Informed Consent

Scales of justice.

With Henrietta unconscious on the operating table…though no one asked if she wanted to be a donor—[Dr.] Wharton picked up a sharp knife and shaved two dime-sized pieces of tissue from Henrietta’s cervix.
The Immortal Life of Henrietta Lacks, pg. 33

Informed consent is a legal procedure to ensure that a patient or client knows all of the risks and costs involved in a treatment. The elements of informed consents include informing the client of the nature of the treatment, possible alternative treatments, and the potential risks and benefits of the treatment. In order for informed consent to be considered valid, the client must be competent and the consent should be given voluntarily. Information on many of the treaties and laws that protect human subjects can be found below:

  • A Guide to Understanding Informed Consent (National Cancer Institute)
    Making a decision about participating in a research study involves understanding the potential risks and benefits as well as your rights and responsibilities. The presentation and discussion of these important issues are part of the process called informed consent. This guide will tell you what to expect during the informed consent process, explain its importance to clinical research participants, and describe how it fits into a larger system that protects the welfare of people who take part in clinical trials. 

  • HeLa, HIPAA and the Ethics of Informed Consent (ACP Internist) 2011.
    At the time of Henrietta Lacks, the concept of informed consent was still in its infancy. Institutions, such as John's Hopkins, where Ms. Lacks received her care, did not have Institutional Review Boards (IRBs) to govern and approve their research protocols.

  • History and Development of the Doctrine of Informed Consent (American Alliance for Health, Physical Education, Recreation and Dance) 2011.
    Adult competent individuals have the right to make their own health care decisions under the United States
    constitutionally protected right of privacy. This right is grounded in the philosophical principle of autonomy. The practical application of this principle takes the form of informed consent.

  • The History of Informed Consent and the System of Protections (National Cancer Institute)
    Over the past half-century, the international and U.S. medical communities have taken numerous steps to protect people who take part in clinical research. The following timeline provides an overview of some of the key events that have contributed to the development of the current system.

  • Informed Consent (University of Washington School of Medicine) 1998.
    The aim of this section is to provide you with the tools required for the "basic minimum" as well as providing a more complete picture of the ideal informed consent process. You will find that the particular circumstances (e.g. the patient's needs or the procedure) will determine whether a basic or complete informed consent process is necessary.

  • Informed Consent (American Medical Association) 2011.
    Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention.

  • Informed Consent (CUNY) 2002.
    If humans are autonomous moral agents who make decisions freely and are held morally responsible for the consequences of their actions then in order to make the decision the agent needs to have accurate information concerning the situation and not be under coercion of any form.  Hence, there is a principle of Informed Consent in both moral theory and in the legal statutes.

  • Informed Consent and Clinical Research by Ruth Faden (Johns Hopkins) 1996.
    Informed consent is a powerful symbol of the commitment and impact of the new, interdisciplinary field of biomedical ethics that the Kennedy Institute has been so instrumental in developing. In the early years of biomedical ethics, there was considerable discussion about the nature of the doctor-patient relationship, about how it ought to be structured, and about how competing values within that relationship ought to be accommodated. By the 1970s and 1980s, the answer was for all practical purposes in. Biomedical ethics was engaged in a clearly reformist project, in step with the values of the times, to right a wrongful imbalance of power and control between physicians and patients.

Related News Stories

  • U.S. scientists knew 1940s Guatemalan STD studies were unethical, panel finds (Washington Post) August 29, 2011.
    U.S. government researchers who purposely infected unwitting subjects with sexually transmitted diseases in Guatemala in the 1940s had obtained consent a few years earlier before conducting similar experiments in Indiana, investigators reported Monday.

  • Johns Hopkins Law Scholar Says Human Rights Violations Undermine Medical Professionalism, Urges Collective Outcry (Berman Institute of Bioethics at Johns Hopkins) August 3, 2011.
    Doctors need to become more aware of how governments subtly, but pr­ofoundly interfere with their professional obligations and results in patients’ human rights being violated, a law scholar at the Johns Hopkins Berman Institute of Bioethics says in a commentary published Aug. 3 in the Journal of the American Medical Association.

  • Medical pot users denied care? (The Record- Stockton) July 31, 2011.
    Additional medical-marijuana patients have come forward to say they were told they were unwelcome at clinics operated by Mark Twain St. Joseph's Hospital.

  • Rule Changes Proposed for Research on Humans (The New York Times) July 24, 2011.
    The government is proposing sweeping changes in the rules covering research involving human subjects, an effort officials say would strengthen protections while reducing red tape that can impede studies.

  • Informed-Consent Forms for HIV Research Too Long: Study (HealthDay News) July 21, 2011.
     The informed-consent documents that study volunteers must sign before joining HIV/AIDS research trials in countries around the world -- including the United States -- are too long and complicated, researchers say.

  • Doctor's use of unnecessary stents raises question of informed consent (The Baltimore Sun) July 17, 2011.
    The "Doctrine of Informed Consent," which is part of the Maryland Constitution, imposes on health providers the duty to inform a patient of any information that a practitioner "knows or ought to know would be significant to a reasonable person in the patient's position in deciding whether or not to submit to a particular medical treatment or procedure."

  • Cardiologist's license revoked over accusations of placing unneeded stents (The Baltimore Sun) July 13, 2011.
    The Maryland Board of Physicians revoked the medical license of Dr. Mark G. Midei on Wednesday, finding that the Towson cardiologist falsified patient records in order to justify unnecessary and expensive cardiac stent procedures.