VA Informed Consent Guidance
Please also see the VA consent form template for specific form, formatting and language requirements
VA Informed Consent Document Requirements
All VA research requires
signed consent to be obtained from all participating human subjects with the
exception of research determined to be exempt from IRB review or for which the
IRB has waived the requirement to obtain informed consent or documentation of
Any VA-research informed
consent form (ICF) accompanying new applications, generated due to protocol
changes, or submitted as part of a continuing review, must meet the following
consent must be obtained for every subject participating in human research
conducted under the auspices of the VA unless the IRB has determined that it
meets the exceptions listed above.
VA research consent documents (form 10-1086 or an electronic form of 10-1086)
that have been approved by both the VA R&D Committee and the UW HS-IRB or
MR-IRB may be used for consenting VA research subjects.
basic elements of informed consent (see below) must be included in all ICFs
unless both the R&D Committee and the HS-IRB or MR-IRB specifically allow
their exclusion. Note:
The wording for basic element #11 (subject injury compensation) differs from
that required by the University.
additional elements of informed consent (see below) should be included in all
ICFs in studies where they are applicable.
tissue banking is involved, VA-specific language addressing tissue banking must
be included in the ICF (see below).
VA ICFs, the signature page must include space for:
signature of the subject being consented, or the subject’s legally authorized
representative if required, and the date signed
signature of a witness to the subject’s, or subject’s legally authorized
representative’s, signature and the date signed [a space for the witness to print name for identification is
recommended] *Note a witness must be someone who is present during the signing
of the consent form
signature of the subject’s representative if required by the IRB due to
signature of the person who is obtaining consent - this may be the investigator
only if the investigator is the one who is directly obtaining consent, however
the consent form should read “person obtaining consent” not “investigator”)
space for the subjects “last four” (final four digits of Social Security
number) unless this requirement is waived by the VA R&D Committee.
Elements for Informed Consent under the VA Regulations
name of the Principal Investigator (or the designated VA Responsible Investigator,
if different from PI)
statement that the study involves research
explanation of the purposes of the research and the expected duration of the
description of the procedures to be followed and identification as to which of
these are being done for research purposes.
of all procedures that are experimental and of those that are considered
standard of care
description of any reasonably foreseeable risks or discomforts to the subject
including, for example, privacy risks (legal, academic, employment and/or
description of any benefits to the subject or to others that may reasonably be
expected from the research.
disclosure of appropriate alternative procedures or courses of treatment, if
any, which might be advantageous to the subject.
statement describing the extent to which confidentiality of records identifying
the subject will be maintained [If appropriate, a statement that other Federal
agencies such as FDA, OHRP, and GAO may have access to the records].
research involving more than minimal risk, an explanation as to whether any
compensation is available and an explanation as to whether any medical
treatments are available if injury occurs and if so, what they consist of, or
where further information may be obtained. The following text should be used
unless otherwise specified by the R&D Committee: “In the event you
sustain physical injury as a result of participation in this investigation, all
necessary and appropriate care will be provided.”
following information must be included:
to contact for answers to questions about the research
to contact in the event of a research-related injury to the subject. [note: a. and b. may be the same person for some protocols]
to contact at the for inquiries regarding research subjects' rights (VA Patient
to contact to confirm the research study is a valid VA study (VA Research
statement that participation is voluntary and that the subject may refuse to
participate or discontinue participation at any time without penalty or loss of
benefits to which the subject is otherwise entitled.
- The VA
requires a statement that a veteran-subject to pay for care received as a
subject in a VA research project and note that some veterans are required to
pay co-payments for medical care and services provided at the VA, which will
continue to apply to medical care and services provided by the VA that are not
part of the study.
Elements of Informed Consent
One or more of the
following elements shall also be provided to each subject when appropriate to a
statement that the particular treatment or procedure may involve currently
unforeseeable risks to the subject or to embryo or fetus if the subject is or
circumstances under which the subject's participation may be terminated by the
investigator without the subject's consent.
additional costs to the subject that may result from participation in the
consequences of a subject's decision to withdraw from the research and
procedures for orderly termination of participation by the subject.
statement that significant new findings developed during the course of the
research which may affect the subject's willingness to continue participation
will be provided to the subject.
approximate number of subjects involved in the study.
human biological specimens obtained could be part of or lead to the development
of a commercially valuable product or if the specimens will be retained after
the end of the study, guidance and regulations found in VHA Handbook on Banking
of Human Biological Specimens shall be followed. See below for more guidance.
appropriate, a statement regarding any payment the subject is to receive and
how payment will be made.
For a study that includes
tissue banking, the consent form must clearly address the following points:
types of samples that will be stored and the name and location of the facility
where they will be stored
the samples will be shared with other researchers for approved research
types of future research that the sample will be used for
length of time the specimen will be stored
of language that notes the specimen will be labeled with a code that does not
contain any personal identifiers (i.e., protected health information as defined
description of any clinical data that will be linked to the samples
and under what conditions research results will be conveyed to the subject, the
subject’s family, or the subject’s physician
steps necessary for the subject to withdraw from the study. The consent must
indicate what will occur to the data collected to that point, what will happen
to the samples already collected, and if applicable, that any links to clinical
data will be destroyed.
of any potential commercial benefits from use of the samples and if the subject
will receive money or other benefits
of any intent to perform genetic tests on the samples
of any potential risks to the subject or the subject’s family including any
related to genetic analysis, if applicable, such as breach of confidentiality,
which may lead to discrimination in the areas of employment, insurability,
social stigmatization, or psychological stress caused by disclosure of adverse
information to the subject or the subject’s family