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The decision to take part in research must always be given careful consideration. Below are some things to think about as you decide if you want to take part in a research study. While these are not all the things you must consider or all of the questions you must ask, this will at the very least offer a solid starting point.
Of utmost importance is that a decision to take part or not to take part in a research study is entirely up to you. Just as important is that you can ask questions about a research study or change your mind about your decision at any time.
Whatever decision you make, it will not have any impact on the care that you receive at any of the Einstein Network facilities.
A research study is an organized activity to learn more about a problem or answer questions. 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. One type of research study is a clinical trial. 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 that may resemble an active substance. However, it typically has no value to treat or prevent an illness.
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 small. The IRB does not make a decision for you. 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.
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 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 Institutional Review Board (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.
The research team will explain the research study to you. 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 are many reasons to participate in research study.
You may want to:
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.
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 information in the form should give a person who is considering taking part in a research study the information needed to make this decision.
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. It may stay the same. It may get worse. No one can predict what will happen with a research study or how it might affect you. The research study may not help you personally. The research study 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 research staff will tell you about any new risks that they learn about during the research study for as long as you take part in the research study.
Before you decide to volunteer to take part in a research study, 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 might want to write your questions down in advance or take this booklet with you. The following are a list of sample questions. Not every question will apply to every research study.
Remember, if you do not understand the answer to one of your questions, ask again. Ask the person to explain the answer in a way you can understand it. If you forget the answers to the questions during the research study, just ask them again.
If anyone asks you to take part in a research study, you have the right to say "no."
Your decision will not affect how you are treated.
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.
For much more information about clinical trials, the U.S. National Institutes of Health provides a publicly available website, ClinicalTrials.gov that provides valuable information about clinical trials, who can take part in them, where they are being conducted and much more.
If you have questions about research at this organization, please contact the Office of Research and Technology Development at:215-456-7217
Please call this number if you have concerns or complaints, or just want to talk to someone about research at this organization.
If you have questions about your rights with respect to the privacy of your health information when it is collected for the purpose of a research study you can contact:
Einstein Healthcare Network Privacy OfficeEinstein Medical Center PhiladelphiaGratz Building1000 West Tabor RdPhiladelphia, PA 19141Phone: (215) 456-0485 firstname.lastname@example.org.
If you have questions about your rights as a research subject, you may contact:
Robert Wimmer, MDChair of the Institutional Review BoardEinstein Healthcare NetworkEinstein Medical Center PhiladelphiaPaley Bldg., First Floor5501 Old York Rd.Philadelphia, PA 19141Phone: (215) 456-6243
If you wish to share a comment or concern anonymously you may do so using the Einstein Comply Line:866-458-4864