What do I need to consider when I am trying to decide if I should participate in a study?
We would like you to understand as much as possible about the decision you are about to make.
These are the some of the other individuals and companies that will be involved with
you in the
All of these titles refer to the one investigator who is responsible for the study. For each study site (office, research site, research clinic or clinical trial site) there is one person who is in charge of all the details of the study and for anyone who works on the study.Sponsor
The sponsor of the study is the company or group of individuals who have the idea or new drug or device that is being tested. The sponsor works with the Food and Drug Administration to present the information received from your participation and all others who have chosen to participate.Institutional Review Board (IRB)
An IRB can be at a hospital or medical center, university or in a region where there is an agreement for a group of study sites to join together to conduct studies. An IRB may also be a company that provides these decisions. The primary responsibility of the IRB is to protect the rights and welfare of any study participant. An IRB does this by reviewing the protocol, which is a detailed description of how the study that the Investigator will use during the study. The IRB also reviews any material that a participant will be asked to read or view. This includes the consent that you will be asked to sign, any advertisements or posters that you may see and the questionnaires, diaries or tests (assessments) that will be used during the study to evaluate your reaction to the study.
An important role of the IRB is to evaluate the information that is reported during the study regarding safety and risk. The IRB has the power to stop the study at any time to ask for more information about trends or issues in the study. The IRB may also stop the study permanently at any site if there are concerns about the way the study is conducted at that site. The IRB will also monitor the progress of the study to evaluate whether the study should continue or if you should be notified of any of the problems that may occur as information about other participants is reported to the sponsor of the study.Institution
Sometimes, investigators conduct research in a hospital or in an academic medical center. When this happens, the IRB at that institution usually reviews the study. Sometimes, the institution may choose an IRB that is outside the institution such as Hummingbird IRB. Institutions often have a research organization in place with its own rules and procedures. Your investigator will be familiar with these requirements.
During the time you are involved in a study and after as well, the IRB, the investigator and sponsor are in nearly constant communication about the progress of the study and your safety.
Ok, now you know who is involved in the study, let’s move on to what you should consider before deciding yes or no.
Listed here are some factors that may help you with your decision:
Your investigator has no choice about which part of the study you are assigned. Studies usually have “arms” these are diff erent ways the study will be conducted. For example, you may be assigned to a low dose arm, a high dose arm or a placebo (no treatment). The decision is made by the sponsor through the way people are enrolling in the study. The decision is made by a computer, through a randomization (flip of the coin) procedure.
Your investigator has no way of knowing if you will benefit from the study. He or she will also not know what “arm” you are assigned.
Studies are often very time consuming with long visits at the study site. Also, some studies may require frequent visits. You should ask to see a visit schedule before you make a decision. Comparing the study visit schedule to your calendar is a good way to see if you can meet the requirements of the study. For example, if you are going away for the summer, have an operation planned or know that you will be out of town caring for a sick friend or relative, you may not be able to participate.
- The study is taking place because the effectiveness of the drug or treatment being studied is not proven
- You may not receive the study treatment after the study is over. Even if you feel better while participating in the study, the study treatment may not be available for sale for years after the study
- You may have to discontinue use of the medications or supplements you are taking. If you feel that you are doing “ok” with your current medications, you may not want to take the chance of feeling worse
- For studies that evaluate pain relief, you should consider whether there is a “rescue” medication that you will be able to take if the study medication does not successfully address your pain relief needs
- The reimbursement for time and study related costs will not be comparable to the actual time you spend at the site. Participating in a study is not a job nor does it pay well. The money you receive will probably just cover gas or transportation to the site.
- You are doing a good deed by contributing to the advancement of research for a disease or condition
- You will be part of a community at the research site with other participants and the research team
- Because of the frequent visits, you will be monitored frequently for blood pressure, vital signs and other medical exams that you may not have received otherwise
- Ask questions of the study team about the study and its requirements
- Gain a clear understanding of the time requirements involved
- Remember that you may be required to complete study related procedures at home. This may include keeping a diary, sending data over your computer or telephone line, or following a diet. If you are not able or want to complete these tasks, participating in a study may not be right for you
- Consult with other doctors or professionals who may be involved in your health care
- Decide if you are comfortable with not knowing which study arm you may be assigned to or in the case where a placebo may be in one of the arms
Deciding if participation in a study is right for you is an important and personal choice. There are many factors that you should consider. We invite you to contact us if you have any questions:
1-855-447-2123 ext. 5