Insight
by Ilene Albala, Margaret Doyle, and Paul S. Appelbaum
The Evolution of Consent Forms for Research:
A Quarter Century of Changes
T
he informed consent process in the research
context typically relies heavily on information
provided to potential research participants in
a written consent form. Federal regulations governing
research with humans list the elements of informa-
tion that consent forms must contain and indicate that
there may be additional elements relevant to particular
types of studies.1 Consent forms typically serve as the
participants’ only written explanation of the studies in
which they have enrolled and as important documen-
tation for researchers and regulators of individuals’
consent to participate in a study. Institutional review
boards (IRBs) often pay considerable—and some would
say excessive—attention to the content and wording of
these forms.2
Despite the critical role of consent forms in the
research context, there is good reason to believe that,
as currently formulated, they are often far from ideal.3
Among the problems that have been documented are
excessive length,4 complexity of wording that exceeds
average reading levels,5 and problems with the accura-
cy with which key aspects of the studies are described.6
Numerous proposals have been made for improving
consent forms,7 but there is little evidence that attempts
at improvement have had a positive effect. Indeed, we
have been unable to find sufficient data examining
trends in consent forms over time to determine whether
most of these concerns mentioned above have been
adequately resolved. To our knowledge, the only avail-
able longitudinal data focus on changes in the length of
forms, and the data suggest that things may be get-
ting worse instead of better. For instance, Baker and
Taub demonstrated that the mean length of consent
forms nearly doubled between 1975 and 1982.8 More
recently, Beardsley and colleagues in Australia found
Ilene Albala, Margaret Doyle, and Paul S. Appelbaum, “The Evolution of
Consent Forms for Research: A Quarter Century of Changes,” IRB: Ethics &
Human Research 32, no. 3 (2010): 7-11.
IRB: E t h i c s & H u m a n R e s e a rc h
that the median length of consent forms increased from
seven to 11 pages between 2000 and 2005.9 These
findings are of particular concern because of data sug-
gesting that greater consent form length is associated
with less understanding by potential participants of key
information related to the study in which they are being
recruited to participate.10
Given the importance for researchers, IRBs, and
policy-makers of understanding the extent to which the
documented problems with consent forms have been
ameliorated or exacerbated over time, the goal of this
study was to explore changes over a quarter century in
the accuracy and length of research consent forms used
by one department in a major academic center.
Study Methods
D ata spanning a 25-year period (1978–2002) were
obtained from a sample of protocols and consent
forms drawn from the files of the IRB serving a depart-
ment in a major academic medical center. The sampling
frame began with the earliest examples of consent
forms and continued for the 25-year period covered
by this study. Protocols were sampled in three-year
increments, with a systematic selection of every third
protocol in those years. Exclusion criteria were pro-
tocols submitted for periodic review after initial IRB
approval, protocols that did not include consent forms,
and protocols that never received final approval from
the IRB whose files we examined. Of the 240 consent
forms sampled, 215 met eligibility criteria (ranging
from 19 to 29 protocols in each of the years sampled)
and were included in this study.
From each consent form, we recorded the page
length of the consent form, year of IRB approval, and
risks to the participant. From the protocol associated
with each consent form, we recorded statements of the
specific risks and overall degree of risk for participants.
Descriptions of risks in consent forms and protocols
M ay -J u n e 2010
7
 Figure 1. The Evolution of Consent Forms: 1978–2002

Average Page Length of % of Risk

Consent Forms Discrepancies
Over Time (N=215) Over Time (N=215)
60
6

50
5
Percentage of Risk Discrepancies

40

Number of Pages
30

3
20

2
10

0 1
1977 1978 1981 1984 1987 1990 1993 1996 1999 2002

were coded in the following categories: no mention of
risk; no risk; social/legal/confidentiality risks; upset or
discomfort upon questioning; minimal discomfort (e.g.,
pain from drawing blood, discomfort from electro-
encephalogram [EEG]); moderate discomfort (e.g.,
moderate nausea or vomiting, headache, slight eleva-
tion in blood pressure, drowsiness); significant discom-
fort that could require medical attention (e.g., fracture
of bones, developing tardive dyskinesia); potentially
life-threatening condition (e.g., heart attack, stroke);
and safety profile unknown, but test drug or device
potentially harmful. When multiple categories of risk
were indicated in a consent form or protocol, only the
highest applicable level of risk, in the order indicated
above, was coded.
All data extraction and coding were performed by
the first author. Variables were entered into an Excel
database for analysis. Consistency of statements in
consent forms was determined by comparing the coding
for consent forms with the coding for the associated
protocols. Statistical analyses were performed using
SAS release 9 (SAS Institute Inc, Cary, NC), with P <
0.05 considered statistically significant.
Study Findings
O f the 215 protocols eligible for inclusion in this
study, 102 (47.4%) were for clinical trials, 76
(35.3%) for observational studies, 23 (10.7%) for
studies involving physical interventions, and 14 (6.5%)
for studies of psychosocial or behavioral interventions.
These protocols represented studies involving inpatients
exclusively (n = 37, 17.2%), outpatients exclusively
(n = 123, 57.2%), healthy volunteers (n = 30, 14.0%),
and both inpatients and outpatients (n = 25, 11.6%).
Thirty-five studies (16.3%) were conducted exclusively
in pediatric populations, eight studies (3.7%) involved
both minors and adults, and 172 studies (80.0%) in-
volved adults exclusively.

M ay -J u n e 2010 IRB: E t h i c s & H u m a n R e s e a rc h

8
 n Length of Consent Forms. The length of the
consent form increased roughly linearly by an average
of 1.5 pages per decade. In the 1970s, the average con-
sent form was less than one page long and often only
a paragraph or two, but by the mid-1990s the average
form had increased in length to over 4.5 pages (Figure
1). The mean and median page length of the consent
forms over the entire course of the study was 3.03 and
3.00, respectively. No year sampled had consent forms
with a mean length that was shorter than the forms
from three years earlier.
A multivariate logistic regression analysis was
performed, with length of forms dichotomized at two
pages or less and greater than two pages, including
those variables that had shown significant effects in
bivariate analyses: type of study, degree of risk, and
year. Significant effects were found for study year (odds
ratio = 1.56 [C.I. 1.38, 1.78] for each additional year
since the start of the window) and risk of the study
(odds ratio = 10.98 [C.I. 3.64, 33.11] for moderate- to
high-risk studies compared to no-risk and minimal-risk
studies); type of study was not a significant predictor
and was dropped from the model.
n Descriptions of Risks. Discrepancies between
the descriptions of the highest level of risks for par-
ticipants in the consent form as compared with the
protocol were found in 25.6% (n = 52) of studies. Fifty
percent (n = 26) of discrepancies involved studies with
minimal risks, while 50% (n = 26) related to studies
with moderate or greater risks. In 45 of 52 studies with
discrepancies, a higher level of risk was indicated in the
protocol than in the consent form.
At the start of the study in 1978, more than 54% of
protocols demonstrated discrepancies in the descrip-
tion of risks; a decided downward trend ended with
0% of protocols revealing such discrepancies in 1999
through 2002. Logistic regression revealed an odds
ratio of 0.84 (p < 0.0001) for the presence of a discrep-
ancy for each additional year beyond the beginning of
the sampling frame. Thus, the odds of discrepancies in
the description of risks in the consent forms decreased
by an average of approximately 16% per year (Fig-
ure 1). Similarly, a statistically significant association
existed between a length of less than two pages and risk
discrepancy, with 43.27% of forms two pages or less
having discrepancies as compared with 9.26% of forms
that were more than two pages (p < 0.001). None of
the independent variables—including study type, type
of patient, protocol risk, and year—were associated
IRB: E t h i c s & H u m a n R e s e a rc h
with discrepancies, hence a multivariate analysis was
not performed.
Of note, in studies from 1978, there was frequently
no mention at all of risks in either the consent form or
the protocol. However, 11 of the 23 studies sampled
were studies of medications, which invariably are as-
sociated with risks of adverse effects, and one proto-
col described the study as involving a “pain-inducing
procedure” but did not include this information in its
consent form. One example of a discrepancy in the
presentation of risks was seen in a 1978 drug study
involving inpatients. The protocol stated, “The one
potential risk is that [X drug] can be psychologically
habit-forming,” but the consent form did not identify
any risks. Another placebo-controlled medication study
in 1978 stated in the protocol that since the study
Our review of consent forms over time revealed
two trends: greater consistency in the description
of risks, and an increase in the length of consent
forms.
evaluates “various drug treatments” and since the
population is depressed, there is a risk “that depressed
patients will become more depressed and suicidal”
during the placebo period. However, the consent form
stated clearly, “there is no risk.”
Although the most striking examples of discrepan-
cies in the presentation of risks were seen in 1978, such
discrepancies continued to appear over the next two
decades. A medication study in 1981 stated in the pro-
tocol that there was a risk of a “hypertensive crisis or
lack of clinical improvement,” while the consent form,
which noted some potential side effects of the medica-
tion, said nothing about these risks. The protocol of an-
other 1981 medication study noted that “suicide is the
greatest risk,” yet the consent form was silent regard-
ing the risk of suicide. For a 1990 medication study,
the protocol included risk information that stated the
“most common side effect is dry mouth . . . rare side
effects include low platelet count [and] seizures,” while
the consent form stated, “there are no anticipated psy-
chological or physical risks.”
Another discrepancy in the characterization of risks
was seen in a 1993 drug study where the protocol listed
three risks: “first of suicide, second risk is that patients
will not improve (placebo), third is risk of side effects,
M ay -J u n e 2010
9
 including dry mouth, heart conduction problems.” The
consent form stated that the “risks to me are the side
effects (dry mouth, and heart conduction problems),
possibility that symptoms of depression could worsen,”
but not suicide. Another drug study in 1993 stated in
the protocol that “risks of drug include: tremor, nau-
sea, overdosing, risk of placebo, and development of
suicidal ideation,” while the consent form noted “side
effects include: nausea, tremor, headache,” but nothing
about the development of suicidal ideation.
Discussion
F ew previous studies have examined changes in the
nature of consent forms over time, and none over
a period of 25 years. Two trends were notable in our
study: greater consistency in the description of risks,
and an increase in the length of consent forms. The
odds of discrepancies between the descriptions of risks
in protocols and consent forms decreased by an average
of 16% per year and finally disappeared after 1996.
Consent forms grew in length by an average of 1.5
pages per decade.
The decrease in discrepancies and increase in page
length suggest a tendency over time toward a greater
focus by researchers and/or IRBs on the accuracy and
completeness of the information provided to prospec-
tive research participants. That is, in more recent years
information in the consent form has become more
detailed and precise. However, by providing more detail
and precision, consent forms became longer. The entire
informed consent document evolved from a paragraph
with information that frequently appeared to have
been inaccurate and/or missing, to multiple pages with
thorough descriptions of the risks and other details of
the study. These changes occurred slowly and steadily
over time, representing a gradual evolution of the
type and amount of information contained in consent
documents. The increase in page length suggests that
additional language was added to clarify risks, though
exactly where the additional wording was added was
not determined in this study. Although discrepancies in
the descriptions of risks between the consent form and
the protocol had ceased before the end of our study
window, page length continued to increase, suggesting
that greater attention to risks has not been the sole fac-
tor responsible for the increase in page length.
We can only speculate about the drivers of these
changes, but it is interesting to note that the relevant
research regulations in 1974 included the same basic
M ay -J u n e 2010
10
eight elements of informed consent that are in the cur-
rent version, including the requirement that potential
participants be provided with “a description of any rea-
sonably foreseeable risks or discomforts to the subject.”
Why, then, were there so many discrepancies in the
disclosure of risks in 1978 and 1981, and why did it
take so many years for the discrepancies to disappear?
The slow implementation of the regulations is consis-
tent with the initial low level of oversight of the decen-
tralized system for review of human subjects research
created by the regulations. Incentives for strict compli-
ance by institutions and investigators were minimal and
increased only as federal oversight became more exten-
sive and as regulatory staff and IRB members became
more experienced. Increased public attention to human
subjects research—including allegations of failure to
disclose risks in research11 and more frequent litigation
over alleged negligence in the conduct of research12—
are other possible explanations for increased accuracy
in consent forms, especially during the latter part of the
study window.
One of the limitations of this study is that the data
are drawn from a single IRB, yet the research enterprise
is characterized by variation across IRBs regarding
approaches to implementing the federal regulations.13
In addition, since the records of the IRB we examined
deal specifically with studies conducted by members
of a single department, they may not be character-
istic of other kinds of medical research. By focusing
on the highest level of risk disclosed, the data do not
allow us to comment on the extent of discrepancies in
other study risks, although it is our impression that
they diminished in a similar way over time. Moreover,
although the coding categories were straightforward,
coding was performed by a single rater without a test
of reliability. Finally, while this study illustrates the evo-
lution of the consent form itself, it cannot capture the
oral portion of the informed consent process. Hence,
we cannot comment on whether the total package of
information received by a potential research participant
was more or less accurate and comprehensive than is
suggested by these data.
Our findings highlight the inherent paradox in
attempting to use consent forms to convey ever-more-
complete information to potential research subjects.
Greater information is associated with increased length
of consent forms, and studies have shown an inverse
relationship between length and individuals’ compre-
hension of the information provided.14 For instance,
IRB: E t h i c s & H u m a n R e s e a rc h
Sharp has pointed to data suggesting that consent
forms longer than 1,000 words (four double-spaced
pages) are unlikely to be read, perhaps in part because
of the time involved.15 He recommends that length
be limited to no more than 1,250 words (five pages),
which would take an average high school graduate five
to seven minutes to read. In many cases for that to be
accomplished, other means would have to be used to
serve the informational and legal interests of potential
participants, investigators, and institutions. These may
include supplementary informational booklets that
potential participants can read at their leisure, video
or computer-based disclosures that would supplement
written documents, and disclosing in consent forms
only the most important information.
This study’s findings—particularly the increasing
length of consent forms—are problematic given other
data showing that the longer a form, the less likely
subjects are to read and understand it. Thus, continu-
ing to use current approaches—which have led to
steadily larger amounts of information being included
in consent forms—is unlikely to be effective in achiev-
ing informed decision-making by research subjects.
Innovative approaches are likely needed as we continue
to strive for genuinely informed consent.
Acknowledgments
We would like to thank Cathy Gere for her insightful
comments.
n Ilene Albala, AB, is a student at the University of Pennsylvania
School of Law, Philadelphia, PA; Margaret Doyle, MPH, is a statisti-
cian in the Department of Neurology, Columbia University, New
York, NY; and Paul S. Appelbaum, MD, is the Elizabeth K. Dol-
lard Professor of Psychiatry, Medicine and Law, and Director of the
Division of Law, Ethics, and Psychiatry, Department of Psychiatry,
Columbia University, New York, NY.
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