My Doctor Has Asked Me To Participate In An Arthritis Clinical Research Trial... What Should I Know?

Once... as recently as 20 years ago, it was not uncommon for patients with arthritis to rapidly become crippled or to die from the devastating effects of arthritis.

Today, many patients are able to experience remission from their arthritis. To get to this point has taken the work of many hard-working researchers as well as the dedication of thousands of patient volunteers.

The goal of arthritis clinical research is to safely translate promising basic laboratory discoveries into safe and effective medical practice.

All clinical research conducted in the United States is guided by the Nuremberg code. These guiding principles were established to protect human subjects from unethical conduct, such as what took place under the Nazis during World War II.

The eight fundamental standards that guide clinical research are:

• The risks of a study must be minimized through sound research design and methodology
• Risks must be reasonable relative to the anticipated benefits of the study
• The selection of research volunteers must be equitable and without bias
• Informed consent must be obtained from the person participating in the study
• The consent language agreed to and the process for obtaining consent must be documented carefully
• Research patient privacy and confidentiality must be protected
• Ongoing safety of research volunteers must be adequately monitored
• Vulnerable patients such as children must be adequately protected

All clinical trials in the United States are overseen by what is called an Institutional Review Board (IRB). This is a panel of people with diverse backgrounds who are unaffiliated with the center conducting the research. While there are many IRBs in the United States, they all have a common goal.

The goal of the IRB is to safeguard the privacy, welfare, and rights of volunteers participating in clinical research. The IRB may approve, disapprove, modify, or suspend research. The IRB has final authority with regard to human research.

The informed consent process is critical to the ethical and safe conduct of a clinical trial. During the process of informed consent, it is important that the prospective volunteer have time to read and understand the consent form and have all questions answered by professionals conducting the study. The consent form must contain sufficient information about the research as well as the risks and benefits so that the volunteer can make an informed decision about participation.

Consent forms should:

• Describe the study as fully as possible
• Point out foreseeable risks or discomforts
• Explain anticipated benefits
• Explain alternatives
• Describe how confidentiality will be maintained
• Describe compensation, if any
• Provide contacts who will provide more information or discuss concerns
• Explain that participation is voluntary and the volunteer may withdraw at any time

The Health Insurance Portability and Accountability Act (HIPAA) was established in 2003 to protect the privacy on health information. Centers conducting clinical research must adhere to HIPAA regulations when it comes to disclosing confidential patient information.

All arthritis research conducted at the Arthritis and Osteoporosis Center of Maryland (AOC) supports and follows the above principles. Any questions should be directed to the principal Investigator, Dr. Nathan Wei.

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