Program
Informed Consent
(Not all items are
applicable to
every program.)
In language understandable
to the participant...
Who,
What, Why, Where, When
o Consent forms must state who
is providing the service and must either be presented on
program or
agency letterhead.
o
An explanation of the purpose
of the program obtaining information
o
A description of the procedures
by which information will be provided
o
Identification of service
options, procedures, or activities
o
The location(s) where
the program or services will be offered
o
The expected total duration
of participation and that of each phase of multi-phase programs
Voluntariness
o
A statement that
participation is voluntary
o
A statement that clients
may refuse to participate or may discontinue participation at any
time
without penalty or loss of benefits to which they are otherwise entitled
o
If surveys and interviews
are used, a statement that subjects may skip any questions they
don’t
wish to answer
o
No language that subjects
are required to waive any legal rights, including any
release of
the program, agency, or its agents from liability or negligence
Risks,
Benefits, Costs, and Gratuities
o
A description of the
reasonably foreseeable risks and discomforts, or a statement
that the program
does not involve risks beyond those encountered in everyday life, as
appropriate
o
A description of possible
direct benefits to the subject, which may reasonably be
expected from
the program, or a statement that individuals may not directly benefit
from
participation though there may be benefits to their families, friends,
or to
society
o
An explanation of any costs
to the subject for program-related procedures, hospital or other
residential stays,
use of equipment, lost compensation or insurance, or extraordinary
transportation requirements
o
An explanation of any gratuities
or direct benefits for participation and, if appropriate,
procedures to prorate
amounts for subjects who withdraw before completing the program
o
As appropriate, an
explanation as to whether any compensation or assistance
is
available if injury occurs (including psychological or social injury),
what it
would consist of (if any), or where further information may be obtained
Confidentiality
o
A
statement describing the extent to which confidentiality of
records identifying subjects will be maintained, including who will
have access
to and the methods for securing such records; as well as how that
information
will be used; and an expiration date for the consent (if appropriate).
Who
to Contact
o
The name(s), title(s), local
or toll-free telephone number(s), and e-mail addresses of the person(s)
to
contact for answers to questions about the program, including those
for the
responsible program manager, if different
o
An invitation to contact the
agency for information about the rights of participants
in agency
programs. Persons may call collect if they identify themselves as
program
participants.
o
As appropriate, the name(s),
title(s), and daytime and evening telephone number(s) of the person(s)
to
contact in the event of a program-related injury, adverse effects, or
complaints
Near
the Signature Line
o
A statement that participants
will be given a copy of the consent form