The Tufts Health Sciences Institutional Review Board (IRB) is a federally mandated organization of scientific and non-scientific persons, whose charge is to review research studies involving human subjects to ensure subject safety and welfare.
The IRB acts as an advocate for people who are participants in research studies by doing the following:
This webpage will provide useful information if you are considering participating in research, are currently involved in research, or want to find out more about research from the viewpoint of a participant.
The Office for Human Research Protection’s (OHRP) Public Outreach Website has useful information such as short videos, a list of questions that you can ask researchers about study participation, and links to additional resources.
A research study is an organized activity to learn more about a problem or to answer questions. There are different types of research studies:
If you decide to participate in a research study, you would do so as a volunteer. It is your decision whether or not you will participate. If you decide not to participate in a research study or choose to end your participation in a research study, this will not affect your care or treatment outside the study, payment for your health care, or your health care benefits.
There are many reasons people decide to participate in a research study.
Informed consent is the process of learning the key facts about a research study in order to help you decide whether or not to participate. Informed consent begins when the researcher or research staff explain the research study to you. Information is generally provided in conversations with the researcher and in a written Informed Consent Form. The consent should be written so you can understand it. If it is hard to understand, be sure to ask the researcher to explain it. Make sure you understand all of the information in the consent form before you decide about participating in the study.
You will be informed about the following:
Here are some questions you can ask your doctor or researcher to help you decide if you want to take part in a research study:
Tufts Health Sciences Institutional Review Board
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1. How can I find a research study to participate in?
There are a number of ways to find a research study. There are websites where you can search for research studies to join. You can answer an advertisement/flyer. Also, your doctor may know of research studies that you could participate in.
2. How is it determined whether I can participate in a study or not?
Not all research studies are right for all people. So researchers follow strict guidelines about who may join a research study. These rules are called eligibility criteria. They protect volunteers from enrolling in studies that may harm them, and ensure that the results of the study will reflect the intervention being studied, rather than outside factors. Eligibility criteria include information about you and your overall health, such as:
Results of medical tests
Medicines that you are taking
Any other health problems
3. What will it cost to participate in a research study?
Usually, your participation in research studies will not cost anything. Most research is funded by the government, pharmaceutical or device companies, or philanthropists. Talk to your research team to find out whether they will reimburse you for travel expenses, what will be billed to your insurance company (e.g. a standard test you will receive anyway), who will pay for injury that may arise as a result of the study, and what will happen to your care at the end of the study.
4. Will I be paid to participate?
Some studies pay participants and others do not. You will be told whether or not you will be paid, how you will be paid, and the payment schedule. The amount of money you may receive should not be so large as to influence your decision to participate. The reason some studies pay you is not to persuade you, but instead is to compensate you for the time spent to participate or reimburse out of pocket costs you may incur (such as travel expenses or missed work).
5. Who will see my records?
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.
6. Are there benefits to being in a research study?
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, or 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, but it may result in information that will help others in the future.
7. Are there risks or side effects in a research study?
Sometimes research procedures and interventions may cause discomfort and side effects. Sometimes the questions being asked during an interview or in a questionnaire could make you feel uncomfortable. The risks and side effects of the research study may not be known completely when you start the research study, but the research staff will discuss with you any 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 that might affect your willingness to continue participating in the research study.
8. 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” without any consequences. However, some drugs or other interventions may not be available or may not be covered by insurance outside of a research study. Be sure to ask about any alternative treatments that may be available to you.
9. What if I change my mind after the start of the study?
If you agree to participate in a study, you have the right to withdraw from the study at any time without penalty. You also have the right to ask that your study data or biological specimens not be used in the analysis of the study unless the Informed Consent Form specifies that data collected about you up to the point you withdraw will still be used.
10. How do I withdraw from a study?
It is important that you contact the researcher right away if you would like to withdraw from a study. The Informed Consent Form will provide the researcher’s contact information and will explain how to withdraw from the study.
11. What if I don’t like something about the study?
You can contact the researcher to report any complaints you may have. You can also contact the Tufts Health Sciences IRB at (617) 636-7512 to report any complaints you may have.
12. Will I be told the results of the study?
The Informed Consent Form should tell you if you will be informed of the study results at completion of the study. Some studies will notify you of results at the end of the entire study, which may be a long time depending on the study and data analysis.
13. What if something with my health changes while participating in a study?
Notify the researcher or your study doctor right away if there is any change to your health while participating in a research study.
14. What if I have questions, comments, or concerns after the study is completed?
You may contact your study doctor or coordinator at any time. You may also contact the Tufts Health Sciences IRB any time before, during, or after your participation in the research study.
The New England Research Subject Advocacy Group (NE RSA) has published a series of brochures and videos to support the communication between researchers and subjects. These resources provide useful information and helpful questions to think about before deciding to participate in a research study.
These brochures and videos have been approved by the Tufts Health Sciences IRB for use and Investigators can provide these brochures or links to these brochures/videos without additional Tufts Health Sciences IRB approval.
The OHRP has a website that includes resources designed to help potential volunteers better understand research and find the information they need to decide whether to participate in research. The website includes short videos, a printable list of questions that potential subjects can ask researchers, and links to additional resources.