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 informed consent.
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 criteria.
- Informed 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.
- Only 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.
- All 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.
- The additional elements of informed consent (see below) should be included in all ICFs in studies where they are applicable.
- If tissue banking is involved, VA-specific language addressing tissue banking must be included in the ICF (see below).
- For VA ICFs, the signature page must include space for:
- The signature of the subject being consented, or the subject’s legally authorized representative if required, and the date signed
- The 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
- The signature of the subject’s representative if required by the IRB due to competency issues
- The 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”)
- A space for the subjects “last four” (final four digits of Social Security number) unless this requirement is waived by the VA R&D Committee.
Basic Elements for Informed Consent under the VA Regulations
- Name of study
- The name of the Principal Investigator (or the designated VA Responsible Investigator, if different from PI)
- 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 as to which of these are being done for research purposes.
- Identification of all procedures that are experimental and of those that are considered standard of care
- A description of any reasonably foreseeable risks or discomforts to the subject including, for example, privacy risks (legal, academic, employment and/or social)
- A description of any benefits to the subject or to others that may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject.
- A 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].
- For 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.”
- The following information must be included:
- Who to contact for answers to questions about the research
- Who 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]
- Who to contact at the for inquiries regarding research subjects' rights (VA Patient Representative; 280-7182)
- Who to contact to confirm the research study is a valid VA study (VA Research Office; 280-7007)
- A 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.
Additional Elements of Informed Consent
One or more of the following elements shall also be provided to each subject when appropriate to a specific study:
- 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 becomes pregnant.
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without 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 and procedures for orderly termination of participation by the subject.
- A 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.
- The approximate number of subjects involved in the study.
- If 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.
- As 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:
- The types of samples that will be stored and the name and location of the facility where they will be stored
- Whether the samples will be shared with other researchers for approved research protocols
- The types of future research that the sample will be used for
- The length of time the specimen will be stored
- Inclusion 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 by HIPAA)
- A description of any clinical data that will be linked to the samples
- When and under what conditions research results will be conveyed to the subject, the subject’s family, or the subject’s physician
- The 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.
- Disclosure of any potential commercial benefits from use of the samples and if the subject will receive money or other benefits
- Disclosure of any intent to perform genetic tests on the samples
- Disclosure 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