Making and Keeping Consent Promises
Mary A. Banks BS, BSN
Director, BU IRB
Introduction
“The man who promises everything is sure to fulfill nothing, and everyone who promises too
much is in danger of using evil means in order to carry out his promises, and is already on the
road to perdition.” Carl Jung (1875-1961)
Frequently, when reviewing informed consent documents (ICFs), the IRB comes across language
that can be best characterized as “overly cheery” or “overly optimistic”. In an effort to allay the
fears of potential subjects, investigators may try to reassure subjects with statements that
represent unrealistic promises and misleading assurances. The purpose of this article is to explore
some potential pitfalls investigators fall into when making promises in consent documents, and
to offer some suggestions for improved language that will truly inform research subjects about
their research participation.
Confidentiality of Research Data
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“Your research data will be maintained with the strictest, utmost
confidentiality.”
“We will never, under any circumstances, release your personal
information to anyone outside the research study.”
“All of your records will be maintained in locked files in the
investigator’s office and only the principal investigator will have access to your data.”
Any of the above phrases can be found in proposed consent documents submitted to the IRB. As
a general rule, it is usually unwise to offer subjects absolutes. What does “absolute
confidentiality” really mean? When referring to study records, it is untruthful in most instances
to say or imply to subjects that absolutely no one but the PI will see their research data. In most
research studies, a number of persons--from study coordinators to administrative staff and
ancillary personnel--have access to subjects’ identifiable data. Even when appropriate
protections are put into place (such as using study ID numbers on all documents and using a
master code to link study data to individual subjects, and limiting access to identifiers), there are
still a number of people who will potentially have access to subjects’ private information, if only
for regulatory purposes (i.e., IRB Auditor, FDA, Internal Audit Department, etc.)
A more candid and informative approach would be to explain to subjects the protections that will
be put into place to protect their privacy and the confidentiality of their data, while at the same
time explaining that absolute confidentiality of their private information cannot be guaranteed.
FDA regulation 21 CFR 50.25 requires that subjects be informed that complete privacy does not
apply in the context of research involving FDA-regulated products. Under the authority of the
Food, Drug, and Cosmetic Act, the FDA may inspect and copy clinical records to verify
information submitted by the sponsor.
The following are examples of more informative consent language:
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“The research staff will take precautions to protect your privacy and the confidentiality of
your private information. We will assign a study code to your private information and use
that study code instead of your name or medical record number in our study records.”
“Absolute confidentiality of your private information cannot be guaranteed because of
the need to provide information to others such as the Institutional Review Board(s) and
the Food and Drug Administration (FDA).”
“Research information collected from you may be published or used in presentations, but
your identity will not be disclosed and you will not be associated with the information. “
Study Risks
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“There are no risks from being in this study”.
“This is an extremely safe study”.
Frequently, when investigators insert the above language into consent documents, what they
really mean is that there are no known physical risks (short of obtaining a paper cut from
completing a written survey) associated with the research. However, the regulations 45CFR
46.116 (a) (2) and 21 CFR 50.25 (a) (2) require that, in the consent, subjects be provided (2) a
description of any reasonably foreseeable risks or discomforts…” This means that subjects
should be informed about all reasonably foreseeable risks and discomforts, not just risks of
physical harm. This includes risks of breach of confidentiality, psychological harms from
embarrassment to legal risks, risks to employability or insurability, etc.
Again, rather than offering absolutes, here are examples of more informative language:
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“There are no known physical risks associated with this study. There may be unknown
risks, but if we identify any new risks we will notify you”.
“Along with the physical risks [described], there is a risk that you will become
embarrassed by the questions that you are asked. You may refuse to answer any question
that makes you feel uncomfortable.”
“There are no known physical risks related to this research. There is a risk that someone
outside the research could learn some private information about you. The study staff will
take precautions to protect your privacy and the confidentiality of your information.”
“This study involves collection of samples for genetic studies. There is a risk that you
could be identified at some point in the future by the genetic information contained in the
samples.”
Other Uses of Study Data
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“Your data will only be used by the investigators doing this study and
will never be given to anyone outside this research study”.
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“The researchers will not, under any circumstances, share your study information with
others.”
The above wording represents the kind of promises that researchers make to research subjects
that they later wish they had not made. Given the extraordinary amount of time, expense and
effort it takes to collect research data, investigators need to consider whether they wish to limit
the potential future uses of the data that they collect. Investigators must understand that if
subjects are absolutely promised at the time of consent that their data will only be used for one
specific research study then, in all likelihood, the IRB will not allow that data to be used for
additional research studies without requiring that subjects be re-consented. So, instead of placing
tight restrictions on the future use of data by making strict promises in the consent form,
investigators should consider whether future uses of research data and samples may be
warranted; and instead, offer subjects the opportunity to opt for future use of their data and
samples (i.e., for secondary analysis, for future studies on samples, etc.) as part of the consent
process.
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“The private information collected about you in this study will be put into a research
database. This information may be analyzed in the future by other investigators. The
other investigators will only be given your information identified by a study code. They
will not be given information that will identify you. “
Opt in language: “I agree to allow the information about me collected in this study be
used in other research studies about XXX [disease] as long as the information is coded
and my identifiable information is not given out to other researchers”.
Opt in language: “I agree to allow my blood and urine samples to be used for other
research studies related to alcohol and drug use or anxiety disorders”.
Opt in language: “I don’t agree at this time to have my samples used for future genetic
research, but I agree to be contacted about my participation in future genetic studies.”
Costs of Research Participation
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“There are no costs to you for participation in this research study. The
cost of the study drug is paid by the sponsor.”
“All costs associated with research participation are paid by the study.”
“All your medical bills will be paid while you are in the study”.
“You will not have to pay for the drugs in this study. Your insurance
will be billed.”
“We will pay all your travel expenses for your study visits.”
Again, making global promises can end up causing serious misunderstandings. The above
language could lead subjects to understand that they will be reimbursed for the cost of
babysitters, train or plane tickets, etc. The regulations 45 CFR 46.116 (b) (3) and 21 CFR 50.25
(b) (3) state that the ICF should state “any additional costs to the subject that may result from
participation in the research”. The most informative approach is to tell subjects specifically
what research related costs (if any) will be covered, and clearly explain what costs they may be
responsible for paying if they participate in the study. This is particularly important for clinical
trials that involve a standard of care component and a research component. If subjects (or their
insurance) will be billed for the standard of care and only the study drug will be paid for by the
study sponsor, then that must be very clear. Subjects need to be told that some insurance carriers
may not pay for the regular (standard of care) treatments that are part of a research project; and,
even if they do pay, subjects will still be responsible for any co-payments (which could be
considerable).
Some examples of more informative consent language would be:
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“You or your insurance company will be billed for the standard psychological or medical
care that is part of this research study. Your insurance company may not pay for this care
because you are in a research study. You may wish to consult with your insurance
company before agreeing to be in this study. Even if your insurance company agrees to
pay for the standard care, you may be responsible for insurance co-payments depending
on your insurance plan.”
“The study sponsor has agreed to pay for any research interventions. The sponsor will not
pay for standard care to treat your drug or alcohol addiction. You should ask the
investigators to explain which costs will be paid by the sponsor and which will not. You
or your insurance will be billed for the costs not paid by the sponsor. “
“If you enter this study, you will be asked to come to BU CARD every week for one
year. You will be reimbursed $25 per visit to cover your transportation, parking, and
meals. No other travel or food will be paid by the study.”
Summary
Investigators need to use caution when developing language for informed consent documents.
Overly optimistic language could result in false assurances and promises to research subjects.