Template Worksheet Examples
How long does the potential study participant have to review the consent document before a response is required,
including time to take the consent document home?
The potential participant is given time to think about the study and encouraged to have discussions with family, friends and
personal physicians. At the next visit (usually within 24-48 hours of the initial visit) the potential participant gives his/her
answer and, if he/she wants to participate, the protocol is again explained. The individual is told that their involvement is not
expected/ demanded/ required/ or even anticipated and the decision not to participate will not affect their clinical care. The
subject and the appropriate individuals (witnesses, physicians) sign the consent form.
Who is available to answer questions?
The Principal Investigator, other sub-investigators and study staff will be available to answer questions. The individual will be
told that their involvement is not expected/demanded/ or even anticipated in regards to their standard treatment. The study
staff member, nurse or CRA, will also discuss the study with the participant who will encourage the participant to ask
questions.
How is the potential study participant's understanding of consent assessed?
The subject will be asked questions (mostly open ended but also multiple choice or true/false) by a research team member
or the study doctor about the research study and about how he/she feels, paying close attention on how the individual
responds and appears to understand the information provided. In particular the patient will be asked questions to find out if
they understand that the research study is completely voluntary.
How is the informed consent process conducted with non-English speaking potential study participants?
The level of English comprehension will be determined during an appointment with the study doctor or a member of the
research team. The subject will be asked questions by a research team member or the study doctor about the individual’s
cancer background, treatments, and about how he/she feels, paying close attention on how the individual responds and
appears to understand the information provided. The subject will be asked which language(s) s/he understands and reads
and which language s/he prefers to read. A number of research staff members speak Spanish and consent documents are
routinely translated into Spanish shortly after the English version is finalized. For other languages, translators fluent in the
subject’s preferred language would have to be identified and a translation of the consent would have to be prepared. An
appointment would be scheduled when the translated consent document, the subject and the translator are all available. A
research staff member or designee who is fluent in the subject’s preferred language is present throughout the consent
process; this includes being available to handle any discussion and questions.
If translations are routinely provided, what process is currently used to translate the informed consent document?
Translations must be done by well qualified persons. Due to a large Hispanic population in the area we routinely have the
consent form translated into Spanish. Whether Spanish or another language, a person fluent in the language including
medical terminology, should translate the IRB approved version of the English informed consent document. This may be an
individual or a commercial translating service/agency (an agency may provide a “certified” translation). If an individual
(versus an agency) provides the translation, then a second qualified person must verify the accuracy and completeness of
the translation. This verification might be completed by back translation or by comparing the English version with the
translated version, sentence by sentence. When using a translating service/agency, the PI should obtain a written statement
that describes the method used by the agency to verify the accuracy and completeness of the translation prior to certifying
it. An institutional translation certification form (Form H-1) will be maintained for documentation that verification has
occurred.
The PI is ultimately responsible for the translations. By signing the form, the PI certifies that: (1) to the best of his/her
knowledge, the translation of the document accurately and completely matches the IRB approved English version and is
ready to be used with prospective research subjects, (2) the PI has information about the credentials of the agency or
individuals who provided the translation and verification, which enabled the PI to conclude they were qualified and the
translation is trustworthy and (3) that specific information can be made available to the IRB upon request.
This process is followed, not only for each newly translated consent document, but also for documents that are amended
during the conduct of the study.
Describe your institution's policy regarding assent by children or impaired adults.
Children
(1) In general, determining whether the assent of children is required for all, some or none of the children in a study, is
guided by the following age ranges:
(a) Ages 0-6 – The capability of children of this age group is so limited that they cannot reasonably be consulted.
Assent is not required.
(b) Ages 7-12 – Children of this age group may be capable of providing assent depending on the maturity and
psychological state of the children involved in the research. Assent may be required.
(c) Ages 13 – 17 – Children of this age group are expected to be capable of providing assent. Assent is usually required
unless waived by the IRB.
(2) If assent is determined appropriate, the child should be given an explanation, at a level appropriate to the child's age,
maturity and condition, of the procedures to be used, their meaning to the child in terms of discomfort and
inconvenience, and the general purpose of the research.
(3) If assent is determined appropriate, documentation of assent is required. Generally, assent of the child is
documented by having the child sign the consent form in the designated signature section. If the investigator prefers to
use a separate assent document using more basic concepts and terms, they must submit that document for IRB
approval.
Adults
Regarding the involvement of adults who are unable to provide consent (e.g., incompetent, has impaired decision
making capacity, etc.), in addition to the consent of a legally authorized representative the feelings and expressed
wishes of the participant should still be respected. Investigators should both inform the subject and solicit his/her assent
to take part in the study.
(1) Assent is required involving decisionally impaired adults, and/or incompetent adults based on their condition. The
research procedures to be used and the general purpose of the research will be explained.
(2) If assent is determined appropriate in decisionally impaired adults, and/or incompetent adults, the individual should
be given an explanation, at a level appropriate to the individual's condition, of the procedures to be used, their meaning
in terms of discomfort and inconvenience, and the general purpose of the research.
(3) If assent is determined appropriate in decisionally impaired adults, and/or incompetent adults, documentation of
assent is required. Generally, assent is documented by having the individual sign the consent form in the designated
signature section.
Describe your institution’s process to receive and address concerns from study participants and others about the
conduct of the research.
The consent form must provide the names of individuals who are qualified and available to answer questions regarding side
effects or medical complications; the document must provide the information about how to contact these individuals both
during business hours and after-hours. The after-hours number could be a home phone, a pager number or an answering
service. [The answering service, however, must contact the investigator in a timely manner and the investigator must return
the subject's call as soon as possible.]
At your institution, describe who may serve as an LAR.
UTHSCSA_LARS
policy.docx
Provide a description of how you assess a potential study participant's ability to provide consent.
The investigator will meet with the participant to determine if the participant has the ability to communicate a yes or no
decision; the ability to understand relevant information; the ability to relate to and understand the situation and its likely
consequences; and if the decisions appear to be consistent with the religious, moral, and other beliefs of the person. The
investigator may use instruments such as the MMSE, the CLOX, Controlled Oral Word Association test or Trail Making test to
assist with the assessment.
Before asking subjects to sign the consent, the investigator will ask the participants to give some basic information such as
what they understand about the study's purpose, the length of involvement in the study and the number of visits, and other
study details.