TELEPHONE SCRIPT TO SCREEN POTENTIAL SUBJECTS WHEN IDENTIFIABLE
PRIVATE INFORMATION, INCLUDING PROTECTED HEALTH INFORMATION, WILL
BE RECORDED OR WRITTEN
Protocol Title: EXAMPLE 1
Principal Investigator:
(Note that the Investigator must request a Waiver of Documentation of Informed Consent and a
Partial Waiver of HIPAA Authorization to ask subjects to perform any research activity—
including providing identifiable information over the phone—prior to providing written informed
consent and authorization.)
(Before submitting to the IRB, the study-specific details must be completed within this
document. Please delete this red instruction text)
1. <Explain who is calling and explain that you are calling about a research study.>
Note: If the prospective subject has a treatment relationship with a member of the research
team, you must state the name of the treatment provider and explain that you are calling on
his or her behalf.
2. <Provide a brief description of the proposed study, including the name of the PI, purpose of
the research, procedures for subjects, risks, and benefits.>
Based on what I’ve told you so far, do you think you would be interested in being in this study?
3. <Provide basic elements of consent and authorization before asking the screening
questions, because verbal consent is being obtained by telephone. This section can be
worded something like the following:>
[ADULTS]
Thanks for your interest. I would now like to ask you some questions that would help us
determine if you qualify to be in this research study. This will take about ___ minutes. These
questions will involve your giving information about your medical history. These questions are
not intended to diagnose or benefit your current health.
Answering these questions is voluntary. You are under no obligation to answer them, and not
answering them will have no effect on your health care at National Jewish Health. Not
answering the questions, however, means that you will not be eligible to participate in this
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research study. If at any time during this prescreening you would like to stop and not participate
or if you have any questions, just let me know.
Here is some information about the confidentiality of the information I collect today. If you do not
qualify for the study or decide not to participate, we will not keep the information we collect
today. If you do qualify for the study and decide to participate, we will ask you to sign a consent
form at your first appointment. The personal information you give me today will become part of
your research record and will be reviewed by Dr. ______ and the research staff. Your name will
not appear on this screening information. We will assign a code number and the key to the code
will be kept in a locked file separate from the other information I collect today. If you change
your mind at any time and decide that you do not want to participate, you can call us and we will
immediately destroy the private information that we collect today. As with any research study,
there is a remote risk that your information could be lost or seen by someone not authorized to
see it.
Would you like to continue now with the screening questions?
[INTERVIEWING PARENTS/GUARDIANS ON BEHALF OF MINORS]
I would like to ask you some questions that would help us determine if your child qualifies to be
in this research study. This will take about ___ minutes. These questions will involve your giving
information about your child’s medical history. Answering these questions is voluntary. You are
under no obligation to answer them, and not answering them will have no effect on your or your
child’s health care at National Jewish Health. Not answering the questions, however, means
that your child will not be eligible to participate in this research study. If at any time during this
prescreening you would like to stop and not participate or if you have any questions, just let me
know.
Here is some information about the confidentiality of the information I collect today. If your child
does not qualify for the study or you decide for him/her not to participate, we will not keep the
information we collect today. If your child does qualify for the study and you decide for him/her
to participate, we will ask you to sign a consent form at his/her first appointment. The personal
information you give me today will become part of your child’s research record and will be
reviewed by Dr. ______ and the research staff. Your child’s name will not appear on this
screening information. We will assign a code number and the key to the code will be kept in a
locked file separate from the other information I collect today. If you change your mind at any
time and decide that you do not want your child to participate, you can call us and we will
immediately destroy the private information that we collect today.
Would you like to continue now with the screening questions?
4. <List the screening questions or provide a separate document with the screening
questions.>
5. <Provide any instructions that the subject may need to follow prior to the first visit. This may
involve bringing in medical records, fasting, temporarily withholding medication, etc.>
[NOTE: The IRB can only approve these activities if the IRB finds that these activities
would involve only minimal risk to subjects.]
<State that subjects should reschedule their appointments if they need to take their
medications, are unable to maintain the fast, etc.>
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6. If you have questions or need to reschedule your appointment, you can reach me at <xxxxxx-xxxx>. If you have questions about your rights as a research participant, you can call
303-398-1477.
7. <Offer closing remarks regarding whether or not the potential subject is eligible for the study,
and further instructions.>
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