Participate in Research

Clinical research tests new ways to understand, diagnose, prevent, and treat diseases in humans. Research has led to important discoveries such as new medicines to treat cancer, diabetes, and other diseases making our lives better. Other words for research are clinical trials, surveys, studies, or experiments. This short video from the National Institute for Child Health and Development can tell you more.

There are different types of clinical research including treatment studies, genetic studies, prevention studies, behavioral studies (to understand how and why people behave in different ways).

To learn more about commonly used the research terms, check out Clinical Trials and You.

Watch the video from the US Department of Health and Human Services. This video explores the basic differences between medical research and medical care to help you make the right decision about whether to join a medical research study.

Clinical research could not be done without the people who agree to take part. Research volunteers are essential to helping get answers to research questions on how to best prevent and treat diseases.

Also, doctors need to know how new medical treatments may affect people differently. Some medical treatments can be affected by certain personal factors. For instance, a person’s gender, age, race, ethnicity, health status, or genetics might affect how they respond to a treatment. That’s why it’s important to have clinical trial volunteers from different backgrounds. Yet, some groups are not well represented in clinical trials. Read section above on why having diverse groups in research is important.

Normally, new medical products go through four phases of testing. Each phase (or stage) has a different purpose.

PHASE 1

Phase 1 is the first time a new treatment is tried in humans, which is also known as human subjects research. The goal of during Phase 1 is to find out if a new drug or treatment is safe. Volunteers are watched closely to see if there are any unwanted effects.

Phase 1 studies usually only include small numbers of people. If the treatment is found to be safe, it can move to the next phase.

PHASE 2
Phase 2 is the first step to find out if a new treatment really works. Phase 2 trials include more people. A larger number of participants allows researchers to see if the treatment shows ways that it is effective. Phase 2 studies are also used to determine the most appropriate doses or frequencies of treatments, and to test the treatment in selected groups of people. For example, a person’s age or gender might affect their response to treatment. With more people, it’s possible to see if the treatment works the same for people of different ages or genders.

Phase 2 research also continues to watch for side effects. With a larger number of people, it’s possible to see different types of side effects.

PHASE 3
Some people might have good results from treatments in Phase 1 or 2 trials. However, these good results could be due to factors other than the treatment. Even though Phase 2 trials have a larger number of participants than Phase 1, larger studies are still needed to make sure the effect of the treatment is real and is safe.

Phase 3 trials can have as many as 3,000 people. With a larger group, researchers can set stricter guideline for saying when and how a treatment is effective. For example, they might control for a lot more factors to be sure that it’s really the treatment that makes the difference.

In some cases, a treatment may already exist. Phase 3 studies can compare two or more treatments to see which one works best.

Unexpected effects are tracked even more closely in Phase 3. As more people try the treatment, it becomes clearer which unexpected effects are likely, whether they are harmful, and who is more likely to have them.

Phase 3 studies are needed to get reliable answers about safety and effectiveness of the treatment being studied. If results are good, the new treatment can be approved for doctors to prescribe to patients.

PHASE 4
Phase 4 trials happen after a drug is approved by the FDA. Phase 4 trials continue to track safety. More information is obtained about who is helped by a treatment. This research also finds out more about risks of combining different medical treatments and products.

Summary
This step-by-step process helps make sure new medical products can have the most benefits and least risks for people and communities. At each phase of research, it’s important to have diverse groups of patient volunteers. Diverse groups may include differences such as race, ethnicity, age, gender, and income, and overall health status. A new treatment can only move forward if it successfully passes each phase.

Having diverse groups gives confidence that research results will apply to a wide range of people. This will help make sure everyone can get the treatment that is best for them. Ensuring diversity in research is also a way to help reduce health disparities and achieve health equity. Health equity means that everyone has a fair and just chance to be as healthy as possible.

Here are a few reasons why having diverse research volunteers is so important.

• Factors like a person’s age might affect the side effects they have.
• New drugs may interact with other medicines that people already take.
• The instructions for how to take a medicine need to be easily understood by everyone, including those who speak a language other than English.
• Genetics can sometimes play a role in how a person responds to a medicine.
• Clinical trials can give people access to the newest medical treatments. The advanced technologies that might be needed are often located in big cities. This can limit access for those who live in rural areas.

Lack of diversity in research can be affected by various reasons including a researcher’s own biases. For example, a researcher might think a person with a disability can’t take part in a research study. In fact, researchers must take steps to make sure people with disabilities can access research. Research must also recognize the different ways people express their gender.

Members of the research team for any clinical research study should be willing and able to answer your questions. Here are some questions you may want to ask:

• What is the purpose of this study?
• What will I be asked to do?
• Will I be asked to take a new medicine that hasn’t been used before?
• What happens if I don’t get the new medicine or treatment?
• How will my care be different if I decide not to take part in the study?
• How will this study benefit me?
• What risks are involved?

Some research centers have Research Participant Advocates. These advocates help ensure the rights, safety, and well-being of people who take part in research. Their job is to make sure that people get the information they need to know while they are in a research study. 

Making sure research is safe for the people who take part is a top priority for researchers and research institutions. All research with humans must be approved before it starts. The group that reviews human research is called the Institutional Review Board (IRB).

What does an IRB do?

The IRB makes sure the possible risks and benefits of a research study have been carefully considered. This group also makes sure people are told about what they will be asked to do. It’s important to fully understand what the research is about and any risks that might be involved. This is called the “informed consent process.”

Every research center or institution that asked people to be in research must work with an IRB. Each IRB must go through an approval process. The IRB must prove that the group meets all requirements for doing this kind of work.

What is the make-up of an IRB?

Each IRB must have at least 5 members. The members can be researchers, doctors, and people outside of the medical field. Each IRB should have at least one member from the local community.

Members of the IRB must complete training that teaches them about all federal research regulations and laws related to human research.

Research studies must include diverse groups of people. The IRB checks to make sure there is a plan to include women, children, and racially and ethnically diverse minority groups in the research.

The IRB itself must be sensitive to the interests and needs of diverse communities. It’s important that IRB members are diverse in terms of race, ethnicity, gender, and cultural backgrounds.

How does the IRB evaluate the safety of a research study?

IRB members look at a detailed written plan of every research study. The research plan gives details about the research. This plan tells why the research is important. The plan also states what participants will be asked to do. This plan is called a protocol.

The IRB makes sure the research plan meets all regulations and laws. The IRB also checks to see that everyone on the research team has the required training to do research with people.

The possible risks that people may face in a study are looked at very closely. IRB members discuss the study plan to decide if risks are acceptable. They make sure that researchers have taken adequate steps to protect participants. They also make sure researchers reduce any risks as much as possible. This includes protecting people’s confidentiality during and after the research study.

What else does the IRB look for?

The consent form is another written document that is carefully checked by the IRB. They make sure the consent form matches the written research plan.

The consent form must tell people everything they will be asked to do in the study. The consent form must also state what the risks may be. The IRB makes sure people know their rights when taking part in a research study.

Signing a consent form is only one step in the process of giving informed consent. Being in a research study is your choice. It must be something you want to do without pressure from other people.

Research with people is guided by three golden rules. These golden rules are to treat people with dignity and respect, to do good, and to be fair.

One way to start searching for a clinical trial is to talk with your doctor. They can provide some guidance on which research studies may be right for you.

You can also search for trials yourself. Study registries let you search for clinical trials by any disease or condition. One example of a study registry is www.clinicaltrials.gov.

Most registries will tell you the purpose of the trial. Registries will also give basic information about who can participate. You can find out where the study is taking place and how to contact the researchers. Once the study is finished, researchers can use the registry to share results with the public.  

To learn more about searching for clinical trials, check out this video by the Baylor College of Medicine.

GHUCCTS can also help you find a clinical trial by searching through current studies at our institutions. Let us know what questions you have about how clinical trials work.  Contact us at 301-909-8135 or contact@wepartner4research.org.

Follow us on Facebook for information about clinical trials.

Clinical Trials sometimes use placebos. A placebo is a substance or treatment that does not have any real medical effects. A placebo can be a pill, a shot, or device made to look like the real medical product.

Why are placebos used in some clinical trials?

Using a placebo is a way to help researchers see if there is a real effect from a new medical treatment. Sometimes just believing you are getting a real treatment can affect how you think, and this helps you feel better. This is called the placebo effect. Making sure everything that happens in a study is the same for everyone avoids the placebo effect.

Do all clinical trials use placebos?

No. Many trials do not use placebos. The choice to use a placebo depends on many factors. For example, when there are proven treatments for many diseases, the research may compare two real treatments to see which one works best. A placebo might not be used in this type of research.

Are there safeguards to assure placebos are used fairly?

Yes, there are safeguards to assure placebos are used fairly. In many trials that use placebos, neither the doctor nor patient know who gets the real drug and who gets the placebo. This is one way to make sure everyone has an equal chance to get the new treatment. The chances of having a side effect are equal too.

Research has not always helped all people equally. See section on how participants are protected in research to learn more.

Clinical trials find new and better ways to diagnose, prevent, and treat illness. These studies find out if new medical products really work. They also make sure the products are safe for most people to use. Some clinical trials use randomization.

Randomization means that people are put into groups by chance, not by choice. The groups may be given different types of medical treatments to see which one works best.

Doctors and patients can’t pick which treatment a person gets. Randomization is usually done by a computer. This way of putting people into groups makes sure the groups will be alike on important things like age and health status.

Why not just give everyone the treatment that doctors think will work the best?

Many factors might affect how a person responds to medical treatment. For example, an athlete might be in good shape before starting a medical treatment. The athlete may be given the same medicine as someone who has a lot of health problems. The athlete might get better while the other person does not. The outcome might be due to the athlete’s health before the treatment and not the treatment itself.

Randomization can help make sure the effects of the new treatment are real. The goal is to make sure groups are balanced on factors that might relate to the risk of becoming very sick. If a treatment appears to work, researchers can be more confident that the effects are real.

Is it fair to use randomization in medical research?

Randomization is a way to make sure everyone is treated fairly in research. With randomization, everyone who volunteers for a study has an equal chance of being in each group.

To take a deeper dive into how randomization works and why it’s important, check out this video from the United Kingdom Medical Research Council, or this video from the Office of Human Research Protections.

Research abuse means that people who take part in research are intentionally harmed, put at risk, or treated unfairly. This goes against the three golden rules of research to respect people, do no harm, and to be fair.

Before the 1970’s, there was not a way to make sure all researchers followed these rules. Many researchers acted ethically. However, some ignored the safety and well-being of the people who took part in research. These studies were usually approved by the institutions where they took place. In some cases, the research was paid for or run by the U.S. government.

What are some examples of past research abuses?

From 1932 to 1972 a research study, now known as the Tuskegee Syphilis Study, caused harm to black men. Men in this study were not told they had syphilis. They were told they had “bad blood”; a term used for various illnesses. When penicillin was discovered as a cure, they were not given the treatment. This is an example of abuse in research.  

Thought these men were not injected with syphilis by the researchers, they were denied proper treatment. There have been, however, other cases where researchers exposed people to harmful or infectious substances on purpose. In some cases, this was done to children who were not able to give consent. There have also been past instances of researchers recklessly exposing people to radiation. In many cases, people were not aware and did not give consent.

In other cases, consent was not always freely given. Research was sometimes done with people in prison or in the military. But researchers didn’t always make sure people felt free to refuse to take part. Research abuses were not limited to the United States. Experiments on prisoners in Nazi concentration camps injured or killed many people. Prisoners of war were subjected to medical torture in Japan.

Sadly, there are many more examples of past research abuse. It is important for all researchers to openly acknowledge the past so that similar actions never happen again.

Am I protected from research abuse?

Since Tuskegee, much has changed.  There are many safeguards to protect the safety, privacy, and rights of research participants. The U.S. Office of Human Research Protections was established to protect the rights, welfare, and well-being of research participants.   Safeguards include:

• Being in a study is voluntary. People are free to decide if they want to join the study. They can also stop at any time.
• All human research is checked by a group called an Institutional Review Board (IRB). Members of the IRB are not part of the study team. Their job is to protect the rights, safety, and well-being of research volunteers.
• In almost every study, researchers must have informed consent of everyone who takes part in a clinical research study. Informed consent means people are given all the important information about the study before they sign up.
• There are some very limited situations where informed consent may not be required. For example, research may be done for treatment of medical emergencies when the person can’t give consent. However, there are very strict rules about when such research can occur.

Remembering the ways that past research has harmed people can help to prevent such harms from occurring again. But we should not let the errors of the past get in the way of advances for the future. Clinical trials help find safe and effective ways to prevent and treat diseases. 

Research has helped make great strides for improving human health. Unfortunately, there are also well-known research abuses that occurred in the past.

The good news is ⎯ researchers have learned from these mistakes. They are now working in new ways to make sure patients and community voices are heard.

How did the story of Henrietta Lacks prompt important changes to how researchers work?

In 1951, Henrietta Lacks was diagnosed with cervical cancer. She was treated at Johns Hopkins Hospital in Baltimore, MD. Her cells were used for research without her consent. It was found that Mrs. Lacks’ cells did not die like most cells in the lab. 

Since then, her cells have been used in many different research studies. Countless new medical products were developed based on research with these cells.

In 2010, a book called The Immortal Life of Henrietta Lacks was published. This book told the story of Mrs. Lacks and how this research abuse affected her family.

After the book was published, Johns Hopkins Medicine stated that the institution, “could have — and should have — done more to inform and work with members of Henrietta Lacks’ family out of respect for them, their privacy and their personal interests.”

Since then, Johns Hopkins Medicine has changed many practices. One important change is that members of the Lacks family now have a say in deciding how the cells are used.

How do communities and researchers work together now?

Today, many research institutions work closely with patients and communities. Their input helps scientists understand how the research they do affects people’s lives. Research is guided by the point-of-view of the people the research is intended to help. These relationships are one way to make sure history does not repeat itself. Read section on how participants are protected in research to learn more.