of other participants within the focus group, the researchers cannot guarantee that other participants will not disclose information shared within the group outside of the focus group setting.
4) Mitigation of Risks:
The primary risk associated with participation in this study is the potential for emotional distress or discomfort related to discussing sensitive topics [mention specific topics if applicable]. To mitigate this risk, participants will be informed of the nature of the discussion beforehand and given the option to decline to answer any question they are uncomfortable with. The focus group facilitator will be trained to create a supportive and respectful environment, to address any emotional responses that may arise, and to provide resources for participants who may need additional support (e.g., contact information for mental health services).
5) Maintenance and Security of All Data and Materials:
All data and materials, including audio/video recordings (see section 6), transcripts, and notes, will be stored securely in password-protected electronic files and/or locked cabinets. Access to these materials will be limited to authorized research team members who have received training in data security and confidentiality. Data will be retained only for the duration necessary to complete the research project and will be securely destroyed after that time.
6) Use of Audio/Video:
Focus group discussions will be audio-recorded to ensure accurate transcription and analysis. Participants will be informed of the recording process in the informed consent form and given the opportunity to decline to be recorded. Video recording will [be/not be] used in this study. If video recording is used, the same consent procedures will be followed. Recordings will be used solely for research purposes and will be stored securely as described in section 5. Transcripts will be created from the audio recordings, and the recordings themselves will be destroyed after transcription is complete and verified.
7) Participant’s Right to Drop Out of Study:
Participants will be explicitly informed in the informed consent form that they have the right to withdraw from the study at any time, for any reason, without penalty. If a participant chooses to withdraw, any data collected from that participant up to the point of withdrawal will be destroyed.
8) Deception/Coercion:
No deception will be used in this study. Participants will be fully informed about the study’s purpose and procedures. Participation will be entirely voluntary, and no coercion of any kind will be used to encourage participation. Participants will be free to make their own decisions about whether or not to participate without any pressure from the research team.
We believe that these procedures adequately address the ethical considerations involved in conducting this qualitative research study and will ensure the safety and well-being of all participants. We are committed to conducting this research in a responsible and ethical manner.
