4. Informed Consent Requirements
The purpose of this section is to assist the investigator by
providing guidance on how to obtain valid informed consent from
potential research subjects. The informed consent process is
fundamental to ensuring the continuous and adequate disclosure of
research related risks and benefits. Written informed consent is
also required by federal regulations and State law.
The Process
of Informed Consent
In the past, it was generally accepted that written informed
consent, obtained at a single contact between an investigator and
a subject, was sufficient to meet legal and ethical obligations
to patients and research subjects. This view was abandoned in the
1970’s. Informed consent is now understood as an on-going
process which starts with the initial presentation of a research
activity to a prospective subject by the investigator and
continues through the research activity until the subject ends
his/her participation or the study closes.
Research subjects are rarely aware of research activities
prior to an initial presentation by the principal investigator or
a member of the principal investigator’s study team. The
initial phase of consent requesting participation in a research
activity commonly begins with the first contact between the
subject and the investigator. Many subjects make their decision
regarding whether to participate in research during the initial
contact. As a result, the greatest potential for misunderstanding
exists in the initial consent process. Researchers are encouraged
to provide sufficient time for a potential subject to reflect on
the nature of participation during the important initial
presentation of a research activity. When subjects are presented
with numerous research and clinical options, the consent process
should include a clear description of the possible ramifications
resulting from each option presented. The presentation should not
include specific "leading" information about whether to
participate in any particular project.
By providing a potential subject with understandable
information in an initial session regarding complex research
issues, potential subjects will have an improved comprehension of
the elements within the consent form and provide a more informed
consent for participation in the research.
The second step in the consent process is the presentation of
the consent form to subjects. The investigator should separate
the research consent form from other clinical information or
hospital admission forms. Subjects should not be asked to sign
hospital admission paperwork or hospital consent documents for
clinically indicated procedures at the same time as the
presentation of the research consent form.
A member of the study team should ensure that the subject
reads the consent form. After the subject reads the consent form,
the member of the study team should ask the subject if he/she
understands the information contained in the form. In situations
where the ability of the subject to understand the form is in
question, for example, the form includes complex scientific
information or the subject is possibly educationally or mentally
challenged, the member of the study team may wish to ask
questions of the subject to ensure an understanding of the basic
elements of the consent form. In performing an assessment of the
subject’s comprehension of the consent form, an investigator
should request that the subject indicate the risks of
participation, how the subject may withdraw, and what
alternatives exist to participation in the research. The
decision-making capacity of subjects with psychiatric disorders
or cognitive deficits (such as dementia) should be evaluated by a
practitioner not otherwise affiliated with the research. (Please
see, "Determining
Decision- Making Capacity," in this Chapter.)
All efforts should be made to offer potential subjects
sufficient time to consider the information contained in the
consent form. The subject should be given an opportunity to take
the consent form home and sign the form on a return visit or the
subject may be left alone to consult enrollment with family or
friends. If the individual decides to participate, he/she would
sign the consent form, the principal investigator would co-sign
the form, and if the research involves more than minimal risk,
the Committee may require a witness to document the process by
also signing the form.
The consent process does not end with the signing of a
consent form. Research is an on-going process which involves
the constant re-evaluation of current information and procedures.
Therefore, investigators are ethically obligated to keep subjects
apprised of all issues related to their participation in the
study. For example, a sponsor may, during the course of a study,
decide to supply a drug free-of-charge to subjects following
their participation in the research. The new information should
be presented to research subjects in a written form and the
subjects should be asked to sign a copy of the form or to sign a
revised consent form. Likewise, adverse
events may occur during a research activity that would
directly affect whether prospective or enrolled subjects would
wish to continue in a particular research activity. Subjects must
also receive the new information as a part of the continuing
consent process. Investigators should note that the HSPC requires
Committee review and approval prior to an investigator providing
subjects with new research information.
Information also may arise regarding the study which should be
shared with previously enrolled subjects after their completion
of the study, or a specific treatment or procedure. For example,
dysfunctional families may participate in qualitative research
examining parenting techniques. Following data analysis, the
investigator finds that a specific technique is superior to the
other study arms of the project. As a health care and educational
institution, UCLA investigators are morally obligated to
provide this valuable new information to research participants.
In conclusion, it is difficult to be confident that volunteers
truly understand the nature of their participation in research
when they are confronted with volumes of complex scientific
details in a brief and isolated consent session. By rejecting the
outmoded belief that informed consent starts and ends with a
consent document, investigators and subjects will work as
partners in a healthy process of an equal exchange of information
and scientific discovery. As a result, subjects will have an
improved understanding of the risks and anticipated benefits (to
themselves, others, and society) of participating in the
research. Creating an ongoing consent process will facilitate an
exchange of information between subjects and investigators in a
scientific environment of increasing complexity. In providing
subjects with a continuing consent process we will ensure that
subjects are completely informed about their participation in the
research. By providing subjects with the opportunity to give
effective and on-going informed consent, in a process that
incorporates the free exchange of information between both the
researcher and the subject, investigators will continue to set
the standards for the conduct of ethical research.
Writing the
Consent Form
The consent form is intended to serve as only one aspect of an
on-going dialogue between the investigator and the subject.
Subjects are autonomous and should voluntarily give their consent
to participate in research. As a result of their voluntary
participation, subjects reserve the right to withdraw their
participation from the research without prejudice. Therefore, the
consent form should serve as just one element in an equal
exchange of information between the investigator and the subject
and not a binding contract between two parties.
Delays in HSPC approval most commonly result from the
submission of an inadequate consent form. The design of the
consent form should carefully reflect the process of informed
consent, i.e., introduce the investigator to the subject;
indicate why the subject is requested to participate in the
study; articulate the purpose of the study; clearly separate the
research procedures from any standard treatment; inform the
subjects of the risks and benefits of participation; and
ultimately document the subject’s willingness to participate
in the project. Oftentimes the consent form is too technical and
includes scientific jargon which can prove incomprehensible and
ultimately intimidating to a subject.
Studies have found that most subjects read at a sixth grade
level or lower. Therefore, consent forms should avoid or define
technical jargon or terminology, adjust for educational
background and age, and provide translations for subjects who are
not facile in English. The HSPCs may require separate forms for
different subject groups, such as parents, children, healthy
control subjects, etc. (Samples of consent
and assent forms can be found in Chapter 12, Application Forms.)
Consent forms that contain medical language, social science
terminology, and metric equivalents for quantities are routinely
returned to investigators for modification. If the subject cannot
understand the consent form they cannot give knowing consent for
their participation in the research. The HSPCs suggest that
investigators have a colleague or staff person, not familiar with
the field of research, review the consent form for content and
readability prior to submitting the form for Committee review.
A typical problem for research requesting the inclusion of
blood draws or biopsies is the use of metric measurements in the
consent form. Most subjects do not understand metric
measurements, i.e., how much blood is in 10 c.c.s. Therefore, the
Committees commonly request the translation of metric
measurements into teaspoons, tablespoons, etc. In a similar
spirit, biopsies should be described or equated with a commonly
recognized amount. (Please see Chapter
11, "Glossary: Suggested Lay Language Translations
for Consent Forms," for suggested common technical
terms and possible lay language explanations which will assist
you in developing user friendly consent forms.)
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October 29, 2004
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