Consent Frequently Asked Questions (FAQs)
What
is informed consent?
As it relates to the conduct
of research within safe and
ethical guidelines, informed
consent is a person's voluntary
agreement, based upon adequate
knowledge and understanding
of relevant information,
to participate in the research
described. In giving informed
consent, research subjects
may not waive or appear to
waive any of their legal
rights, or release or appear
to release the investigator,
the sponsor, the institution
or agents thereof from liability
for negligence [Federal Policy;
21 CFR 50.20 and 50.251].
There are a very few instances
in which the requirement to
obtain informed consent or
in which written documentation
of consent might be waived.
These might include, for example:
- Instances in which an
investigational drug or
device might be used in an
emergency situation, the
circumstances of which make
obtaining informed consent
impossible.
- Research
in which information about
a potentially illegal activity
is being collected and
the informed consent could,
in and of itself, pose a
risk to participants of identification
and arrest.
- In cases where the requirement
for informed consent
or for written consent is
waived, additional protections
for research subjects are
considered and typically
included in the research
procedures.
What
should my consent form contain?
The Consent Form Checklist - 12/07/05 (doc) 58 kb provides
specific guidance to you on what
any consent form should contain. Additional
guidance is available regarding consent,
including sample forms, on the Consent
Forms page.
Who
should be listed on consent
forms?
The principal investigator
should always be identified
on the consent form. Also listed
should be the members of the
study team who have been delegated
the responsibility of administering
informed consent and those
who will have on-going contact
with study subjects.
Federal regulations and UW
standards require that each
participant in a research study
be provided with adequate information
about the study, including
who is conducting it. Listing
the names and contact information
of the study team at the top
of a consent form is an effective
way to tell subjects who is
conducting the study.
The principle guiding who
is listed on the consent form
is that subjects should be
able to get in touch with
those with whom they have had
contact during the study or
others who can speak with knowledge
and authority about the study
and subjects' involvement.
Typically, that includes:
- The
lead researcher or principal
investigator (and usually
the co-investigators).
- Those who
obtain informed consent.
- Those
with whom the subject will
have regular contact during
the study, such as study
interviewers, coordinators,
and nurses.
- Faculty
advisors (for student research
only).
It usually does not include:
- Data entry staff or statisticians,
or co-investigators who
will not have contact with
subjects.
- People who provide a one-time
service (x-ray, blood draw,
eye exam, etc.).
- People who are available
for emergency purposes
only.
Exceptions to this standard
may occur, but they are granted
on a case-by-case basis by
the reviewing Committee.
Alternative arrangements must
not defeat the main purpose
of the standard requirement,
which is to provide research
subjects with a clear idea
of (a) who are the responsible
members of the study team
and (b) how they can be contacted.
Who should sign as the investigator on the consent form?
Consent
forms should be signed by the person actually administering consent,
at the time consent is administered. The person who administers
consent, if that person is not the principal investigator, is acting
as the agent of the principal investigator and must be able to
represent the study with full knowledge and authority to prospective
subjects; this person should be listed as an investigator in the
Investigators' Information section of the consent form. The principal
investigator is ultimately responsible for any defects in the consent
process, and the chain of responsibility must be clear.
May the investigator pre-sign the consent
form?
Except in very specific circumstances, approved on a case-by-case
basis by the reviewing Committee or subcommittee, consent forms
should not be pre-signed.
|
