Participants in clinical trials can play a more active role in their own health care, gain access to potentially new treatments that are not available to the public, have access to expert medical care during the trial, and help others by contributing to medical research. In addition, participants receive study related medical care and medication at no cost. Compensation for time and travel is available.

People volunteer to participate in a clinical trial. They may be people who have, or are at risk for having, the disease the drug or treatment is designed for. The drug or treatment may also be tested in healthy volunteers. Volunteers must meet the criteria for participation, which are different for each clinical trial.

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.

The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

All participants are guaranteed rights that ensure they are treated professionally and respectfully. When you take part in one of our studies, you have the right to:

• Be treated with respect.
• Make your decision without feeling any pressure from the research staff.
• Know the risks of participation in the study.
• Know what alternatives are available.
• Know the name, credentials and contact information of the study’s principal investigator.
• Know the purpose of the study.
• Know who will have access to your information.
• Know what procedures may be performed and what drugs or medicines may be used.
• Seek additional help or clarification during the informed consent process and at any time during the study.
• Withdraw from the study without penalty.

All participants are expected to comply with the specific requirements of the study protocol. In addition, study participants are expected to adhere to a general set of requirements that apply to ALL participants. They include:

• Following the directions of the investigator and research staff (including but not limited to study drug compliance and return).
• Making sure your contact information is up to date.
• Arriving for all scheduled appointments or calling ahead if you are unable to keep an appointment.
• Arranging your own transportation to and from the study site.
• Providing “to the best of your ability” accurate information about your medical history if it is relevant to the study.
• Seeking healthcare for any medical conditions unrelated to the study.
• Informing the research staff of any negative experiences or any hospitalizations you have while participating in the study.
• Informing the research subject advocate and, if necessary, the Institutional Review Board if you feel your rights as a study subject have been violated.
• Asking the researchers to completely answer any questions you may have at any time during the study.

Clinical research studies are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures that need to be done at visits, the drugs and dosages used in the clinical research, the length of the clinical research study, as well as the outcomes that will be measured. There often may be more office visits required than if you were not participating in research. Each person participating in a clinical research study must consent to participate in the clinical research and agree to following the requirements of the clinical research study.

The clinical research team includes clinical research doctors who are called investigators, coordinators who work with the investigators to conduct the clinical trials, pharmacists, and other health care professionals. Together as a team, they work to make sure each research participant is placed in the right research study and are followed very closely. As a research participant, it is especially important that you follow the research team’s instructions carefully, take all clinical research study medication as instructed, and complete each clinical research visit.

All clinical research is reviewed by the Food and Drug Administration (FDA) and an Institutional Review Board (IRB). The FDA is responsible for making sure the drugs used in clinical research is safe and ethical. An IRB is a committee of medical and non-medical personnel who reviews, approves, and monitors clinical research involving human subjects. Both the FDA and IRB responsibilities is to ensure the clinical research upholds patient rights and takes adequate steps to safeguard their safety and well-being.

Specific patient rights in clinical research include:

• Ensuring through completing the informed consent process, the participant has the received clear and detailed information about the purpose of the clinical research study, its potential risks and benefits, what is required of them during the clinical research study, alternative treatment options that may be available outside the clinical research, and any compensation for their time and travel.  As a potential clinical research participant, you should be given time to read the informed consent form, discuss the clinical research with your family, friends, caregivers, and/or primary care physician.

• As a clinical research participant, you have the right to withdraw from the study at any time and will not be penalized for doing so. You will be asked to complete certain end-of-study procedures per the clinical research protocol to ensure your safety.

• Participants have the right to privacy regarding their participation. Any personal health information that is collected during a clinical trial will comply with data protection laws such as the Health Insurance Portability and Accountability Act (HIPAA) in handling participant medical history data.

• Participants have the right to adequate safety monitoring throughout the duration of the clinical research study. The sponsor of the clinical research study is responsible for making sure there is a monitoring plan in place which involves ongoing assessments of potential risks to patient safety, and indications of possible adverse events which must be addressed quickly. When a severe adverse event occurs, the study may be stopped until it can be determined if the adverse event was related to the study medication or intervention.

• Participants continue to receive appropriate medical care for their disease when participating in a clinical research study. The clinical research study should not jeopardize a patient’ access to any treatments deemed necessary that may fall outside of the clinical research protocol requirement.

• Participants in clinical research will be treated respectfully and with dignity, without discrimination based on age, race, ethnicity, socioeconomic status, disability, or medical condition.

• Your clinical research team will maintain ongoing communication with all clinical research participants regarding any significant findings that may impact their decision to remain in the clinical research study.

Participants have many rights as outlined, but they also have certain responsibilities when taking part in clinical research. Participants responsibilities will be outlined in the clinical research protocol and the Informed Consent Form.

Specific patient responsibilities in clinical research include:

• Following the clinical research requirements as outlined in protocol.

• Adhere to instructions provided by the clinical research team to include, but not limited to, attending scheduled visits, taking all medications as prescribed, completing questionnaires or assessments accurately and on time, and reporting any changes in their health status.

• Participants must also be open to share all medical history as needed for the clinical research team to protect their health and safety, and to ensure they meet the inclusion and exclusion criteria of the clinical research protocol.

• Participants must also ensure all information provided to the research team is true and accurate.

• Other specific requirements may exist and will be outlined clearly in the clinical research protocol and the informed consent form and will be explained during the informed consent process.

A clinical research participant may withdraw their participation in the clinical research at any time, however, it is important they communicate with their clinical research team and perform end of study requirements to ensure protection of their health.

All participants involved in clinical research are guaranteed rights that ensure they are treated professionally and respectfully. When you take part in one of our studies, you have the right to:

• Be treated with respect.
• Make your decision without feeling any pressure from the research staff.
• Be informed of all known risks of participating in the study.
• Understand what alternatives are available for treatment of your disease.
• Know the name, credentials and contact information of the clinical research study’s principal investigator.
• Understand who will have access to your personal health information.
• Be clear on any procedures that may be performed and what drugs or medicines may be used.
• Seek additional help or clarification during the informed consent process and at any time during the study.
• Withdraw from the study without penalty and at any time.

Complementing the daily practice, AHG fosters research collaboration to build upon the strengths of each practice and to bring cutting-edge therapy to the patient populations we serve.  Bringing innovative new therapies for the many complex rheumatological diseases allows our physicians to best optimize each patient care plan.

If you  would like to see if you qualify for a existing study at AHG, or you have a family member interested, please contact a member of the AHG research team.