The heading and the instructions don’t agree! The
research is
not being done because of the risks and alternatives. You
have 3 options:
- If your study is complex, and involves several
sessions, an outline like what is in the instructions is a good idea. But
change the heading to “Summary”, and keep this box around it
to set it apart from all the other headings, which are in question form.
- If there is a general reason for the research
and this is a specific part of it, it would be reasonable to reply to the
question in the headline. Then this answer (box optional) tells the
overall reason (“X is a major problem and no data tell us how to deal with
it”) while the next section (Purpose) says what this experiment will do to
answer a part of it (“will test whether Y changes behavior, ameliorates,
etc”).
- Rather than simply fill space with a redundant
answer, simply eliminate this box and heading.
What
is the purpose of this research?
The
purpose of this research is: (this may supercede the
previous box) Do NOT repeat the preceding as both
a subheading and your first sentence!
[Explain research question and purpose in lay
language.]
What
procedures are involved?
If
you agree to be in this research, we would ask you to do the following things:
à Describe the procedures
chronologically using simple language, short sentences and short paragraphs.
The use of subheadings helps to organize this section and increases
readability. Medical and scientific terms should be defined and explained.
Identify any procedures that are experimental.
à Specify the subject's assignment to
study groups, length of time for participation in each procedure, the total
length of time for participation, frequency of procedures, location of the
procedures to be done, etc.
à If there are calendars, flowcharts,
tables or pictures, that would help explain the procedures, note what they are
and attach them.
Approximately
[add number of subjects] may be involved in
this research at the University of Illinois at Chicago.
[If a multicenter research add the total number of subjects anticipated and
projected number of research sites.] It is often
better to put this paragraph at the beginning, so it doesn’t sound like you are
asking the subjects to recruit N people.
What
are the potential risks and discomforts?
The
research has several risks:
[Explain
the risks, discomforts and inconveniences including the likelihood, severity,
and reversibility, if applicable, of each risk.]
Don’t repeat the first sentence. Many people say “The research has several
risks: There are several risks to the research:”
àIf there are significant physical or psychological risks to
participation, the subject should be told under what conditions the researcher
would stop the research itself or stop the subject’s participation in the
research.
à If there is a potential
for a subject to be participating in more than one research protocol at the
same time, add a statement that the subjects should inform the researcher if
they are currently participating in a research protocol. This applies
mainly to medical research, although smoking or diet studies might interact.
Are
there benefits to taking part in the research?
[Include a statement describing any benefits to the
subject or others (science or society) that may be reasonably expected from the
research. If there are no direct benefits to subjects, state that here. Payment or PEC for
participation is not, in and of itself, a direct benefit of the research.] Subject pool
people receive the benefit of the education your debriefing supplies.
What
other options are there?
[Describe the
appropriate alternative procedures or courses of treatment that might be
advantageous to the subject. If there are no alternatives, as is the case in some
survey research, this item need not be included in the consent form, however,
the reason for not including this item should be explained in the research
protocol itself.] This is not needed for subject pool; the alternative
is not to bother. Remember, the subject gets the PEC even if he or she drops
out…
Will I be told about new information that may
affect my decision to participate?
During
the course of the study, you will be informed of any significant new findings
(either good or bad), such as changes in the risks or benefits resulting from
participation in the research or new alternatives to participation that might
cause you to change your mind about continuing in the study. If new information
is provided to you, your consent to continue participating in this study will
be re-obtained. This is unnecessary for a study that
takes a single session. You are not going to rush into the middle of the
session announcing that answering surveys causes cancer! It also may be omitted
from some multi-session studies, where there are no such dangers remotely
possible. This is really intended for medical studies in which the patient may
be on an experimental drug that could be found to have unexpected side effects.
What about privacy and confidentiality?
Suggested text: (Remember to remove the
note that this is suggested text) The only people who will know that you
are a research subject are members of the research team. 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 when the UIC
Institutional Review Board monitors the research or consent process); or
- if required
by law. This often scares people. If you are
cannot reasonably get information about illegal activities, the law won’t
intercede. If you are asking about such things, you may want a Certificate
of Confidentiality. Anonymous or multiple-choice
questionnaires may be safe, while open-ended interviews and focus groups, are not.
When the results of the research are
published or discussed in conferences, no information will be included that
would reveal your identity. If photographs, videos, or audiotape recordings of
you will be used for educational purposes, your identity will be protected or
disguised. Don’t include this stuff about photos or
tapes if you are not taking photos or making recordings!
Any
information that is obtained in connection with this study and that can be
identified with you will remain confidential and will be disclosed only with
your permission or as required by law.
à If information will be released to
any other party for any reason, state the person/agency to whom the information
will be furnished, the nature of the information, and the purpose of the
disclosure.
à If activities are to be audio-
or videotaped, describe the subject's right to review/edit the tapes, who will
have access, if they will be used for educational purpose, and when they will
be erased.
à Describe the
subject's right to review/edit the tapes, who will have access, and when they
will be erased. Describe how personal identities will be shielded, disguised,
etc.
à Give a brief description
of how personal information, research data, and related records will be coded,
stored, etc. to prevent access by unauthorized personnel.
à Explain how
specific consent will be solicited, if any other uses are contemplated.
If applicable, state if
and when individual responses to survey questionnaires will be destroyed,
following analyses of the data
There is a distinction between confidentiality and privacy: confidentiality
refers to the measures you take to protect the identities and data of your
subjects; privacy refers to the subjects’ control over their own data
and how it is used. Similarly, “anonymous” means no one can know who you were; “confidential”
means no one outside the research will be told. (It could still be considered
confidential if others see the data as long as they don’t have a way of
associating it with individual subjects. It also would be possible for others
to know who participated as long as they don’t learn any of the personal data
such as what the participants said).
Bear in mind that you cannot promise this in a focus group because
other participants in the group saw and heard. For focus groups, be sure to
emphasize to participants that they should hold confidence, but that you cannot
guarantee the compliance of other participants.
What
if I am injured as a result of my participation?
In
the event of injury related to this research study, treatment will be made
available through the
University
of Illinois at Chicago Hospital. However, you or your third party payer, if
any, will
be
responsible for payment of this treatment. There is no compensation and/or
payment for such
medical
treatment from the University of Illinois at Chicago for such injury, except as
may be
required of the University by law. If you feel you have
been injured, you may contact the
researcher, [add name] at[add phone
number]. Use common sense. Subjects don’t get
injured filling out questionnaires. On the other hand, a
questionnaire may trigger depression or discomfort, and you may want to say
what referral or action you will take.
Note that if a
subject becomes suicidal, OAPS and Student Health are not appropriate
places for emergency intervention. You should escort the subject to the
UIC hospital (or other) Emergency room. The campus police can be called to send
an officer to escort the subject. Never just point a suicidal subject
toward the emergency room.
Suggested
text:
If the research is sponsored by a for-profit organization, identify the sponsor
and describe the extent of compensation and/or payment for medical treatment
available from the sponsoring company.
à The
“Compensation for Injury” element is required if the research involves more
than minimal risk.
What are the
costs for participating in this research?
[Include
an explanation of additional research costs for which the subject will be
responsible.] A simple “none” will suffice, but is probably not necessary for
subject pool subjects who know they are not receiving a service. This is
directed at medical work in which the subjects also get examinations, drugs,
etc.
Will
I be reimbursed for any of my expenses or paid for my participation in this
research?
Guidelines:
à State whether
the subject will be paid or offered other gifts (e.g., free care).If not, state
this clearly.
à If the subject will receive
payment, describe remuneration amount, when payment is scheduled and proration
schedule should the subject decide to withdraw or is withdrawn by the
investigator.
à If the subject will be
reimbursed for expenses such as parking, bus/taxi, baby-sitter, travel
companion/assistant, etc., list payment rates.
The compensation for subject pool people
is the PEC (Psychology Experience Credit). Please use the correct name for the
acronym! They should know what that is. State how many credits they earn.
Can I withdraw or be removed from the study?
You can choose whether to be in this study or not. If you volunteer to
be in this study, you may withdraw at any time without consequences of any
kind. You may also refuse to answer any questions you don’t want to answer and still
remain in the study. The investigator may withdraw you from this research if
circumstances arise which warrant doing so. How vague!
Give some idea of why (can’t do the task, funding lost, etc). If no one will be
removed, leave out that sentence.
à 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.
à If applicable, explain the
consequences of a subject's decision to withdraw from the research and state
whether withdrawal must be gradual, for reasons of safety.
à Be sure that this aspect of
terminating participation at the request of the PI is also noted in the section
on Payment for Participation, and that the information in both sections is
consistent.
Who
should I contact if I have questions?
The researchers conducting this study
are [add name(s)]. You may ask any questions
you have now. If you have questions later, you may contact the researchers at:
Phone: [add phone number(s)]
[If the researcher is a
student, include the adviser's name
and telephone number.] N.B.
What
are my rights as a research subject?
If
you have any questions about your rights as a research subject, you may call
the Office for Protection of Research Subjects at 312-996-1711.
What
if I am a UIC student?
You
may choose not to participate or to stop your participation in this research at
any time. This will not affect your class standing or grades at UIC. The
investigator may also end your participation in the research. If this happens,
your class standing or grades will not be
affected. You will not be offered or receive any special consideration if you
participate in this research. (Fix the
typo). This seems a strange question for
subject pool.
What
if I am a UIC employee?
Your
participation in this research is in no way a part of your university duties,
and your refusal to participate will not in any way affect your employment with
the university, or the benefits, privileges, or opportunities associated with
your employment at UIC. You will not be offered or receive any special
consideration if you participate in this research.
Subject pool people are there in their capacity as students, and any who are
also employed need not be reminded about this.
Remember: Your participation in this
research is voluntary. Your decision whether or not to participate will not
affect your current or future relations with the University or [insert the names of any other cooperating institutions
as well]. If you decide to participate, you are free to withdraw at any
time without affecting that relationship.
You will be given a copy of this form for your
information and to keep for your records.
Signature of Subject or Legally Authorized Representative Subject pool people will never have a legally
authorized representative. Competent
adults in general do not have an authorized representative.
I
have read (or someone has read to me) We assume our
students can read English – but if a blind student could participate, this
would apply--. the above information. I have been given an opportunity
to ask questions and my questions have been answered to my satisfaction. I
agree to participate in this research. I have been given a copy of this form.
Signature Date
Printed
Name
Signature
of parent or guardian Date(must
be same as subject’s)
Printed
name of parent or guardian This is strange! If they are adults, no parent
signature is
needed; if children, a separate permission form should be used. Note that in
permission forms, it is useful to have a place to list the name of the person
for whom permission is being granted!
Signature
of Researcher Date
(must be same as subject’s)
Signature
of Witness (if appropriate) Date
(must be same as subject’s)
Printed
name of Witness (if appropriate) Witnesses are only needed if the subject is not competent to
sign. Leaving this on the form scares away subjects (“gee, if a witness is
needed, what am I getting into?”)
Return to main Psychology
Human Subjects Procedures page
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Mistakes”