what do i need to know if i am thinking of participating

What to consider Learn as much as possible about the clinical trial you are considering. Ask members of the research team questions about the study. Here are some of the questions you might want answered:

  • What is the purpose of the study?
  • Who is going to participate in the study?
  • What is my role in the study-am I a healthy volunteer (a control) or a patient volunteer?
  • Why do researchers think the experimental treatment being tested may be effective? Has it been tested before?
  • What types of tests and experimental treatments are involved?
  • Will the study directly benefit me?
  • Will the study benefit others?
  • How do the possible risks, side effects, and benefits of the study compare with my current treatment?
  • If there are risks, what are the chances they will occur?
  • How might this trial affect my daily life?
  • What will the study require of me?
  • How much of my time will be involved?
  • How long do trials last?
  • Will hospitalization be required? Outpatient visits? How long and how many?
  • Who pays for the experimental treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term, follow-up care is part of this study?
  • How will I know if the experimental treatment is working? Will I be told about trial results?
  • Who is responsible for my care?

Write down any questions you may have before talking with the research team. Ask a friend or relative to come along for support and to hear responses to the questions. Bring a tape recorder to record the discussion, so you can replay it later.

Risks and benefits Clinical research entails risks, as do routine medical care and the activities of daily living. In weighing the risks of research consider two important factors:

1) the degree of harm that could result from participating in the study, and
2) the chance of any harm occurring.

Most clinical studies pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in trials of experimental therapies. The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to sign before participating in research. Also, a member of the research team explains the major risks of participating in a study and will answer any questions you have about the study. Before deciding to participate, carefully consider possible risks and benefits.

Potential benefits Well-designed and well-executed clinical trials provide the best approach for participants to:

  • Play an active role in their health care.
  • Gain access to new research treatments before they are widely available.
  • Receive regular and careful medical attention from a research team that includes doctors and other health professionals.
  • Help others by contributing to medical research.

Potential risks Risks to participating in clinical trials include the following:

  • There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.
  • The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more treatments, hospital stays, or complex dosage requirements.

A word to the wise... Understanding risk

Informed consent Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. The process of providing information to participants continues throughout the study. To help someone decide whether to participate, members of the research team explain details of the study. If the participant has limited English proficiency, translation assistance can be provided. The research team provides an informed consent document, which includes such details about the study as its purpose, duration, required procedures, and who to contact for various purposes. The informed consent document also explains risks and potential benefits.

The participant then decides whether to sign the document. Informed consent is not a contract. Volunteers are free to withdraw from the study completely or to refuse particular treatments or tests at any time. Sometimes, however, this makes them ineligible to continue the study.

For more information about informed consent, see:

From the National Cancer Institute:

A Guide to Understanding Informed Consent: http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide

Children's Assent to Clinical Trial Participation: http://www.cancer.gov/clinicaltrials/understanding/childrensassent0101

From the National Institute of Mental Health

A Participant's Guide to Mental Health Clinical Research: http://www.nimh.nih.gov/publicat/clinres.cfm

For more information on participants' privacy and confidentiality, see:

National Institutes of Health, HIPAA Privacy Rule: http://privacyruleandresearch.nih.gov/default.asp

For more information on protections for clinical research participants, see:

U.S. Department of Health and Human Services, Office for Human Research Protections:

Office for Civil Rights, Health Information Privacy:

The Food and Drug Administration, FDA's Drug Review Process:

Ensuring Drugs Are Safe and Effective: http://www.fda.gov/fdac/special/testtubetopatient/drugreview.html

National Cancer Institute, Monitoring the Safety of Clinical Trials: http://www.cancer.gov/clinicaltrials/understanding/monitoring-safety-of-trials