________________________________________________________________________
NEBRASKA’S HEALTH SCIENCE CENTER
OFFICE OF REGULATORY AFFAIRS (ORA)
Institutional Review Board (IRB)
ADDENDUM K
Waiver or Alteration of Informed Consent in
Social Science and Behavioral Research Involving Adult Subjects
SECTION I
DATE:
IRB #
TITLE OF PROTOCOL:
PRINCIPAL INVESTIGATOR:
SECTION II
Instructions: In accordance with HHS regulations at 45 CFR 46.116(d), 45 CFR 46.116(c), and
equivalent sections of the Common Rule as adopted by other federal departments or agencies, the
IRB may waive the requirements to obtain informed consent, or approve a consent procedure which
does not include or which alters some or all of the elements of informed consent, provided certain
conditions are met.
If the research involves children, the IRB may waive the requirement for obtainment of parental
permission (consent) in research involving children under the provisions of either 45 CFR 46.116(d)
or 45CFR46.408(c). Requests for waivers of parental permission or child assent must be addressed
by completing Addendum L: Waiver or Alteration of Parental/Guardian Permission/Child Assent and
HIPAA Authorization.
Submit this addendum with the IRB application. To determine if a waiver/alteration of
consent/authorization is allowable under the applicable regulations, the investigator must provide
thorough and complete responses to the attached questions. This addendum must be completed in
order for the IRB to review the research protocol.
A. WAIVER OR ALTERATION OF INFORMED CONSENT REQUIREMENTS UNDER 45
CFR 46.116(D) FOR SOCIAL SCIENCE AND BEHAVIORAL RESEARCH
1. Does the study require a complete waiver of the requirements for informed consent?
No
Yes
2. Does the study require an alteration or waiver of one or more of the elements of
consent?
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No
Yes. Specify the element(s) of informed consent that will be altered or waived.
3. Will informed consent be waived or altered for all subjects or just a subset of subjects?
All subjects
A subset of subjects. Describe the characteristics of these subjects.
Note: In some research projects, the waiver of the requirement to obtain informed
consent is only applicable to a subset of subjects.
4. Provide a complete description of all the research related tests and procedures, and
explain how each involves no more than minimal risk to the subject.
Note: Minimal risk means "The probability (of occurrence) and magnitude (seriousness) of
harm or discomfort (e.g., psychological, social, legal, economic) associated with the research
are not greater than those ordinarily encountered in daily life (of the average person in the
general population) or during the performance of routine physical or psychological
examinations or tests." Minimal risk, therefore, is used to define a threshold of anticipated
harm or discomfort associated with the research that is low. A waiver of consent is not
permitted if the research is more than minimal risk.
5. Explain how the waiver or alteration will not adversely affect the rights and welfare of
the subject.
Note: This justification should take into consideration the “reasonable person” standard; that is,
whether or not a reasonable person in the subject’s position would consider the waiver as
adversely affecting his/her rights and welfare. For example, a “reasonable person” would
probably not object to innocuous identifiable information (e.g., number of children, automobile
preference) being entered into a database without their knowledge or consent. The same
reasonable person might, however, object if the identifiable information was sensitive (e.g.,
number of divorces, age at first pregnancy).
It should also be noted that the Family Education Rights and Privacy Act (FERPA; 20 U.S.C.
§1232g; 34 CFR Part 99) is a federal law that protects the privacy of personally identifiable
information contained within a student’s educational record. FERPA applies to all schools (K-12
and postsecondary institutions) that receive funds under various programs from the U.S.
Department of Education. Generally, schools must have written permission from the student (or
parent if the student is a minor) in order to release any information from a student’s education
record unless it meets some of the specified criteria for which release is allowed. (For example
studies conducted by organizations for or on behalf of the school). Other than this exception, if an
investigator from a local university’s college of education requests a waiver of consent to review
the educational records (grades and GPA) of students at the university for the past 20 years and
maintain identifiers for a research project, the rights granted to students under the federal
legislation of FERPA would be violated and this condition could not be met. A waiver of consent is
not permitted if the waiver will adversely affect the rights and welfare of the subjects.
6.
Explain why the research could not be practicably carried out without the waiver
of consent.
Note: In some research projects it would not be practicable to perform the research (as it has
been defined in the application by its specific aims and objectives) if informed consent was
required. Examples may include:
1)The sample size required is so large (studies involving public records) that include only those
samples/records/data for which consent could be obtained would prohibit conclusions to be drawn
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or bias the sample such that conclusions would be skewed;
2) The subjects for whom records would be reviewed may have moved with no forwarding
address;
3) Disclosure of the study purpose would bias the research subjects so that study results are not
meaningful;
4) There is a risk of creating additional threats to privacy by having to link otherwise de-identified
data with nominal identifiers in order to contact individuals to seek consent;
5) There is a risk of inflicting psychological, social, or other harm by contacting individuals or
families with particular conditions, or
6) The study does not qualify for a waiver of signed consent under 45 CFR 46.117(c)(1) since
subject identifiers must be maintained in order to complete the research. However, subjects will
not participate if they are required to sign a consent form due to concern about protection of
confidentiality. In this case, verbal consent would be obtained and documented in the study
records.
It should be noted that, in general, investigator inconvenience or cost does not determine
"impracticality" and there should be a clear rationale why the research could not be conducted
with a population from whom consent could be obtained. A waiver of consent is not permitted if
the research could practicably be conducted without a waiver.
7.
Will subjects be provided with additional pertinent information after participation?
Yes. Describe what information will be shared, and when and how subjects will
be informed.
No. Provide justification.
Note: In general, this criterion is designed to address de-briefing after research is conducted.
In these situations, it may be ethically required or determined to be respectful to provide the
subject with pertinent information after the research is complete. Use of the reasonable
person standard can help assess when and how this criteria should be satisfied. For
example, research involving a deception strategy would generally require disclosure of
pertinent information. A waiver of consent can be granted only if the subject is provided with
additional pertinent information whenever appropriate.
B. WAIVER OR ALTERATION OF INFORMED CONSENT REQUIREMENTS UNDER 45
CFR 46.116(C) FOR SOCIAL SCIENCE AND BEHAVIORAL RESEARCH
1.
Is the research or demonstration project to be conducted by or subject to the
approval of state or local government officials?
No
Yes. Specify the type of research from the following categories:
Public benefit of service programs
Procedures for obtaining benefits or services under public benefit of service
programs
Possible changes in or alternatives to those programs or procedures
Possible changes in methods or levels of payment for benefits or services
under those programs
2.
Explain why the research could not be practicably carried out without the waiver of
consent.
Note: In some research projects it would not be practicable to perform the research (as it has
been defined in the application by its specific aims and objectives) if informed consent was
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required. For example, 1) the sample size required is so large (studies involving public
records) that including only those samples/records/data for which consent could be obtained
would prohibit conclusions to be drawn or bias the sample such that conclusions would be
skewed; 2) the subjects for whom records would be reviewed may have moved with no
forwarding address; 3) there is a risk of creating additional threats to privacy by having to link
otherwise de-identified data with nominal identifiers in order to contact individuals to seek
consent; 4) there is a risk of inflicting psychological, social, or other harm by contacting
individuals or families who are participating in public benefit programs (e.g., Medicaid); or 5)
disclosure of the exact purpose of the study would bias subject participation and invalidate
study results. It should be noted that, in general, investigator inconvenience or cost does not
determine "impracticality. A waiver of consent is not permitted if the research could
practicably be conducted without a waiver.
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