The Ethics of Research and Evaluation: Consent and Human Subjects Protections

I recently heard a story about wearable AI devices that can record all your interactions with other people (see Best AI Wearables 2025 - Forbes Vetted for some examples). One commentor reported being conscious that all her conversations are now potentially being recorded due to this new technology. All these recordings are data that might be used in ways that haven’t been anticipated and while technology rapidly moves forward, discussions of protecting the rights of human subjects in these scenarios have lagged in the U.S.

For the last thirty years or so with the increases in computing power, the advent of the internet, and ubiquity of data collection mechanisms, more entities have been conducting aspects of what would have been originally considered social science research, but without having to get approval through an Internal Review Board (IRB) that would ensure human subjects are protected. For example, back in the day, conducting a survey required sending out paper copies, calling people on the phone, or going to a person’s home. Now we get asked to fill out a survey almost immediately after we receive a service or purchase something.

Though possibly not strictly “research” in the traditional sense, data are being collected and analyzed, and thus human subjects’ protections should apply. Indeed, many of the guidelines of the 2018 EU General Data Protection Regulation (GDPR) seem based on the principles of human subjects’ protections (see General Data Protection Regulation (GDPR) Compliance Guidelines for more information). Under the GDPR, consent must be informed and freely given. I was on a project once where a junior staff member asked whether to tell people at the place where we were conducting a case study whether we should be asking people we had conversations with outside of a formal data collection session if we could use the information in the report. I told them “Yes,” because all research participants are entitled to provide informed consent if they are participating in research, and withdraw without penalty if they don’t want to participate.

I was once tasked with creating an Internal Review Board at the organization where I worked so I had to learn the history of human subjects’ protections and informed consent. This was in the 2000’s and I remember receiving a VHS tape training from the relevant government agency that I could use to help train the staff. The harmful medical origins of human subjects’ protections are well-documented – the Nuremburg Trials, the Tuskegee Experiments - but there were also cases of unethical social science-related data collection. One case of this was the illegal taping of jury deliberations during the 1950’s for legal research (see History of Research Ethics | Research and Innovation | University of Missouri - Kansas City for more information).

The concept of informed consent comes from the idea of respect for persons encapsuled in the Belmont Report. Respect for persons means that individuals are autonomous agents with the right to make their own choices (see The Belmont Report for more information). As described in The Belmont Report, “respect for persons demands that subjects enter into the research voluntarily and with adequate information (p.6).” As more entities seek to harvest and use data on customers, users, participants, etc., it is imperative to keep in mind that there are humans behind that data that require respect. Some tips for gathering informed consent as part of your studies include:

1. Use Clear and Simple Language

• Avoid jargon, technical terms, or complex legal language.

• Tailor the language to the participant’s age, education level, and cultural background. Translate the information into multiple languages.

2. Explain the Purpose of the Research

• Clearly state what the study is about.

• Describe why the research is being conducted and what it hopes to achieve.

3. Describe What Participation Involves

• Outline procedures, duration, and any tasks participants will be asked to do.

• Mention any audio/video recording, surveys, or physical activities.

4. Discuss Risks and Benefits

• Be honest about any potential risks, discomforts, or side effects.

• Highlight any direct or indirect benefits to the participant or society.

5. Emphasize Voluntary Participation

• Make it clear that participation is entirely voluntary.

• Explain that participants can withdraw at any time without penalty.

6. Address Confidentiality and Data Protection

• Explain how data will be stored, who will have access, and how privacy will be protected.

• Mention anonymization or pseudonymization if applicable.

7. Provide Contact Information

• Include details for the researcher and ethics board in case participants have questions or concerns.

8. Allow Time for Questions

• Encourage participants to ask questions and give them time to consider their decision.

9. Use a Written Consent Form

• Provide a document that summarizes all key points.

• Ensure participants sign and date the form and give them a copy.

10. Consider Special Populations

• For minors, obtain parental/guardian consent and child assent.

• For vulnerable groups (e.g., cognitively impaired), use adapted procedures and possibly legal representatives.