INFORMED

CONSENT
The Ethical Principle
The Regulations
The Document
The Process

What Should It All Mean

To Me?
 The Ethical Principle

• The Belmont Report outlines

three basic ethical principles:
– Respect for Persons
– Beneficience
– Justice

Which principle supports informed

consent?
Respect For Persons

Respect for Persons

carries with it a
number of
responsibilities for a
researcher.
 Respect for Persons
Respect the person’s autonomy.
The person has the right to make
decisions for him/herself.

The person has a right to

information that will help them
make that decision.

The person has a right to enough

time to make a decision without
feeling coerced.

The person has a right for

information to be presented in a
language and in words they can
understand.
 What Information
Does a Person Need
in Deciding Whether
to Participate in Your
Study?
Information For Potential
Subjects
• They need to know that it is research!
• They need to be told what is the purpose
of doing the research.
• They need to know how long they will be
expected to participate in the research.
• They need to know what you plan to do
and what are they going to be expected to
do.
• They need to know which of the
procedures are experimental and if
applicable how that might differ from
anything they would undergo if they
didn’t participate.
Information For Potential
Subjects
• They need to know what potential
risks or discomforts they may
experience as a result of
participating in your study.
Need to address not only any
physical risk to the participant but
also any emotional or
psychological risk or discomforts
they may experience and any risks
to a person’s ability to get or
retain employment, get insurance,
be arrested, or be sued.
Information For Potential
Subjects
• They need to know what potential
benefits they may receive by
participating. BEWARE – do not
overstate any potential benefits! And,
acknowledge that they may not receive
any benefits, if that is the case.
• They need to know if there are any
alternatives available to them should
they choose not to participate.
• They need to know whose going to see
the information they provide. (You
need to be comprehensive in describing
individuals, agencies, etc that will have
or may have access to the data. )
 Information For
Potential Subjects
• If the study involves greater than
minimal risk, the potential subject
needs to know whether there will be
any compensation and
medical/psychological/social
services available to them.
• They need to know that their
participation is 100% voluntary.
They won’t be forced to participate
and they won’t be forced to stay in
the study, should they want to
withdraw at any time.
 Information For
Potential Subjects
• They need to know who they
can call or contact to ask
questions about:
– Things that occur in the research
– Their rights as participants in
the research
– Who to contact should they
become distressed, physically or
emotionally injured.
 Information For
Potential Subjects
• You might also want to tell potential
subjects:
– That there may be risks about which you
are currently unaware;
– That there may be certain circumstances
that may cause you to terminate their
participation;
– That there may or may not be additional
costs associated with their participation;
– How many other people are participating
in the study;
– That if new findings become available
during the research that would impact
their willingness to continue participation,
you will share that information with them.
The Consent Process

The consent process begins

when you begin recruitment
of subjects.
Informed consent does not
end with the signing of a
document.
 The Consent Process
How do you show respect for
persons in each of these
situations?
•Information gathered to identify
potential subjects?
•Information provided in flyers?
•Information provided in published
ads?
•Information provided when
contacting the potential subject?
The Consent Process
The consent process is an
on-going, dynamic
“conversation” with your
subject to ensure:
• the person understands
what’s being asked of
him/her;
• that the person has an
opportunity to ask
questions; and
• that the person truly
wants to continue in the
study.
The Consent Process

Are there times when it is

not appropriate to have a
consent process?

How do I inform the IRB

that the process is not
appropriate?
 Request for Waiver of
Consent Process
The IRB may waive the consent
process if the following
conditions exist:
• the study involves no greater than
minimal risk;
• the rights and welfare of the subjects
would not be adversely affected;
• the research could not be practicably
carried out without the waiver;
• when appropriate, subjects will be
provided pertinent information after
participation is completed.
 Documentation of
Informed Consent
The consent form is one of the
most important ways to
document your respect for
persons.
 Informed Consent
Document
Common problems found
during IRB review include:
•Information is not presented in
terms the average person
understands (usually 8th grade level);
•Typographical or grammatical
errors;
•All of the procedures are not
included;
•The risks are not appropriately
described;
•The benefits are overstated; and
•The person isn’t told that they are
participating in research!!!
Informed Consent
Document

Are there times when

documentation of
informed consent is
not appropriate?
 Informed Consent
Document
There are times when signed consent is
not absolutely required and
documentation can be waived.
Waiver of documentation requires a
formal request to the IRB with
justification that the study is:
• The study poses no greater than
minimal risk;
• The only record linking the subject
and the research would be the
consent document;
• The principal risk would be harm
resulting from breach of
confidentiality; and
• Each subject is asked whether
he/she wants documentation.
Request for Waiver of
Documentation of
Consent
Typically, whenever possible, the
IRB will ask that you provide a
letter to the participant that
contains all of the elements of
informed consent. This can
serve as a cover memo for a
survey, be provided at the
beginning of an interview, or be
sent subsequent to a telephone
research procedure.
 What if my subject
population is not fully
autonomous?
Certain “vulnerable” populations
are not considered totally
autonomous and therefore must
have someone else sign informed
consent for them. Examples of
these populations include
children, individuals with limited
mental capacity, or individuals
under acute stress or sedation.
 Parental Permission
Children are not considered
autonomous individuals (unless
they meet the definition of
emancipated). However, we want
to respect them as individuals. To
use children in research, you must
first obtain the permission of the
parent(s) and then obtain assent
from the child.
Minors (children) are defined as
those individuals under the age of
18 years.
 Emancipated Minors

• Individuals under 18 years of age

that are considered emancipated
(therefore able to give consent for
themselves) include:
– Minors declared emancipated by
the courts
– Minors who are married or have
been married
– Minors who are pregnant and are
being asked to participate in research
about pregnancy or impacts the well-
being of the mother or her unborn
baby
Verbal and Documented
Assent
Children participating in research
should be given the opportunity to
agree to that participation.
For children under 7 years of age,
it is an informal process.
Children 7 – 12 years of age, assent
is verbally obtained and
documented in the research
records.
Minors 12 – 17 years of age, should
be given the opportunity to
document their assent on an IRB
approved assent form.
Where do I go and
What do I do?
USF on-campus mailing: MDC35

Off-campus mailing: USF Division of

Research Integrity and Compliance
12901 Bruce B. Downs Blvd.
MDC35
Tampa, FL 33612

Hand delivery:USF Division of Research

Integrity and Compliance
University Technology Center
3702 Spectrum Avenue, Suite 155
Tampa, Florida

Fax number: (813) 974-5618

Call us at:(813) 974-9343
Visit our web site:
http://www.research.usf.edu/cs/irb.htm