Human Subject Participants in your Study

Scenario: You have been requested by the Institutional Review Board to justify your study using a qualitative research design.  You have selected 2 focus groups with 12 participants in each of the two groups.

Address how you will protect the human subject participants in your study.  Consider the following issues:

1) informed consent,

2) voluntary participation,

3) confidentiality,

4) mitigation of risks,

5) maintenance and security of all data and materials,

6) use of audio/video,

7) participant’s right to drop out of study, and

8) deception/coercion.

Protection of Human Subjects in Qualitative Research

In conducting this qualitative study using two focus groups with 12 participants each, I will adhere to ethical principles to ensure the protection of all human subject participants. The following safeguards will be implemented:

1. Informed Consent
   Each participant will receive a detailed informed consent form explaining the study’s purpose, procedures, potential risks and benefits, and their rights as participants. This form will be written in clear, accessible language. Participants will have the opportunity to ask questions before signing, and they will be provided with a copy of the consent document.

2. Voluntary Participation
   Participation in the study will be entirely voluntary. No individual will be pressured to join, and participants will be informed that they are free to decline or withdraw at any point without consequences.

3. Confidentiality
   To protect participant confidentiality, all personal identifiers will be removed from data, and pseudonyms will be assigned. Focus group discussions will be transcribed without identifying details, and any potentially revealing information will be redacted. Participants will be asked to maintain the confidentiality of discussions shared in the group.

4. Mitigation of Risks
   The study will be designed to minimize psychological or emotional risks. If sensitive topics arise, participants will be reminded that they can choose not to answer any question. Should distress occur, resources for mental health support will be provided.

5. Maintenance and Security of All Data and Materials
   All study-related data, including transcripts and consent forms, will be securely stored on a password-protected computer and encrypted external drive. Physical documents will be kept in a locked cabinet accessible only to the research team. Data will be retained for five years per Institutional Review Board (IRB) requirements and then securely destroyed.

6. Use of Audio/Video
   Focus group discussions will be audio-recorded for accuracy in transcription. Participants will be informed of the recording process during consent, and they may opt out if uncomfortable. Video recording will not be used to further protect anonymity.

7. Participant’s Right to Drop Out of Study
   Participants can withdraw from the study at any time without providing an explanation. Any data collected from them before withdrawal will be excluded from analysis if they request removal.

8. Deception/Coercion
   No deception will be used in this study. All participants will be provided with full transparency regarding study procedures. To prevent coercion, no incentives that may unduly influence participation will be offered.

The post Human Subject Participants in your Study appeared first on Academic Research Experts.