聽By HFA Staff

Patients with bleeding disorders are no strangers to engaging in conversations with medical, research and pharmaceutical staff. Emergency rooms, doctors鈥 offices, pharmaceutical company offices, conference rooms and exhibit halls have all become places to engage in medical discussions. Each of these venues has different, but similar, codes of ethics to follow when engaging in conversations about patients鈥 health, and all require obtaining informed consent before conducting health care intervention or research through a study or trial.

Consent can only be obtained from a mentally competent adult or a legally authorized representative of a mentally incompetent adult. This legal status refers to the capacity of a person to act on their own behalf and their ability to understand the information presented, to appreciate the consequences of acting or not acting on that information, and to make a choice.

Participation by Minors

A parent or legal guardian provides consent for a minor. However, children 12 and older who are asked to participate in a research project must do so voluntarily and must verbally assent to the research project. The explanation of the project and the language used must be appropriate to the child. In some localities, even children as young as 7 years old are asked to assent to participate in research studies.

FDA Regulations

Under the U.S. Food and Drug Administration regulations, an Institutional Review Board is an administrative body that has been formally designated to review and monitor biomedical research involving human subjects. The IRB has the authority to approve, require modifications needed to secure approval, or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. (The local IRB that approves the study can provide more information about consent as it relates to children.)

Research and Clinical Trials

Consent works differently in a hospital setting versus a research/clinical trial setting. In the research/clinical trial setting, the first step to understanding is discovering that a research study or clinical trial exists. Patients may learn about the existence of a research project or clinical trial via mail, telephone, through a friend or during an in-person visit with a doctor.

Tips for Understanding Clinical Trials & Research Studies

We cannot emphasize enough that participants, sometimes referred to as human subjects in a clinical research setting, should ask questions about their participation in a clinical trial or research study prior to signing up. Here are questions you should ask about a clinical trial or research study and the information you should glean from asking:

What should I ask?

  • Is a written copy of the research procedures available?
  • What are the benefits and risks of this research project?
  • How will I be informed if there are changes to this project?
  • Am I waiving any of my rights by signing this consent form?
  • May I ask a person I trust to read this document?
  • Will my name and address be kept confidential or will it be shared with others?
  • How will my information be stored to protect my privacy?
  • May I refuse to participate in this research project?
  • What if I change my mind after I agree to participate?
  • How do I withdraw my consent after I sign the form?
  • If I withdraw my consent and stop participating, what will happen with the information already collected from me?
  • Are there negative consequences if I withdraw my consent?
  • (In case of pharmaceutical trials) Will I be given the actual medication or a placebo?
  • (If English is not your first language) Is the information available in my preferred language?

What have I learned?

  • The purpose of the research.
  • The name, address and phone number of the Principal Investigator.
  • How long I am expected to participate.
  • If any of the medications or procedures are experimental.
  • The possible risks or discomforts.
  • If there are any alternative procedures or courses of treatment.
  • If my information and medical records will be kept confidential.
  • If I will be paid for my participation.
  • The medical treatments available if I get injured.
  • Who I can call if I have questions.
  • If I am required to participate in this study.
  • If there is a penalty if I refuse to participate.
  • If there is a penalty if I stop participating at any time.

More than a signature: Informed consent is about your understanding
and willingness to participate in a study, not about signing a form.

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