Information for Research Participants
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:
- Making sure that any risks are as small as possible
- Making sure that all risks and potential benefits of the study are presented fully and openly
- Deciding whether it is right to ask people whether they want to take part in a research study
- Reviewing each research study while it is going on to make sure participants are protected
- Acting as a liaison between the research team and the participant, if there is any issue that needs to be resolved
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.
The Tufts Research Participant Advocate can help you with questions or concerns about participating in research.
What is a research study?
A research study is an organized activity to learn more about a problem or to answer questions. There are different types of research studies:
- Studies that test if a treatment is safe and effective
- Studies that find out what health care practices work best
- Studies that determine the best way to prevent an illness
- Studies that use surveys or interviews to understand feelings people have about their health or other topics
Should I participate in a research study?
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.
- 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
- Take part in a research study that is trying to find a better treatment for a condition that you have
What is Informed Consent?
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:
- That this is research and your participation is voluntary
- The purpose of the research
- How long the study is expected to take, including the length of individual study visits
- What will happen in the study and which parts of the study are experimental
- Possible risks or discomforts
- Possible benefits
- Any appropriate alternative procedures that may be advantageous to you
- The person to contact with questions about the study, about your rights, and about any injuries related to the research study
- Confirmation that being in the study is voluntary and you can quit at any time
- How your confidentiality will be maintained throughout the study
- Whether there is any compensation for participating
- Whether any medical treatments are available if injury occurs
- Whether participation may involve risks to you or your embryo or fetus if you are pregnant
- Anticipated circumstances under where your participation may be terminated by the investigator without regard to your consent
- Any additional costs to you that may result from participation in the research
- The consequences of your decision to withdraw from the research and procedures for orderly termination of participation
- That significant new findings developed during the course of research which may relate to your willingness to continue participation will be provided to you
- The approximate number of subjects involved in the study
Considerations Before Deciding to Take Part in a Research Study
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:
- Who is doing this research study and what question might it answer?
- Will this research study help in understanding my condition? If so, how?
- How do I qualify for this research study?
- 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 to the study center/hospital in order to participate?
- What could happen to me, good or bad, if I take part in the research study?
- How long will this research study last? How long will each study visit take?
- What follow-up will there be?
- What will happen to any specimens that I give?
- Who has reviewed and approved this research study?
- Who is paying for this study and what is their involvement?
- 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 I am injured while taking part in the study, will my medical expenses be covered?
- Will I be compensated?
If you have any Questions, please contact the Tufts Health Sciences IRB Office:
Tufts Health Sciences Institutional Review Board
800 Washington Street
Boston, MA 02111
- 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.
- 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
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Why would a researcher need to know my sex and/or gender?
A researcher would need to know your sex and/or gender if there is a scientific or safety reason for needing to know this information. Researchers are required to provide specific reasons for needing to gather this information related to the research study at hand (e.g., “We are studying the effect of testosterone therapy on people assigned the female sex at birth”, or “Some study procedures may affect people who can get pregnant”). This rationale is reviewed and requires approval by the Institutional Review Board (IRB). The IRB is a group of doctors, nurses, and non-medical people who review human research studies for safety and protection of people who take part in the studies. If you have question about your rights as a research study subject, call the Tufts Health Sciences Institutional Review Board (IRB) at (617) 636-7512.
You never need to provide information you do not feel comfortable providing. However, researchers might not be able to evaluate whether it you are eligible or it is safe for you participate in a research study if you do not provide this information.
- 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.
- 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.
- 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.
Websites to Search for Research Studies
Brochures and Videos
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.
Office for Human Research Protection’s (OHRP) Public Outreach Website
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. This page is available in Spanish as well.