Denise Mouro, R.N., explains the informed consent process and how patient confidentiality is protected.
Glossary of Clinical Trials Terms
Terms to know before you volunteer
Confidentiality:
If you enroll in a research study, the privacy and confidentiality of your medical information must be protected according to federal law.
The informed consent document for the study must describe how your medical records will be kept confidential and who will have access to the
information.
Informed consent:
A process to ensure that research volunteers understand all the risks of participating in a clinical trial and are choosing to participate
without coercion or pressure from anyone. The principal investigator or his or her associates are required to explain the study carefully and
answer all your questions before you volunteer.
Informed consent document:
A detailed multi-page document that describes the study, identifies the physicians and staff associates in charge, lists all study
procedures and explains the potential risks and benefits. Before you enroll in a clinical trial, you must sign the informed consent
document and be given a copy for your records.
Investigational (or experimental) treatment:
The new drug or therapy being tested in the clinical trial.
Principal investigator::
The doctor responsible for conducting the clinical trial.
Ken Pienta, M.D., director of U-M's Michigan Institute for Clinical and Health Research discusses eligibility requirements, randomization and why following protocols is vital.
Inclusion and exclusion criteria:
To ensure the validity of the study results, most clinical trials can accept only those people who match a list of specified characteristics.
Often, these include a specific age range, type and stage of cancer, current medications and previous treatments received. People who don't match
these specifications cannot enroll in the study.
Protocol:
A detailed plan for the study that specifies who can enroll, what will happen during the study, how long the study will last and measurable
outcomes. The protocol includes inclusion/exclusion criteria, the timing and dosage of medications and a schedule for all tests and procedures
to take place during the study.
Randomization:
Volunteers cannot choose between treatments to be compared in a clinical trial. To ensure the validity of the study outcome, participants
must be assigned at random. In most cases, neither the study participants nor the doctors running the study know which volunteers are receiving
the experimental treatment.
Side effects:
Results of experimental treatments other than the desired therapeutic effect. Some side effects are expected and will be listed in the informed
consent document. Others are unexpected and can be serious. Be sure to tell your doctor or research nurse about any side effects you notice
while you are enrolled in a clinical trial.
Standard (or conventional) treatment:
The accepted, established treatment available for people with your type of cancer.
Study coordinator:
A staff person who works for the principal investigator. The study coordinator is often the person who contacts patients about enrolling in the
study, schedules appointments, maintains required records and manages the day-to-day operation of the study.
ClinicalTrials.gov
A searchable registry of national and international clinical trials with information about each study and phone numbers to contact
for more details.
