What You Should Know Before You Participate in a Research Study

Ascension Seton doctors and other healthcare providers continuously search for new ways to improve medical care for the patients we serve and are committed to discovering new ways to prevent and treat disease in people. These efforts involve a form of clinical research called clinical trials.

Medical advances are dependent on research and clinical research cannot happen without patient participants. A patient who participates in clinical research not only receives a potentially helpful treatment, they also generously help others who may be diagnosed in the future. It is because of past research participants that we have the treatments available today.

Research Participants

People who participate in clinical trials do so voluntarily and are known as research volunteers or research participants or research subjects. Some trials are for adults only, while others are open to children, who may participate if permission is provided by a parent or guardian. The length of a clinical trial varies according to the questions it is trying to answer, and ranges from a few hours to several years.

While clinical trials are considered the fastest way to determine if a proposed intervention is safe and effective, they include both potential benefits and risks. A research participant has the chance to receive a potentially promising treatment that is not available to the general public. However, they also face the chance that their disease or condition will not improve with the study treatment, and they could experience adverse side effects, among other possible risks.

Your Decision to Participate in Research

To help you decide, a member of the research team will explain details of the research study to you. They will give you an informed consent document describing important information about the study. You will have the opportunity to ask questions about the study before you make a decision to participate or not. You should consider the informed consent thoughtfully and discuss it with family and friends, with another doctor or with other people you trust.

Your Rights as a Participant

You should take as much time as you want to think about your decision and ask us questions if there is anything you don’t understand. As a research volunteer, you have many rights that protect you:

  • You have the right to choose; no one else should make that decision for you.
  • You have the right to understand what the research is before you agree to take part.
  • You have the right to change your mind at any time. You may leave the study for any reason.

Your Protections as a Participant

Medical research has built into it many layers of protection for you as a research volunteer: We must ask you or your legal representative if you agree before we put you in a research study. Doctors, nurses and medical staff have a code of ethics they follow while taking care of you. Medical researchers must also follow codes of ethics for medical research involving humans. There are rules that have been developed over the decades to protect the rights of research participants.

Seton’s Institutional Review Board (IRB) protects your safety and rights before and while you take part in a study. The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (DHHS) also have laws that regulate how we protect volunteers in research.

Institutional Review Boards

Since 1966, the United States Department of Health and Human Services (DHHS), formerly called the Department of Health, Education and Welfare (DHEW), has required prior review and approval of all research using human subjects that is funded by federal agencies. The review is done by a committee usually called an Institutional Review Board. Between 1974 and 1978, the National Commission on Protection of Human Subjects of Biomedical and Behavioral Research met and issued a series of reports and recommendations resulting in revised regulations issued by DHHS in January of 1981.

The United States Food and Drug Administration (FDA) was simultaneously developing its own regulations, which were also issued in January of 1981 and have since been revised, most recently in October 1996. DHHS issued revised regulations in March of 1983 and again in June of 1991. These regulations, which provided standards for review of human research activities by what are known commonly called Institutional Review Boards (IRBs) now apply to all activities involving human subjects at all Ascension Seton locations where research occurs.

Ascension Seton Institutional Review Board

Before a Ascension Seton doctor or other healthcare provider can ask you to participate in a research study, the study must be reviewed and approved by the Ascension Seton Institutional Review Board (or another board that Ascension Seton allows). The doctor or provider must also complete certain training and certifications in order to be approved to conduct the research. None of the research being conducted at Ascension Seton could happen without first being reviewed and approved by an IRB.

Ascension Seton holds an approved Federalwide Assurance (FWA) from DHHS (FWA00004937). This is a written agreement in which Ascension Seton describes the jurisdiction, composition and methods of procedure by which the IRB will function.