Elements of Informed Consent:
Requirements and Guidelines for Consent Forms:
Informed consent is the process of communicating to the subject the purpose, risks,
benefits, and voluntary nature of a specific study.
The consent form documents
that the communication process took place.
The consent form must contain all of the required "elements"
of informed consent. The "sample
consent form" should be used as a guide for writing a consent form. The consent form should be written in lay
terms; jargon and technical language should be avoided. The IRB recommends that researchers write the
consent forms using simple declarative sentences, avoid technical language.
Tips for completing consent form:
·
Write
the form in second person "You," e.g., "You are invited to
participate in a research project conducted by HealthPartners AVOID language
like "You have been told” or "you understand.” Numerous language and
coercion pitfalls result when using those phrases.
·
Define
or explain research terms like "randomization" (like the flip of a
coin), "double-blind" (neither the researcher nor the subject will
know.)
·
Quantities
for blood drawing should be listed in lay term equivalents, not milliliters.
(teaspoon equivalents)
·
Headings
for paragraphs are helpful and make the form easier to read.
·
Typeface
should be a comfortable-readable size; avoid fine print. The form may not fit onto
one page; additional pages are acceptable as long as they are essential.
·
Signature
space should be added to document "assent" of children to participate
in the study. Parent signatures are
still required.
Elements of informed
consent that must appear in the consent form:
(Based on DHHS
Guidelines, FDA Regulations and requirements made by the IRB)
1. An explanation of the purposes of the research and the
expected duration of the subject's
participation, (including an estimate
of the total amount of the subject's time involved in participation, a
description of the procedures to be
followed, and identification of any procedures which are experimental. The reason for
the subjects' selection. An approximate number of subjects
involved in the study may be relevant.
2. A description of any
reasonably foreseeable risks or
discomforts to the subject. A statement
that the particular treatment or procedure may involve risks to the subject (or
to the embryo or fetus, if the subject is, or may become pregnant which are
currently unforeseeable.
3. A description of any benefits to the subjects or others
which may reasonably be expected from the research. If there is no benefit to participation to the
individual subject an honest
declaration of that fact must be included in the text of the consent form.
4. A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject. If any standard treatment is withheld as a
result of participation, the subjects must be informed.
5. For research involving more
than minimal risk, or involving any invasive procedure, an explanation as to
whether any compensation for injury and
any medical treatment are available
if injury occurs and, if so, what
they consist of, or where further information may be obtained.
6. An offer to answer questions
and 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 problem. A telephone
number should be included.
7. A statement that
participation is voluntary, the
subject may refuse to participate, and may discontinue participation at any
time without penalty or loss of benefits to which he/she is otherwise
entitled. The consequences of a
subject's decision to withdraw from the research, if any, and procedures for an
orderly termination of participation by the subject, should be included.
8. A statement describing the
extent to which confidentiality of
records identifying the subject will be maintained. If data obtained will be made available to
any person or organization other than the
subject, the investigator, and the investigator's
staff, or become part of a permanent record maintained in the subject's name,
the purposes of the disclosure, and the nature of the information to be
furnished must be described. That
statement should note that the FDA and or drug company sponsor may inspect the
research records, if applicable. If
audio or video tape recording, photographs, or movies will be taken, they
should be described. The duration of
time they will be retained before erasure or destruction should be
specified. Use of such data for other
purposes, including educational purposes, must be disclosed and permission
obtained in a special portion of the consent form.
9. An
offer to the subject of a copy of the consent form.
10. Space for signatures and date. If applicable there should be a signature for
parent or guardian, including space to indicate relationship to the
subject. The signature of the
investigator is recommended in order that it can be established who discussed
the study with the subject.
11. Anticipated circumstances
under which the subject's participation may be terminated by the investigator without regard to the subject's
consent. i.e. when in the investigator’s opinion, it would be detrimental to
the subject to continue.
12. Any additional costs to the subject that may result from participation in the research.
13. A statement that significant new findings developed
during the course of the research which may relate to the subject's willingness
to continue participation will be provided to the subject.
14. Space provided to document
oral or written assent of minors. Note: if a parent "Consents" to
allow a child to participate, and the child refuses to "assent', the
child's refusal should take precedence and the research may not be undertaken.
(Mere failure to object should not be construed as assent to participate.)
15. If a subject will receive compensation or if there is an inducement or reward for participation,
specific information concerning the terms of disbursement must be clearly
described on the consent form. FDA
regulations require that payment to subjects is pro-rated over time so that in
the event a subject withdraws from a study, prior to termination of the
research, he/she received some compensation for participation.
The "sample consent form" should be used as a guide for
writing a consent form. Rules and
regulations are subject to change and revision.
Standards for consent documents change over time, the investigator
should be prepared to revise and update consent forms at the request of the
IRB.
SAMPLE CONSENT FORM
[Insert Title of Study and,
"Consent Form"]
You are invited to be in a research study of [insert general statement about study].
You were selected as a possible participant because
[explain how subject was identified]. We ask that you read this form and
ask any questions you may have before you decide whether or not you want to-be
in the study.
This
study is being conducted by: [Indicate
HealthPartners affiliation]
Background Information:
The
purpose of this Study is: [Explain research
question and purpose in lay language]
[Explain if the drug or device
tested is experimental or if any procedures are experimental]
Procedures:
If you agree to be in this study, we would ask you to do
the following things: [Explain tasks and
procedures: subjects should be told about assignment to study groups, length of
time for participation frequency of procedures etc. If standard treatment is
withheld, the subject must be so informed. Reminder: quantities, such as blood
drawn. should be listed in lay term equivalents, i.e., teaspoons]
Risks and Benefits of Being in the
Study:
The study has several risks: First, ____________________;
Second, ______________________ [Risk must
be explained, including the likelihood of the risk.]
[If
there are significant physical or psychological risks to participation, the
subject should be told under what conditions the researcher would terminate the
study.]
The benefits to participation are: [If no benefit, state that fact here.]
You will receive payment: [Include payment or
reimbursement information here. Explain
when disbursement will occur and conditions of payment.]
Alternatives to participating in this study:
[A
disclosure of appropriate alternative procedures or courses of treatment that
might be advantageous to the subject must be included.]
Compensation:
The following
statement must be included in the consent form.
In the event that this
research activity results in an injury, treatment will be available, including
first aid, emergency treatment and follow-up
care as needed. Payment for any such
treatment must be provided by you or your third party payer, if any, (such as
health insurance, Medicare, etc.)
Costs
[Any additional
costs or charges for the research procedures must be disclosed with estimated
amounts.]
Confidentiality:
The records of this study will be kept private. In any sort of report we might publish, we
will not include any information
that will make it possible to identify a subject. Your record for the study may, however, be
reviewed by the drug manufacturer or by representatives of the Food and Drug,
Administration. [Include study sponsor,
if applicable.] To that extent, confidentiality isn't absolute.
Voluntary Nature of the
Study:
Your decision whether or not to participate will not affect
your current or future relations with HealthPartners [or with other cooperating institutions, insert names]. If
you decide to participate, you are free to withdraw at any time without
affecting those relationships. [Explain
here if monetary benefits will be adjusted due to early withdrawal.]
New Information:
If during the course of this research study, there are any
significant new findings discovered which might influence your willingness to continue, the researchers will
inform you of those developments.
Contacts and
Questions:
The researchers conducting this
study are and . You may
ask any questions you have now. If you have questions later, you may contact them at Phone: [If
the researcher is a student, include advisor's name and telephone number here.]
[Subjects
should have access to a disinterested party if they have concerns about their
participation. Please use the following
statement or revise accordingly.]
As is the case for all
patients at
You will be given a copy of this form to keep for your
records.
Statement of
Consent:
I have read the above information. I have asked questions and have received
answers. I consent to participate in the study.
Signature of Subject: Date
Signature of parent or guardian: Date
Signature of
Investigator Date