Salem Cancer Institute - A part of Salem Health

Protecting Clinical Trial Participants

Research with people is conducted according to strict scientific and ethical principles. Every clinical trial has a protocol, or study plan, which acts like a “recipe” for conducting the trial.

 

The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. The same protocol is used by every doctor or research center taking part in the trial.

 

All clinical trials that are federally funded, or that evaluate a new drug or medical device, subject to Food and Drug Administration regulation, must be reviewed and approved by an Institutional Review Board (IRB).

 

Salem Hospital also requires that all clinical trials, regardless of funding, be reviewed and approved by the Salem Hospital IRB.

 

The IRB includes physicians, other healthcare providers, consumers, and sometimes members of the clergy, who do not have any personal interest in the results of the study.

 

As neutral reviewers, they ensure that the study is conducted fairly and that there is not a high probability of harm to the participants. The IRB also reviews each study on a yearly basis.

 

An IRB can stop a clinical trial if the researcher is not following the protocol or if the trial appears to be causing unexpected harm to the participants.

 

NIH-supported clinical trials require data and safety monitoring. Some clinical trials, especially phase III clinical trials, use a Data and Safety Monitoring Board (DSMB).

 

A DSMB is an independent committee made up of statisticians, physicians, and patient advocates.

 

The DSMB ensures that the risks of participation are as small as possible, makes sure the data are complete, and stops a trial if safety concerns arise or when the trial’s objectives have been met.

 

Obtaining an informed consent is a process by which patients learn the important facts about a clinical trial to help them decide whether to participate.

 

This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits.

 

In addition to talking with the doctor or nurse, the patient will receive a written consent form explaining the study. Patients who agree to take part in the study are asked to sign the informed consent form.

 

However, signing the form does not mean the patient must stay in the study. A patient can leave the study at any time — either before the study starts or at any time during the study or the follow-up period.

 

The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants.

 

Participants may be asked to sign new consent forms with updated information if they wish to stay in the study.