Questions to Consider before Enrolling

  • What is the study for and what is the purpose of the research?
  • What are the required procedures and timeframes? Are you able and willing to comply with these requirements? Clinical trials usually have very specific requirements to analyze the effects of what is being studied and to monitor your safety. You should understand what these requirements are and be sure that you will be able to comply with the requirements before agreeing to participate. Treatment studies may also monitor your health for a period of time after the treatment is finished, and you may need to come in to see your physician for office or clinic appointments at specific time intervals after your treatment is finished. Be sure you understand what these requirements are before agreeing to the study.
  • What are the reasonably foreseeable risks or discomforts to the clinical trial? Risks and discomforts can range from none to many depending on the medication or intervention being studied.  Often, such side effects are similar to complications of standard therapies. As a rule, the benefits should outweigh the risks in any clinical trial. However, you should review these risks to make sure you understand what the potential complications are and ask any questions you may have.
  • What are the potential benefits to participating? Potential benefits, or lack there of should be understood before participation. If the study involves treatment, are there other options to consider? When other treatment options are available for your condition, these should be discussed so you can decide which treatment option is best.
  • Who will have access to your medical records? This should be described in the patient informed consent or a research-specific HIPAA form. At a minimum, those required to have access to your medical records for research purposes will include the institution where you are participating in the research, any outside research sponsor (if applicable), and monitoring agencies which are responsible for ensuring that the study is being conducted accurately, including the FDA. Any other groups requiring access will be stated in the informed consent form.
  • Who can you contact for questions and in case any research-related injury occurs? This information should be listed in the informed consent. You should always contact the primary physician who entered you onto the clinical trial. Research-related injuries are important to know about not only for your own safety, but also for anyone else being treated on the same study or other studies using the same drugs or devices.
  • Will there be any extra costs for participating in the research? It is important to know if you will be responsible for any extra costs. Before enrolling in the clinical trial, talk to your study contact person about who will pay any trial related costs and if your insurance will continue to cover standard procedures.
  • How long will the clinical trial last? This can be a two-part question. If the clinical trial is studying the effects of a therapy, you should find out how long you will be on this therapy. Most therapy clinical trials, especially medication studies, will also follow your progress for a period of time after you have completed treatment. This may be months, years, or a lifetime. This "follow-up" period may require a physical exam, or may only be a phone call to find out how you are. You can consult the informed consent or your physician to find out how long the trial will last.
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