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INFORMED CONSENT
STATEMENT & STUDY INFORMATION SHEET INSTRUCTIONS
An Informed
Consent Statement has two purposes: (1) to enable potential
research subjects to make an informed choice as to their
participation in a study, and (2) to document their decision to
participate. In order to make an informed choice, potential subjects
must understand the study, how they are involved in the study, what
sort of risks it poses to them, and what to do if something untoward
happens. The words and language used to describe these factors
must be understandable to potential subjects.
A Study
Information Sheet
enable potential research subjects to make an informed choice as to
their participation in a study.
Study Information Sheets are normally used for Exempt studies that
do not require signed consent. The subject's participation is
considered consent; their signature is not required.
All protocols,
except for existing data studies, must include one of these forms.
SAMPLES OF INFORMED CONSENT STATEMENTS AND STUDY INFORMATION
SHEETS ARE PROVIDED HERE. Following the format of the samples
will help to ensure that the necessary criteria for approval are
included. Assistance in the preparation of the consent
statement or information sheet is available. Contact the IRB Office,
520-4181, A102A,
sbirb@iusb.edu.
All sections
are required elements of an Informed Consent Statement except those
in
Purple italics;
these should only be included if they are applicable to your
research.
General
Information:
1.
Study Information Sheets for mailed surveys may take the format of a
letter, as long as all required information is included.
2.
For studies done with subjects that speak a foreign language you must
submit the Informed Consent or Study Information sheet in both the
subject's language and English.
3.
If your Informed Consent form is more than one page long, there should be
a line at the bottom of each page for the subject's initials, except
for the last page where the signature is obtained.
4.
The committee considers the terms “subject” and “participant” synonymous.
You can use either term, but be consistent throughout your document.
5.
All pages must be numbered using the format “Page 1 of 2.”
6.
Use a type size no smaller than Arial 11-point.
7.
Leave a blank space of at least 1-1/2" high by 3" wide at the bottom of
the last page for the approved and expires stamp that will be
affixed by the IRB. A copy of the stamped version will be returned
to you for your use.
Sections
-
Heading Put
Study # in the upper right hand corner of the document.
The IRB will fill in the number. Then centered on
the next line put:
INDIANA UNIVERSITY SOUTH BEND
INFORMED CONSENT STATEMENT or STUDY INFORMATION SHEET
List title of project here
2.
Opening Paragraph: Invite the subjects to participate (using third
person language), state that the study involves research, and
describe the purpose.
-
Information Section:
a.
Describe all procedures (interviews, surveys, etc.), preferably in chronological order, which
will be employed in the study. Point out any that are considered
experimental (i.e. new drug or devise) and explain technical and
medical terminology.
b.
State
the amount of time required of the subject per session and for the
total duration of the study.
If applicable to your study,
describe:
c.
Alternative procedures or courses of treatment [when
experimental procedures are being used].
d.
The approximate number of subjects involved in the study
should be indicated when the subject population is small in number.
If subjects
might be identifiable in reports because individual responses will
be described (possible when the N is small), a statement to this
effect should be included in the consent statement or information
sheet.
e.
If you plan to audio tape,
videotape or film the subjects, request permission to do so in
writing and indicate how you will be using this material (research
purposes only?, research and instruction?, who will have access to
or view the tapes?, will subjects be allowed to preview the tapes?,
what will happen to the tapes at the end of the study?; what will
happen to the tapes if the subject withdraws?). All possible uses of
the tapes/films/photos (current & future) must be described. If
tapes are kept by the PI beyond the end of the study and/or
archived, then the following statement must be included: "The
tapes/films/photos will not be used for any additional purposes
without your additional permission." and signed/documented consent
is required.
f.
IF
DECEPTION IS USED,
include a statement to the effect that the research cannot be fully
described at this time, but at the conclusion of participation, an
explanation will be provided. (Provide a copy of the debriefing
script with your packet for IRB review.)
4.
Risk Section:
Describe any reasonably foreseeable risks or discomforts, if any, of
each of the procedures to be used in the study, and any measures
which will be used to minimize the risk.
If there is no risk involved, this section does not have to be
included in a Study Information Sheet. Even if there is no risk, this
section MUST be included in every Informed Consent Document. It can
say “We do not anticipate any risk associated with this study.”
If appropriate include a statement that the particular treatment or
procedure may involve currently unforeseeable risks to the subject
(or to the embryo or fetus,
if the subject is or may become pregnant).
-
Emergency Medical Treatment Section.
If the study
is Department of Health and Human Services (DHHS) funded, or if
the study involves risk procedures (exercise, medical, stress,
alcohol, and so on), you must contact the IRB office for
appropriate wording.
DO
NOT INCLUDE THE EMERGENCY MEDICAL TREATMENT SECTION IF IT IS NOT
APPLICABLE TO YOUR STUDY
-
Benefit Section:
Describe any benefits to the subject or to
others; or the extent of contribution to the body of
literature/knowledge. If there are no benefits to the
participants indicate with language such as: "While there are no
direct benefits to you for participating in this research, we hope
to learn…”
-
Confidentiality Section:
Describe the extent, if any, to
which confidentiality of records identifying the subject will be
maintained. If subjects are identified in reports, signed
consent is required. If research is conducted over the Internet,
you must tell subjects that you cannot guarantee confidentiality
while their data are being transferred across the internet.
-
Compensation Section:
State the terms of subject compensation for study participation,
if any. If the subjects will be paid (or receive other
compensation) for
participation, state how and when they will receive payment
and/or compensation (i.e., compensation = toys, books, gifts,
etc.). List value of gifts or service. If class credit will be
given, list the amount. List alternative ways to earn the same
amount of credit. Explain the amount of partial payment if the
subject withdraws prior to completion of the study. (See policy
at
http://www.iusb.edu/~sbirb/compensation.html)
DO
NOT INCLUDE THE COMPENSATION SECTION IF IT IS NOT APPLICABLE TO
YOUR STUDY
-
Contact Section: Include an invitation for the subject
to ask any questions at any time about the study and its
procedures, or their rights as subjects.
Include the principal investigator's name, office address, telephone number, and
e-mail address that the subject may use to ask questions and
report any study related problems. If there are
co-investigators you can include their information here but only
one contact person is absolutely necessary. For student studies
include your sponsor's information as well. For studies done outside the
USA, list both foreign and USA contact information and the dates
that apply to each. Include the IUSB IRB office as the place to
contact with questions about participants' rights. You must
include this specific paragraph verbatim:
If you feel you have not been treated according to the
descriptions in this form, or your rights as a participant in
research have been violated during the course of this project,
you may contact the Indiana University South Bend Institutional
Review Board for the Protection of Human Research Subjects, 1700
Mishawaka Ave., A247, South Bend, IN 46634, 574-520-4181, by
e-mail at
sbirb@iusb.edu.
If appropriate to your research include a statement that if the
subject experiences adverse effects, the investigator should be
contacted immediately – contact the IRB for appropriate wording.
-
Participation Section:
Tell the subject that participation is
voluntary. Further, state that refusal to participate will
involve no penalty or loss of benefits to which the subject
is otherwise entitled. The Federal regulations for the
protection of human subjects require these words or an
equivalent statement. Tell subjects what will happen to
their data if they withdraw from the study. If the data include
identifiers you must describe what will happen to it if the
subject withdraws. If the data do not include identifiers then
it is impossible to either return or destroy it.
If appropriate to your research give any anticipated
circumstances under which the subject's participation may be
terminated by the investigator without regard to the subject's
consent. Also, if appropriate to your research
include a statement that says that significant new findings
developed during the course of the research, and which may be
related to the subject's willingness to continue
participation, will be provided to the subject.
-
Consent Section:
Include a statement that says the subjects
have read the consent form, have had questions answered to their
satisfaction, acknowledge receiving a copy of the form, and
agree to take part in the study. Provide a line for signature(s)
and the date. Provide two copies of the Consent Form, one to
be retained by the subject and one to be submitted for the
research records. The submitted copy must be signed by the
subject and, if applicable, the subject's parent(s)/guardian/legal
representative. The signed submitted forms must be retained by
the researcher for three years after the completion of the
study. This section does not need to be included in a Study
Information Sheet.
If subjects are
minors use the following guidelines for obtaining
consent/assent:
-
6 years old and younger
- only parent(s)/guardian/legal representative need sign;
-
7- 8 years old - signature of minor is optional, requires
signature of parent(s)/guardian/legal representative;
-
9 through 17 years old
- requires signature of both minor and parent(s)/guardian/legal
representative.
When young
children are subjects, a script that will be used to explain the
study to the children may be required. Check with the IRB office.
If the
subject or legal representative is unable to read and/or understand the
written consent form, it must be verbally presented in an
understandable manner and witnessed (with signature of witness) by
someone not associated with the study.
This might apply in cases where subjects are: MENTALLY DISABLED,
SERIOUSLY ILL, INSTITUTIONALIZED, INCARCERATED (PRISONERS), or A
MEMBER OF ANOTHER VULNERABLE GROUP.
If appropriate to your research disclose any
additional costs to the subject that may result from participation
in the research. (If subjects will be charged for participation in
the research project, then all costs must be itemized on the
consent form. If alternative, non-investigational procedures are
available, then these procedures should be discussed and the average
costs included in the consent form.)
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