Page 6 - HFA Dateline 2022 Special Edition
P. 6

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

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