Informed consent is a process in which a patient
learns and understands about the purposes of a research project and
then voluntarily agrees to participate. This means the patient knows
and understands the potential benefits and risks involved in participating.
A patient may decline to participate. If the patients signs an informed
consent forms and agrees to participate, he or she may freely withdraw
from participation in the study at any time. If a person does not agree
to become part of the study, or if a patient withdraws from they study,
they will not be treated any differently by the medical staff.
Assent Form:
What is "Informed Assent"?
Attaining informed consent depends on the educated
and voluntary decision by the subject being studied. In our research
office, children are the subjects. According to the law, children are
not recognized as being capable of making their own decisions. Therefore,
we can not attain informed consent. Under these circumstances, the researchers
must get informed parental permission and child assent. The Informed
Assent form explains to the child, in language that is understandable
to them, the details of the research project as well as any benefits
or risks. The child Informed Assent form must also be read
out loud to the child.
HIPAA Form:
What is the "Health Insurance Portability and Accountability Act"
Form?
The American Health Insurance
Portability and Accountability Act of 1996 (HIPAA) is a set of rules
to be followed by health plans, doctors, hospitals and other health
care providers. HIPAA took effect on April 14, 2003. In the health care
and medical profession, the great challenge that HIPAA has created is
the assurance that all patient account handling, billing, and medical
records are HIPAA compliant.
HIPAA is a multifaceted piece
of legislation. The first two components–portability and accountability–have
already been put into effect. The third component is administrative
simplification.
Two key rules enacted under
the administrative simplification component concern the privacy
and security of health information.
The privacy rule protects
individuals' right to control access to and disclosure of their protected
health information. The security rule requires organizations to control
the means by which this information remains confidential.
Privacy requires security.
The security regulations were established to complement the privacy
measures. Under the security regulations, researchers have responsibility
for keeping records private and secure. In addition to following standard
procedures for storing study records in locked files, researchers are
required to use secure procedures for all computer-based storage of
protected health information including servers, handheld and laptop
computers.
