An informed consent training program was developed at the National Institute of Mental Health (NIMH) Intramural Research Program to improve the informed consent process. The training program consisted of a 24-minute video demonstrating effective communication techniques during an informed consent discussion, and a didactic presentation covering regulatory requirements. Thirty-four physicians and eighty nurses participated in the training and completed pre- and post-tests to assess knowledge gained. Both groups showed a statistically significant increase in scores from the pre-test to the post-test, indicating the training improved understanding of informed consent requirements and communication skills. The training emphasized conveying information through clear language, building rapport, allowing time for questions, and ensuring a private environment for the discussion.

1. Journal of Empirical Research on
Human Research Ethics
2014, Vol. 9(4) 71­–75
© The Author(s) 2014
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DOI: 10.1177/1556264614546096
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Informed Consent
To improve the informed consent process at the National
Institute of Mental Health (NIMH) Intramural Research
Program, an informed consent training program was devel-
oped. For over a decade, clinical research advocates
(CRAs), of the Human Subjects Protection Unit (HSPU)
have monitored the informed consent process for subjects
enrolling in more than 50 mental health research protocols
conducted at the National Institutes of Health (NIH) Clinical
Center. The CRAs have observed wide variability in the
communication styles used during discussions held between
investigators and subjects. This prompted the creation of
the pilot training program on the informed consent process
described in this article.
A review of the informed consent literature suggests that
there have been tools developed to teach communication
skills in obtaining informed consent for research, but they
have limitations. For example, one study reviewed subject
understanding of the components of the study in which they
participated, but did not address investigator style or com-
munication skills in presenting that material during the
informed consent discussion (Joffe, Cook, Cleary, & Weeks,
2001). Another study noted that “the research team mem-
bers’individual personal approach to obtaining consent was
important to a successful interaction” (Kost, Lee, Yesis,
Coller, & Henderson, 2011, p. 408). Participants (research
subjects) noted “a surprising area of poor communication”
(Kost et al., 2011, p. 411). Consequently, the authors con-
cluded that there is “compelling evidence for the need for
continuous performance improvement activities in clinical
research” (Kost et al., 2011, p. 411). These studies were not
limited to mental health or vulnerable populations.
Other articles describe programs that provide informed
consent training (Brown, Butow, Boyle, & Tattersall, 2007;
Hietanen et al., 2007; Jenkins, Fallowfield, Solis-Trapala,
Langridge, & Farewell, 2005; Yap et al., 2009). In one
paper, authors noted that “although several participants had
undergone some communication skills training, none had
received specific training on how to talk about trials”
(Jenkins et al., 2005, p. 5). These studies support the need,
as did our own experience as independent monitors, to
focus on specific training on the communication styles of
investigators conducting an informed consent discussion.
An example of training materials that specifically
instruct clinical research investigators on how to conduct an
effective informed consent discussion with subjects is a
546096JREXXX10.1177/1556264614546096Journal of Empirical Research on Human Research EthicsCadman et al.
research-article2014
1
National Institutes of Health, Bethesda, MD, USA
Corresponding Author:
Mary Ellen Cadman, Human Subjects Protection Unit, Office of the
Clinical Director, National Institute of Mental Health, 9000 Rockville
Pike, Building 10, Room 3 N218, Bethesda, MD 20892, USA.
Email: marycadman@mail.nih.gov
A Training Program for Improving the
Informed Consent Discussion Between
Clinical Researchers and Their Subjects
Mary Ellen Cadman1
, Jean H. Murphy1
, Julie Brintnall-Karabelas1
,
Carol Squires1
, Katherine Whorton1
, and Maryland Pao1
Abstract
Although there are many training programs on informed consent, they seldom model the contextual factors that support
the vital elements of communication, including presentation style, body language, providing a comfortable environment,
utilizing clear language, and establishing overall rapport with the subject. A team of clinicians at the National Institute of
Mental Health (NIMH) created a pilot program that consists of a video (http://www.youtube.com/watch?v=l26hdCD9g2I)
and didactic presentation to train investigators to conduct informed consent discussions. Thirty-four physicians and eighty
nurses were tested on the training content including these contextual factors. Both groups showed an increase in content
knowledge after the training. An informed consent training program such as this is feasible and may improve both the
knowledge and communication skills necessary for this important process.
Keywords
informed consent training, communication skills, clinical research, video
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2. 72 Journal of Empirical Research on Human Research Ethics 9(4)
video titled, “General Informed Consent Requirements”
(U.S. Government Health & Human Services, 2014).
Although this video demonstrates an informed consent dis-
cussion between an investigator and a subject, it focuses
primarily on Federal policy requirements and does not pro-
vide material on the additional contextual factors and com-
munication skills involved in an informed consent
discussion, nor does it provide a method to measure changes
in viewer knowledge. Temple University also developed a
helpful and comprehensive toolkit to improve the informed
consent process, “A Practical Guide to Informed Consent,”
(http://templehealth.org/ICTOOLKIT/html/ictoolkitpage1
.html, retrieved June 6, 2014). The authors mention that “all
too often, this process is a mere formality with the consent
sheet thrust in front of the patient for signature with mini-
mum explanation. Even in institutions with more regard for
the process, there is ample room for improvement.”
In 2007, the Joint Commission publicized “Informed
Consent; What Did the Doctor Say?” and highlighted “the
need for improved informed consent.” In addition, the Joint
Commission’s sentinel event database cites that “65% of
the identified adverse events have been found to have com-
munication failures as the underlying root cause” (The Joint
Commission, 2007). Consequently, the Joint Commission
has been closely monitoring the informed consent process
in health care in clinical and research settings and continues
to promote improvement in this essential area.
We describe a pilot educational training program devel-
oped at the NIMH that may enhance the manner in which
investigators conduct an informed consent discussion with
prospective research subjects. In addition to a video, the
program includes a didactic session and a pre- and post-test.
Preliminary data on the pre- and post-test evaluation mea-
suring change in knowledge among research nurses and
physicians are presented.
Method
The training consists of a video, “The Elements of a
Successful Informed Consent,” and a didactic presentation
focusing on regulatory requirements. In addition, the video
highlights communication skills and contextual elements,
including communication style, body language, and environ-
ment. In the video, actors portraying a narrator, an investiga-
tor, and a research subject demonstrate salient features of an
effective informed consent. Although the subject and investi-
gator are involved in a mental health study, the contents of
the video are applicable to any informed consent discussion.
The 24-min video begins with a narrator who introduces
the video by stating that “everyone has his or her own style
of discussing a research study and consenting subjects.” She
gives recommendations that will facilitate a smooth and
thorough consent process, including suggestions pertaining
to presentation style, body language, and environment. The
video then presents an investigator conducting an informed
consent discussion with a research subject. This subject has
a diagnosis of depression, but does not have impaired judg-
ment or lack capacity to understand the research being pre-
sented. The video highlights the importance of building
rapport with the client through both effective verbal and
non-verbal communication styles and through the utilization
of plain language to describe complex scientific terminol-
ogy. The investigator demonstrates the need to conduct the
informed consent discussion in a private space. He allows
time for the subject’s questions and gives responses which
facilitate the building of investigator/subject rapport and
trust in this important partnership. Following that discus-
sion, the narrator emphasizes the importance of body lan-
guage, tone of voice, and eye contact in achieving an
effective style of communication. During the video, the ele-
ments of informed consent as required by 45 Code of Federal
Regulations (CFR) 46.116 (U.S. Government Health and
Human Services, 2010) are highlighted. See Table 1, 45
CFR 46, subpart A required elements.
A didactic slide presentation, including both Federal and
NIH policies and practices, is targeted to the needs of the
specific audience in attendance. This presentation is updated
on a regular basis with relevant current events such as the
recent controversy surrounding the study to understand
prognoses and preferences for outcomes and risks of treat-
ments (SUPPORT; Hudson, Guttmacher, & Collins, 2013).
Open discussion of the material presented is encouraged.
This informed consent training can be tailored to emphasize
specific roles and responsibilities of nurses, physicians, or
others engaged in clinical research. Thirty-four physicians
and 80 nurses completed this training over the course of a
year.
A 20-item test was administered prior (pre-test) to and
following (post-test) the training, and was utilized to evalu-
ate improvement in a trainee’s knowledge of Federal policy
requirements of informed consent. Knowledge of the ele-
ments of communication style is also addressed in several
questions on the test (4, 9, 12, 17, and 18). See Table 2,
Pre- and Post-Test for Informed Consent Training.
Results
The pre- and post-tests were administered to both the nurse
and physician groups and a t test for significance within
each group was performed. Thirty-four physicians partici-
pated. The difference between the mean pre-test score of
79.6 (approximately 16 out of 20 correct answers) and the
mean post-test score of 92.2 (approximately 18 out of 20
correct answers) was significant for the physician group:
n = 34, t(33) = −4.21, p < .001. Eighty registered nurses
participated. The difference between the mean pre-test
score of 87.5 (approximately 17-18 of 20 correct answers)
and the mean post-test score of 94.6 (approximately 19 of
20 correct answers) was significant for the nurse group: n =
80, t(79) = −6.72, p < .001.
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3. Cadman et al. 73
Discussion
The NIMH informed consent training program was devel-
oped to address the educational needs of clinical research
investigators involved in obtaining informed consent at the
NIH. After observing tremendous variation in the style and
content of the informed consent discussion performed by
researchers, the NIMH Human Subjects Protection Unit
created a training program that demonstrated both the
Federal regulatory required elements of informed consent
as well as many of the communication skills needed in an
informed consent discussion. The physician group con-
sisted primarily of clinical research fellows who were new
to the NIH and were at various stages in their post-graduate
medical education. Most had not been involved in obtaining
informed consent for research prior to participating in the
program. The nurses who completed the training were pri-
marily in clinical research nurse positions and had spent
more time in a research setting. Therefore, their higher pre-
test scores may have reflected an increased familiarity with
informed consent in a research setting. Information was not
collected from trainees as to whether they had previously
observed an informed consent discussion conducted by an
experienced investigator. The improvement in post-test
scores in both groups indicates increased knowledge of the
required elements of informed consent, including the
communication and contextual factors involved in conduct-
ing an informed consent discussion.
Our findings support that a brief training program focus-
ing on communication processes in addition to the regula-
tory requirements of the informed consent process can be
systematically presented to new investigators as well as
clinical research nurses and may have a positive impact on
consent discussions.
Limitations
This program was conducted at the NIH and may not gener-
alize to other research settings. Research participants’ satis-
faction was not measured. The program did not assess the
performance of a researcher engaged in an actual informed
consent discussion with a subject enrolling in clinical
research.
Best Practices
The informed consent training described in this article
emphasizes not only the content of the consent discussion
but also the verbal and non-verbal components of this
important process. Those who are performing clinical
research and interested in providing training for their inves-
tigators and staff can view this video, “The Elements of a
Table 1. Comparison of 45 CFR 46 Required Elements and Elements Contained in Video.
45 CFR 46, subpart A required elements Elements contained in video
1. 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 of any
procedures which are experimental
1. Introduction and study purpose
Qualifications to participate
Design and duration
Study procedures
2. A description of any reasonably foreseeable risks or discomforts to the subject 2. Risks/discomforts
3. A description of any benefits to the subject or to others which may reasonably
be expected from the research
3. Benefits (if applicable)
4. A disclosure of appropriate alternative procedures or courses of treatment,
if any, that might be advantageous to the subject
4. Alternative Treatments—such as standard
clinical care in a community facility
5. A statement describing the extent, if any, to which confidentiality of records
identifying the subject will be maintained
5. Confidentiality
6. For research involving more than minimal risk, an explanation as to whether
any compensation 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
6. Policy regarding research-related injuries
Compensation
7. An explanation of whom to contact for answers to pertinent questions about
the research and research subjects’ rights, and whom to contact in the event
of a research-related injury to the subject
7. Problems or questions
Contact information for principle investigator
and hospital patient representative
8. A statement that participation is voluntary, refusal to participate will involve
no penalty or loss of benefits to which the subject is otherwise entitled, and
the subject may discontinue participation at any time without penalty or loss
of benefits to which the subject is otherwise entitled.
8. Voluntary nature of research participation
Right of withdrawal
Disclosure of new findings to subject
Note. CFR = Code of Federal Regulations.
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4. 74 Journal of Empirical Research on Human Research Ethics 9(4)
Successful Consent,” at http://www.youtube.com/watch?v
=l26hdCD9g2I (NIMH, 2013). This material is relevant to
research activities involving human subjects undertaken in
diverse settings throughout the world. The training under-
scores the universal importance of the communication pro-
cesses that must be present between investigator and the
prospective subject for effective informed consent to occur.
Research Agenda
Utilization of this training program in a variety of settings
would provide those who obtain informed consent with a
guideline of the elements that are necessary to include
within that discussion. In addition, it affords the trainee the
opportunity to observe an informed consent discussion in
which the important components of effective communica-
tion are modeled. Similar informed consent training pro-
grams could focus on the trainee’s ability to utilize good
communication practices and a performance assessment
tool could be used to evaluate an actual informed consent
discussion. Modifications to the training can be made as
necessary to reflect and respect specific cultural beliefs,
customs, values, and/or follow the appropriate international
guidelines.
Table 2. Pre- and Post-Test for Informed Consent Training.
True or false
1. The only elements of informed consent that need to be discussed by the investigator and the research subject are as follows: study
purpose, risks, procedures, confidentiality, compensation, and alternatives to research. T/F
2. During the informed consent discussion, the investigator should utilize a copy of the consent document obtained from his or her
own research file, to ensure it is both current and accurate. T/F
3. It may be difficult for the potential subject to understand the purpose of the study, so under special circumstances, the investigator
may choose to omit this from the discussion but must always include a discussion of the other elements. T/F
4. It is best to present consent document information in your own style versus that of other investigators. T/F
5. Most research subjects are unaware that the main purpose of a clinical trial is primarily to advance scientific knowledge, not to
benefit them, so it is important to discuss this further at the time of the consent. T/F
6. The role of a clinical research advocate is to provide an additional layer of protection for subjects participating in some studies
that are greater than minimal risk or involve a vulnerable population. T/F
7. Once the subject signs the informed consent form, he or she may withdraw from the research study only after a review of his or
her request is conducted by the Institutional Review Board. T/F
8. It is required for the investigator to discuss his or her collaboration with pharmaceutical companies with the subject during the
informed consent discussion. T/F
9. To facilitate an efficient and streamlined approach for both the research team and the subject, it is preferable to obtain consent for
multiple studies in one discussion session. T/F
10. Although the inclusion criteria for a subject to participate in a specific research study may be similar from one study to another at
NIH, it is still important for the investigator to spend time discussing them with the subject. T/F
11. If an individual has been pre-screened via telephone interview by a member of the research staff, it is unnecessary to review the
eligibility criteria for the study during the informed consent discussion. T/F
12. When obtaining consent, the very best method to employ is reading the written consent out loud to the subject. T/F
13. The signatures on the consent form represent an acknowledgment on the part of all parties involved that this document is a legal
and binding contract between the investigator and subject. T/F
14. Even though reviewing the risks associated with a study may be anxiety provoking for a prospective subject, this discussion must
occur before the subject signs the consent. T/F
15. The investigator should not convey to the subject that there may be alternative medical care for their condition already available in
the community as this will only confuse the issue and may unnecessarily hinder recruitment efforts. T/F
16. Due to the fact that NIH is a teaching/research facility, all research staff in the team should be present for the informed consent
discussion. T/F
17. Examples of unsuitable environments where informed consent should not be obtained are: the admissions waiting room, the clinic
lobby, or the unit lounge area. T/F
18. Most conversations pertaining to the contents of the consent document can be brief, with the subjects encouraged to hold their
questions until the entire presentation is finished. T/F
19. At the time of the informed consent discussion, it is not necessary for the investigator to provide the research subject with
information regarding how to reach him or his staff. T/F
20. A way to enhance the informed consent process is for investigators to mail out consent documents prior to a subject’s arrival at
NIH. T/F
Note. NIH = National Institutes of Health.
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5. Cadman et al. 75
Educational Implications
The informed consent video and pre- and post-tests may be
of particular use to educators attempting to impart to their
staff both the communication process and regulatory content
of effective informed consent discussions. Preliminary results
from our pre- and post-tests indicate that the level of knowl-
edge of training participants increases with the program.
Acknowledgments
Additional appreciation for editorial assistance is given to Jeanne
Radcliffe, RN, MSN. The script for the video was reviewed by
Barbara Karp, MD, Chair of National Institutes of Health
Combined Neuroscience Institutional Review Board; Donald
Rosenstein MD, former National Institute of Mental Health
(NIMH) Clinical Director; Peter Schmidt, MD, Chief of the NIMH
Behavioral Endocrinology Section; and Carlos Zarate, MD, Chief
of the NIMH Experimental Therapeutics and Pathophysiology
Branch. Lisa Horowitz, PhD, and Ian Stanley, NIMH, provided
statistical assistance. Diana Nora, NIMH, greatly assisted with
document formatting. To Michelle Feige, MSW, Licensed
Certified Social Worker-Clinical, currently with Office for Human
Research Protections, a special thanks for participating in early
stages of writing the video script.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support
for the research, authorship, and/or publication of this article: This
study was conducted with the support of the Office of the Clinical
Director, National Institute of Mental Health (NIMH).
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Author Biographies
Mary Ellen Cadman is a Clinical Research Advocate (CRA)
with the Human Subjects Protection Unit at National Institute of
Mental Health (NIMH) and a co-creator of the script utilized in the
Informed Consent video and of the pre- and post-test question-
naire. She helped develop the didactic portions of the training,
conducted many of the presentations, and administered the tests.
Jean H. Murphy was the Associate Clinical Director of NIMH
from 1989 to 2009. She was a co-creator of the script utilized in
the Informed Consent video and of the pre- and post-test question-
naire. She helped develop the didactic portions of the training,
conducted some of the presentations, and administered the tests.
Julie Brintnall-Karabelas is a CRA with the Human Subjects
Protection Unit at NIMH. She helped develop the didactic portions
of the training, conducted many of the presentations, and adminis-
tered the tests.
Carol Squires is a CRA with the Human Subjects Protection Unit
at NIMH. She helped develop the didactic portions of the train-
ings, conducted many of the presentations, and administered the
tests.
Katherine Whorton is a CRA with the Human Subjects Protection
Unit at NIMH. She helped develop the didactic portions of the
trainings, conducted many of the presentations, and administered
the tests.
Maryland Pao is Clinical Director and Deputy Scientific Director,
Intramural Research Program, NIMH, National Institutes of
Health (NIH). She oversees the conduct and practices of the
Human Subjects Protections Unit and provided the support for this
research. She reviewed the script for the video and participated in
the writing of this manuscript.
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