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The Feinstein Institute for Medical Research

Empowering Imagination. Pioneering Discovery.
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Research Participant and Community Information

“Should I be in a Research Study?” is a short educational program meant to assist potential research participants in deciding if being in a research study is the right decision for them. It will help potential participants understand the issues they need to consider and their rights as research participants. Click here to start the program. (Program  only plays on Internet Explorer.) This module has been funded by the NIH under grant #RR018137.

The video above shows how the community plays an instrumental role in helping
scientists develop new cures for human disease. Hear from people currently
participating in research programs and learn how you too can get involved.

 

Frequently Asked Questions

What is a research study?
A research study is an organized activity designed to answer questions. Scientists conduct many different kinds of studies. For example, a research study may test if a drug is safe and effective. Some other words that describe research are trial, clinical trial, protocol, survey, project or experiment. Research is not the same as treatment.

A research study may be carried out to find out what health care practices work best. A research study may be conducted to determine the best way to prevent or treat an illness. A research study may use a survey or an interview to understand feelings people have about their health. A research that will try to decide whether new treatments are safe and effective is called a clinical trial. 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.

Why is research important?
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
  • Ways to stop smoking

Should I be in a research study?
Thousands of research studies are conducted each year. These research studies have contributed to health improvements for many people from every walk of life. Advances in health care would not be possible without people willing to volunteer to take part in research study.

Why should I volunteer for a research study?
There are many reasons to participate in research study. You may want to:

  • Help find a cure for an illness
  • 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

Are there benefits to being in a research study?
There may or may not be a direct benefit when participating in a research study. For example, a participant’s health or health condition may get better as a result of participation in the research study, or it may stay the same, or it may get worse. No one can predict what will happen with a research study or how it might affect the participant. The participant might be a healthy volunteer. Being a healthy volunteer for a research study may not help the participant personally, but it may result in information that will help others in the future.

Are there risks or side effects in a research study?
Sometimes research procedures and drugs may cause discomfort and bad side effects. The questions being asked could make the participant feel uncomfortable. The risks and side effects of the research study may not be known completely at the start the research study. The research staff will discuss the known possible risks so a decision can be made to volunteer and participate in the research study. The research staff will tell the participant about any new risks that they learn about during the research study for as long as the participant takes part in the research study.

Who will answer my questions?
The research team will explain the research study and answer any questions. In addition, aconsent form will have an explanation of the purpose of the research.

Usually, the consent document or other information can be taken home. It is recommended that participants discuss participation with family, friends, a health care provider, or others before deciding to take part in the research study. If the decision is made to take part in the research study, the participant signs a research consent form, but can decide to leave a study at any time.

If you have questions about research or just want to speak with someone about research at this organization, please contact the Community Relations Manager at 516-562-1264. If you have concerns or complaints about research at North Shore-LIJ Health System, please contact the Human Research Protection Program at (516) 321-2100.

For more information about participating in a research study, you can watch this video. (This program will currently only play on Internet Explorer.)

What questions should I ask before I agree to take part in a research study?
Before deciding to volunteer to take part in a research study, obtain as much information as possible about the research study. If there are any issues or concerns, be sure to ask questions. Writing questions down in advance might be helpful.

The following is a list of sample questions. Not every question will apply to every research study.

  • Who is doing this research study and what question might it answer?
  • Will this research study help in understanding my condition? If so, how?
  • What tests or procedures will be done?
  • Is it possible that I will receive a placebo (inactive substance)?
  • Will I have to make extra trips?
  • What could happen to me, good and bad, if I take part in the research study?
  • How long will this research study last?
  • What will happen to any specimens that I give?
  • Who has reviewed and approved this research study?
  • Could my condition get worse during the research study?
  • What will happen if it does?
  • What other options or choices do I have if I decide not to take part in this research study?
  • Who will be in charge of my care? Will I be able to continue to see my own doctor?
  • Will I be charged anything or paid anything to be in this research study?
  • If I decide to participate in this research study, how will it affect my daily life?
  • What will happen to me at the end of the research study?
  • Will I be told the results of the research study?
  • Who will find out that I am taking part in this research study?
  • How do I end my participation in this research study if I change my mind?
  • Whom do I contact for questions and information about the research study?

If the answers to any questions are unclear, ask again. Ask the person to explain the answer in a way that can be understood. A participant should ask the question again if they forget the answer to the question during the research study.

What if I do not want to take part in a research study?
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 will not affect how we treat you.

What is an IRB?
The Institutional Review Board (IRB) is a group of people who review and approve research conducted in humans. The IRB includes medical people, scientists and people from the local community. They review this research to make sure it is well-planned and ethical. The IRB serves to protect participants’ rights and 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 someone should participate. The IRB decides whether it is right to ask people if they want to take part in a research study. The IRB also regularly reviews each research study while it is ongoing to make sure volunteers are protected.

How do I report a problem or concern regarding research at North Shore-LIJ Health System?
If you have a problem or concern regarding a research project in which you or a relative are participating the first approach is usually to contact the principal investigator for the project. Every project has a principal investigator and their contact information is contained in the informed consent document. If you enrolled in a study, you should have been given a copy of that document, so you should have the investigator’s contact information.

If you do not have the contact information or you have contacted the investigator and are not satisfied with the response, please feel free to call the Human Research Protection Program at 516-321-2100 or report it here. You can be assured that anyone you speak with will hold your concerns in confidence if you so desire. Any of the office staff are available to speak with you if you desire. You may also use email addresses which can be found in the IRB Contact Information section of this website.

We are here to protect members of the community that participate in our research projects. Do not hesitate to call if you have a concern.

How do I volunteer to be an IRB member?
The IRB is the committee responsible for ensuring the protection of the rights and welfare of human research subjects. The committee is made up of those that have a scientific and/or medical background as well as clergy, and lay members who are also referred to as community members. There are two IRBs which each meet once a month at the North Shore-LIJ Health System.

IRB members are required to attend at least 6 IRB meetings per year. Each meeting lasts approximately 2 hours. Preparing for the meetings also requires an additional 4-5 hours of work per month.

If you are interested in becoming a member of the IRB, please contact the IRB office for more information: 516-321-2100.