Here are a few basic terms you should know:
The terms "research study" and "clinical trial" generally refer to research that is being done on a drug or device to see if it is safe and effective for use to treat a human disease or condition.
The consent form is the document you sign to acknowledge you have been made aware of the risks and responsibilities of participating in research, which should be clearly explained.
Institutional Review Board (IRB)
An IRB is a committee made up of scientists, doctors, and non-scientists who review the research protocol to make sure it is well designed, that the risks to human subjects are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research.
The IRB also reviews the consent form for the research to make sure it is accurate. If it approves the research, the IRB continues to review the research as it progresses. It is important to understand that IRB approval does not mean that a research project is completely safe or that it is right for you. When an IRB approves research, it means the members of the IRB believe that the research has the potential to answer an unanswered scientific question. However, you should look carefully at the details of the research and decide whether it is right for you.
For more information, review our related resources and the Research Subjects section in our FAQ.
The research protocol is a written document that describes in detail how a clinical trial will be conducted, including how the safety and rights of research participants will be protected. It also describes the trial's hypotheses, objectives, methodology, and other information.
Risks, rights, and responsibilities
The U.S. government requires that, before a drug or a device can be sold in the U.S., it must be studied in research and the results must show that it is relatively safe and effective for its intended use in humans. If you decide to enter a research study, be sure you know what question the research is trying to answer.
Risks for participants
Joining a research study will usually involve risks, which vary from study to study. The risks should be listed in the consent form, but there can always be unanticipated risks for human research subjects. You can and should ask for more information regarding the listed risks.
Benefits for participants
Sometimes the person who joins a research study will benefit directly, and their disease or problem will be helped. However, the possibility of receiving a benefit varies from study to study, just like the risks. It is important to remember that the main goal of research is to collect information that may help future patients, not the person participating in the research study. You should always ask questions and keep asking until you understand how the research study is different from the treatment you would get outside of the research study.
Responsibilities of human research subjects
Research participants also have responsibilities. For example, you will be expected to show up for all scheduled appointments, notify the research study personnel if you have a bad reaction, and follow all instructions. You may also be expected to go in for many more visits than you would with regular care. Therefore, you may have extra costs, such as parking, babysitting, and time off work.
Rights of human research subjects
As a research subject, you have several rights:
- You have the right to decide not to participate in the research, and there will be no penalty or loss of benefits.
- If you decide to participate, you have the right to quit at any time. Again, there will be no penalty or loss of benefits.
- You have the right to be informed about the research study, without any coercion, undue influence, or pressure. Your written source of information about the research study is usually the consent form. But asking questions about any information that is not clear is important before you make your decision about taking part.
- You have the right to ask questions before and while you take part in the research study.
- You have the right to get a copy of the consent form.
- You do not waive any of your legal rights by joining a research study or signing a consent form.
For more information, visit our FAQ. If you are looking for more resources to learn about research in general, visit AAHRPP's website. AAHRPP is an organization that accredits high-quality human research protection programs, such as WIRB's.
Enrolling a child in research
We suggest that you review the information available on www.bostonchild.vitalconsent.com. It is an excellent website devoted to research with children and the concerns parents have about allowing their children to be in a research study.
Gene transfer long-term follow-up
"Gene transfer" means putting modified DNA into people. Scientists do not yet fully understand the long-term consequences of gene transfer. Usually these research studies ask for safety follow-up visits that could go on for a long time (years or a lifetime). To learn more, review this NIH brochure about gene transfer.