How to Participate in Research

Research is a study that is done to answer a question. Scientists do research because they don’t know for sure what works best to help. Some other words that describe research are clinical trial, protocol, survey, or experiment. Research is not the same as treatment.

Research has led to important discoveries that make our lives better. Some examples are: 

• New medications to treat diseases
• Improved medical procedures
• New or improved tests (like ultrasounds, X-ray machines, etc.)
• Vaccines

The Institutional Review Board (IRB) is a group of people who review and approve human research. The IRB includes medical people, scientists, and people from the local community. They review human research to make sure it is well-planned and ethical. The IRB serves to protect your rights and your welfare before and during the research study. For example, the IRB makes sure that any risks are as small as possible. The IRB does not make a decision about whether you should participate. The IRB decides whether it is right to ask people whether they want to take part in a research study. The IRB also reviews each research study while it is going on to make sure volunteers are protected.

Research is a study that is done to answer a question. Scientists do research because they don’t know for sure what works best to help. Some other words that describe research are clinical trial, protocol, survey, or experiment. Research is not the same as treatment.

Scientists conduct many different kinds of studies. For example, a research study may test if a drug is safe and effective. A research study may be done to find out what health care practices work best. A research study may be done to determine the best way to prevent an illness. A research study may use a survey or an interview to understand feelings people have about their health. A clinical trial is a research study that will try to decide whether new treatments are safe and effective. In clinical trials, drugs or treatments are often compared with placebos to check the effectiveness of that drug or treatment. A placebo is an inactive substance which may resemble an active substance. However, it typically has no value to treat or prevent an illness.

Thousands of research studies are being conducted each year. These research studies have contributed to health improvements for many people from every walk of life. The advances in health care would not be possible without people willing to volunteer to take part in research study. You may be asked to volunteer for a research study approved by this IRB. This pamphlet will help you understand your rights as a research study volunteer. It will also help you to decide if you should take part in a research study. It will also help you understand some of what is needed for a good research study. We urge you to review this information and discuss it with other people you trust.

Like your medical record, the information in your research study record will be confidential. Information will be given only to the people who need it. This includes researchers and staff who carry out the research study. This includes the IRB, the company or group funding the research study, and various government oversight agencies. It is important for these groups to be able to look at your records so they can ensure that the research study is conducted using acceptable research practices.

If you have questions about the research study, the Principal Investigator or a member of the research team will assist you. You will be provided their contact information within the study consent form.

Who can I talk to about my about my rights as a study participant?

If you have questions, concerns or complaints about the study, please contact the PPHS Office (the office that runs the IRB) at (212) 824-8219 and they will promptly assist you.

There are many reasons to participate in research study. You may want to:

• Help find a cure for an illness that you have or have experienced
• Help other people who are sick
• Help find ways to provide better care
• Help scientists find out more about how the human body and mind work

If you decide to take part in a research study, you do so as a volunteer. That means you decide whether or not you will take part. If you choose to do so, you have many important rights.

It is important to know that all research involving human subjects (participants?) at the Icahn School of Medicine at Mount Sinai and its affiliates is reviewed by an Institutional Review Board for safety and ethics standards.

Informed consent is the process of learning the key facts about a research study before you decide whether or not to volunteer. Your agreement to volunteer should be based upon knowing what will take place in the research study and how it might affect you. Informed consent begins when the research staff explains the facts to you about the research study.

The research staff will assist you with the informed consent form that goes over these facts so you can decide whether or not you want to take part in the research study. These facts include details about the research study, tests or procedures you may receive, the benefits and risks that could result, and your rights as a research volunteer.

The consent form includes this explanation. You should take your time when you read the consent form. If you have any questions, ask the research staff. If you don’t understand something, ask them to explain it to you so you do understand. The information will be given to you in a language that you know. If English isn't your native tongue, ask for an interpreter to be present when you are discussing the research study with the research staff.

You can take the information home. You can discuss it with your family, friends, a health care provider, or others before you decide whether or not to take part in the research study. If you decide to take part in the research study, you will be asked to sign the consent form.

The informed consent process is more than just signing a piece of paper. It is a process that goes on throughout the research study. During the course of the research study, you may be told of new findings, benefits, or risks. At that time, you can decide whether or not to continue to take part in the research study. You may decide not to take part. You may change your mind and leave the research study before it starts. You may also leave at any time during the research study or the follow-up period.

There may or may not be a direct benefit to you if you take part in a research study. For example, your health or a health condition you have may get better as a result of your participation in the research study, or it may stay the same. It may get worse. No one can predict what will happen with a study or how it might affect you. The research study may not help you personally, but may result in information that will help others in the future.

Sometimes research procedures and drugs may cause discomfort and bad side effects. The questions being asked could make you uncomfortable. The risks and side effects of the research study may not be known completely when you start the research study. The research staff will discuss with you known possible risks so you can decide if you want to volunteer. If you do volunteer, the staff will tell you about any new risks that they learn about during the research study for as long as you take part in it.

Before you decide to volunteer, you need to know as much as possible about the research study. If there are any issues that concern you, be sure to ask questions. You may want to prepare your questions in advance.

The following are a list of sample questions. Not all questions will apply to every research study.

• Who is doing this research study and what question might it answer?
• Who has reviewed and approved this research study?
• Will this research study help in understanding my condition? If so, how?
• What tests or procedures will be done?
• If I decide to participate in this research study, how will it affect my daily life?
• Will I have to make extra trips to the medical center?
• Is it possible that I will receive a placebo (inactive substance)?

If anyone asks you to take part in a research study, you have the right to say "no."

Remember:

• Your decision will not affect how we treat you.
• You need to weigh both the risks of the research study and the benefits.
• It may be helpful to talk with family members, friends, or your health care providers.
• If you decide to volunteer for a research study, you can change your mind and stop or leave the research study at any time. Your decision to withdraw from a research study will not affect how we treat you.

If you have questions, concerns or complaints about research at this organization, please contact the PPHS office at (212) 824-8200