Concordia College’s Official IRB Policy
on Informed Consent
Respect for Persons: Voluntary Participation and Informed Consent
One of the most important elements in any research involving human research
subjects is the assurance of voluntary informed consent. Any person who is
to be a research subject, whether designed for his/her own direct benefit
or for the advancement of scientific knowledge in general, must understand
as completely as possible what is to be done and what the potential risks
and benefits are. The person must give his/her consent freely, without pressure
or inappropriate inducement. The CC IRB strives to ensure voluntary informed
consent of research subjects through careful review of the recruitment and
consent process, and of the consent form or information sheet to be used
with subjects.
The informed consent concept is extended to those studies in which the subjects
are not able to give personal consent for themselves. Here a permission document
is addressed to those who have been designated responsible for the research
subject’s well being (e.g. parents of children). The IRB’s concern is to
verify that the consent process and permission document are likely to assist
these persons to make an informed decision, which is in the best interest
of the research subject. The capacity for truly informed and voluntary participation
in research varies widely among study populations. The IRB must exercise
special care when considering subjects whose ability to give free and informed
consent may be compromised in any way.
General Principles
Informed consent is one of the primary ethical requirements underpinning
research with human subjects; it reflects the basic principle of respect
for persons. Informed consent seeks to ensure that potential subjects will
understand the nature of the research and can knowledgeably and voluntarily
decide whether or not to participate.
It is important to remember that consent is a process. This process is distinct
from the consent form and involves meeting with a potential subject, finding
out whether he or she is capable of giving consent, and discussing the purpose,
risks, benefits, and alternatives to participation. The consent form formalizes
the agreement to participate and should be designed to document the process.
Obtaining informed consent, therefore, is not just giving a potential subject
a consent form and having them sign it. It starts well before any forms are
signed and continues until the subject's participation is complete.
Investigators must seek consent only under circumstances that provide the
potential subject or the legal representative sufficient opportunity to consider
whether or not to participate and that minimize the possibility of coercion
or undue influence. To achieve understanding of complex or hazardous research,
potential subjects should not be presented information all at once or at
the last minute. People need time to think about whether or not they want
to participate. They may wish to discuss the decision with family or close
friends. They should not feel rushed or coerced. They need time, especially
if the information is disturbing or particularly complex, to digest the information
and come to terms with it.
If consent is to be informed, the subjects must genuinely understand the
research. This means that the information that is given to the subject or
the representative must be readable and in a language understandable to the
subject or the legal representative. Even highly educated people need to
have technical information presented in simple terms. A good rule of thumb
is to write consent forms in “lay language” (no higher than a 7th grade reading
level), in the second person, and in a minimum of 12pt font (a larger font
is recommended for young children and for geriatric populations).
No informed consent, whether oral or written, may include any exculpatory
language through which the subject or the representative is made to waive
or appear to waive any of the subject's legal rights, or releases or appears
to release the investigator, the sponsor, the institution or its agents from
liability for negligence.
Documentation
Informed consent must be appropriately documented, in accordance with, and
to the extent required by 45 CFR 46.117 or 21 CFR 50.27.
1. Informed consent is documented by the use of a written consent form approved
by the IRB and signed and dated by the subject or the subject's legally authorized
representative at the time of consent. A copy of the consent form must be
given to the person signing the form.
2. The consent form may be either of the following:
· a written consent document that embodies the elements
of informed consent. The subject or representative must be given adequate
opportunity to read it before it is signed.
OR
· an abbreviated written consent document ( short
form) stating that the elements of informed consent have been presented orally
to the subject or the subject's legally authorized representative. When this
method is used:
o there must be a witness to the oral presentation; and
o the IRB must approve a written summary of what is to
be orally presented to the subject or representative; and
o the witness must sign both the short form and a copy
of the summary; and the person actually obtaining consent must sign a copy
of the summary; and
o a copy of the summary must be given to the subject or
representative, in addition to a copy of the short form.
Waiver of Informed Consent
[45 CFR 46.116 (c) and (d)]
The IRB may approve a consent procedure which does not include, or which
alters, some or all of the elements of informed consent set forth above,
or waive the requirement for informed consent provided the IRB finds and
documents that:
· the research involves no more than minimal risk
to the subjects and involves no procedures for which written consent is normally
required outside of the research context; and
· the waiver or alteration will not adversely affect
the rights and welfare of the subjects; and
· the only record linking the subject and the research
would be the consent document and the principal risk would be potential harm
resulting from a breach of confidentiality (Note: Subjects must be asked
whether they want documentation linking them with the research, and their
wishes must govern), or the research could not practicably be carried out
without the waiver or alteration; and
· whenever appropriate, the subjects are provided
with additional pertinent information after participation;
or
· the research or demonstration project is to be
conducted by or subject to the approval of state or local government officials
and is designed to study, evaluate, or otherwise examine:
o public benefit or service programs;
o procedures for obtaining benefits or services under those
programs;
o possible changes in or alternatives to those programs
or procedures; or
o possible changes in methods or levels of payment for
benefits or services under those programs;
and
· the research could not practicably be carried
out without the waiver or alteration.
In cases in which the documentation requirement is waived, the IRB may require
that the investigator provide subjects with a written statement regarding
the research. Note that Informed Consent cannot be waived for research involving
FDA-regulated products.
Language Barriers
Researchers should prepare both English language and translated consent forms
for proposals that include non-English-speaking subjects. The IRB may consult
with language experts or require a "back-translation" into English. Investigators
should provide documentation or evidence to verify the accuracy of the translation
and back-translation.
If a non-English-speaking subject is enrolled unexpectedly, researchers may
rely on an oral translation of the English language consent form, but should
take extra care in the informed consent process to ensure that the subject
has understood the project. A statement in the research records (and on the
English language consent form) should indicate that the translation took
place, identify the translator, and document the translator's belief that
the subject understands the study and the consent process. If the subject
is a patient, a note about the translation should be made in the patient's
research records as well. Researchers should try to provide a written translation
of the vital emergency contact information.
Sample Informed
Consent Form
Informed Consent
When conducting assessment of student learning activities, faculty, administrators,
etc. should provide students with "informed consent" information. A
brochure explaining the purpose and benefits of student participation in
assessment activities is available from the office of assessment. Faculty
are welcome to share copies of this brochure with students. Informed
consent information for students is also available on the assessment web
page.
Major components of informed consent should address the following:
Research Purpose: State the purpose of the assessment.
How will results be used? By whom?
Research Procedures: Explain what the student is being
asked to do. How much time will it take? Explain why the student was
selected to participate (because of their enrollment in a course, as a member
of a random sample, etc.)
Benefits: What are the benefits to the student for
participating?
Confidentiality: The informed consent process must describe
the level of confidentiality of the research data and the measures that you
plan to take to ensure that confidentiality is maintained. Describe how you
will protect the participant's privacy. Clearly explain who will have
access to the assessment portfolio, exam, survey, etc. Students should
be assured that their identity will not be disclosed without their permission.
Contact Information: Provide the name(s) of people
who can answer questions about the project, if this information is not obvious.
Focus Group Invitation: Informed Consent
Research Purpose: Since you have almost completed a
year of classes at Concordia College, I am interested in learning about your
experiences as a transfer student. Concordia wants to do a better job
of serving transfer students and you can help us do that.
Research Procedures: You are invited to participate in a
transfer student discussion session. This is your chance to tell us
what Concordia is doing well and what we need to improve. These discussions
will be held at the following times:
Benefits: This is your chance to tell us what Concordia is
doing well and what we need to improve.
Confidentiality: Although I will be taking notes from
today's session, I will not associate your comments with your name.
The summary of our session today will not include any information that will
identify individual students. To further protect your confidentiality,
no one other than myself will know who participated in these focus group sessions.
Contact Information: If I can provide any additional
information, give me a call at 299-4723 or e-mail me at schneide@cord.edu.
Thank you! Sincerely, Kay Schneider, Director of Assessment and Institutional
Research.
Portfolio Assessment Informed Consent form
In order to monitor student progress and to assess student learning outcomes,
_____ majors are asked to maintain a portfolio of coursework. These
portfolios will include samples from the following courses: 222, 333,
and 444. (Additional details are available on the "portfolio instructions"
handout.) (Research Procedures) Portfolio materials will only be used to
assess how effectively _____ majors have met the student learning goals for
the program. We will use this information to determine in what areas
we need to improve our curriculum and in what areas the curriculum enables
students to accomplish learning goals. (Research Purpose) . The portfolio
project will not impact students' grades in any course.
Access to portfolio materials is restricted to faculty in the _______ department
and the department secretary. Portfolio items will not be used for
purposes other than those described above. (Confidentiality)
We need to request your permission to use your portfolio materials in the
manner described above. If you do not want us to use your portfolio
for assessing achievement of student learning goals, please indicate this
below. There is no penalty for refusing permission.
If you would like additional information about this project, please contact:
(Contact Information)
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Please indicate your choice below. Sign and return this form to _______________________________.
____I give my permission for the _______ faculty to use my portfolio to
assess the ____ program as a whole, as described on the _______ department
informed consent form.
____I do not give my permission for the _______ faculty to use my portfolio
to assess the ____ program as a whole, as described on the ____ department
informed consent form.
Name (please print): ___________________
Signature: ______________________
Date: ______________
Note: This consent form does not address the issue of "benefits."
If applicable, this information should be included.
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