Frequently Asked Questions
Regarding Clinical Research
What is clinical research?
Clinical research is research that evaluates a new treatment (medicine, medical
procedure, education from a health professional, medical device, etc.) A
clinical research investigator invites people to volunteer and try out the new
treatment. Scientists, doctors, and other health care professionals are looking
for the safety and effectiveness of these new treatments.
Why would I be interested in clinical research?
Patients participate in clinical research because they hope it will benefit them
and because they want to contribute to a research effort that helps patients in
the future. Whether the outcome of clinical research is beneficial or
disappointing, patients involved in clinical research are helping to find new and
better treatments for health conditions.
What kinds of clinical research are there?
By visiting our main clinical research page
and choosing one or more categories, you can access a list of healthcare areas where research is
being done at Meriter Hospital. Click on the area of interest to learn more
about the research in that area. Research can involve:
-
A new drug (investigational drug)
-
An existing drug that is now being tested for a new use
-
Studies of tissue samples with the consent of the donor to examine properties
important to treating various health conditions
-
A new device such as an implant or joint
-
Medical procedures to see which one gives the best outcome for patients
-
Surveys or rating scales to learn about the relationship of health conditions
and healthcare services on a patient's life
-
Studies of specific health conditions (for example kidney failure and
transplants or alcohol exposure to fetuses) and their features that may give
further information about effective treatments
-
Studies that look back at previous patient records in an effort to uncover how
medical conditions and the procedures used affected patients' health
How is research approved for volunteer participation?
If the research involves an investigational drug or device, the U.S. Food and
Drug Administration reviews the research proposal and must approve the drug or
device before it can be used in clinical research with volunteers.
Next, the researcher must submit the proposed research to the Meriter Hospital
Institutional Review Board. The Institutional Review Board is made up of
physicians, scientists, a nurse, and lay people, who review the research for
safety, ethics and need. After rigorous review, if the Board judges the research
to be safe for volunteers, it gives approval for the research to begin.
It is the researcher's duty to report any changes or problems with the research
to the Meriter Hospital Institutional Review Board. Ongoing research is reviewed
at least annually (sometimes more frequently) to ensure the safety of the study.
How do I know whether I qualify for clinical research?
The clinical research listings will give some information about whether or not you
qualify. Each clinical research project seeks patients with a specific health condition,
medical history, and other factors. You, your primary care physician, and the
researcher will need to determine if you fit all the criteria for a given
clinical research project.
Are there any risks?
Clinical research for new treatments may cause side effects. Some side effects are
known and expected, but others may not be known ahead of time. Though
researchers make every effort to discover and explain to patients what side
effects may occur, serious side effects are a possible outcome in clinical
trials.
What does it cost to be in clinical research?
The study sponsor (i.e. drug company, etc.) may pay some of the costs associated
with clinical research. However, because nearly all clinical research includes
administering some standard treatment to the patient, some costs are billed to
the insurance company and/or the patient (any "standard" treatment charges can
be billed to the insurance provider). Before you enroll in clinical research, you
should understand what costs will be paid by the study sponsor, what costs will
be charged to your insurance company, and which costs may be billed to you. The
researcher is responsible for telling subjects what costs you will be expected
to pay.
What are my rights as a volunteer?
Before you enroll in clinical research, you must give
your consent. The researcher must go over an informed consent document with you.
This document includes information on the following:
- The study
involves research
- Describes any
known risks
- Describes any
known benefits
- Tells about
alternative treatments or procedures
- Describes how
your confidentiality will be protected
- Explains
whether there is any compensation should a research related injury occur
- Who to contact
for further information
- Tells you that
your participation is voluntary. You may withdraw from the research at any
time. Refusal to participate does not affect your medical care
2/11/2008
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