________________________________________________________________________
NEBRASKA’S HEALTH SCIENCE CENTER
OFFICE OF REGULATORY AFFAIRS (ORA)
Institutional Review Board (IRB)
ADDENDUM Y
Research Involving Adults as Subjects
Participating in a Pediatric Trial
SECTION I
DATE:
IRB #
TITLE OF PROTOCOL:
PRINCIPAL INVESTIGATOR:
SECTION II
INSTRUCTIONS: Research involving children must comply with 1) HHS regulations at 45 CFR
46, Subpart D in accordance with HRPP policy, and 2) FDA regulations at 21 CFR 50, Subpart
D, as applicable. Subpart D provides additional protection for children enrolled in research
because they are considered to be a vulnerable subject population.
This addendum application is designed to assist the investigator in developing the
documentation necessary to verify compliance with Subpart D. All questions should, therefore,
be completely addressed by consulting this section of the regulations which can be accessed at
the IRB web site: http://www.unmc.edu/irb.
This addendum should be submitted with the IRB application. To determine if the research is
approvable under the applicable regulations, the investigator must provide thorough and
complete responses to the questions below. This addendum must be completed in order for the
IRB to review the research protocol. Information should be provided by site for all studies
involving more than one site for which the UNMC IRB or PedsIRB is the only IRB of record.
ADDITIONAL INFORMATION REQUIRED
1.
What is the justification for including adults in research?
2.
What is the age range of the adult subjects to be included in the research?
Note: The lower and upper end of the age range must be stated.
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3.
What is the rationale for the age range of the subjects?
Note: Participation of adult subjects in research should be age-restricted unless there is
scientific and/or medical justification. The age of majority in Nebraska is 19 years of age.
4.
Capacity to Consent
a. At the time of initial consent, will all subjects have the capacity to give informed
consent?
Yes
No. Complete Addendum E.
b. Is there a reasonable likelihood that some subjects may lose the capacity to
continue to provide informed consent during the course of the study?
No
Yes. Complete Addendum E.
Note: When a research protocol is not designed with the intent to enroll decisionallyimpaired individuals but there is, nevertheless, a reasonable likelihood that some
subjects could lose the capacity to continue to provide valid informed consent during
the study (i.e., participation in an ongoing consent process), the investigator should
utilize the IRB “Assessment of Capacity to Consent to Participate in Research Form”
(available on the IRB website, www.unmc.edu/irb). This form is designed to assist the
investigator in determining whether or not the subject has the capacity to consent. If a
subject lacks that capacity, an LAR must provide consent in order for the subject to
continue participating in the research.
5.
Process of Informed Consent for Competent Adult Subjects
a. When will the prospective subject be approached relative to their actual
participation in the study?
Note: Prospective subjects should be approached sufficiently far in advance of their
involvement in research to enable them to have time to make an informed decision to
participate in the study. This helps minimize the possibility of coercion or undue
influence.
b. What is the location where informed consent will be obtained, and how will the
environment be conducive to discussion and thoughtful consideration?
Note: The environment where informed consent will be obtained should be a private
and quiet location, conducive to discussion and thoughtful consideration by the
prospective subject with consideration given to the need to minimize the possibility of
coercion or undue influence.
c. Who will be involved in the process of consent and what are their
responsibilities?
Note: This section should identify by name and describe the specific responsibilities of
research personnel who will be involved in the process of consent (e.g., explanation of
the research, demonstration of a procedure…). Individuals involved in the process of
consent should take all necessary steps to minimize the possibility of coercion or
undue influence. In addition, no exculpatory language should be used which suggests
or implies in any way the subject is waiving any of their legal rights or appears to
release the investigator, sponsor, or the institution from liability for negligence.
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d. How much time will be allotted to the process of consent?
Note: The amount of time allotted to the process of consent is dependent upon the
nature and complexity of the study and the need to minimize the possibility of coercion
or undue influence. In some studies (e.g., complex or risky research) a delayed
consent procedure should be incorporated into the protocol in order to afford the
subject, or subject’s representative, an opportunity to discuss participation in the study
with family, friends, counselors, or other confidants before they sign the consent form.
In all cases subjects should be encouraged to take the consent form home before
signing whenever they are uncomfortable about participation in the research.
e. How will the process of consent be structured for subjects who are likely to be
more vulnerable to coercion or undue influence?
Note: Subjects such as those who are educationally disadvantaged, have limited
reading skills, are economically disadvantaged, or are disabled may be vulnerable to
coercion or undue influence to participate in research. Additional protections during
the process of consent may include but are not limited to appointment of a subject
advocate, involvement of the subject’s family or friends, use of a short form (verbal)
consent, reading the consent to the subject, and use of teaching aids.
f.
How will you obtain consent from a non-English speaking subject?
Note: Use of an interpreter is allowed for a limited number of non-English speaking
subjects. However, if it is anticipated that a substantial number of subjects will not
speak English, a translated consent form should be used. Translated consent forms
must be back-translated for assessment of the accuracy of the translation. Assent
forms are not required to be routinely translated; documentation of assent can be
added to the parental consent form in lieu of translation with IRB approval.
g. How will it be determined that the subject understood the information
presented?
Note: All investigators have a legal and an ethical obligation to ensure that the
prospective subject has sufficient knowledge and comprehension of all of the elements
of informed consent to enable him/her to make an informed and enlightened decision
whether or not to participate or allow participation in research. The fact that an
individual is prepared to sign the informed consent form and has no unanswered
questions does not necessarily represent sufficient evidence of an adequate level of
comprehension. Some investigators, therefore, choose to determine the level of a
person's comprehension by questioning the individual concerning his/her
understanding of all the elements of informed consent. This section should clearly
document that the investigator has an adequate plan in place to assure existence of an
acceptable level of comprehension of all the elements of consent.
h. Will there be a formal process of on-going re-consent (over and above reconsent associated with changes in protocol)?
No
Yes. Describe.
Note: HRPP policies, federal regulations and sound ethical practice require that
subjects have the opportunity to withdraw from the research at any time. In certain
cases, it may be appropriate to seek active re-consent from subjects. A subject's
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preferences and interests may change over time, even in the absence of material
changes in the research protocol. Therefore, investigators should consider obtaining
re-consent, or at least reaffirmation of the subject's willingness to continue participation
on a routine basis. In most cases, such re-consent need only be verbal agreement on
the part of the subject after questioning by the investigator or research team member.
In rare cases, more formal re-consent (for example, quarterly or at the time of each
research intervention) may be appropriate
6.
Consent and Assent Forms
Indicate the type of consent and assent forms to be used in this research:
Adult consent form
Legally authorized representative (LAR) consent form
Adult assent form
Screening consent form
Addendum consent form
Other:
Note: Consent and assent forms must conform to the IRB-required format and reading
level. Refer to the model consent and assent forms.
7.
Waiver or Alteration of Informed Consent
Is a waiver or alteration of consent requested?
No
Yes. Complete Addendum J.
Note: The IRB seldom waives the requirement for informed consent in Biomedical
Research. However, under certain limited circumstances, as defined by HHS regulations
at 45 CFR 46.116(d) and the HIPAA Privacy Rule as applicable, an 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. The IRB may also
waive the requirement for obtaining parental or guardian permission in research involving
children under the provisions of 45 CFRF 46.408(c).A waiver or alteration of informed
consent is not permitted in FDA-regulated studies except for emergency research where
an exception is granted by the IRB under the provisions of 21 CFR 50.24. If an
investigator intends to conduct emergency research, HRPP policy #6.050 should be
consulted and all requirements addressed in sequence in an addendum to this application.
8.
Waiver of a signed consent form
Is a waiver of the requirement to obtain a signed consent form requested?
No
Yes. Complete the Addendum M.
Note: 45 CFR 46.117(c) permits the IRB to waive the requirement for a signed consent for
some or all subjects if it finds either 1) the only record linking the subject with the research
would be the consent document and the principal risk would be a potential harm resulting
from a breach of confidentiality. In this case each subject must be asked whether they
want documentation linking them with the research and the subject’s wishes will govern, or
2) the research presents no more than minimal risk of harm to subjects and involves no
procedures for which written consent is normally required outside of the research context.
FDA regulations at 21 CFR 56.109(c) permit the IRB to waive signed consent only if the
research satisfies #2 above.
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