It is important to consider how safe health research is, if you are thinking about being involved in a study. Since research studies aim to answer questions that have not been asked before, there is a certain amount of risk that comes with the unknown. Some studies have few or no risks. For instance, responding to a survey or having blood tests have low risk. Other studies may have greater risks. Taking a new medication or being in an intervention may have higher risks. In some cases, these higher risk studies offer the chance of improving your health. Some tests or procedures can have unpleasant or even serious side effects, including life-threatening ones. These side effects may also not be well known. New treatments are not always better than the standard care to which they are being compared.
To ensure that health research is safe, studies are designed to keep the risks to subjects as low as possible. There are also protections and safeguards that are required by law. To ensure that a study is conducted safely, a review board called the Institutional Review Board (IRB) must review and approve each protocol. The IRB is made up of a team of doctors, nurses, researchers, and members of the community. The IRB also makes sure that there is little risk for participants. All studies have a very detailed "protocol," or study plan.
A study plan explains:
All this information is given to research volunteers by the study staff before the beginning of the study in a written form that is called "informed consent." Study staff explain the study in detail to people who are thinking about being in a study so that they can discuss it with their doctors, family members or friends. People are encouraged to ask questions about the study they are planning to join. Before being in any study, participants should carefully read the informed consent form, and sign it only after they have had a chance to discuss it with the study staff. One copy of the informed consent is given to the volunteer. It includes the phone number of the doctor in charge of the study, and a phone number of the IRB, for any issues and questions about safety.
It is crucial to remember that being in a study is completely voluntary. People can change their minds and decide to stop being in a study at any time.
As an additional safety feature, studies that have more risks are closely monitored by groups of doctors who collect and review volunteer safety data. These committees are called Data and Safety Monitoring Boards (DSMB). A DSMB is made up of doctors who are not part of the study. This group of doctors regularly looks at the results during the study. The DSMB makes sure that the risks of taking part in the research are as small as possible. The DSMB can stop the study at any time either because of new concerns about safety or because the study proved that the new drug is not better than the old one. If the new drug is not better than the old one, it would not be "ethical" (meeting the accepted standard of conduct) to continue the study and have volunteers take a medication that is not as effective.
Several rules and regulations safeguarding research volunteers resulted from the Belmont Report created by the Department of Health and Human Services in 1979, with the goal of setting principles and guidelines for the protection of research volunteers.
Finally, the Research Subject Advocate (RSA) is another person who can offer help and protection to research volunteers, by:
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