Participating in PHN Research

Research helps to improve understanding of these challenging conditions.

Learning about Research Opportunities

As you get more involved in the care for yourself or your child who has been diagnosed with CHD or acquired heart disease, you may learn about research to study these conditions. You may read about or be asked about clinical trials in many ways. A member of the research team may contact you, or your primary care doctor may speak with you about a study. You may learn about a study from seeing information on a community post or from others who have participated. You may see a brochure or information sheet that gives some details about a study. This will help identify what studies might be out there, but to learn if one is right for you or your child, you will want to talk to your or your child’s doctor as well as a study coordinator, and read the consent form carefully.

Before you decide whether to participate in a clinical study, be sure to know your rights and responsibilities.

Questions to Consider

This form is required by law to explain:

  • The study involves research
  • Why the study is being done
  • The length of time you or your child will be in the study
  • The procedures to be followed and which of those are experimental
  • Potential risks or discomforts
  • Potential benefits to yourself/your child or to others
  • Appropriate alternative procedures or courses of treatment that might be good
  • How privacy of records and confidentiality will be maintained
  • Whether any compensation or medical treatments are available if injury occurs and, if so, what they consist of, or where information may be found
  • Whom to contact in the event of a research-related injury
  • Whom to contact for answers about the research and research participants’ rights
  • That participation is voluntary, refusal to participate will involve no penalty or loss of benefits and that a participant may leave the study at any time

Your rights are protected through laws in the United States, Canada and the European Union. These laws have been created over time and exist to protect study subjects and help them understand the details about a study. Additional legal protections are given for pregnant women, human fetuses, neonates and children. The rights these laws protect are outlined below.

  • You have the right to be informed as fully as possible, to understand what has been explained to you and to be given time to ask questions and have them answered by one of the investigators.
  • Your consent to join a study must be voluntary and you must not be forced in any way to agree to join.
  • You have the right to stop the study at any time and continue to receive your regular care. It will not harm your relationship with your doctors and nurses if you choose to stop the study.
  • You must not be given promises of benefits that are not likely to result from being in a study.
  • You must be given a copy of a signed and dated written consent form. The form must be written in simple language that you can understand.
  • The research team will tell you how you may reach them in case you have questions or concerns.
  • Consider the extra time and effort that may be needed to be in a study.
  • When you decide that you or your child will be in a study, it is important to follow the study instructions very carefully. This may mean giving the proper doses of study medicine at the right time, returning for each study visit and letting the study team know if you or your child had any adverse effects from the treatment.
  • Keep in regular contact with the study team. Let the research team know if your address, email or phone number changes and how you can best be reached. Call the research team if you will not be able to go to one of the study visits. They will want to know that you are okay and will help you to find another time that is good for you. Talk with them if you have transportation, childcare or other needs. Often, the study team can help you to find other resources to help you during the study.

If you decide to leave the study, talk with a member of the study team before you do so. Your child may need to be placed on a different medicine or need a certain test so you can leave the study safely. On the Children and Clinical Studies website, watch the video “Leaving a Study” for more information.

Helpful Resources

The Children and Clinical Studies website provides important information to help you decide whether a clinical study is right for your family. Check out the following topics: