Page 6 - HFA Dateline 2022 Special Edition

Informed Consent:

A Process, Not Just a Form

BY HFA STAFF

atients with bleeding disorders are no strangers to Participation by Minors
engaging in conversations with medical, research A parent or legal guardian provides consent for a
P and pharmaceutical staff. Emergency rooms, doctors’ minor. However, children 12 and older who are asked to
offices, pharmaceutical company offices, conference participate in a research project must do so voluntarily
rooms and exhibit halls have all become places to engage and must verbally assent to the research project. The
in medical discussions. Each of these venues has different, explanation of the project and the language used must be
but similar, codes of ethics to follow when engaging appropriate to the child. In some localities, even children
in conversations about patients’ health, and all require as young as seven are asked to assent to participate in
obtaining informed consent before conducting health care research studies.
intervention or research through a study or trial.

Consent can only be obtained from a mentally competent FDA Regulations
adult or a legally authorized representative of a mentally Under the U.S. Food and Drug Administration regulations,
incompetent adult. This legal status refers to the capacity an Institutional Review Board (IRB) is an administrative
of a person to act on their own behalf and their ability to body that has been formally designated to review
understand the information presented, to appreciate the and monitor biomedical research involving human
consequences of acting or not acting on that information, subjects. The IRB has the authority to approve, require
and to make a choice. modifications needed to secure approval, or disapprove

6 DATELINE FEDERATION < www.hemophiliafed.org