Porphyria Educational Services
PORPHYRIA EDUCATIONAL SERVICES BULLETIN Vol. 1 No. 20 May
16, 1999
Focus: Medical Research and Patient Rights
Protecting the rights of people in medical research is an
obligation of those who conduct research. This obligation needs
to be taken very seriously.
The physicians and nurses who work with people participating in
the research studies conducted must be very careful to respect
the rights of the patients participating in the studies.
Because of abuses that have occurred in research in the early
1900's.
including during and after World War II, the United States
Federal Government has passed a number of laws and rules that
strict;y regulate all research that involves human beings. The
laws are designed to protect the rights of human beings who
become research participants.
Some of the mandates are enforvced through Institutional Review
Boards [IRBs]. An IRB is an independent group of scientists and
community representatives. Their role is to review all research
projects that use human beings as subjects to assure that their
rights are being protected.
This review and approval of the project must occur before the
work begins.
If the research continues, the IRB must review and approve the
project at least once a year. If there are any changes in the
project, they must be approved by the IRB also. The IRB must also
be notified if any undesirable orharmful consequences to research
participants occurr as a result of the project.
People who participate in research studies should be aware of
their rights as research participants. If you are approached to
participate in a research study, here are some of the questions
your should be asking of the researcher:
* What is the purpose of the study?
* What are the possible benefits and risks to me in participating
in the study?
* What will be done to minimize risks?
* How and why was I chosen for the study?
* What will be expected of me as a participant [ie., tests,
procedures, surveys, etc.]
* Do any of the tests or procedure have any risks?
* Will there be any pain or discomfort?
* What will be done to protect my privacy and assure
confidentiality of the information about me?
* Who do I contact if I have questions or need more information?
* How do I withdraw from the sgtudy if I change my mind about
participating?
* Where do I get help if I think I am being pressured to
participate in a study or if I think I am not being treated
appropriately?
* Are there appropriate alternative procedures or courses of
treatment?
In order for a person to participate in a research study he/she
must give "informed consent". Informed consent is a
person's voluntary agreement, based upon adequate knowledge and
understandingof relevant information, to participate in a
research.
If you are asked to participate in a research study, expect to
get information from the researcher. The information must be in
everyday language that a non-specialist can understand.
Once a research participant signs a consent form, he is given a
copy of it to refer to later.
Researchers are obligated to protect the rights of people who
participate in their research studies. The research participants.
themselves, also can protect their own rights by being aware of
what those rights are by being assertive in asking questions
about the study.
Research is important in improving the healthcare of people,
however, it must be conducted in a way that is respectful of the
rights of the people participating.
There are several types of porphyria research currently being
undertaken. DNA family mapping of porphyrics is being directed by
Dr. Robert J. Desnick MD at Mt. Sinai Hospital in Manhattan, New
York. Dr. Karl E. Anderson continues on research related to the
use of heme arginate in porphyric patients. Other studies deals
with drug testing, studies focusing on porphyric women and cyclic
manifestations. Some studies focus on chemical toxicology. In
addition there are countless other porphyria studies worldwide
that look at different aspects of the disease.
Dr. Michael Moore's drug reporting site is a simple but most
useful research tool. All that is required is to fill in the
information on every drug you take, whether the results are good
or bad, and that way researchers can deam a drug as
"safe" or "unsafe" by looking at the
feedback.