What is an Institutional Review Board (IRB)?
An IRB is a review board designed to protect the rights and well-being of research participants. It acts as a system of checks and balances for any research involving people.
Welcome to the next article in our Research 101 series! We're excited to share with you some important information about Institutional Review Boards (IRBs), which are essential to the research process.
If you’ve ever thought about participating in research, you may have had some questions about how the research could affect you. You may have wondered:
- What are the risks and benefits?
- How will my data be used?
- How do I know I am safe?
Researchers care a lot about providing a safe and ethical study experience. One way we do this is by submitting our research protocols to an Institutional Review Board (IRB).
What is an IRB?
An IRB is a review board designed to protect the rights and well-being of research participants. It acts as a system of checks and balances for any research involving people.
IRBs work to ensure the following:
- Research studies have scientific merit and purpose
- The activities involved in the research are ethical
- All regulatory requirements are followed
Every IRB has at least five members with different backgrounds. The members may have training in scientific areas, have expertise and training in non-scientific areas, or be members of the community who may represent the people who would participate in the research study.
IRBs are the gatekeepers when it comes to being able to conduct research involving human beings. Without IRB approval, researchers are unable to conduct their research.
History of the Institutional Review Board (IRB)
The idea of an Institutional Review Board (IRB) began in 1974 when President Richard Nixon signed into law the National Research Act. The act led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Events such as the Tuskegee Trials and the Willowbrook Experiments, where research was conducted in an improper manner, proved there was a need for unbiased oversight.
This commission was in charge of identifying the principles that should underlie the conduct of research. They also created guidelines to make sure research is carried out following those principles. In 1979, the commission published "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," also known as the Belmont Report.
The Belmont Report is made up of three core principles:
- Respect for Persons - Giving people the right and capacity to make their own decisions.
- Beneficence - Minimizing potential harms and maximizing benefits
- Justice - Distributing benefits and risks fairly
IRBs were founded on these three basic principles which are still referenced when reviewing research proposals.
What does the IRB review?
The people who make up the committee carefully consider the following:
- Are procedures in place to reduce any harm or risks to the participants?
- Do the benefits outweigh the associated risks?
- Is the selection of participants equitable and fair?
- Are potential participants able and willing to give informed consent?
- Will a participant's consent (or permission) be properly documented?
- Do the researchers have a plan for monitoring the quality of the study data to ensure participant safety?
- Are there adequate procedures in place to protect the privacy of participants?
- Will the researchers be able to maintain the privacy of study participants?
- Are there protections in place for vulnerable populations?
- Does the research meet all regulatory requirements?
Evidation Studies & IRB Oversight
Research conducted by the Evidation Studies (formerly Achievement Studies) team often requires approval from an IRB. The decision to have a study approved by an IRB is based on the design of the study and what the researchers will use the results for.
At Evidation Studies, we have a dedicated team of researchers who help oversee the protection of our study participants every step of the way. Even when IRB approval is not required.
Our study participants can be confident that we’re committed to their safety and that our studies are conducted according to the highest standards.
Want to know more about any of our Evidation Studies and how to get involved? Reach out to us at study@evidation.com and one of our friendly team members can help you get started.
If you want additional general information on health research, we recommend checking out the following public resources:
- U.S. Department of Health & Human Services, Office for Human Research Protections
- FDA, Clinical Trials and Human Subject Protection
- National Institutes of Health (NIH), Educational Resources
- Clinical Research Resource HUB, Resources for Participants
What is Good Clinical Practice (GCP) and why is it important?
Good Clinical Practice (GCP) is an international guide for how to conduct ethical and good quality research. GCP applies to all stages of research: design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of any research involving people.
It’s important to understand what Good Clinical Practice is and why it matters. Especially if you are participating (or thinking about participating) in research.
Good Clinical Practice (GCP) is an international guide for how to conduct ethical and good quality research. GCP applies to all stages of research: design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of any research involving people.
GCP consists of 13 principles focused on the following:
- Safety
- You feel protected throughout the entire research study.
- Rights are Protected
- You have the right to information about the research.
- You decide whether or not you want to participate in the research.
- You have the right to withdraw from the research at any time without penalty.
- Your privacy and confidentiality will be protected.
- Quality of Research Data
- The data collected from you is for the purpose of the research and is based on a scientific protocol approved by an ethics committee.
Why do we need Good Clinical Practice (GCP)?
The idea of a “good physician” and “good clinical/medical practice” dates back to the Hippocratic Oath from about 400 B.C. This oath represents the earliest idea of medicine being practiced in a just and ethical manner. It established several principles of medical ethics that remain important today. These include the principles of “confidentiality,” “privacy,” and “doing no harm.”
While the oath itself was a good start, it was not enough to protect all of the people who participated in research from harm. Additional rules and regulations were necessary to help keep people safe.
The United States put into place the first legislation to help regulate drugs that are available over the counter, The Food and Drugs Act of 1906. Before this legislation, harmful and deadly drugs could be purchased by anyone, just like any other product. These unsafe products led to serious illness, injury, or death because the ingredients were not tested for safety.
Well known examples of drugs available at the time include:
- Kopp’s Baby’s Friend - contained a mixture of morphine and alcohol
- Dr. King’s Consumption Cure - contained a toxic mixture of chloroform, morphine, and pine tar
- Dr. Bull’s Cough Syrup - contained dangerous amounts of opium
In 1938, the Food and Drug Administration (FDA) approved the Federal Food, Drug, and Cosmetic Act. This was the first time manufacturers were required to not only test drugs for safety, but to also provide real-world evidence of that safety to the FDA prior to being available to the public.
The importance of Real-World Evidence
Real-world evidence comes from real-world data, and is evidence about the use, risks, and/or benefits of a medication, product, or treatment. Without real-world safety evidence, the product could not be sold. Companies that broke this rule could now be fined, sued, or even prosecuted by law if their products caused harm.
While research can be used to help people, the label of “research” has also been used across history to cause harm, particularly in times of war.
One of the most well-known occurrences was in World War II, when German physicians conducted horrific experiments on individuals in the concentration camps of Europe. These war crimes, performed under the banner of “research,” resulted in the development of the Nuremberg Code in 1947. This code is part of the reason research participants have the right to decide whether or not they want to participate in a research study.
Your voice and your choice matters.
GCP over time
Over time, new guidelines have been developed to better define the idea of ethical medical practice in clinical research. Unfortunately, nearly all of these guidelines were created in reaction to research that was harmful to participants or was unethical.
These guidelines include the Declaration of Helsinki (written in 1964, updated in 2013), the Belmont Report (1979), and the International Guidelines for Biomedical Research Involving Human Subjects (1982).
The primary goals of these guidelines are to protect research participants, allow people to participate in research when it can be helpful to the world, and treat all research participants equally and justly. As new research types emerge, like the use of technology or developments in genetic research, new ethical challenges arise. These documents help guide researchers through ethical challenges and define the principles within GCP guidelines.
How does the team at Evidation Studies ensure Good Clinical Practice?
From the design of our research studies to the final analysis of the information that’s collected, our research team holds each other accountable.
Our team is trained in GCP annually and attends discussions on the importance of Good Clinical Practice in human research studies. It is our guidebook for making sure our research is safe and the rights of our participants are protected.
Additionally, our research studies are reviewed and approved by an ethics committee called an Institutional Review Board (IRB), whose goal is to keep people safe and make sure research is done ethically.
We feel strongly about the importance of GCP because our participants are top priority to us.
Our mission is to encourage everyone to participate in better health outcomes. In order to fulfill our mission, we must provide a safe and educational experience for all of our research participants.
Want to know more about any of our Evidation Studies and how to get involved? Reach out to us at study@evidation.com and one of our friendly team members can help you get started.
If you want additional general information on health research, we recommend checking out the following public resources:
Community Results: The connection between mood and activity levels
Because day-to-day mood is such an important aspect of our wellbeing, we recently began asking members to keep track of their mood by completing a daily offering asking them how they feel.
We all know that exercise is supposed to make us feel better. In fact, even mild exercise can increase endorphins or feel good hormones.
And exercise enthusiasts may know this to be true without needing the science. We’ve all heard of “runner’s high”.
But for some, it may be difficult to see or notice the impact activity has on our mood. And understanding how our mood affects our activity levels adds another layer to consider.
Because day-to-day mood is such an important aspect of our wellbeing, we recently began asking members to keep track of their mood by completing a daily offering asking them how they feel.
In the first two weeks we received 743,401 responses from over 131 thousand members!
Overall, the majority of responses indicated that people were feeling good.
- Good: 56.9% (423,268)
- Okay: 37.3% (277,273)
- Bad: 5.8% (42,860)
The “best” days seem to be Saturday (Good = 59.2%) and Sunday (Good = 58.4%), and the “worst” days seem to be Monday (Bad = 6.1%) and Thursday (Bad = 6.14%).
In this short time, we noticed a significant connection between those who said they felt “good” and their activity, sleep levels, and resting heart rate.
More specifically, we took a look at participating members over the first two weeks and examined the relationship between each individual’s self-reported mood and their steps, sleep, and resting heart rate.
Members who indicated they had a better mood walked more and slept more, and had a lower resting heart rate.
In fact, we observed that "good" days were associated with an increase of nearly 1900 steps when compared to "bad" days
What does that mean?
Well, it shows that for these members at least, mood and activity levels appear to have some connection.
It could be that keeping active makes them feel good. Or maybe, feeling good allows them to keep active.
Curious about how your mood and activity are connected? If you haven’t paired an activity app or wearable to your Evidation app yet, do it today. You’ll earn points for connecting and be eligible to receive more personalized insights.
And stay tuned for more community insights from Evidation!
The daily mood survey is a new offer type we’re currently testing and is only available in the app at this time. If you typically log in on the web, be sure to download the app.
What does Informed Consent Mean?
Researchers use the process of informed consent to give potential participants important information about a study. They do this so an individual understands the purpose of the research, potential risks, benefits, and alternatives available and has the voluntary option to participate based on what is best for them.
At Evidation (formerly Achievement) Studies, our primary goal is to put individuals first.
One way we do this is by ensuring the safety, protection, and comfort of the individuals who participate in our studies.
To make sure we ALWAYS meet this goal, we follow a standard process for outlining important information related to the study and providing that information to potential participants to support knowledgeable, voluntary decision-making. We call that process Informed Consent.
We hope this information helps you better understand the informed consent process and how it fits into health research as a whole.
What is Informed Consent?
Informed consent is both a process and an action.
Researchers use the process of informed consent to give potential participants important information about a study. They do this so an individual understands the purpose of the research, potential risks, benefits, and alternatives available and has the voluntary option to participate based on what is best for them.
To provide consent, participants sign an Informed Consent Form (ICF). This form guides a person through all the relevant information related to the study and gives them the option to enroll. At Evidation studies, this process is done online through our online platform.
What information is in an Informed Consent Form?
It’s important that study participants understand all the important details of a study before providing their consent (in other words, their permission) to participate. To make sure participants have all the information they need, the Informed Consent Form (ICF) includes the following:
- The purpose of the research
- A description of each activity they will need to do and how long each should take to complete
- What data will be collected, who will have access to the data, how the data will be used, and how we will make sure the data stays safe
- Potential risks and benefits of participating in the study
- A statement that participation is voluntary and that participants can withdraw at any time during the study
- If and how they will be compensated for participating in the study (for example, direct deposit, gift card, travel vouchers, products, etc.)
Evidation Studies puts a lot of time and care into developing the Informed Consent Forms for each study. This helps to ensure that we communicate openly, honestly, and clearly with our participants.
Who creates the ICF?
Every study has a team of individuals dedicated to protecting the safety of participants. This team works together to decide what the ICF should include for each study and then submits it to an Institutional Review Board (IRB) for review and approval. An IRB is a group of qualified individuals who work to protect the rights and well-being of research participants. One way they do this is by making sure our ICFs are clear and thorough.
Why is Informed Consent Important?
Informed consent is important from an ethical point of view, because we need to make sure that everyone who participates in our studies is doing so voluntarily (by choice) and is comfortable with everything the study will involve.
Informed consent is also a legal requirement: it has to occur before a participant is enrolled in any clinical research study.
The guiding principles of the informed consent process are taken from historical documents that focus on respecting the people who participate in research. Documents like the Nuremberg Code and the Belmont Report detail the ethical principles of ‘Respect for Persons’. These principles include:
- Participants have the choice to agree to participate or not (“voluntary consent”).
- Participants have the option to withdraw at any time (that is, they are free to stop at any time).
- People are autonomous and should be treated with respect
- Protected groups like participants who are unable to consent for themselves/require additional protections. (The consent in these cases may be provided by a caregiver or legal guardian.)
Who do I contact if I have questions about the Evidation Studies informed consent process?
The Evidation Studies Support team is available to answer any and all questions participants may have about a study before signing the informed consent form, as well as any questions that come up throughout their study participation. We have a team of individuals (dedicated to making the experience as easy and comfortable as possible.
Want to know more about any of our Evidation Studies and how to get involved? Reach out to us at study@evidation.com and one of our friendly team members can help you get started.
If you want additional general information on health research, we recommend checking out the following public resources:
- U.S. Department of Health & Human Services, Office for Human Research Protections
- FDA, Clinical Trials and Human Subject Protection
- National Institutes of Health (NIH), Educational Resources
- Clinical Research Resource HUB, Resources for Participants
What is Eligibility?
We encourage all of our members to actively participate in better health outcomes. One way to do that is by joining a research study! Before you can join a research study, you’ll first need to learn if you’re eligible.
Welcome to the next article in our Research 101 Series! This post talks about eligibility for health research studies.
We encourage all of our members to actively participate in better health outcomes. One way to do that is by joining a research study! Before you can join a research study, you’ll first need to learn if you’re eligible. But what does that mean?
Below, we describe the research eligibility process and how this process matches you to the right research opportunities.
What is the eligibility process?
The eligibility process is a way for researchers to make sure that you’re a good fit for a study. All research studies have rules that outline who is eligible to participate in the study. Those rules are called the eligibility criteria.
There are two main reasons for this:
1. We use eligibility criteria to make sure the participants who are included in the study are able to help us answer the questions that the study hopes to answer. For example, in a study about birth control in women, we would only include women because that is the only group that’s appropriate for the purposes of the study.
2. We also use eligibility criteria to make sure that we don’t include people in studies when they may be harmed by study activities. For example, we would not enroll individuals with heart disease in a study that asks participants to take a daily medication that could have side effects for people with heart disease
The eligibility criteria are usually related to things such as age, sex, medical conditions, or medical history. All of these factors are assessed by researchers and compared to the study definitions to decide if you’re a match for the study. Every study has different eligibility criteria, because every study is different.
How can I find out if I’m eligible for a study?
Once you find a research study that you’d like to participate in, you’ll go through the eligibility process.
At Evidation, we ask potential participants to answer an eligibility screening questionnaire which is completed online before joining a study. We may also ask you to take part in other eligibility activities, such as interviews or lab tests depending on the study requirements. All of this helps us determine if a person is a fit for the study.
How does eligibility affect me?
By finding the right participants for a study, we’re able to conduct good research. It also allows researchers to obtain meaningful results. Research studies have the possibility to impact healthcare for all, and so it’s important to do them right.
Want to know more about any of our Evidation Studies and how to get involved? Reach out to us at study@evidation.com and one of our friendly team members can help you get started.
If you want additional general information on health research, we recommend checking out the following public resources:
- U.S. Department of Health & Human Services, Office for Human Research Protections
- FDA, Clinical Trials and Human Subject Protection
- National Institutes of Health (NIH), Educational Resources
- Clinical Research Resource HUB, Resources for Participants
How to Participate in a Research Study on Evidation
Finding the right research opportunity can be difficult. We try to make it easier by matching you with research opportunities we feel are likely to be a good match for you.
At Evidation, we’re all about encouraging our members to actively participate in their health. One way to do that is by participating in health research.
In order for the information gathered during a study to represent and benefit everyone, it’s important that the individuals who are participating in that research are truly representative of society.
When research is fully representative it contributes to health insights that have the potential to improve lives. Not the lives of a few, but the lives of all.
But you might be wondering…
Whether or not you should participate is a personal choice that only YOU can make, but hopefully the information here and in the rest of our Research 101 series can help provide some useful information to help you make an informed decision.
How do I get offered a research opportunity on Evidation?
In general, finding the right research opportunity can be difficult. There are so many studies and knowing which ones are right for you can be especially challenging. At Evidation, we try to make it easier by matching you with research opportunities we feel are likely to be a good match for you - based on what you tell us of yourself and your preferences.
So, before we can match you with study opportunities, we need to learn more about you. This helps us find opportunities that are relevant to you.
And because we know that one way doesn't work for everyone, you have several choices about what information you share and how you choose to share that information.
And you always have the right to change those choices or to opt out of any of our surveys or offers.
Tell us about yourself
Currently, there are three ways you can tell us more about yourself. You can share information through any or all of these. The more you’re comfortable sharing, the higher the chances that we can find the right research opportunities for you.
1. Complete Surveys
Surveys are a quick way to tell us about who you are and about your individual health journey. These surveys take an average of about 1-5 minutes to complete, and you earn points just for filling them out! The points you earn can be redeemed for cash or donated to a variety of charities.
2. Connect your health apps/devices
If you’re currently using health apps and/or devices, you can connect these to your Evidation account. This way you can earn points for some of the activities you’re already doing and create additional opportunities to participate in research.
How does pairing an app or a device help with research opportunities?
Some research studies are interested in information like how many steps individuals walk in a day or how your pain levels affect your sleep. If you have a device that provides that information (for example, a smartphone, a Fitbit, or an Apple Watch), you’re more likely to qualify for that particular study.
3.) Respond to 1-click offers
One-click offers are a fast, easy way to tell us more about yourself. Typically, we ask Yes or No questions about your health and other personal information. Again, the more we know about you, the better chance we have of helping you find information and research opportunities that are relevant to you!
To learn more about how we protect the information you share, click here.
How do I get matched with a research opportunity?
Our expert team analyzes the data you provide and matches you with opportunities you may be interested in or eligible for[link in article 5]. Some examples of what we look at are your age, your health factors, etc.
When we find an opportunity that we think you may be eligible for (and interested in), we send you an offer!
What happens once I get an offer to participate?
When we send you a research participation offer, we’ll include information about the study, the topic, and the study commitments. Once you receive this offer and information, there are a few steps you need to take to help determine if the study is right for you.
Step 1: Decide if you’re interested
- Read about the topic of the research.
- Understand the time commitment and activities involved.
- Review the guidelines to see if you feel you’re eligible.
Step 2: Complete the eligibility survey
- Answer questions to confirm that you’re eligible to participate in the research. Learn more about eligibility here.
Step 3: Provide your consent
- Read and sign the informed consent. You can learn more about informed consent here.
Step 4: Start participating in activities.
- Activities will vary from study to study, but typical examples include answering questions, at-home test kits, wearing an activity tracker, using an app or device, and so on.
Why should I participate in research?
People participate in research for a variety of reasons. Some want their voices to be counted, others want to contribute to better health outcomes for themselves and others. Whatever your personal reasons for participating, being a part of health-related research can have a lasting impact.
But don’t take it from us -- here’s a breakdown of what over 36,000 participants said about why they chose to join our recent COVID-19 Experience Study:
What kind of support can I expect if I participate?
Our team is here to help you through the research participation process. We have a dedicated team of individuals (the Participant Support Team) who are here to make the experience as easy and comfortable as possible.
Some of our support features include:
- Answering questions about the study
- Helping with the enrollment process
- Providing technical or troubleshooting support for most study activities
- Assisting with payment inquiries
Want to know more about any of our Evidation Studies and how to get involved? Reach out to us at study@evidation.com and one of our friendly team members can help you get started.
If you want additional general information on health research, we recommend checking out the following public resources:
- U.S. Department of Health & Human Services, Office for Human Research Protections
- FDA, Clinical Trials and Human Subject Protection
- National Institutes of Health (NIH), Educational Resources
- Clinical Research Resource HUB, Resources for Participants