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.

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).

Phil and I did not expect to hear IRB horror stories over our exhibit table at the recent American Evaluation Association conference, but that’s exactly what happened.

“Yeah, and then when we got the invoice they’d just … added a line for closing the project?!! You know how tight our budget is. We had to move money around, our partner was pissed, and we had to reconsider if we could continue using an IRB for our projects – and we really want to!” 

It’s the stuff that evaluators’ and researchers’ nightmares are made of. And we heard stories like this from multiple people!

There are a lot of IRBs out there and picking one can feel overwhelming—especially if you’re doing community-based or evaluation research and haven’t worked with one before. And choosing the wrong IRB can be a costly, demoralizing mistake!

Asking the right questions can make all the difference. Let’s break it down so you can find an IRB that works for you, your project, and your budget.

Does the IRB Know Evaluation, Community-Based and/or Applied Research?

Not all IRBs are created equal, especially when it comes to projects that are rooted in the community or are evaluation oriented (i.e., not academic research). Ask about their experience with studies like yours:

• Have they worked with folks doing program evaluations or community-based research?
• Do they understand the unique ethical and practical challenges of this kind of research?

An IRB with the right expertise will give you feedback that actually makes sense for your project.

How Transparent Is Their Process?

Ever feel like research processes are full of mystery and red tape? You don’t need that kind of stress with your IRB. Ask how they handle communication:

• How frequently can you expect to be updated on your submission’s progress?
• Do they explain the steps and timelines clearly?

The right IRB will make things easy to understand, so you’re not left wondering what’s going on.

“Our public health research and evaluation consulting firm has transferred all our projects requiring IRB approval to VIRB. We have used multiple academic, nonprofit, and for-profit IRBs and VIRB stands above them all. We appreciate their pre-submission communication, their simple form and upload requirements, the speed at which they review submissions, and their straightforward pricing structure. They are an excellent IRB solution for small and big independent firms, as well as any other institution looking for fast, competent, thorough reviews of the research projects. Highly recommended!” – Becky Garrow, Garrow Consulting, Inc.

What Do They Charge For?

Money matters, and IRB fees can add up fast. Some charge for everything—project closures, amendments, or even basic changes.

At Viable Insights, we don’t believe in nickel-and-diming you. Our Institutional Review Board (VIRB) keeps things simple: no fees for project closures, PI changes, amendments, or continuations.

When talking to IRBs, ask:

• What’s included in the price?
• You might literally need to ask them “Do you charge for ____________?” because they might not volunteer that information.

You deserve to know exactly what you’re paying for. (Depending on the complexity of your application, VIRB’s fees range from $1,000 – $1,500.) 

Will They Actually Get Back to You?

Research moves fast, and waiting forever for IRB responses can throw off your whole timeline. So, ask about their responsiveness:

• How quickly do they reply to emails or questions?
• Is there someone you can talk to if you hit a roadblock?

A responsive IRB is a lifesaver, especially when deadlines are looming.

Do They Provide Personalized Support?

Every research project is different, so cookie-cutter feedback won’t cut it. You want an IRB that takes the time to understand your work and provides advice that fits.

• Do they ask questions about your project?
• Can they help align your methods with ethical standards while keeping things practical?

At VIRB, we specialize in tailoring support to researchers doing evaluation and community-based work. Your project deserves that kind of attention.

Are They Focused on Ethical Oversight, Not Red Tape?

The whole point of an IRB is to protect participants and ensure ethical research, but some seem more interested in adding unnecessary barriers. Ask how they approach ethics:

• Do they understand the community you’re working with?
• Are they balancing ethical rigor with practical guidance?

Look for an IRB that protects your participants without turning the process into an obstacle course.

What Happens If You Need to Make Changes?

Let’s face it—projects evolve. Whether it’s an amendment, a continuation, or a new PI, you need to know how your IRB will handle these changes. Ask:

• What is the amendment process?
• Do they charge extra for amendments, continuations, or a new PI? How much?
• How much longer will it take if you make amendments, etc?

At VIRB, we don’t charge for amendments or continuations, and we keep the process simple so you can adapt without stress.

How Fast Do They Approve Applications?

Time is everything in research. Delays in approval can set your whole project back. When choosing an IRB, ask:

• What’s their average turnaround time?
• Do they have a track record of missing deadlines?

At VIRB, we prioritize efficiency, so you can keep your research moving forward without unnecessary delays. Expedited applications will be reviewed in 7 – 10 days, while full board reviews may take up to 21 days.

Do They Fit Your Budget and Goals?

At the end of the day, your IRB should work for you. That means fitting your budget, aligning with your project’s needs, and making the process as smooth as possible.If you’re looking for an IRB that’s affordable, responsive, and built for evaluators and community-based researchers, Viable Insights’ VIRB might be just what you need!

If you’re interested in learning more, drop us a line and let’s chat!

Deciding whether to offer incentives for research participation is a big decision. It’s not just about funding or logistics—there are ethical considerations and practical implications. Will incentives make recruitment easier? Will they improve the quality of your data? Or could they complicate things? Let’s break it down so you can decide what’s best for your project.

Why Incentive Work: The Benefits of Compensation

Incentives can be game-changers for research. When people feel valued for their time, they’re more likely to participate. Sure, some participants might join out of curiosity or to contribute to societal good, but most people appreciate tangible recognition—especially when research is time-consuming.

Offering compensation also shifts the dynamic between researchers and participants. It’s about more than just saying “thank you.” Paying participants acknowledges their time, energy, and expertise. This approach challenges the idea that participants are mere data sources and reinforces that they’re key contributors to the research process.

Incentives can also boost engagement. When participants feel appreciated, they’re more likely to show up fully, providing thoughtful and detailed responses. This is especially important in survey research, where participation without incentives often skews toward individuals with extreme opinions, potentially distorting results.

The Ethical and Practical Drawbacks

While incentives have clear benefits, they’re not without their challenges. One significant concern is coercion. For some, particularly economically disadvantaged participants, the promise of compensation might feel like something they can’t afford to pass up. This raises ethical questions about whether they’re truly giving informed consent.

Another issue is the potential for falsified qualifications. Imagine offering $500 for a study on sleep disorders. Suddenly, everyone has a sleep disorder. This can muddle your data and make it difficult to draw meaningful conclusions. Incentives need to strike a balance—compelling enough to encourage participation but not so enticing that they lead to dishonesty.

Finally, consider whether incentives are necessary at all. In some cases, the ask might be so minimal—like a quick, 30-second survey—that offering compensation doesn’t make sense. In these scenarios, alternatives like raffles or small thank-you tokens may be a better fit.

When Incentives Might Not Be the Right Fit

Not every research project needs incentives. For instance, if your study targets an already invested audience, like members of an organization directly benefiting from the research, you might not need to offer compensation. Similarly, if participation requires little effort, people might not expect anything in return.

Cost is another factor. Incentives can significantly increase the expense of your project, which may not align with your budget. If funds are tight, consider creative alternatives, such as non-monetary tokens of appreciation or partnerships that provide access to valuable resources.

Balancing Costs and Benefits

Deciding whether to use incentives isn’t always black and white. It’s about understanding your audience, the scope of your research, and your resources. A well-designed incentive program can make recruitment easier, improve data quality, and show participants that you value their time.

However, if not carefully planned, incentives can introduce ethical dilemmas, skewed data, or unnecessary costs. Taking the time to weigh the pros and cons will help you decide whether incentives make sense for your project.

A Quick Recap of Incentive Pros and Cons

Pros:

• Simplifies recruitment by motivating participation.
• Compensates participants, making the process less extractive.
• Boosts engagement, encouraging participants to provide thoughtful responses.

Cons:

• Risks coercion, particularly for vulnerable populations.
• Can lead to falsified qualifications, compromising data quality.
• May not be necessary for minimal-effort tasks or invested audiences.

Ready to Make Incentive Decisions Easier?

If you’re still unsure about using incentives, you’re not alone. Deciding how to approach participant compensation is one of many challenges researchers face. That’s where we come in.

At Viable Insights, we specialize in guiding researchers through the complexities of ethical and effective study design. Our Institutional Review Board (VIRB) is here to help you craft a participant-friendly approach that aligns with your project goals and ethical standards.

Learn more about VIRB and connect with us today!

Let’s make your research impactful, ethical, and a success for everyone involved!