________________________________________________________________________
NEBRASKA’S HEALTH SCIENCE CENTER
OFFICE OF REGULATORY AFFAIRS (ORA)
Institutional Review Board (IRB)
ADDENDUM L
Waiver or Alteration of Parental-Guardian Permission and Child Assent
And HIPAA Authorization
SECTION I
DATE:
IRB:
TITLE OF PROTOCOL:
PRINCIPAL INVESTIGATOR:
SECTION II
Instructions: As per HHS regulations at 45 CFR 46.116(d) and the HIPAA Rule at 45 CFR
164.512(i)(2)(ii), as applicable, an IRB may waive the requirements to (1) obtain informed
consent/authorization from parents or guardians (hereafter referred to as “parents”), or (2)
approve a consent procedure which does not include or which alters some or all of the elements
of informed consent/authorization, provided certain conditions are met. FDA regulations have no
similar provision for waiver or alteration of the requirement to obtain consent from parents (also
referred to as “permission”).
The IRB also may waive the requirement for obtainment of parental permission (consent) in
research involving children under the provisions of 45CFR46.408(c). FDA regulations, however,
have no similar provision for waiver of parental permission.
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. Note: The IRB may waive the requirement for obtainment of permission (consent) of
parents for research involving children in accordance with 45 CFR 46.116(d) as described in
this Addendum. The IRB may also grant a waiver under the provisions of 45 CFR 46.408(c). It
is important to note that a waiver under 46.408(c) may apply to research involving greater than
minimal risk, whereas a waiver granted under 46.116(d) applies only to minimal risk research.
A waiver of parental permission for FDA-regulated research is not allowed.
Submit this addendum with the IRB application. This addendum must be completed in order for
the IRB to review the research protocol.
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For waiver of CHILD ASSENT
Complete SECTION A to request waiver because the children lack capacity to provide
assent, or because there is direct benefit to the children which is only available in the
context of the research
Complete SECTION B to request waiver because obtaining consent is impracticable [45
CFR 116(d) and 21 CFR 50.55(d)].
For waiver of PARENTAL PERMISSION
Complete SECTION C to request waiver because obtaining consent is impracticable [45
CFR 116(d)].
Complete SECTION D to request waiver because the research designed for conditions or
for a subject population for which parental or guardian permission is not a reasonable
requirement to protect the subjects.
A. WAIVER OR ALTERATION OF CHILD ASSENT BECAUSE (1) THE CHILDREN
LACK CAPACITY TO PROVIDE ASSENT, OR (2) BECAUSE THERE IS
DIRECT BENEFIT TO THE CHILDREN WHICH IS ONLY AVAILABLE IN THE
CONTEXT OF THE RESEARCH [45 CFR 46.408(C) AND 21 CFR 50.55(C)]
1.
Explain why the capability of some or all of the children is so limited that they
cannot reasonably be consulted [45 CFR 46.408(c) and 21 CFR 50.55(c)].
Note: Based on available developmental literature, the IRB presumes that children
younger than 7 years of age lack the capacity to provide meaningful assent, and
therefore they cannot reasonably be involved in a formal process of assent [45 CFR
46.408(a) and 21 CFR 50.55(c)]. However, depending upon the cognitive ability of an
individual child, the investigator should engage that child in an appropriate discussion
about the research to the extent possible. For children 7 years of age or older, the IRB
presumes that they can reasonably be involved in the assent process unless the
investigator provides an explanation why the children individually or as a group lack
such capacity. The explanation might relate to the children’s underlying disease,
condition, or other relevant factors.
OR
2.
Explain how the intervention or procedure involved in the research holds out a
prospect of direct benefit that is important to the health or well being of the
children and is available only in the context of the research [45 CFR 46.408(c)
and 21 CFR 50.55(c)].
Note: Benefit based waivers should be rare. For example, most drugs being tested in
phase I (toxicity) and II (efficacy) in children have already been tested and approved in
adults, and therefore they are available outside the context of research.
B. WAIVER OR ALTERATION OF CHILD ASSENT BECAUSE OBTAINING
CONSENT IS IMPRACTICABLE [45 CFR 116(D) AND 21 CFR 50.55(D)].
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Explain how the research satisfies the requirements of 45 CFR 46.116(d) and 21 CFR
50.55(d). Note: Address sequentially all the questions in Section C of this form.
Note: Even if assent is waived, the child should be involved in discussions regarding the
research to the extent possible in consideration of age and psychological factors.
Investigators, however, should not invite a child’s decision about study participation unless
they intend to honor that decision. The practice of asking a child for a decision, then
disregarding that decision if it conflicts with the investigator’s or parent’s wish is
disrespectful of the child’s growing autonomy.
If assent cannot be waived under any of the above categories, then a child who fails to
provide assent, or who actively dissents, cannot be enrolled in the research.
C. WAIVER OR ALTERATION OF PARENTAL PERMISSION (CONSENT) AND
HIPAA AUTHORIZATION REQUIREMENTS BECAUSE OBTAINING
CONSENT IS IMPRACTICABLE [45 CFR 46.116(D) AND 45 CFR
164.512(I)(2)(II)]
1. Does the study require a complete waiver of the requirements for informed
consent and HIPAA authorization?
2.
Does the study require an alteration or waiver of one or more of the elements of
informed consent/authorization? If yes, specify the element(s) that will be altered or
waived.
3.
Will informed consent/authorization be waived or altered for all subjects or just a
subset of subjects? If a subset, then describe the characteristics of these subjects.
Note: In some research projects, the waiver of the requirement to obtain parental
consent/authorization is only applicable to a subset of subjects.
4.
Do any of the research-related tests and procedures involve 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 child in the general population) or during the
performance of routine physical or psychological examinations or tests."
Minimal risk is used to define a threshold of anticipated harm or discomfort associated
with the research that is low. The evaluation of whether or not research involves
minimal risk must take into consideration not only the risk associated with interventions
(e.g., a blood draw), but also the risk of violating the privacy of subjects in the case of
unauthorized use or disclosure of PHI. In this case, the determination of whether the
research involves more than minimal risk is also based upon a) the adequacy of the
plan to protect subject identifiers from improper use and disclosure and b) the
adequacy of the plan to destroy the identifiers at the earliest opportunity. A waiver of
consent/authorization 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
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welfare of the subjects. Note: This justification should take into consideration the
“reasonable person” standard; that is, whether or not a reasonable person in the
parent’s position would consider the waiver as adversely affecting the child’s rights and
welfare. For example, a “reasonable person” would probably not object to innocuous
identifiable medical information such as height or weight 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., previous psychiatric treatment,
HIV status, age at first pregnancy). It should also be recognized that in some cultures
any waiving of consent may well be interpreted by the community as adversely
affecting the rights and welfare of members of that community. A waiver of
consent/authorization 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
or alteration 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. For example, 1) the sample size
required is so large (epidemiological studies) 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 be lost to follow-up. Individuals
likely to have relocated or die may be a significant percentage of the proposed subject
population, thus decreasing the statistical power of the study if consent was required.
3) Disclosure of the study purpose would bias the research 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 or 5) There is a risk of inflicting psychological, social, or other harm by
contacting individuals or families with particular conditions. And finally, 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 parental consent could be obtained. A waiver
of consent and authorization is not permitted if the research could practicably be
conducted without a waiver.
7.
If the research is classified as biomedical, explain why the research could not be
practicably carried out without access to and use of the protected health
information (PHI). Note: Biomedical Research involving the collection and use of PHI
is subject to HIPAA requirements. In order for a waiver to be granted, it must be clear
that the research could not be practicably conducted without access to PHI. A waiver
of consent/ authorization is not permitted if the biomedical research could be
practicably conducted without access to the PHI
8.
If the research is classified as biomedical, describe the plan to protect subject
identifiers from improper use and disclosure. Note: In order for a waiver to be
granted, there must be an adequate plan to protect confidentiality of research data
which contains PHI. It is important that the data contain as few of the 18 HIPAAspecified subject identifiers as possible. This section may be answered by referencing
the information in Section II.15 of the Biomedical Application or Sections II.10-18 of the
Medical Records Research application. A waiver of consent/authorization requires
an adequate plan to protect data which contains subject identifiers from
improper use and disclosure as a result of a breach of confidentiality.
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9.
If the research is classified as biomedical, provide written assurance that the PHI
collected and used in this research will not be reused or disclosed to any other
person or entity, except as required by law or for authorized oversight of the
research. Note: This section should include a brief assurance attesting to compliance
with the above-specified HIPAA requirement for a waiver. A waiver of
consent/authorization in biomedical research cannot be granted without this
assurance.
10. Will parents be provided with additional pertinent information after their child’s
participation? If yes, describe what information will be shared, and when and how
subjects will be informed. If 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 parent 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, information
which becomes available during the course of research which has direct medical
relevance to the subject would generally be considered “pertinent” and should,
therefore, be disclosed to subjects that can be contacted. A waiver of
consent/authorization can be granted only if the subject is provided with
additional pertinent information whenever appropriate.
D. WAIVER OR ALTERATION OF PARENTAL PERMISSION (CONSENT)
BECAUSE THE RESEARCH IS DESIGNED FOR CONDITIONS OR FOR A
SUBJECT POPULATION FOR WHICH PARENTAL OR GUARDIAN
PERMISSION IS NOT A REASONABLE REQUIREMENT TO PROTECT THE
SUBJECTS [45 CFR 46.408(C)].
1.
Is the research designed for conditions or for a subject population for which
parental or guardian permission is not a reasonable requirement to protect the
subjects? If yes, provide rationale. Note: The following is an example which may
justify a waiver: The research is important to the health and well-being of adolescents
and the subjects are capable of understanding informed consent at an adult level. For
example, the research involves testing for sexually transmitted diseases, asking female
subjects about their sexual practices, and use of birth control. Such procedures are
reasonably commensurate with routine gynecologic services that the adolescents are
permitted by law to receive without parental permission.
2.
Is there an appropriate mechanism in place for protecting the children who will
participate as subjects in the research? Explain. Note: The choice of an
appropriate mechanism depends upon the nature and purpose of the research
activities, the risks and anticipated benefit to the subjects, and their age, maturity,
status, and condition. For example, the appointment of an advocate who can act in the
best interests of the child, provisions for referral to counseling, or other safeguards may
be necessary
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