Below are the definitions of “research” from several governing bodies:
Food and Drug Administration (FDA) has defined "clinical investigation" to be synonymous with "research". "Clinical investigation" means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA...or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
U.S Department of Health and Human Services (HHS) has defined "research" as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
National Institute of Health (NIH) defines Clinical research as research that directly involves a particular person or group of people, or that uses materials from humans, such as their behavior or samples of their tissue. NIH defines a Clinical Trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
By taking part in a research study, you can try a new treatment that may or may not be better than those that already exist. You can also help others better understand how the treatment works in people of different races and genders.
What is the Purpose of this registry?
Participation in the research volunteer registry may benefit you if you are interested in participating in upcoming research studies. The registry will collect and maintain information about you so that we may contact you for future research studies when we have them at the University of Pennsylvania Based on the information you give us, we may be able to partially determine whether you are eligible for a research study, when one is available.
Confidentiality this volunteer registry provides:
- Information you provide for the registry will be kept on a highly secured server at Penn Medicine.
- Only authorized PennMedicine staff will be able to access your information.
- Your name and any other information you provide will not be shared with unauthorized person(s).
- The information in this registry may be reviewed members of the PennMedicine’s Perelman School of Medicine’s Institutional Review Board or regulators from the federal Food and Drug Administration, to ensure that it meets federal and state patient safety and privacy regulations.
- Your participation in the volunteer registry is entirely voluntary. The information you provide for the registry will be kept indefinitely.
- However, if you decide you are no longer interested in being contacted for future studies, you may withdraw your participation at any time by either of the following means:
- Call the Office of Clinical Research- 215-662-4484
- Email the recruitment team at firstname.lastname@example.org
- If you choose to withdraw your participation, you will be removed from the pool of people whom we may contact and your withdrawal will have no effect on your status as a PennMedicine patient, employee, student, or volunteer.
- Please note that compensation varies by study, this information will be provided to you only if you are eligible for a study and choose to take part in it.
What are the possible risks of being part of this registry?
The registry will help us contact you about a study for which we think you may choose
to participate. Please note that you might not receive a benefit from participation.
It is possible that there may not be a research study available at the University of Pennsylvania
that you will be eligible for, or there may not be a study that you are interested in
Maintaining the safety and security of your information is our top priority and every effort will be made to keep your information confidential, but we cannot make a guarantee against potential breaches of electronic information. Your personal information may be given out if required by law.
In the past, most drug testing had been done on white men. This means that some groups, such as African Americans, Hispanics/Latinos, American Indians, Asians, Pacific Islanders and women, had not always been included in the tests done on drugs. But sometimes drugs work differently in these people than on white men. So FDA wants people from many different groups included in these studies.
Clinical drug trials are conducted in phases. The trials at each phase have a different purpose and help researchers answer different questions:
- In Phase 1 trials, researchers test an experimental drug or treatment for the first time in a small group (typically 20 to 80 people) to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase 2 trials, the experimental study drug or treatment is given to a larger group of people (typically 100 to 300) to see if it is effective and to further evaluate its safety.
- In Phase 3 trials, the experimental study drug or treatment is given to large groups of people (typically 1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
- Phase 4 trials are conducted on drugs after the US Food and Drug Administration (FDA) has approved them for marketing, in order to provide additional information on the drug's risks, benefits, and optimal use.
Research studies are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all.
Some treatments that are being tested have side effects that can be unpleasant, serious or even life-threatening. Because the treatments being studied are new, doctors don't always know what the side effects will be. Many side effects are temporary and go away when the treatment is stopped. But others can be permanent. Some side effects appear during treatment, while others may not show up until after the treatment is over. The risks depend on the treatment being studied and all known risks should be fully explained to you by the researchers.
Informed Consent To help you decide if you want to be in a study, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. FDA requires that people be told:
- that the study involves research of an unproven drug or device
- he purpose of the research
- how long the study will take
- what will happen in the study and which parts of the study are experimental
- possible risks or discomforts
- possible benefits
- other procedures or treatments that you might want to consider instead of the treatment being studied
- that the FDA may look at study records, but the records will be kept secret
- whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment
- the person to contact with questions about the study, your rights, or if you get hurt
- you can quit at any time.
Informed consents must be written so you can understand it. If you don't, be sure to ask the doctor or other medical person to explain it. Make sure you understand all of it before you agree to be in the study. Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is NOT a contract and you can leave the study at any time, for any reason.
Clinical trials are sponsored or funded by a variety of sources:
INSTITUTIONAL REVIEW BOARDS (IRBS)
Scientists, doctors and other people from the local community serve on IRBs to review and monitor their hospital's or research institution's medical research involving people. They monitor studies to help make sure that there is the least possible risk to volunteers and that the risks are reasonable in relation to the expected benefits. IRBs make sure volunteer selection is fair and that informed consent is done correctly.
DATA MONITORING COMMITTEES
These committees are used mainly when one treatment is being compared with another. These committees are particularly important in tests of treatments for serious or life-threatening disease. They review information from studies to make sure they are being done in a way that is safest for the volunteers. During a study, if the committee finds that the treatment is harmful or of no benefit, it will stop the study. If a study shows that one treatment works better than another, the committee stops the study and all volunteers are offered the better treatment.
The FDA inspects records and various scientists, clinics, and other research sites involved in a study. The agency does this to make sure volunteers are being protected and studies are being done correctly. From time to time such inspections are done in response to complaints.
Here are some questions to ask your doctor to help you decide if you want to take part in a research study:
- What is the study trying to find out?
- What kinds of test and exams will I have to take while I'm in the study? How much time do these take? What is involved in each test?
- How often does the study require me to go to the doctor or clinic?
- Will I be hospitalized? If so, how often and for how long?
- What are the costs to me? Will my health insurance pay for it?
- What follow-up will there be?
- What will happen at the end of the study?
- What are my other treatment choices? How do they compare with the treatment being studied?
- What side effects can I expect from the treatment being tested? How do they compare with side effects of standard treatment?
- How long will the study last?
- Research studies are tests of medical treatments to see if they are safe and if they work.
- Before you agree to take part in a study, you must be given complete information about the study, including possible side effects and benefits.
- You should ask lots of questions to be sure you understand the study.
- You must sign a special agreement called "Informed Consent" before taking part in the study.
- The Informed Consent is not a contract. You can leave the study at any time.
Acknowledgments: The information above was adapted from the following sources:
- US Food and Drug Administration: Clinical Trials and Investigational Drugs Clinical Trials and Investigational Drugs
- US Food and Drug Administration: Basic Questions and Answers about Clinical Trials
- National Institutes of Health: Understanding Clinical Trials
- National Cancer Institute: Cancer Clinical Trials