Elements of Informed Consent
Voluntariness - an investigator must provide the
prospective subject or the subject's representative sufficient
opportunity to consider whether or not to participate without
coercion or undue influence.
Comprehension - the information that is given to
the subject or the subject's representative shall be in language
understandable to the subject or the representative.
Information - includes specific items for disclosure
intended to assure that subjects will be given sufficient
information (procedures, purposes, risks, anticipated benefits,
alternative procedures (if applicable), person(s) conducting
the research, and a statement offering the opportunity to
ask questions and to withdraw at any time from the research.
No informed consent, whether oral or written, may include
any language through which the subject or the representative
is made to waive or appear to waive any of the subject's legal
rights, or releases or appears to release the investigator,
the sponsor, the institution or its agents from liability
for negligence.
Information Required on Consent Forms
Federal regulations require that the following information
must be provided to each subject as part of the informed consent
process:
- A statement that the study involves research, an explanation
of the purposes of the research and the expected duration
of the subject's participation, a description of the procedures
to be followed, and identification of any procedures which
are experimental.
- A description of any reasonably foreseeable risks or discomforts
to the subject.
- A description of any benefits to the subject or others,
including scientific benefits which may reasonably be expected
from the research.
- A disclosure of appropriate alternative procedures or
treatments, if any, that might be advantageous to the subject.
- A statement describing the extent to which confidentiality
of records identifying the subject will be maintained.
- For research involving more than minimal risk, an explanation
as to whether any compensation, or medical treatments are
available if injury occurs, and, if so, what they consist
of, and whether subjects are expected to pay for treatment
of research-related injuries or illness.
- A statement of whom to contact for (a) answers to pertinent
questions about the research, (b) research-related illness
or injury, and (c) the rights of research subjects.
- A statement that participation is voluntary, that refusal
to participate will involve no penalty or loss of benefits
to which the subject is otherwise entitled, and that the
subject may discontinue participation at any time without
penalty or loss of benefits to which the subject is otherwise
entitled.
Additional elements as required:
- A statement that the particular treatment or procedure
may involve risks to the subject which are currently unforeseeable.
- Anticipated circumstances under which the subject's participation
may be terminated by the researcher without regard to the
subject's consent.
- Any additional costs to the subject that may result from
participation in the research.
- The consequences of a subject's decision to withdraw from
the research as well as the procedures for orderly termination
of participation by the subject.
- A statement that significant new findings developed during
the course of the research which may relate to the subject's
willingness to continue participation will be provided to
the subject.
- The approximate number of subjects involved in the study.
Written Documentation of Informed Consent
In most cases, federal regulations require that informed
consent is to be documented in writing. Documentation usually
involves the use of a written consent form containing all
of the information to be disclosed and signed and dated by
the subject (or the subject's legal representative) and by
the person obtaining the consent. One copy should be given
to the subject (or representative), and one copy should be
retained by the investigator for at least three years.
Federal regulations require that IRBs give special consideration
to protecting human subjects who are particularly vulnerable.
These subjects include children, prisoners, pregnant women,
cognitively impaired individuals, traumatized or comatose
individuals, persons who are terminally ill and those who
are economically or educationally disadvantaged. With the
exception of research involving children, investigations using
special populations are approved only when the research objectives
cannot be met using populations outside this special category
and when there is only minimal risk involved or when the research
will directly benefit the subjects.
In rare instances, the IRB may waive written documentation
of the consent process (but not the process itself) for research
presenting no more than minimal risk. In certain instances
of research involving no more than minimal risk where the
research could not be practically carried out if written documentation
were required ( such as telephone surveys), the IRB also may
waive the requirement for written documentation of the consent
process.
In some cases (if the subject is unable to read or if written
consent is found to be culturally disrespectful or inappropriate),
the information about consent may be presented verbally. In
these cases, the researcher reads the consent form to the
subject, and a short written consent document is substituted.
This document should state that the elements of informed consent
have been presented orally to the subject. When a short form
is used, there should also be a witness to the oral presentation.
All parties should sign the short written consent document.
Constructing the Consent Document
The consent document should have three parts: beginning,
middle, and end.
Beginning
- Who is doing the experiment
- The nature, purpose, and duration of the research
- The uses to be made of the data
Middle
- The methods to be employed
- The hazards, inconveniences, discomforts, and any potential
risks to which the subjects will be subjected
- The availability of compensation and treatment, if injured
- The benefits that might be expected
- Disclosure of alternate procedures the subject may choose,
if applicable
- The conditions of participation if any
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