Description of Informed Consent Forms
General
Requirements
The consent form gives potential research subjects sufficient
written information to decide whether to participate in a
research study. Legal informed consent requires that potential
human subjects be given a full and fair explanation of the
proposed research in order to understand the nature of their
participation. The consent form documents and protects all
parties: the subject, the investigator, and the institution.
Therefore, it is important that consent forms present information
in an organized and easily understood format. Research has
concluded that consent forms written at approximately a sixth
grade reading level facilitate comprehension by research
subjects. We strongly suggest that investigators use the sample
consent form or assent form when planning to conduct human
subjects research. (Please see Chapter 12, "Form HS-2 or Form HS-3")
The form should be easily identified in bold text as
"Consent to Participate in Research" at the top of the
first page. Specific identifying information may also be included
such as "Consent Form for Children" or "Consent
Form for Controls" to ensure that the proper form is used to
enroll potential subjects before initiating the research
activity.
The title of the research should be descriptive and not
unnecessarily scientific. The title submitted on a grant is often
too technical and thus uninformative, therefore it is suggested
that investigators create a lay title. Section headings should be
used to clearly identify the required elements of informed
consent.
The initial text of the consent form should include a
statement identifying the names and degrees of all investigators,
their department affiliation, and the basis for the selection of
subjects. Inclusion criteria (e.g., a specific disease,
condition, characteristic, background) should be explained as
well as exclusion criteria (e.g., pregnancy, age
limitations, health restrictions).
For example, a study regarding drug use may read: "You
are asked to participate in a research study of drug use in Los
Angeles because you are over eighteen years of age and are
currently attending a drug rehabilitation program sponsored by
the City of Los Angeles."
A study into a new AIDS therapy may read: "You are
asked to participate in a research study testing the safety and
effectiveness of a new AIDS drug because you are over eighteen
years of age, have symptoms of AIDS, and are currently receiving
no therapy for this disease."
The first paragraph of a consent form should clearly state
that the investigator is presenting research and that as a
result, the subject’s "participation in this
research is entirely voluntary" [45 CFR
46.116(a)(1)] and the subject is free to
discontinue or withdraw at any time.
Purpose of
the Study
This section should provide a clear and accurate statement of
the scientific purpose, the objectives of the research, the
reasons why the study is being conducted, and a description of
the background supporting the activity [45 CFR
46.116(a)(1)]. For instance, a "Purpose of the
Study" section may read as follows for research with service
programs for the homeless and the effectiveness of the services
for the homeless community:
Many service programs are offered to homeless
individuals who live without adequate food and shelter.
However, many of these programs are not fully used by the
homeless community. This research has been designed to
determine whether homeless individuals actually require the
services of these support programs and whether the programs
are effectively informing the homeless community of available
services.
Pilot
Studies or Phase I Drug Studies:
Subjects making an informed decision regarding their
willingness to undertake the risks of a project is a principal
element of the informed consent process. The consent form should,
therefore, indicate that the study is a "pilot" study
or "Phase I" study and that the subject is one of the
first to participate in the process, treatment, or intervention.
Procedures
This section should clearly identify the procedures that will
be followed during the course of the research activity. The
procedures should be presented to subject in the order of their
occurrence and should detail the approximate duration for each
activity the subject is expected to complete [45 CFR
46.116(a)(1)]. The following example may provide insight
into how to write the "Procedures" section:
If you volunteer to participate in this research you
will be asked to answer three sets of questions. The first
set will include 25 questions about your living conditions.
This section is expected to take about thirty (30) minutes to
complete and will ask questions about how long you have been
homeless, how often you eat, etc.
The second set of questions should take approximately
one (1) hour to complete. There will be 40 questions about
your knowledge of the support programs in your area. This
section will ask you questions like, "Where would you go
if you would like a hot dinner?" or "Where can you
take a shower?"
A final set of questions should take approximately 30
minutes to answer. You will be asked twenty (20) questions
about the services that would help you most.
There are situations where the difference between clinically
indicated and experimental interventions must be explained for
subjects in the "Procedures" section of the consent
form. These sections should contain a clear statement regarding
which procedures are experimental and which procedures are
standard of care. Consider the following sample:
If you agree to participate in this research you will
be asked to have a chest x-ray to make sure that you are
healthy. The x-ray is performed on all patients with your
condition whether or not they decide to participate in this
research. Following the chest x-ray, you will be asked to
provide ten (10) cc’s (approximately one tablespoon) of
blood (usually from a vein in your arm). This blood draw will
be performed for the purpose of this research only.
Potential
Risks and Discomforts
The consent form is required to provide subjects with a clear
understanding of any risks or discomforts which are reasonably
anticipated during their participation in the research [45 CFR
46.116(a)(2)]. All foreseeable risks and/or discomforts
of participating in a research should be addressed in the
"Risks/Discomforts" section.
Risks should not be understated or overstated. In some cases
it is appropriate to cite statistical probability of risk
occurrence, risk prevention measures, reversibility and
treatment. Appropriate disclosure of the potential risks
associated with an intervention can be particularly difficult in
clinical regimens where decisions are based upon available data.
Investigators should consider the following example when
addressing the risks/discomforts of participation in a research
activity.
Because you will be asked questions about personal
aspects of your life, you may feel embarrassed or
uncomfortable while answering them. Also, because it may take
up to two (2) hours for you to answer all the questions, you
may become tired. You may stop answering questions and take a
break at any time.
Anticipated
Benefits to Subjects
This section of the consent form should state whether there
are any direct benefits to the subject that may reasonably be
expected as a result of participation in the research. Examples
of direct benefit to the subject may include treatment of an
illness, or knowledge of value to the subject (e.g.,
results of a cardiac stress test, results of an educational test,
etc.). The potential benefits to the subject should not be
overstated, coercive, or guaranteed. If there are
no benefits to the subject it should be so stated [45 CFR
46.116(a)(3)].
Anticipated
Benefits to Society
This section is suggested to ensure fair representation of
potential benefits to prospective subjects. All research should
have some underlying potential benefit to society (e.g.,
advancement of knowledge, health benefit to others, etc.).
NOTE: This section should not address payment
issues as a benefit. Payment will be addressed later in the
consent form. To continue the homeless survey example,
benefits of the study might be described as follows:
You should not expect to benefit directly from this
research. However, your participation in this research may
lead to information that could help individuals who are
homeless if it identifies better ways to support homeless
people.
Alternatives
to Participation
In clinical research, all consent forms are required to
indicate any therapeutic alternatives available to the subject in
the non-research and/or research context that may be of
reasonable benefit to the subject. When appropriate, the relative
risks/benefits of the therapeutic alternative vs. the research
should be stated [45
CFR 46.116(a)(4)]. It is important to remember that an
alternative could be supportive care or "watchful
waiting" only.
Medical protocols which are not therapeutic in nature should
state: "Since this protocol is not therapeutic in nature,
the only alternative to participation is not to
participate in this research." For studies involving
alternative therapies, the research alternatives as well as other
available treatments should be clearly distinguished and
described. For example, a research study of a new schizophrenia
medication may be described as follows:
You should be aware that you have alternatives to
participation in this research activity. If you choose not to
participate in this study, you may receive medications which
are currently available, such as Clozapine and Risperidone.
Your doctor can give you additional information about these
therapies at any time.
In non-medical research the consent form should state any
alternatives that may be advantageous to the subjects. For
instance, if the subjects are students who will receive academic
credit, the consent form should describe the alternatives
available to earn equivalent academic credit.
Payment for
Participation
Cash payments (if any) should be described in dollar amounts.
Subjects should also be told how much of the payment they will
receive if they do not complete the research. The HSPCs, in
compliance with the stated position of the FDA, encourage
adoption of a pro-rated payment system whenever possible.
The nature, amount and method of payment or other remuneration
must not constitute undue inducement to participate (e.g.,
the payment alone should not serve as sufficient inducement for
the subject to volunteer). Reimbursement may be provided for
costs of participation (parking fees, travel, lost time from
work, baby-sitters, etc.). Therefore, partial participation in a
research activity would obligate partial payment. Also, any
anticipated delays in processing payment (i.e., "it
will take up to six weeks for you to receive your check")
should be mentioned. A "Payment for Participation"
section in a homelessness study might read as follows:
As a part of this study you will be asked to complete
two 30-minute questionnaires, and one 1-hour questionnaire.
You will be given $10 for each of the thirty minute
questionnaires you complete and $20 for completion of the
1-hour questionnaire. If you complete the entire study, you
will receive $40. If you decide to stop before completing all
of the questionnaires, you will be given a portion of money
based upon how much of the study you have completed.
If payment will be in the form of academic credit that will be
awarded for research participation, the amount and type of credit
should be clearly stated as well as any required conditions for
credit.
Possible
Commercial Products
The California State Supreme Court decided in the Moore vs. UC
case that subjects have the right to know if material such as
tumor tissue, bone marrow, blood, etc., will be turned into a
commercial product. As a result, investigators are required to
inform subjects in the consent form if any human materials (tumor
tissue, bone marrow, blood, etc.) may be used to establish a
commercially useful product (e.g., a cell line). Subjects
should also be informed that they may not benefit from the
development of the cell line. Standardized language is included
in the Sample Consent Form for Medical Research (Please
see Chapter 12, "Form
HS-2").
Financial
Obligation
This section of the consent form is required for medical,
dental, psychological, research., etc., and should clearly state
all financial obligations the subject may incur as a result of
participation in the study (e.g., for physician fees,
hospital charges, medication, pharmacy dispensary charges,
laboratory tests, post-treatment follow-up, etc.). In addition,
the section should also indicate if drugs, devices, tests or
services will be provided free-of-charge. The consent form should
disclose all potential additional costs to the subject as a
consequence of procedures carried out for research purposes (e.g.,
extended hospitalization, additional tests, etc.). Potential
subjects should be advised that most health benefit plans do not
cover experimental treatments, and they must be told if their
insurance companies will be billed.
Emergency
Care and Compensation for Injury
A statement regarding "Emergency Care and Compensation
for Injury" is a required element of the consent form for
all research that presents more than minimal risk as determined
by the HSPCs [45
CFR 46.116(a)(6)]. "Minimal Risk," as defined
by the federal regulations, is "where the probability and
magnitude of harm or discomfort anticipated in the proposed
research are not greater, in and of themselves, than those
ordinarily encountered in daily life or during the performance of
routine physical or psychological examinations or tests" [45 CFR 46.102(i)].
For example, the risk of drawing a small amount of blood from
a healthy adult for research purposes is no greater than the risk
of doing so as part of a routine physical examination.
Investigators should explain in the consent form whether any
compensation/medical treatments are available if injury occurs
and, if so, describe the extent and nature of the compensation.
Standardized language currently approved by the University of
California describes compensation for research-related injuries
as follows:
If you are injured as a direct result of research
procedures not done primarily for your own benefit, you will
receive treatment at no cost. The University of California
does not provide any other form of compensation for injury.
Privately
Sponsored Drug and Device Trials
The University of California, Office of the President, issued
a memorandum on February 3, 1995, entitled "Requirements
for Administration of Agreements with Private Sponsors for Drug
and Device Testing Using Human Subjects" (Please see Appendix 11, "February 3,
1995 memorandum form the Office of the President" for more
information). Section II of the memorandum indicates that all
contracts with private sponsors, "...must make explicit that
the sponsor assumes responsibility for reimbursing the University
for the reasonable cost of medical treatment for injuries
directly resulting from participation in the study. It is not
acceptable for such agreements to require billing of third party
insurance companies in lieu of recovery of such costs from the
sponsor, nor is it appropriate to accept provisions restricting
participation of human subjects on the basis of medical insurance
coverage status or on the subject’s ability to pay."
Therefore, all consent forms requesting participation of human
subjects in privately sponsored drug and device trials are
required to indicate that:
If you are injured as a direct result of participation
in the research, you will receive treatment at no cost. The
University of California does not provide any other form of
compensation for injury.
Privacy and
Confidentiality
This section should state that any information obtained in
connection with the research and that could identify the subject
will remain confidential and will be disclosed only with the
subject’s permission or as required by law. It should detail
the extent to which confidentiality will be adhered to and how
specific records identifying the subject will be maintained [45 CFR
46.116(a)(5)].
Suggested text for this section is as follows:
- The only people who will know that you are a research
subject are members of the research team and, if
appropriate, your physicians and nurses. No information
about you, or provided by you during the research, will
be disclosed to others without your written permission,
except:
- if necessary to protect your rights or welfare
(for example, if you are injured and need
emergency care); or
- if required by law
Limits to
Confidentiality:
Depending on the subject matter of the research, there may be
limits to the investigator’s promise of confidentiality to
the subject. An example would be if a subject reveals information
about possible child
or elder abuse or if the investigator and/or the research
staff discover the possibility of abuse. (Please see Chapter 7, Responsibilities of Principal
Investigators: Confidentiality" and Chapter 10, "Special State of
California Requirements: Reporting Suspected Abuse of Children,
Elderly Individuals, and Others"
for more information.) The HSPC recommends the following text for
the consent form:
Under California law, the privilege of confidentiality
does not extend to information about sexual or physical abuse
of children or the elderly. If any member of the program
staff has or is given such information, he or she is required
to report it to authorities. The obligation to report
includes alleged or probable abuse as well known abuse.
Confidentiality
of Audio/Video-Tapes and Photographs:
Investigators are required to protect and/or disguise an
individual subject’s identity when using photographs,
videos, or audio-tape recordings. Statements regarding the use of
photographs, videos, or audio-tape recordings should be
consistent in both parental permission forms and children assent
forms. For example, if the child’s assent form indicates
that the photographs, videos, or audio-tape recordings are
confidential and only the investigators will have access to the
material, then the parental permission form should not indicate
that the parent/guardian will have access to the tapes or
photographs.
The investigator should clearly outline in the consent form
whether the tapes will be used for classroom presentations,
conventions, presentations, or possibly released to news or
advertising media. The consent form should also indicate when the
tapes/photographs will be destroyed. In addition, the consent
form should indicate the provisions for masking the
subjects’ identity. The HSPC recommends the following
consent form statements for research that includes photographs,
videos, or audio-tape recordings:
In the process of the research you will be videotaped
(and/or photographed, and/or audio-taped). The tapes or
photographs will be used for teaching and/or research
purposes [indicate the types of purposes] only and your
identity will not be disclosed. [The statement should also
include an indication of when the tapes will be destroyed.]
If the subject is identifiable from the photographs, videos,
or audio-tape recordings, the HSPC suggests the following
statement:
You have the right to review the tapes/photographs made
as a part of the study to determine whether they should be
edited or erased in whole or in part.
Releasing
Information:
If the investigator intends to release any information, the
standard statement of confidentiality should be modified to state
the person(s) or agency to whom information will be furnished,
the nature of the information, the purpose of the disclosure and
whether the subject’s name will be used. When the research
records may be subject to inspection by the FDA, a funding
agency, or an industrial sponsor, the following information must
be included:
Authorized representatives of the Food and Drug
Administration (FDA) [or a funding agency such as the
National Institutes of Health] and the manufacturer of a drug
[or device] being tested [insert name of company] may need to
review records of individual subjects. As a result, they may
see your name, but they are bound by rules of confidentiality
not to reveal your identity to others.
When the results of the research are to be published or
presented at conferences, it is the investigator’s
responsibility to make sure that no personal information will be
included that would reveal a subject’s identity.
Participation
and Withdrawal
Federal regulations require a clear statement in all consent
forms that participation in the study is voluntary, refusal to
participate will involve no penalty or loss of benefits to which
the subject is otherwise entitled, and the subjects may
discontinue participation at any time without penalty of loss of
benefits to which the subject is otherwise entitled [45 CFR
46.116(a)(8)].
The Participation and Withdrawal section of a medical
consent form is required to contain the following notice:
Your participation in this research is VOLUNTARY. If
you choose not to participate, that will not affect your
relationship with UCLA (or UCLA Medical Center), or your
right to health care or other services to which you are
otherwise entitled. If you decide to participate, you are
free to withdraw your consent and discontinue participation
at any time without prejudice to your future care at UCLA.
The Participation and Withdrawal section of a
non-medical consent form is required to contain the following
notice:
Your participation is VOLUNTARY. If you decide to
participate, you are free to withdraw your consent and
discontinue participation at any time without penalty. Your
decision whether or not to participate will not affect your
relationship with [name agency, health care provider, school,
etc. where subject was recruited].
Consequences
of Withdrawal
When appropriate, the consent form should state the
consequences (e.g., medical/health) of a subject’s
decision to withdraw from the research. If applicable, the
consent form should also state any anticipated circumstances (e.g.,
adverse reactions, non-adherence to protocol instructions) under
which the subject’s participation may be terminated by the
investigator or sponsor without regard to the subject’s
wishes.
The investigator may withdraw you from this research
activity (without your consent) if certain circumstances
arise. For example, you may be withdrawn from this study if
the investigator feels that your continued participation
places you at unnecessary risk of harm or you become
ineligible (because of illness) to continue. [If appropriate,
describe the anticipated circumstances under which the
subject’s participation may be terminated by the
investigator without regard to the subject’s consent.]
The section (if applicable) should address the following: In
some cases withdrawal from a study may involve some consequences
for the subjects that they should be made aware of prior to
enrolling into a study. For example, during the course of a
vaccine trial, a subject may be challenged with an infectious
agent. If the subject decides to end participation in this type
of activity after the challenge, there may be a period of time
where the individual may be forced to continue quarantine prior
to discharge from the study discharge. Sample language follows:
Although you may decide to withdraw from this research
at any time, you are enrolling into a trial where you will be
given a bacteria that causes disease in unvaccinated
individuals to see if the vaccine protects you from becoming
sick. After the injection, the study team must ensure that
you cannot infect others with the bacteria. You will
therefore be required to stay for three days and receive
antibiotic therapy. You will be allowed to leave the study
after that three day period.
New Findings
In medical, dental, psychological research, etc., the federal
regulations require the inclusion of a separate statement
indicating that if new information, such as changes in the
risk/benefit ratio, or new alternatives to participation develop
during the course of the study that may affect a subject’s
willingness to continue participating, the subject will be
informed promptly and may then decide whether to continue
participating in the ongoing study. The HSPC will advise the PI
whether or not subjects should be asked to sign a revised consent
form.
Identification
of Investigators
All consent forms must include a section explaining who can be
contacted for answers to questions about the research, such as
the results, and whom to contact in the event of a research
related injury [45
CFR 46.116(a)(7)]. The "Identification of
Investigators" section should clearly identify the members
of the study team who may be contacted and a contact telephone
number that can be used (24 hours a day, 7 days a week for
greater than minimal risk studies). For more than minimal
risks research the "Identification of Investigators"
section of the consent form may be provided to subjects by the
following statement:
In the event of a research related injury or emergency,
or if you experience an adverse reaction, please immediately
contact one of the investigators listed below. If you have
any questions about the research, please feel free to contact
the following individuals at their listed numbers (24) hours
a day, (7) days a week.
Rights of
Research Subjects
For research determined by the HSPCs to be more than minimal
risk the investigator is required to make a statement regarding
the rights of research subjects. (Please see Chapter 5, "Risk/Benefit
Assessment" for information regarding risk.) This
section of the Consent Form may not be modified by investigators.
It must read as follows:
You may withdraw your consent at any time or
discontinue your participation without penalty. By signing
this consent form you are not waiving any legal claims,
rights or remedies because of your participation in this
research study. If you have any questions regarding your
rights as a research subject, you may contact the Office for
the Protection of Research Subjects, University of California
Los Angeles, Box 951694, Los Angeles, CA 90095-1694;
telephone: (310) 825-8714.
Additional
Elements
Additional elements of informed consent may apply to certain
research activities. Current federal regulations can be found at [45 CFR
46.116(b)(1-6)]. The following items should be addressed
if they apply, and investigators should feel free to select
simple titles for these sections:
- When appropriate, a statement that a particular treatment
or procedure may involve risks to the subject (or to the
embryo or fetus, if the subject is or may become pregnant
or if the male can induce harm to an embryo or fetus
through contact with pregnant female) which are currently
unforeseeable [45 CFR
46.116(b)(1)].
- When appropriate, the approximate number of subjects
involved in the study should be detailed in the consent
form [45
CFR 46.116(b)(6)].
- When appropriate, subjects should be told who is funding
the research (drug company, device manufacturer, CIA).
Contact OPRS
October 29, 2004
Contact Webmaster
| 
