Your Responsibilities in a Clinical Research Trial

The study team will explain your responsibilities as a participant. Before signing the Consent Form:

• Make sure you understand everything that is involved in the clinical research trial, that you are comfortable with the things you need to do, and that you can fulfill your commitment.

• Ask as many questions as you can. Print a list of questions to ask the study team.

• Learn all you can about the study team (credentials and experience), the research facility, and the study drug.

Once the study is underway, your primary responsibilities are to contact the study center in the event of prodromal symptoms or an HAE attack. Other responsibilities include:

• Contacting the study doctor as soon as possible in the event of an emergency or if you are hospitalized for any reason.

• Telling the study doctor about any side effects you think may be related to the medication.

• Letting your other doctors know you are participating in a clinical research trial and providing them with contact information for study doctor, if necessary.

• Keeping a diary, if requested, of your experiences with treatment.

Should you decide to withdraw from the study, let the study team know. In order to get FDA approval for a drug, it is important that volunteers complete the study, if possible, and be available for follow-up.

Your Rights

• You cannot be enrolled in a clinical research trial without your knowledge. You are protected from unauthorized research without your consent through informed consent.

• Your privacy will be protected. Your name cannot be revealed, and your medical information must remain confidential.

• You always have the right to say “no,” if you are uncomfortable with what you are being asked to do or if you don't fully understand it.

• Because participation is voluntary, you can withdraw from a clinical research trial at any time.

• You should NOT have to pay to participate in a clinical research trial. Costs of routine tests and procedures that are part of your normal health care will be paid in accordance with the terms of your health insurance plan. This can be one of the advantages of being part of a clinical research trial.