In the early 1990s, members of the Havasupai Tribe gave blood samples to researchers from Arizona State University. They believed the samples would be used solely to study diabetes, a major concern within their community. But without their knowledge or consent, the samples were later used to investigate schizophrenia, inbreeding, and ancient migration patterns—topics that not only violated their cultural beliefs but deeply damaged their trust in researchers.

The tribe sued, the university settled, and the case became a landmark example of how even when consent forms are signed, real informed consent can fail, especially when researchers don’t fully understand the vulnerabilities of the populations they’re working with.

It’s a cautionary tale that every new researcher should take seriously. Because while federal regulations highlight certain “vulnerable populations,” there are many more who face subtle, systemic, or situational risks that often go unacknowledged.

Let’s dig into 15 of those groups—and why ethical research means thinking beyond the usual checklist.

1. Undocumented immigrants

Undocumented people often fear that participating in research could expose their legal status, putting them or their families at risk. Even if personal data is anonymized, the power dynamics and fear of deportation can silence questions or concerns, undermining truly voluntary participation.

2. People experiencing homelessness

This group may be particularly susceptible to coercion, especially if research participation comes with incentives like meals or shelter. Beyond that, their lack of consistent access to communication, support systems, or medical care can make follow-up and comprehension more difficult.

3. LGBTQIA+ individuals

In hostile environments or communities where their identities are not protected, LGBTQIA+ participants may risk being outed through participation. Ethical research must ensure privacy, respect gender identity, and avoid assuming a one-size-fits-all approach.Research from The Trevor Project highlights how LGBTQIA+ individuals are vulnerable to discrimination and mental health challenges.

4. People in abusive or controlling relationships

Someone in a coercive relationship might feel unable to make independent decisions about research participation. They may also face risks if their partner discovers their involvement, especially in studies related to health, trauma, or autonomy. Further, research directly focusing on survivors of domestic violence may inadvertently re-expose survivors to past trauma.

5. Individuals in any organized religious groups

Individuals in organized religions, particularly conservative ones, may fear punishment or ostracization if they’re seen engaging in outside research. Their fellow members if non-conservative views or practices are revealed.In other words, data exposure could result in significant social consequences.

These contexts can dramatically alter what “voluntary” really means.

6. People with low health literacy

If a participant doesn’t fully understand medical terms or research jargon, they may agree to studies without comprehending the risks. It’s not enough to hand over a consent form, we must meet people where they are, with plain language and opportunities to ask questions.The CDC defines health literacy as essential to good health outcomes—and research is no exception.

7. Active military personnel (especially enlisted members)

In military hierarchies, it can be hard to say no, especially if the request is coming from a superior. Enlisted members may feel pressured to participate even when they’re uncomfortable, making power dynamics a major ethical concern.

Researchers from the Army Public Health Center’s Behavioral and Social Health Outcomes Practice Division partnered with APHC Soldiers to run a data collection training exercise to assess social and behavioral health risk factors of Soldiers. Source.

8. Precariously employed individuals + people living in poverty

For people juggling multiple jobs or surviving paycheck to paycheck, research incentives can be coercive—even when unintended. If participating means being able to pay rent or buy groceries, the power imbalance is real.

9. People in crisis (natural disasters, medical emergencies, etc.)

People in acute crisis situations may be more focused on survival than fully understanding a study’s risks. Timing matters. Ethical researchers know when to pause and when to ask better questions about readiness.

10. Refugees and asylum seekers

Displacement, trauma, language barriers, and cultural differences all contribute to heightened vulnerability. Refugees may feel compelled to participate out of gratitude or confusion about institutional authority.

11. People facing digital or technological barriers

In a world of online surveys and digital consent forms, people without internet access or digital literacy are left behind or pressured to sign documents they don’t understand. Accessibility isn’t just physical, it’s digital too.

12. First-generation college students

They may not seem “vulnerable” at first glance, but first-gen students often face information gaps, imposter syndrome, and financial pressure. In research settings, they may feel obligated to participate—especially if faculty or college departments are involved.

13. People subjected to systemic racism or historical trauma

For many Indigenous, Black, and Latinx communities, past abuses—like the Tuskegee Syphilis Study or the Havasupai case—still shape how they perceive research today. Trust is fragile, and rightly so. Respecting that history is part of doing ethical work.

This JAMA article explores how historical trauma impacts medical and research mistrust.

14. Caregivers of people with disabilities or chronic illnesses

These individuals may feel emotionally tied to research in hopes of finding solutions for their loved ones. But that hope can blur the lines of informed consent, especially if they’re participating in studies alongside or on behalf of someone else.

15. Non-native researchers in host countries

Non-native researchers doing research abroad might lack the awareness and cultural understanding to engage with communities in non-exploitative ways. Cultural misunderstandings, language barriers, and power imbalances can lead to unethical outcomes, even with good intentions.

What This Means for You as a Researcher

If you’re new to human subjects research, it’s tempting to focus on the standard categories of vulnerability—children, prisoners, pregnant people. And yes, those protections are essential.

But real-world ethics require more.

They require asking deeper questions about power, access, trust, and history. They require slowing down long enough to consider who’s not at the table, or who’s there but doesn’t feel safe enough to speak freely.

Want to make sure your research is ethical, inclusive, and human-centered? Explore our PPRE course and learn how to protect the people who make your work possible.

Whether you’re conducting a student survey or a large-scale community evaluation, informed consent is more than a check-the-box requirement. It’s a cornerstone of ethical research and a signal that you respect the dignity, autonomy, and well-being of your participants.

Let’s unpack what informed consent really means, why it matters, and how to do it well—especially when things feel a little murky.

The Three Pillars Of Informed Consent: Disclosure, Understanding, Voluntariness

Informed consent is built on three simple but powerful ideas.

Disclosure: researchers must provide enough information so that people can make an informed decision. That includes explaining why you’re doing the research, what participants can expect, any potential risks, and how their information will be protected.

Understanding. This one gets overlooked a lot. It’s not just about handing someone a form; it’s about making sure they get what you’re asking of them. That might mean using everyday language, offering examples, or encouraging them to ask questions. A novel technique? Ask participants to summarize what they heard/read in their own words.

Voluntariness. This means participants know they have a real choice—before, during, and after the study. Consent isn’t one-and-done. People should feel free to withdraw at any point, without consequence. Be especially mindful about incentives. What feels generous to you might feel coercive to someone else.

When these three elements are in place, you’re not just getting a signature—you’re building trust.

More Than a Signature: Different Ways to Give Consent

Consent doesn’t always mean a signed form. Depending on the context, there are different ways to ethically and appropriately secure informed consent.

Signed consent is the standard for higher-risk studies. It usually involves a form that participants sign (physically or digitally) to indicate they understand and agree to take part.

Implied consent often shows up in surveys or online forms, where the act of submitting a response implies agreement.

Assent is used when you’re working with folks who can’t legally give consent, like children or some adults with cognitive impairments. Their assent complements the consent of a parent or guardian. Here’s more information about working with vulnerable populations. 

Waived consent is a special case. Sometimes, getting consent just isn’t feasible—like in large-scale anonymous studies or certain observational research. But this isn’t a judgment call you make on your own. It requires IRB or ethics board approval – we can help with that!

What all these have in common is that researchers are still responsible for making sure people know what’s going on and feel like they have a say in whether or not to participate.

Where Researchers Get Stuck 

It’s easy to assume that if a space feels casual or familiar, informed consent is somehow baked in. But ethical research means making sure expectations are clear and decisions are truly voluntary, even when things seem low-stakes.

So what do you do if a participant seems confused or just rushes to sign the form without really reading it? Slow down. Explain things in everyday language. Invite questions and use examples. Encourage a little back-and-forth to check that they understand; it’s worth the time.

And if you’re dealing with a situation where traditional consent feels complicated—maybe you’re working with a captive audience or planning a big anonymous survey—that doesn’t mean you get to skip the process. It means you need to be more thoughtful about how you do it.

If you want deeper support with these nuances, our PPRE course is packed with real-world scenarios, expert guidance, and tools that help you meet the mark. Plus, it helps you earn your human subjects research certificate, so you can move forward with clarity and confidence!

Making Consent a Habit, Not a Hurdle

Informed consent isn’t a box you check once. It’s an ongoing practice that reflects how you show up as a researcher. When you build a habit of transparency, empathy, and respect into your work, people notice—and they respond with greater trust, clearer feedback, and stronger data.

That means making space for questions and being open to a “no.” It means checking in regularly, not just at the start and examining how your role, your methods, and even your incentives might be shaping participants’ choices.

Ethics Aren’t A Burden; They’re A Practice

The most ethical researchers aren’t perfect—they’re intentional. They ask questions, stay curious, and reflect on how their work affects real people in the real world.

Whether you’re aiming for IRB approval or running an internal evaluation, starting with solid informed consent is one of the most powerful ways to show that your work is rooted in respect.

Let’s keep raising the bar for research ethics, together.

Ethical research isn’t just about designing sound studies and obtaining IRB approval—it’s also about ensuring the safety, dignity, and well-being of participants throughout the research process. When participants raise concerns or experience adverse events, how researchers respond can make all the difference.

Let’s start with some definitions:

• Adverse events are any unintended harm or risk experienced by a participant due to their involvement in the study. These can be physical (e.g., injury in a behavioral intervention) or psychological (e.g., distress from sensitive survey questions).

• Participant complaints can range from concerns about consent procedures, discomfort with study procedures, or dissatisfaction with how their data is handled.
  

In a perfect world, researchers wouldn’t have to deal with either of these scenarios. But in reality, being prepared to address them is critical. As an IRB ourselves, Viable Insights approaches these situations openly.

Our policy is that if there are participant complaints or adverse events, researchers must inform us. From there, we communicate with participants and assess how best to address the issue. These procedures aren’t about punishing or embarrassing researchers but ensuring participant protection and rights.

Researchers should share this goal. It fosters trust between researchers and participants and ensures compliance with ethical research principles and IRB requirements. It also helps prevent legal and reputational risks for research teams and institutions. And when researchers share this goal, it improves the quality of research by identifying unanticipated risks or issues.

Understanding the Role of IRBs

Institutional Review Boards (IRBs) exist to ensure research upholds ethical standards, particularly concerning participant safety, informed consent, and data protection. But their role isn’t limited to just approving studies. IRBs also help researchers navigate unexpected challenges like participant complaints or adverse events.

By engaging with your IRB throughout the research process, you can:

• Receive guidance on ethical dilemmas and how to handle sensitive participant concerns.
• Ensure documentation of adverse events for transparency and continuous improvement.
• Mitigate risks by having a structured approach to addressing participant issues.

Proactive Strategies to Prevent Complaints and Adverse Events

Rather than only reacting to participant concerns, researchers should take proactive steps to minimize risks and improve study experiences. Here’s how:

Set Clear Expectations in the Consent Process

Start by informing participants of their rights and how to raise concerns with the researcher or IRB directly. Provide a direct, responsive point of contact rather than a generic email address. You’ll also want to ensure consent materials are clear, accessible, and free of complex jargon.

Maintain Open Communication Throughout the Study

Regularly check in with participants, especially in long-term studies. You should also create opportunities for participants to share concerns, even if they are hesitant. And work to normalize feedback so participants feel comfortable voicing discomfort.

Implement a Rapid Response Plan

Designate a team member responsible for addressing participant concerns in real-time. It’s also a good idea to ensure research staff understands the protocol for handling complaints and adverse events. Lastly, keep thorough documentation to track issues and responses.If you need help with any of the above, we’d love to chat!

What to Do When an Issue Arises: Responding to Complaints and Adverse Events

Even with strong preventive measures, participant complaints and adverse events can still happen. Here’s how to handle them effectively:

Acknowledge the Concern Immediately

Respond promptly and show empathy. Let participants know their concerns are taken seriously and do your best to avoid defensive or dismissive language.

Assess the Severity of the Issue

Begin by determining whether the complaint is related to discomfort, privacy, or ethical concerns. Then evaluate if an adverse event caused physical, emotional, or psychological harm. Consult your IRB to determine the next steps if needed.

Document the Incident Thoroughly

Record details of the complaint or adverse event and track actions taken and any necessary follow-ups. Maintain confidentiality while ensuring transparency.

Take Corrective Action and Follow Up

Modify study procedures to prevent similar issues in the future and then offer additional support resources, such as counseling services. Keep participants informed about the actions taken to resolve their concerns.

If a participant experiences distress from a survey question, researchers could modify or add a warning before sensitive topics. Offering mental health resources also demonstrates ethical responsibility.

Strengthening Your Research Practices for the Future

The best researchers don’t just react to complaints—they learn from them. Here’s how to continuously improve your research approach:

Conduct Regular Ethical Audits

Periodically review study procedures to ensure ethical alignment and gather feedback from both participants and research staff.

Foster a Culture of Ethical Reflexivity

Train your team on participant-centered research practices and discuss past challenges to refine future studies. Stay informed on evolving ethical research standards.

Build Long-Term Relationships with Your IRB

Engage with your IRB beyond just approval processes and participate in IRB-led discussions on ethical research.

Ethical research isn’t just about compliance—it’s about fostering trust, protecting participants, and strengthening the integrity of your work. A participant-centered approach ensures both ethical responsibility and research excellence.

If you’re looking to enhance your research practices, we offer expert guidance. Let’s work together to ensure research that prioritizes both quality and participant well-being.

Protecting vulnerable populations in research isn’t just the right thing to do—it’s essential for ensuring ethical integrity and credible outcomes.

Neglecting these safeguards can lead to significant harm for participants and lasting damage to organizations. Let’s explore who these vulnerable groups are, why they need extra care, and how researchers can implement best practices to protect them.

And a reminder that vulnerable populations in research is a module in our PPRE training. If you’re interested in learning more, you can find more information here.

Who are vulnerable populations?

 Vulnerable populations are individuals who are more likely to experience harm or exploitation during research. According to the U.S. Department of Health and Human Services, these groups include but aren’t limited to:

• Pregnant women, fetuses, and neonates: Risks in biomedical research can affect both mother and child.
  

• Prisoners: Limited autonomy makes them more susceptible to coercion.
  

• Minors (under 18 years old): Their ability to comprehend risks complicates informed consent.
  

• Individuals with impaired decision-making capacity: Cognitive challenges make it harder to evaluate risks and benefits.
  

• Economically and educationally disadvantaged individuals: Financial incentives to take part in research might create undue influence on participation.
  

• Native/Indigenous populations: Historical trauma, systemic oppression, limited healthcare access.
  

• Folks for whom English is a second language or are non-English speaking:
  Language barriers, limited resources, difficulty accessing essential services.
  

• Elderly individuals: Physical vulnerabilities, social isolation, financial insecurity.
  

• Those with chronic health conditions: Ongoing medical needs, financial burdens, reduced mobility.
  

• Those with limited literacy: Difficulty accessing information, job barriers, reliance on others.

Recognizing these groups is the first step to creating ethical research frameworks that prioritize their safety and dignity.

Why is protection so important?

Protecting vulnerable populations isn’t just about avoiding harm—it’s about ensuring the research is ethical, impactful, and trustworthy.

When we do research and evaluation IN partnership with people, we reduce exploitation and increase trust. There’s more integrity, validity, and reliability and ultimately better data = better insights = better action.

And on a pragmatic level, this also means your data is more likely to result in landing the grants your organization deserves. 

• Preventing exploitation: Safeguards ensure participation is voluntary and informed, not coerced by circumstances or incentives.
  

• Building trust: Ethical practices create confidence in both the research process and its outcomes, benefiting participants and the community.
  

• Strengthening data integrity: When research is conducted ethically, results are more reliable and applicable to broader populations.

Without these protections, the consequences can be severe—for both participants and the organizations conducting the research.

What happens when protections are overlooked?

Neglecting the safety and rights of vulnerable populations can have far-reaching consequences:

• Harm to participants: Physical, psychological, and social harm can occur. Participants may lose trust in research altogether, impacting their willingness to engage in future studies. They may share their concerns with other people in their community, creating a resistance to research within the entire population.
  

• Legal and financial repercussions: Lawsuits, hefty fines, and loss of funding can derail an organization’s work. Pfizer’s 1996 clinical trial in Nigeria violated ethical standards by failing to obtain informed consent and exploiting vulnerable populations, resulting in child fatalities, long-term harm, lawsuits, and a $75 million settlement.
  

• Reputation damage: Once trust is broken, it can take years to rebuild, affecting partnerships, public perception, and the ability to secure grants or participants.

Remember, these protections are not just for the participant – they are for you, the researcher, your organization, and the integrity of your work.

How to conduct ethical research with vulnerable populations

When we make the research process better for vulnerable, historically excluded, marginalized, and harmed groups — it makes the experience better FOR EVERYONE. It’s just good practice.

Ethical research is about more than compliance—it’s about fostering trust and prioritizing the well-being of participants. Here’s how:

• Obtain clear informed consent: Use accessible language and methods to ensure participants understand what they’re agreeing to.
  

• Implement extra safeguards: Use community advisory boards to protect participants’ rights and well-being.
  

• Design thoughtful incentives: Compensation should recognize participants’ time and effort without creating undue pressure to participate. You might think you are being super generous with an incentive (and you may be), but consider whether the single parent, broke college student, or dislocated worker you are asking to participate can afford NOT TO participate.
  

• Customize your approach: Every population is different. Tailor your research methods to reflect the specific needs and vulnerabilities of your participants. Don’t know how? Ask someone that regularly works with that population, or is themself a member of that population (or both!). 

At Viable Insights, we specialize in supporting organizations with thoughtful, actionable evaluation plans that prioritize participant safety. Whether you need help designing an ethical research framework, crafting an evaluation plan, or developing data collection protocols, our team is here to help.

What can you do to safeguard your research?

Protecting vulnerable populations starts with intentional planning and support. By prioritizing ethics and focusing on participant well-being, your organization can create impactful, trustworthy research that benefits everyone involved.

At Viable Insights, we’re here to help you navigate these challenges. Our expertise in evaluation and community-based research ensures that your work aligns with ethical standards while achieving measurable impact.Ready to ensure your research is both ethical and effective? Let’s start a conversation and explore how we can help you design research that makes a difference—for your participants, your community, and your organization.

This blog contains information sourced from the U.S. Department of Health and Human Services (HHS).

Viable Insights is excited to announce the launch of VIRB Learning Center, a training program built from the ground up for researchers and evaluators in social and community-based research.

VIRB Learning Center makes training relevant, affordable and specific to your field of practice. You’ll walk away with a clear, actionable understanding of your IRB requirements and how to apply them to your work.

Curriculum That’s Relevant To Your Work

IRBs typically require some form of certification saying that researchers have completed a human-subjects training. The problem? Many of the existing training options don’t consider the folks that are approaching human-subjects from an evaluation or community-based research perspective.

VIRB Learning Center was built from scratch to address the unique needs and challenges faced by researchers and evaluators in the social and community sectors. Our training is tailored for those fields of study, ensuring every lesson is directly applicable to your projects.

Clear Guidance on IRB Requirements

Another big red flag with existing training options is that they’re extremely clinical and academic. Even if the information they present is relevant to your research, it’s rarely stated plainly. You’re often left wrestling with uncertainty, frustration and unclear takeaways.

When you enroll in a VIRB Learning Center course, you’ll walk away with a clear, comprehensive understanding of your next steps and how to apply your learnings to your research. You’ll learn when and how IRB approval is needed, empowering you to confidently navigate ethical research practices.

Accessible, Affordable Certification

Thorough, professional IRB-oriented training shouldn’t be cost-prohibitive, but that’s the unfortunate world that many research teams, both small and large, live in.

We’re excited to offer VIRB Learning Center courses at an accessible price point to ensure that everyone can benefit from high-quality training, regardless of their budget. Individuals can access courses for a simple flat price, while organizations can access unlimited learning for their entire team and select clients/partners.

Enrollment is easy. Just choose your VIRB Learning Center course, pay the simple price for access, and get clear insights that are relevant to your work. 

Get Certified with VIRB Learning Center

VIRB Learning Center is your path to conducting ethical, impactful research and evaluation. 

Our first course, Protecting People in Research and Evaluation (PPRE), goes live on September 1, 2024. Participants will earn a human-subjects certificate that satisfies most IRB certification requirements. Be sure to check with your IRB first.

Stop wasting time with courses that don’t add contribute to people-first research practices. Join the waiting list for our PPRE course and move your research forward with VIRB Learning Center.