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Research & Clinical Trials

Participating in research allows people to contribute to medical knowledge and offers the opportunity to receive cutting-edge care.

Research & Clinical Trials > Participating in Research > Protection of Participants

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Protection of Participants

Participation in research sometimes carries risk; some studies carry very small risks, while other studies — particularly those involving new medications — may carry significant risks.

Researchers in the United States and most other developed countries must follow stringent guidelines to assure that all individuals are aware of the risks and their rights before they participate in research.

Study guidelines require that researchers provide an "informed consent form” for anyone who is interested in participating. This document explains key elements of the research to potential participants:

  • the purpose of the study
  • potential risks, which may range from very slight to significant; the risk of participating may be particularly greater when the study involves the use of new medications
  • criteria for participation
  • alternatives to participation
  • contact information for reporting an adverse effect during participation
  • patient information that will be collected during the study
  • the voluntary nature of the study, and the participant’s right to withdraw at any time

In the United States, an Institutional Review Board (IRB) must approve any study that is supported by federal research funds or is used to apply for drug approval to the FDA, before any patients are enrolled. The IRB includes physicians, researchers, and consumers who assure that:

  • the study is ethical
  • participant risks are minimized
  • participants’ rights and welfare are protected
  • the informed consent form is understandable and appropriate for the study

All approved clinical research studies have plans for protecting the privacy of participants’ medical records and any information they provide, including their responses to study questionnaires.

Once a clinical trial begins, a data monitoring committee watches the results to further monitor patient safety and ensure no harm is done. Committee members may include physicians, scientists, ethicists, statistical experts, and in some cases, patient advocates. If one or more patients has a serious side effect, the data monitoring committee may decide to end the trial prematurely. The trial might also be ended early if the drug being tested is shown to be more beneficial than expected.

Learn about the latest breakthroughs in research and our ABOUT Network.

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