Office for Protection from
Research Risks
TIPS ON INFORMED CONSENT
The process of obtaining informed consent must
comply with the requirements of 45 CFR 46.116. The documentation of informed consent
must comply with 45 CFR 46.117.
The following comments may help in the development of an approach
and proposed language by investigators for obtaining consent and
its approval by IRBs:
- Informed consent is a process, not just a
form. Information must be presented to enable persons to
voluntarily decide whether or not to participate as a
research subject. It is a fundamental mechanism to ensure
respect for persons through provision of thoughtful
consent for a voluntary act. The procedures used in
obtaining informed consent should be designed to educate
the subject population in terms that they can understand.
Therefore, informed consent language and its
documentation (especially explanation of the study's
purpose, duration, experimental procedures, alternatives,
risks, and benefits) must be written in "lay
language", (i.e. understandable to the people being
asked to participate). The written presentation of
information is used to document the basis for consent and
for the subjects' future reference. The consent document
should be revised when deficiencies are noted or when
additional information will improve the consent process.
- Use of the first person (e.g., "I
understand that ...") can be interpreted as
suggestive, may be relied upon as a substitute for
sufficient factual information, and can constitute
coercive influence over a subject. Use of scientific
jargon and legalese is not appropriate. Think of the
document primarily as a teaching tool not as a legal
instrument.
- Describe the overall experience
that will be encountered. Explain the research
activity, how it is experimental (e.g., a new drug, extra
tests, separate research records, or nonstandard means of
management, such as flipping a coin for random assignment
or other design issues). Inform the human subjects of the
reasonably foreseeable harms, discomforts, inconvenience
and risks that are associated with the research activity.
If additional risks are identified during the course of
the research, the consent process and documentation will
require revisions to inform subjects as they are
recontacted or newly contacted.
- Describe the benefits that
subjects may reasonably expect to encounter.
There may be none other than a sense of helping the
public at large. If payment is given to defray the
incurred expense for participation, it must not be
coercive in amount or method of distribution.
- Describe any alternatives to
participating in the research project. For
example, in drug studies the medication(s) may be
available through their family doctor or clinic without
the need to volunteer for the research activity.
- The regulations insist that the
subjects be told the extent to which their personally
identifiable private information will be held in
confidence. For example, some studies require
disclosure of information to other parties. Some studies
inherently are in need of a Certificate of
Confidentiality which protects the investigator from
involuntary release (e.g.,subpoena) of the names or other
identifying characteristics of research subjects. The IRB
will determine the level of adequate requirements for
confidentiality in light of its mandate to ensure
minimization of risk and determination that the residual
risks warrant involvement of subjects.
- If research-related injury (i.e.
physical, psychological, social, financial, or otherwise)
is possible in research that is more than minimal risk
(see 45 CFR 46.102[g]), an explanation must be given of
whatever voluntary compensation and treatment will be
provided. Note that the regulations do not limit
injury to "physical injury". This is a common
misinterpretation.
- The regulations prohibit waiving
or appearing to waive any legal rights of subjects.
Therefore, for example, consent language must be
carefully selected that deals with what the institution
is voluntarily willing to do under circumstances,
such as providing for compensation beyond the provision
of immediate or therapeutic intervention in response to a
research-related injury. In short, subjects should not be
given the impression that they have agreed to and are
without recourse to seek satisfaction beyond the
institution's voluntarily chosen limits.
- The regulations provide for the
identification of contact persons who would be
knowledgeable to answer questions of subjects about the research,
rights as a research subject,
and research-related injuries.
These three areas must be explicitly stated and addressed
in the consent process and documentation.
Furthermore, a single person is not likely to be
appropriate to answer questions in all areas. This is
because of potential conflicts of interest or the
appearance of such. Questions about the research are
frequently best answered by the investigator(s). However,
questions about the rights of research subjects or
research-related injuries (where applicable) may best be
referred to those not on the research team. These
questions could be addressed to the IRB, an ombudsman, an
ethics committee, or other informed administrative body.
Therefore, each consent document can be expected to have
at least two names with local telephone numbers for
contacts to answer questions in these specified areas.
- The statement regarding voluntary
participation and the right to withdraw at any time can
be taken almost verbatim from the regulations (45 CFR 46.116[a][8]). It is important not to overlook the
need to point out that no penalty or loss of benefits
will occur as a result of both not participating
or withdrawing at any time. It is equally important to
alert potential subjects to any foreseeable consequences
to them should they unilaterally withdraw while dependent
on some intervention to maintain normal function.
- Don't forget to ensure provision for
appropriate additional requirements
which concern consent. Some of these requirements can be
found in sections 46.116(b), 46.205(a)(2), 46.207(b), 46.208(b), 46.209(d), 46.305(a)(5-6), 46.408(c), and 46.409(b). The IRB may impose additional requirements
that are not specifically listed in the regulations to
ensure that adequate information is presented in
accordance with institutional policy and local law.
Revised 3/16/93