Frequently Asked Questions
Q. What is health research?
Health research (which refers to clinical trials and studies) is the way we learn new and better ways to help people be healthier. Every trial or study is a partnership between members of the community (you), doctors, and researchers. The results determine whether these new ideas do a better job at treating or preventing a disease and ultimately improving medicine for everyone.
You may hear a lot about how important your participation is in health research. Participation from volunteers ensures there are ongoing advances in the medical field. More than that, it's the only way medical breakthroughs can reach the public. Health research - and your involvement in it - plays a crucial role in improving the health of current and future generations.
Q. What are the different types of health research?
There are several different kinds of health research and not all involve new treatments for a disease.
Intervention studies look at specific medications, procedures, and devices to see if they are more effective at treating a disease or medical condition, or at modifying risk behaviors. (Risk behaviors are lifestyle choices that increase a person's chance of suffering from a particular condition.)
Prevention studies help determine how we can better prevent a certain disease or condition from occurring in healthy people.
Diagnostic and screening studies search for better ways to detect and diagnose disease.
Behavioral research seeks to identify how certain behaviors are related to a variety of diseases, and how these behaviors can be modified.
Quality of life studies look for ways to help those with chronic or incurable diseases.
Observational studies follow participants over a period of time - monitoring their health over the course of months or years - without changing their treatment.
Q. What kinds of conditions and diseases is UR researching?
At any given time, we're involved with hundreds of studies, performing health research on dozens of diseases, from diabetes and cancer to muscular dystrophy, arthritis, and many more. We also do research involving healthy people, looking at ways to prevent diseases with things like vaccines and healthier lifestyles.
For a list of open studies, click here.
For a list of open studies that are looking for healthy people, click here.
Q. What are the phases of a clinical trial?
Clinical trials have four phases. Each has a different purpose and provides important information for the researchers. Think of the phases as a chain of events - the researchers use the findings of each phase to determine how or if to proceed with a study. You'll see that safety is a priority from the very beginning.
Phase I Trials help evaluate the safety, side effects, and proper dosage range for a new drug or treatment. Let's say a researcher has found what might be a promising idea and has reached the point where the drug is ready to be evaluated on people. In the Phase I Trial, researchers typically ask for a group of 20-80 healthy volunteers. These volunteers help researchers determine if the medication is doing what the researchers predicted, if the medication amounts are accurate, and to make sure there are no unwanted side effects.
Phase II Trials involve a greater number of volunteers, usually 100-300 individuals of which a portion have the specific condition the medication or therapy is trying to treat. In Phase II Trials, volunteers help researchers study effectiveness by seeing whether or not the medication, behavior, or therapy is actually having an impact on the condition that's being treated. Safety evaluations are continued as well.
Phase III Trials expand to a much larger group; anywhere from 1,000-3,000 individuals and multiple medical centers are often involved This phase is really a bigger version of Phase II with one exception; the group of volunteers tries to represent the broader demographic you see in our communities. For this to happen, researchers need volunteers of different ages, genders, health, race, and ethnicity. This allows researchers to look for reactions that might affect a certain population such as people with pre-existing or inherited conditions. Researchers look closely at how the new approach compares with the best drugs or treatments currently available.
Phase IV Trials take place after a new drug or treatment has received permission to be sold. Researchers watch for rare side effects, study interactions with other drugs, consider other uses for the new drug or treatment, and examine how it works in select populations.
After a Trial
No matter the final outcome, every trial is valuable and considered a success. Sometimes what started as a promising idea is now available to the public and supported with research, findings, and knowledge. Other times, results lead scientists to entirely new ways of thinking about how to help people live healthier and feel better. Either way, researchers make important discoveries. And all of it was made possible because of volunteer efforts.
Q. Why should I participate in a clinical trial or study?
Think for a moment about everything you do to stay healthy. It may be leading a certain lifestyle to lower your risk of developing heart disease or taking medication to help a medical condition. What might not come to mind is how you and your family might benefit from health research - your son's vaccinations, your mom's migraine medication, your partner's physical therapy, or your brother's blood transfusion - none of these would be available if health research didn't prove that they were safe and effective.
Becoming involved in health research is also a way to participate in the very latest approaches in treatment and prevention for a particular challenge you may be facing, such as cancer, diabetes, heart disease, depression, or obesity. While there are no guarantees, participating in a study may be the only way to gain possible access to these new treatments until they are approved for public use.
And, if you're a member of an underrepresented group, such as African Americans or Latinos, your participation becomes especially important. For a variety of reasons, some medicines and treatments work differently depending on an individual's race or ethnicity. In other cases, the symptoms of a condition may differ, which affects a doctor's ability to make a correct diagnosis. We want people from all groups represented in health research. That way, everyone can potentially benefit.
Even when health research doesn't immediately identify a better approach, it inspires new ideas for further study. So unless we try - and try with your help - health care improvements simply don't occur. Each and every study brings all of us closer to a healthier way of living.
Q. How do I get involved in health research?
You've already taken the first step by learning more about health research happening right here at the University of Rochester Medical Center (UR). When you're ready, take a look at our Open Studies page and see if there's a study that interests you. Once you find a study, you'll be able to contact the study coordinator or lead researcher directly, or you can call the Call Center at (585) 758-7877.
Talking to your doctor is another way to get involved. Your doctor knows you and your health history and can provide good advice on whether participating in health research is for you. Your doctor may also be able to help you determine what studies are available for a specific disease or condition.
Q. What questions should I ask my doctor about a research study?
If your doctor suggests that you consider a clinical trial or research study - or you decide to get involved yourself - it's important to have good information when you're deciding whether to participate.
Start with the questions that immediately come to your mind. Then, look at this list for ideas of others you might want to ask.
- What is the purpose of this study?
- How long will the study last?
- What kinds of tests, therapies, or treatments will I receive?
- Why do researchers think this approach will work?
- What other similar studies have already been done?
- What are the short-term benefits?
- Who has reviewed and approved the study?
- What are my responsibilities during the study?
- Who will be in charge of my care during the study?
- Will I still be able to see my own doctor?
- Will I be paid for my participation in this study?
- What risks should I be aware of?
- How will the researchers be monitoring my safety?
- What if I get sick from the study? Will the cost of my care be covered?
- How will my medical records be protected?
- How do these benefits and risks compare with the standard care that people already receive?
- Can I speak with other people who are participating in the study?
- Will I be made aware of the study results?
Your doctor will have some of the answers, but for study-specific questions, you may want to call the study coordinator (the study coordinator's contact information is provided with each study). Of course, not every one of these questions will apply to you. But getting the answers you need should help you feel more confident about participating in health research.
Q. Is my privacy protected?
Your privacy, and the privacy of your medical records matters to you, and it matters to us, too. You can read and download more about UR privacy topics as they relate to your internet use and medical information.
Your confidentiality will also be protected. When you participate in or request more information about a particular study your name and other information that identifies you will not be sent outside of UR unless we have your written permission. In some cases, the law may allow us to send your personal information. If you have any questions or concerns about your privacy please call us at (585) 275-1020 or ask the study coordinator for more information.
Q. Why is it important that people from all races and ethnicities participate in health research?
Vulnerability to sickness and medical conditions is something we all have in common. Because the purpose of health research is to benefit everyone, different medicines and treatments need to be studied on all types of people representing diversity in gender, race, ethnicity, age, and even health.
African Americans and Latinos represent the two largest minority populations in the U.S. yet both are critically underrepresented in health research. That concerns us. Some medicines and treatments work differently depending on an individual's race or ethnicity. In some cases, such as skin cancer in African Americans, the symptoms of the cancer appear on the skin differently, which directly affect a doctor's ability to make a correct and timely diagnosis. Health research could be one way for doctors to improve their ability to identify the early stages of skin cancer on darker skin tones - knowledge that could ultimately save lives.
Bottom line: without the involvement of African Americans, Latinos, Asians, and other ethnic and racial groups, our researchers can't gather the information they need to determine the best ways to keep individuals of these groups healthy. The University of Rochester Medical Center is working hard to eliminate these health inequalities in underrepresented populations. We're partnering with community leaders and organizations and getting the word out on the importance of health research to make sure everyone understands how vital it is that all groups - not just some - participate in research.
If you are a Latino or African American, your participation means good things for the health of your community. Make a big difference today. You can start by looking over the open studies to see what might interest you.
Q. Do I need to be sick to participate?
No—health research needs the help of healthy volunteers too! In some studies researchers need to compare healthy volunteers with people who have a specific disease or condition. Quite often, in the earliest phase of health research, new drugs and treatments are tested on healthy volunteers first. Either way, your efforts will help treat and prevent disease for those at risk or who are already suffering.
Take a look at the list of open studies that need healthy volunteers.
Q. What exactly is a healthy volunteer?
There are actually two types of healthy volunteers. The first type is a person who has no known medical conditions. The second is someone who may have a medical condition, but one that is unrelated to the clinical trial or study in question. For example, let's say you have asthma, but are interested in being part of a study on diabetes. If you don't have diabetes you may be considered a healthy volunteer for that particular study.
Take a look at the list of studies currently looking for healthy volunteers to see if anything interests you.
Q. How much of my time will it take?
Every health research study has different time requirements. Some might involve very little of your time, while others will require visits once a week or more. Occasionally, a long-term study will want to check in with you over the course of several years.
The description on our Open Studies page will have information about time requirements. If you need more details, feel free to contact the study coordinator or lead researcher listed.
Q. Will I be paid for being involved in health research?
In some cases, participants in trials and studies receive a payment for their involvement in a study or reimbursement to cover the cost of transportation and any other out-of-pocket expenses. The amount and method of payment varies from study to study. The University of Rochester is currently switching to a new system of payment for clinical research participants, called Participant Payments. If your study is using this new system and you have questions or issues, please review our Participant Payments webpages and/or contact your research coordinator for full details.
Q. Will there be any costs to me?
Usually, the care you receive through health research — such as doctor visits, medications, tests, and procedures — are provided at no cost to you. However, this varies from study to study. Be sure to ask your research coordinator for full details.
Q. Can I withdraw from a study once I get started?
Yes. You may withdraw from a clinical trial or study at any time, for any reason. While your participation is very valuable to us, it is even more important that you make the decisions that are right for you. All our researchers will support your decision if you decide you can't continue participating in a study.
It's also important to understand that we can choose to end your participation, as well, if we decide that the study is not in your best interest, if you don't follow the rules of the study, or if the study is discontinued. If we ever have to end your participation, we'll make sure you understand the reasons why.
Q. Is health research safe?
All health research at the University of Rochester Medical Center (UR) have important ethical and legal safeguards in place to ensure your safety.
- Extensive professional review. All health research at UR is reviewed by panels of doctors, researchers, and community members to help protect the health and safety of participants. If, for any reason at any time, the doctor or researcher feels a study is not in a participant's best interest they will withdraw that person from the study. Remember, in the four phases of a clinical trial, the first phase is dedicated entirely to evaluating safety-related concerns for a new study.
- Widespread community considerations. We also work with Community Advisory Boards to help us understand priorities regarding research and how it impacts the community.
- Strict federal regulations. In addition to the above listed safeguards, most health research is federally regulated. Numerous laws and guidelines help protect the safety and privacy of participants in health research. For example, the Institutional Review Board (IRB), made up of an independent committee, must approve and monitor every clinical trial in the U.S. The IRB is highly concerned with protecting the rights of study participants and ethics. Researchers have to do a lot of reporting so their findings can be monitored but volunteer names are not mentioned in these reports; your identity remains secret and protected.
Even with these safeguards, some people have understandable concerns about the safety of trials and studies. Fortunately, the precautions and regulations we have in place today make a poorly conducted study inconceivable. In fact, UR has been a proud leader in protecting the health and safety of study volunteers.
Even so, there are benefits and risks involved in any medical research, and it is important for you to understand them thoroughly. Be sure to talk about any risks, discomfort, or possible side effects with your doctor and the researchers involved.
Q. What if I can't find a trial or study that interests me?
If you wish to participate in health research but do not see a clinical trial or study listed in your area of interest you have a couple of options.
The UR Volunteer Registry is an easy, convenient way to find out about new studies that would be a good match for you. Anyone can join this free service and it only takes a few minutes! If you change your mind, you can easily remove your name at any time.
All you have to do to sign up is provide your name and contact information so UR can let you know about future studies. When you register you can be specific about the types of studies that appeal to you most, such as high blood pressure, cancer, menopause or even being a healthy volunteer. This will allow us to send you a more customized list of studies. You can join the registry by following this link to the UR Volunteer Registry.
You can also contact our Call Center at (585) 275-2107 or by email.
In addition, UR researchers recruit potential research volunteers from a national recruitment registry called ResearchMatch. To learn more click here.
Q. Where can I learn more about health research?
The National Institutes of Health has a website that can provide more information about research.