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:

1. Respect for Persons - Giving people the right and capacity to make their own decisions.
2. Beneficence - Minimizing potential harms and maximizing benefits 
3. Justice - Distributing benefits and risks fairly 

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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

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Nearly 1 in 5 US adults live with some form of mental illness. And the numbers are rising.

Mental illness is a common issue among Americans, but it’s something we can work on by practicing self-care all year round. And during the months of summer, there are a variety of self-care methods we can take part in to boost our mood while enjoying the warm weather.

In today’s article, we’ll be sharing 5 summer self-care tips to boost your mood and mind, all while embracing the sun. Keep reading to learn more. 

Get some sun

Many people struggle with what's known as seasonal depressive disorder (SAD). SAD relates to the change in seasons, many people experience symptoms in the fall and later in the winter months.

And most people affected by SAD live at latitudes far south and far north of the equator where there’s much less sunlight during the fall and winter months.

‍But why?

The reason for this could be that in the darker months of winter and fall people are exposed to less sunlight. The skin produces Vitamin D when it’s exposed to the sun, and Vitamin D can help increase serotonin activity.

‍What’s serotonin?

‍And what does serotonin have to do with our mood?

‍Serotonin is a neurotransmitter (a chemical messenger) that carries messages between your brain and throughout the body. It has several roles, including influencing our memory, learning, and happiness. 

‍Low levels of serotonin may cause depression.

Getting out in the sun may be a great way to not only get more Vitamin D, but it may also help increase the level of serotonin activity within us. Potentially improving our overall mood. 

While getting sun is important, it’s vital to protect yourself from getting a sunburn or heat stroke.

It’s best to protect your skin with sunscreen and reapply every so often throughout the day. Reflective clothing is another great way to keep your skin safe in the sun.

Keeping cool is also important, as spending long amounts of time exposed to the sun could result in heat stroke. Try taking breaks from the sun in the shade and do your best to not over-exert yourself. 

Exercise outdoors

In many places, one of the great things that summer has to offer is the ability to exercise outdoors.

‍Physical activity can:

• Help improve brain health - regular exercise may help improve cognitive function and sleep, and it may reduce depression and anxiety risk and overall improve our quality of life.
• Help manage weight - physical activity can help burn calories, build muscle, and decrease total body fat. This could result in better self-esteem and overall a more positive mood.
• Help improve our ability to do day-to-day tasks - when we improve our overall health, day-to-day tasks become easier. This can lead to a better quality of life and can greatly improve mood and well-being.

When compared to indoor activity, outdoor activity seems to have a greater impact on improving mental health. Studies suggest spending time in natural environments may have a positive impact on well-being.

The combination of mental health benefits from spending time outdoors as well as exercise is something worth taking advantage of.

So instead of going for a run at the gym, take a jog around your neighborhood. Or, try getting involved with some outdoor sports.

Relax outdoors

In one review of research, there’s evidence that spending time outdoors with nature can increase happiness and positive social interactions. It may even help bring a sense of purpose and meaning to our lives.

Combining your favorite way of relaxing with spending time outdoors might be an effective way to maximize your self-care this summer.

Different forms of relaxation may have different effects, but relaxation can help us:

• Reduce stress
• Improve sleep quality
• Improve mood and focus
• Reduce anger and frustration
• Reduce muscle tension and chronic pain 

So, what are some of the different ways we can relax outdoors?

It depends on what you like to do, but a few ideas might include:

• Yoga
• Reading
• Meditating
• Breathing techniques 

We encourage you to get outside and take some time to relax and unwind during the summer months!

Take some time off

The summer months are some of the best times to take a break from work.

Whether you decide to go on a vacation outside the country or enjoy the weather in your local area. It’s important to take time off to destress, and physically and mentally recharge.

Some benefits of taking a vacation from work might include:

• Lower stress
• Improved mental health
• Improvement in productivity

Overall, taking time off is important. And summer presents an opportunity for all of us to enjoy a break from work while embracing the warm weather.

Explore nature

As discussed earlier, spending time outdoors may help improve our well-being and happiness.

And exposure to sunlight could help increase the levels of serotonin in the body.

‍But how does exploring nature help?

Just as completing a workout can help us develop confidence, exploring nature may have the same effect. 

You can try taking on a difficult hiking trail, or exploring a new area while paddling. Spending time outdoors and conquering a challenging task can increase your confidence and overall self-belief. 

Closing thoughts - 5 Summer Self-Care Tips to Boost Your Mood 

With such a variety of options, summertime may be one of the best times to practice self-care and boost your mood. 

From getting your summer self-care essentials like sunscreen to relaxing outdoors by meditating or reading, there are many options when it comes to self-care in the summer.

And as more research comes to the forefront, we'll have a better understanding of how the sun and nature affect our moods.

Make sure to share this with a friend or family member who could use some self-care tips to boost their mood during the summer!

Flu Trends from Down Under

Flu season is picking up in Australia, with an earlier uptick in infections than previous years. In the graph below, we can see that flu cases in Australia typically peak in June, July, and August. The solid red line for 2022 shows that cases actually started peaking in late April—two months earlier than usual.

How can you protect yourself and others this fall?

It may not be flu season yet in the Northern Hemisphere, but it’s never too early to learn about flu prevention. According to the CDC, receiving a yearly flu vaccine is the most important step in protecting against flu viruses. Other preventive measures include avoiding close contact with people who are sick, covering coughs and sneezes, disinfecting surfaces that may be contaminated with viruses, and washing your hands with soap and water.

Although arthritis is commonly associated with older aged people, a form of arthritis known as juvenile arthritis affects approximately 300,000 teenagers and kids in the United States.

That’s why it’s so important for us to observe Juvenile Arthritis Awareness Month every year.

During July, we look to not only observe, but also spread awareness and educate ourselves and those around us about this condition.

1 in 250 kids is affected by some form of juvenile arthritis.

‍So, what can we do to help?

‍What is juvenile arthritis and what causes it?

‍What are the symptoms we should look out for in our children? 

‍And how can you get the proper diagnoses and treatments?

We’ll be speaking on these matters and sharing how you can take part during this important month and make an impact on people's lives and communities. Keep reading to learn more.

What’s juvenile arthritis? What causes it?

Juvenile arthritis isn’t a singular disease. It’s an umbrella term used to describe rheumatic and inflammatory diseases that affect children under the age of 16.

‍Autoimmune and autoinflammatory diseases make up most types of juvenile arthritis.

This means that the immune system, which normally fights against foreign bodies like germs and viruses, becomes confused and starts releasing inflammatory chemicals that attack healthy tissue and cells.

‍But how does this affect the body?

This results in joint pain, tenderness, swelling, and inflammation. 

But in some cases, none of these symptoms are visible on the joints. It sometimes only affects the internal organs and skin.

‍So, what causes juvenile arthritis? 

The verdict behind the cause of it is still up in the air. But several factors like our environment and certain genetics may lead to juvenile arthritis. 

This means it could get passed down through families or triggered by exposure to certain things.

Symptoms and diagnosis

‍What are common symptoms associated with juvenile arthritis?

People dealing with juvenile arthritis might experience:

• Pain - it’s common to feel a certain degree of pain in the joints or around them.
• Stiffness - as joints become painful they may also become stiff. 
• Swelling - when certain joints become inflamed it’s common to notice some swelling.
• High fever, rash, and swollen lymph nodes - in rare cases, children who have juvenile arthritis may experience these symptoms.

‍Now, how is juvenile arthritis diagnosed?

There is no particular test to confirm the condition. But when a healthcare professional examines someone who may have juvenile arthritis, they look at their health history and they may do a physical examination.

They usually ask about symptoms the person is experiencing and any recent illnesses that may have occurred. In many cases, when inflammation symptoms have been present for 6 weeks or more, juvenile arthritis may be the cause.

There are different forms of tests that may also be performed. Common forms of testing include blood tests and imaging tests. 

‍Some blood tests include:‍

• Complement tests - these tests measure the level of complement in the bloodstream. Complement is a protein found in our bloodstream. Low levels are often linked to immune disorders.
• White blood cell count - higher levels of white blood cells may indicate an infection is prevalent. Lower levels may show a sign of some autoimmune diseases or even reactions to medications.
• Antinuclear antibody (ANA) and other antibody tests - these tests measure the levels of antibodies in the blood. The levels are often elevated in people who have autoimmune and inflammatory diseases.

‍Imagery tests could include:‍

• MRI
• X-Rays
• CT scan
• Bone scan

Urine tests might also be performed. They’re used to find blood or protein in the urine which could indicate the kidneys aren’t working properly. 

Another form of testing for juvenile arthritis is joint aspiration. This test consists of taking synovial fluid (a thick liquid that lubricates the joints) from a joint and examining it to see if bacteria or viruses are present. Juvenile arthritis can be activated by certain viruses and bacteria.

Treatment options

Medications, lifestyle changes, and different forms of therapies are all used to treat juvenile arthritis.

Some medications that are commonly prescribed include:

• Corticosteroid medicines - these medications are often used to treat severe symptoms people may experience and to reduce inflammation
• Nonsteroidal anti-inflammatory medicines (NSAIDs) - NSAIDs are sometimes used to reduce inflammation and pain.
• Disease-modifying antirheumatic medicines (DMARDs) - these medications work to ease inflammation and control juvenile arthritis.

Medicines known as biologics are sometimes used if other forms of treatment aren’t working. These medicines work by interfering with the inflammatory response of the body.

Different forms of therapy are also used to improve certain aspects of life that juvenile arthritis might hinder. 

To improve and maintain joint and muscle function, some people do physical therapy. Occupational therapy might also be another solution to help people in their ability to perform regular daily activities.

Some lifestyle changes that may help include:‍

• Weight control
• Exercising regularly 
• Nutritional coaching 
• Getting enough rest

How to participate in Juvenile Arthritis Awareness Month

What can you do to help your community and those affected by this condition? 

One way we can participate is by educating ourselves and spreading awareness around Juvenile Arthritis Awareness Month. 

Educating ourselves gives us the chance at having a better understanding of the condition and how we can help those affected by it. It also allows us to educate others.

And spreading awareness is a great way to introduce this condition to those who may be unaware of it. We can spread awareness by speaking with friends, family, and coworkers, or we can even share information and articles on social media.

Another way to get involved would be to take part in community events or even host one of your own. 

Conclusion

Juvenile Arthritis Awareness Month is about educating, spreading awareness, and taking part in events that help those who are living with this condition.

Whether you decide to take part in community events or speak with your friends and family, we encourage you to take part.

Arthritis is often seen as a condition that only affects older adults, but with more awareness, we can change that conversation.

Make sure to share this with your friends, family, coworkers, or even your social media, and do your part in helping this important cause.

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: 

• 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

According to the CDC, Heart disease, cancer, and COVID-19 are the leading causes of death in men. 

And due to many societal factors, men often pay less attention to their overall health compared to other genders. 

‍According to Harvard Health, men are more likely to not take part in regular checkups. They’re also more likely to smoke tobacco and drink alcohol - increasing the risk for heart disease.

‍But most of the health problems men face are preventable. 

During National Men’s Health Month we look to spread awareness around men's health and encourage men to take care of themselves by getting regular checkups and take care of themselves through exercise, diet, and disease prevention.

So, how can men take control of their health?

‍What can they do? 

‍What actions should they take?

And what are some of the most common health problems men face?

In today’s article, we’ll be answering all these questions. Keep reading to learn more!

Common health problems men face

What are some of the common health problems men face?

How can they prevent these health problems from happening?

Among all cancers, prostate cancer is the most common among men. It’s said to be the second leading cause of death from cancer for men in the United States. 

Although there are steps you can take to prevent it, some aspects that affect health are out of our control. Age, race, and genetics can all increase the chances of getting prostate cancer. 

But making changes in your lifestyle and diet could help prevent it. Some changes you can make to help prevent prostate cancer include: 

• Eating a healthier diet
• Increasing Vitamin D intake
• Quitting smoking and drinking less
• Staying sexually active (with or without a partner)
• Regular exercise and maintaining a healthy weight

Although prostate cancer is common, the leading cause of death in men in the United States is actually heart disease. In 2019 it caused 1 in 4 male deaths in the United States.

‍But there are steps men can take to reduce their risk of heart disease:‍

• Lower stress levels
• Quit smoking and limit alcohol intake
• Maintain a healthy weight and eat a healthy diet
• Get regular checkups and ask about checking for diabetes and high cholesterol

Men face a lot of physical health problems, but one of the most stigmatized issues men face is mental health. And although the conversation has changed drastically, men, like many others, are still suffering from mental health issues. 

‍Approximately 30.6 percent of men suffer from a period of depression in their life, and the suicide rate in American men is four times higher than it is in women.

But there are steps we can all take to care for our mental health. Self-care is one way we can maintain good mental health. We can practice self-care by:

• Practicing gratitude
• Focusing on positivity
• Getting regular exercise
• Setting goals and prioritizing
• Staying connected with people
• Taking part in a relaxing activity
• Getting an adequate amount of sleep 
• Staying hydrated and eating regular healthy meals

But sometimes self-care isn’t enough. Recognizing the signs that you or a loved one is dealing with mental health issues can help someone take the first steps in treatment.

‍Some signs of depression might include:‍

• Irritability
• Decreased energy or fatigue
• Feelings of guilt, worthlessness, or helplessness
• Loss of interest or pleasure in hobbies and activities 
• Thoughts of death or suicide or even suicide attempts 

There are treatments for mental illness, and if you think you or a loved one are suffering make sure to reach out to a health care provider to get the help needed.

‍If you or someone you know is in crisis, you can call the National Suicide Prevention Lifeline at 1-800-273-8255, or text “HELLO” to the Crisis Text Line at 741741.‍

How to participate

We can all participate in National Men's Health Month in one way or another. 

It’s a great time for men to take a look at their health and start changing their habits and routines to create a healthier lifestyle.

‍Men can take charge of their health by:‍

• Exercising regularly - exercising can help people maintain a healthy weight, fight health conditions and diseases like cancer and depression, promote sleep, and even boost energy. 
• Eating a more balanced and healthy diet - eating a more rounded diet may help to maintain a healthy weight, get the nutrients for optimal health, and even improve your heart health.
• Taking care of their mental health - activities like meditating, yoga, or time spent with hobbies and loved ones are all great ways men can practice self-care and relieve any stress, anxiety, and worry they may be feeling.
• Participating in some activities - spend some time hiking, playing soccer, dancing, or painting with some friends, loved ones, or even co-workers. 

We can also encourage the men in our lives to speak about their mental health issues. Creating a safe place for men to express their concerns is a great way for us all to participate in Men’s Health Month. 

Spreading the word about Men’s Health Month is also a great way to participate. It helps educate people on common issues men face, and it opens the door for more conversations to take place in our communities.

You could even participate in a fundraiser or create your own for men's mental health or even prostate cancer. 

Another way we can participate is by dawning the color of blue during Wear Blue Day. Wear Blue Day is a day people wear the color blue to spread awareness around men’s health month, it takes place each year, on the Friday before Father’s Day.

Closing thoughts - National Men’s Health Month

Men’s Health Month is a time to make changes, spread awareness, and open the conversation about topics that are sometimes stigmatized in today's society.  

We can all do our part during this month either directly by helping the people in our lives or ourselves, or even by participating in fundraisers and events that highlight the common health issues men face every day.

Make sure to share this with a friend or family member who could benefit from some of the information we provided so you can do your part to spread awareness around this important month for men's health!