## Module 5 Informed Consent

When humans are used in medical research studies, we call them . The Food and Drug Administration (FDA) regulates clinical trials in the United States. A central part of clinical trials is the idea of informed consent. Here’s an excerpt from the FDA’s website explaining the concept.

What is Informed Consent?

As new medical products are being developed, no one knows for sure how well they will work, or what risks they will find. Clinical trials are used to answer questions such as:

- Are new medical products safe enough to outweigh the risks related to the underlying condition?,
- How should the product be used? (for example, the best dose, frequency, or any special precautions necessary to avoid problems),
- How effective is the medical product at relieving symptoms, treating or curing a condition.

The main purpose of clinical trials is to “study” new medical products in people. It is important for people who are considering participation in a clinical trial to understand their role, as a “subject of research” and not as a patient.

While research subjects may get personal treatment benefit from participating in a clinical trial, they must understand that they:

- may not benefit from the clinical trial,
- may be exposed to unknown risks,
- are entering into a study that may be very different from the standard medical practices that they currently know

To make an informed decision about whether to participate or not in a clinical trial, people need to be informed about:

- what will be done to them,
- how the protocol (plan of research) works,
- what risks or discomforts they may experience,
- participation being a voluntary decision on their part.

This information is provided to potential participants through the informed consent process. Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work.

There are some rare exceptions to the requirement for informed consent. Right now, you are a potential test subject in a clinical trial happening at the University of Utah. Unless you’re wearing an “opt out” bracelet, if you are picked up by an AirMed helicopter after suffering blunt or penetrating trauma with significant risk for bleeding, you will receive either a placebo (saline solution) or tranexamic acid (TXA). TXA is known to reduce bleeding in trauma patients who are in an emergency room, but doctors want to know if earlier administration of the drug (in the AirMed helicopter) will lead to better outcomes. The TXA study has been approved with waived consent, as the people who are candidates for the treatment - trauma patients - are usually incapable of providing consent due to their injuries. To learn more, read a Deseret News article about the controversial study (https://www.deseretnews.com/article/865651140/U-blood-clot-study-will-use-controversial-research-method.html) and see what the University of Utah hospital says about it (https://healthcare.utah.edu/staamp/).

Biotechnology owes a lot to Henrietta Lacks. The Immortal Life of Henrietta Lacks is well worth a read, or a watch of the 2017 HBO movie version!