Data Privacy and Informed Consent
Protecting data privacy and obtaining informed consent are fundamental to ethical oral history and qualitative research. Informed consent not only fulfills legal and ethical responsibilities but also ensures participants are fully informed about their rights and the scope of their involvement. This tab outlines best practices for safeguarding data privacy and implementing informed consent in research.
It is important to note that each institution, repository, and publisher may have unique standards for privacy and informed consent. Be sure to consult the relevant point person or office for your specific project. If you need consent forms for a Utah State University Fife Folklore Archives-based project, contact the Curator for guidance.
1. What is Informed Consent?
Informed consent is both a process and documentation. It ensures participants are provided with all necessary information to make an educated decision about their participation, including:
- The purpose and scope of the research.
- How their data will be used, stored, and shared.
- The risks and benefits of participation.
- Their rights, including the right to withdraw at any time.
Consent must be informed, voluntary, and documented through either written or verbal means.
2. Elements of Informed Consent
Informed consent must include the following elements:
- Purpose and Use of the Research: Clearly explain the goals of the project and how data will contribute to these goals.
- Participation Details: Outline what is expected of participants, including the duration, activities, and any follow-ups.
- Risks and Benefits: Highlight any potential risks (e.g., privacy concerns) and benefits (e.g., contributing to public knowledge).
- Data Handling: Explain how recordings and transcripts will be stored, shared, and preserved, and clarify whether they will be anonymized or publicly accessible.
- Withdrawal Rights: Emphasize that participation is voluntary and that participants can withdraw at any point without penalty.
3. Methods for Obtaining Consent
Written Consent
- Standard for Most Research Projects: Consult your institution for relevant forms.
- Documentation: Requires a signed form documenting the participant’s understanding and agreement.
Verbal Consent
Verbal consent is an alternative to written consent, often used in situations where cultural norms, practicality, or the nature of the study make obtaining a signature unnecessary or inappropriate. It ensures participants are fully informed while avoiding the formalities of written documentation.
When Verbal Consent is Appropriate
- Cultural Sensitivity: In communities where signing documents is uncommon or inappropriate.
- Logistical Challenges: Remote or time-sensitive interviews where written consent is impractical.
- Low-Risk Studies: Research deemed minimal risk by the IRB, often with an exemption from formal documentation requirements.
Best Practices for Verbal Consent
- Clearly Communicate Key Information: Explain the purpose of the study, how the data will be used, and participants’ rights, including their ability to withdraw at any time.
- Record the Verbal Consent (Optional): If allowed by the IRB and culturally appropriate, consider recording the participant’s verbal consent at the beginning of the interview. Example: "Do you understand the purpose of this project and your rights as a participant? Do you agree to participate in this study?"
- Note-Taking: Maintain internal notes summarizing when and how consent was obtained, especially for exempt studies where forms are not required.
When Documentation is Necessary
In some cases, verbal consent may still require supporting documentation:
- Short Form: A brief document stating that the elements of informed consent were presented orally. This is typically signed by a witness if required by the IRB.
- Written Summary: A detailed overview of what was explained during the verbal consent process, signed by the researcher and, if applicable, the participant.
4. Privacy Considerations During the Consent Process
- Confidentiality:
- Allow participants to opt for anonymity or pseudonymity.
- Redact sensitive details upon request.
- Data Security:
- Store signed forms securely, using encryption for digital files.
- Avoid sharing identifiable consent documents unless necessary.
5. Addressing Cultural and Contextual Nuances
- Respect for Cultural Norms:
- Tailor the consent process to cultural expectations, such as using verbal consent in communities where written signatures are uncommon.
- Special Considerations for Vulnerable Populations:
- Use simplified consent forms or supplemental materials (e.g., videos or infographics) to enhance understanding.
- For minors or individuals unable to provide consent, seek permission from legally authorized representatives (LARs).
6. Waivers and Alterations to Informed Consent
In some cases, the requirement for written consent can be waived or altered if:
- Minimal Risk Research: The study poses minimal risk, and written consent is impractical.
- Cultural Sensitivity: Collecting signatures would violate cultural norms.
- Confidentiality Risks: The only link between participants and the study is the signed consent form, and its existence could pose a risk to privacy.
In these cases, researchers must document the steps taken to inform participants and ensure voluntary participation.
7. Best Practices for Informed Consent
- Use Accessible Language: Avoid jargon; ensure forms and explanations are clear and easy to understand.
- Interactive Consent Processes: Consider incorporating visual aids, videos, or Q&A sessions to enhance participant understanding.
- Ongoing Consent: Recognize that consent is not a one-time event. Revisit consent if project goals or data use plans change.
Additional Resources