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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.