INDIANAPOLIS 317-566-9600
KOKOMO 765-865-9300
BLOOMINGTON 812-566-2600



INDIANAPOLIS 317-566-9600
KOKOMO 765-865-9300
BLOOMINGTON 812-566-2600





The Importance of Informed Consent in Clinical Trials

A researcher reads the risks of a clinical trial from a notebook and obtains informed consent from the patient.

As part of clinical research, clinical trials have been the root of medical advances for the past century. Clinical trials help us find new ways to treat, prevent, and detect diseases. At the root of all clinical research is something even more important than the discovery—fully informed consent.

Informed consent is one of the highest principles in the medical profession. It is an ethical and legal requirement for all physicians. Research professionals must provide the patient/participant with all the relevant information about treatment and research. In this process, the participant will completely understand the risks associated with the trial.

Informed Consent in Clinical Research

In clinical research, volunteers take risks to help advance medicine and receive compensation. Informed consent in clinical research is ethically imperative. Informed consent means providing potential participants with key facts about a clinical trial before they decide whether to participate.

A lack of informed consent prevents a participant from fully understanding the study and making the right decision. According to the U.S. Food and Drug Administration, researchers build trust and transparency by providing accurate and understandable information about the study. Transparency helps the patient understand their options, risks, and right to withdraw at any time without consequence. 

Elements of Informed Consent

Obtaining informed consent for research requires a few vital elements:

  • Disclosure of information,
  • Volunteerism, and
  • Full decision-making capacity.  

Disclosure of information is critical for valid informed consent. The researcher must disclose all information, including:

  • The purpose of the study,
  • Treatment or intervention details,
  • Potential risks and benefits,
  • Alternative treatments,
  • Right to withdraw,
  • And more.

Researchers must ensure truthful and ethical disclosure, eliminating any bias in presentation or inadequate information to pass along. 

Volunteerism is at the core of any clinical trial, as all participants must know and understand all aspects of the trial. Researchers must allow participants significant time to review materials, ask questions, and consult with others if desired. They must strictly avoid influencing or pressuring the participant.

Decision-making capacity is defined by the Veterans Health Administration (VHA) Handbook as “the ability to understand and appreciate the nature and consequences of health decisions and to formulate and communicate decisions concerning health care.” Researchers should ensure that participants understand all the information they’ve provided and the participant can make an informed decision.

Research Malpractice and Lack of Informed Consent

Participants who suffer any harm or consequences from a clinical trial may seek compensation for their ailments. A medical malpractice attorney can bring peace of mind to the afflicted if/when complications arise involving a lack of informed consent.

Generally, participating in a clinical trial requires permission and a signature on a large amount of paperwork. Still, there are times when a severe reaction or complication must be addressed. 

In some situations, you may experience complications due to negligence that could fall into any of the following:

  • Lack of proper explanation of the clinical trial’s risks;
  • Did not receive guidance or clarification on paperwork and consent forms;
  • Coercion to participate in the clinical trial; or
  • Health worsened as a result of taking part in the clinical trial.

How We Help

Inadequate informed consent can have significant legal implications. Patients have the right to be fully informed about their medical treatments or procedures, and failure to obtain informed consent may lead to medical malpractice claims. 

Navigating the complexities of medical malpractice cases involving inadequate informed consent can be challenging. Patients often receive consent forms shortly before a procedure or operation, leaving little time for a thorough review. However, it is the patient’s responsibility to read the consent form prior to any procedure. If any questions or concerns arise regarding the risks, it is crucial for patients to request a discussion with a doctor.

If you feel you are a victim of a lack of informed consent, seek legal representation from a medical malpractice firm. An experienced attorney can help you understand your legal options and hold the responsible parties accountable for their actions. In addition to seeking legal recourse, work with healthcare providers to ensure you receive the appropriate medical care and support. 

To schedule a free consultation, call us at 317-566-9600 (Indianapolis), 765-865-9300 (Kokomo), or 812-566-2600 (Bloomington), or complete our online inquiry form to schedule an appointment* with one of our health professional attorneys to review your case. We have offices in Indianapolis, Kokomo, and Bloomington to serve you.

*Free consultation; no retainer fee. You don’t pay a fee until we obtain a settlement for you. All attorney fees are based on the amount of your recovery.

*The amount of medical malpractice attorney fees are set by Indiana Law.