________________________________________________________________________
NEBRASKA’S HEALTH SCIENCE CENTER
OFFICE OF REGULATORY AFFAIRS (ORA)
Institutional Review Board (IRB)
ADDENDUM J
Waiver or Alteration of Informed Consent and HIPAA Authorization
In Biomedical 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), the equivalent section
of the Common Rule adopted by other federal departments or agencies, and the HIPAA Privacy
Rule, 45 CFR 164.514(b)(2)(i) as applicable, the IRB may waive the requirements to obtain
informed consent/authorization, or 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 consent.
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 45 CFR 46.116(d) or
45CFR46.408(c). FDA regulations, however, have no similar provision for waiver of parental
permission. 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. 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.
1.
Does the study require a complete waiver of the requirements for informed consent
or HIPAA authorization?
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Yes
No
2.
Does the study require an alteration or waiver of one or more of the elements of
informed consent or HIPAA authorization?
No
Yes. Specify the element(s) that will be altered or waived.
3.
Does the study require a waiver or alteration of the process of consent or HIPAA
authorization?
No
Yes. Describe the proposed altered process of consent.
Note: In some research projects it may be appropriate to only obtain verbal consent via
the telephone because prospective subjects do not live close to the study and transmittal
of a consent form via fax, e-mail or mail is not feasible or necessary to protect human
subjects.
Another example might be the situation where a clearly competent patient entering the ER
for treatment is asked to verbally consent to provide a extra blood sample for research
because it would not be in the patient’s best interests to either obtain written consent or
use an unsigned consent form either before or during the treatment.
4.
Will informed consent/authorization 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.
5.
Do any of the research-related tests and procedures involve more than minimal risk
to the subject?
No
Yes
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 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.
6.
Explain how the waiver or alteration will not adversely affect the rights and welfare of
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the subjects.
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 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.
7.
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 died may be a significant percentage of the
proposed subject population, thus decreasing the statistical power of the study if
informed consent was required.
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, or
4) There is a risk of inflicting psychological, social, or other harm by contacting
individuals or families with particular conditions.
5) Because of the nature of the research and/or circumstances of the prospective
subject, there is not sufficient time to obtain consent. For example, a study involves
interviewing emergency room patients. The interview consists of sensitive
questions. There is not enough time to obtain written consent in this case. Verbal
consent may be acceptable.
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 consent could be obtained. A waiver of
consent/authorization is not permitted if the research could practicably be
conducted without a waiver.
8.
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 research
could be practicably conducted without access to the PHI.
9.
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
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confidentiality of research data which contains PHI. It is important that the data contain as
few of the 18 HIPAA-specified 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.
10. 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 abovespecified HIPAA requirement for a waiver. A waiver of consent/authorization cannot be
granted without this assurance.
11. 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 the research is
completed. In this situation, it may be ethically required or determined to be respectful
to provide the subject with pertinent information pertaining to their participation in
research under the waiver of consent/authorization granted by the IRB. When this is
the case, the subject must be presented with an informed consent form (ICF) for
continued participation in the research. The ICF must include a provision for the
subject to withdraw their data and/or samples from use in research should they
choose not to participate.. Use of the reasonable person standard can help assess
when and how this criteria should be satisfied. A waiver of consent/authorization
can be granted only if the subject is provided with additional pertinent
information whenever appropriate.
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