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Additional Information
Center for Information and Study on Clinical Research Participation
Provides education about clinical trial participation.


National Cancer Institute
Provides an array of materials including A Guide to Understanding Informed Consent


U.S. Office for Human Research Protections
Provides extensive information on clinical trials, including the brochure: Becoming a Research Volunteer: It’s Your Decision

 
 

about Your Rights

Before you enroll in a breast cancer trial, you should learn about and understand your rights as a volunteer participant in a research study.


The Rights of Research Participants

  • To be told about all aspects of the research study.
  • To know how treatments you receive may differ from the standard of care.
  • To learn about potential adverse side effects that you may experience.
  • To be aware of any benefit you can expect from participating in the study.
  • To know what will happen if you should experience any complications.
  •  To be told whether there are other treatment choices that might be better than what you are being offered in the study.
  • To be given new information that becomes available while you are in the study that may affect your decision to stay in the study.
  • To know how your privacy will be protected.
  • To ask questions and concerns at any time.
  • To drop out of the study at any time.
  • To enroll in a study without feeling pressured or coerced.
  • To refuse to take party in a study.

Informed Consent

Before you can enroll in a research study, you will need to sign a document called an informed consent form. An informed consent must include an explanation of the purpose of the research, a description of the research procedures, and information about possible risks and benefits. Signing this form indicates that you fully understand all aspects of the trial and that you agree to take part. You should not sign this document until you have had all of your questions about the trial answered to your satisfaction. You should receive a copy of the informed consent document for your own files. If you are not given one, you should ask for one.

You Can Leave a Study at Any Time  

Just because you have signed the informed consent form does not mean you have to stay in the trial. At any point you can decide that this trial is not right for you and that you no longer want to participate.

 

From the NIH Policy for Protection of Human Research Subjects