Before patients can be enrolled in clinical research, investigators are ethically and legally required to seek the patient's agreement in regards to the research procedures, risks, potential benefits, and other relevant information. Patients can decide whether to participate in research, and this is called informed consent.
In general, the informed consent process involves both written and oral components. The written Informed Consent Document provides the basic details of the study-how it will be conducted, what it involves, by whom, the risks, potential benefits, alternatives to participation, right to withdraw, whether the patient will receive payment for participation, and other key information.
It is equally important that patients have an opportunity to meet with researchers and discuss the study in person. Once a patient has met with the researchers, had their questions answered, and decided that they would like to participate in the study, they should they sign the Informed Consent Document. Signing the Informed Consent Document verifies that the patient's questions have been answered, that they agree to participate in the research, and their participation is voluntary. Many patients take the informed consent document home to read and share with family members before deciding to participate in clinical research. If a patient has additional questions, researchers are expected to make themselves available to discuss the concerns.
Voluntary participation is a cornerstone of ethical research. Therefore, when doctors are also researchers they should ensure that every patient is treated without prejudice whether they decide not to participate in a research study at all, or choose to withdraw from the study at a later time. This is an important point for patients to understand: signing an informed consent document does not require them to continue in the study if they change their mind. Also, if a patient decides to stop participation the researchers must ensure their medical needs are met and facilitate their further care.
The Informed Consent Document is developed by the individuals conducting the research and it must follow explicit government regulations for the protection of human subjects. In particular, the Informed Consent Document must be approved by an Institutional Review Board (IRB), a committee with the legal authority to protect the rights and welfare of research subjects. The IRB has the authority to require changes in the consent document if it believes that the information is incomplete or too complicated. After the IRB is satisfied that the Informed Consent Document is accurate, they approve the document.
Further Reading about Informed Consent
The US Department of Health and Human Services, Office of Human Research Protections has a series of Frequently Asked Questions about Informed Consent on their website. This includes questions that parents have regarding informed consent for children participating in clinical research and participation of those with diminished capacity to provide consent:
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html
The National Cancer Institute also maintains information about informed consent:
https://www.cancer.gov/about-cancer/treatment/clinical-trials/patient-safety/informed-consent
The American Cancer Society, a non-governmental organization, also provides information about informed consent on their website:
http://www.cancer.org/docroot/ETO/content/ETO_1_2X_Informed_Consent.asp