Instructions: Addressing the Criteria for a Waiver of Consent/Authorization
A waiver of consent/authorization is a request to involve human participants and/or their data
without obtaining written informed consent and/or authorization from each participant. This
applies to studies that are obtaining no informed consent, verbal informed consent, or
accessing/collecting PHI for the study prior to the informed consent process.
It is a misconception that retrospective chart reviews “don’t require informed consent”!!
PLEASE NOTE: This guide is being provided to help investigators understand the
rationale behind the regulatory criteria that must be addressed in order for the
IRB/Privacy Board to grant a waiver of written informed consent and/or authorization.
The samples given below should not be copied and pasted into the Research
Application. You must address the criteria as they pertain to your specific research
study. Research Applications will be rejected back to the submitter upon HRPP prereview if the waiver request includes inappropriate or inadequate answers.
The IRB reviews all requests to conduct research without written informed consent and
authorization. In order to approve requests for a waiver of consent/authorization the 5 following
statements must be adequately justified:
1) This research involves no more than minimal risk to participants.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in daily life or
during the performance of routine physical or psychological examinations or tests. Risks to
consider include not only potential physical harm, but risks to privacy and confidentially such
as the chance that sensitive information about the individual may be damaging if wrongfully
disclosed. Minimal risk applies to retrospective studies as well as prospective studies.
Please describe how this research activity involves no more than minimal risk to participants.
Be sure to include the following:
 Any potential risks to the subject for participating
 What PHI will be used or disclosed
 Who will have access to the PHI
 The plan to protect PHI from improper use and disclosure
 The plan to destroy identifiers at the earliest time possible.
 If identifiers must be maintained for longer than the life of the study, please include
justification.
Sample Answers:
 “This retrospective study involves the collection of PHI to ensure data integrity.
Identifiers collected are name, date of birth, and medical record number. The data
will be stored electronically in a restricted access network folder and will only be
accessible to the research team and qualified clinical care givers. All members of the
research team are part of Hartford Hospital’s workforce. No data will be disclosed for
this activity. The information collected does not include information that may be
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Instructions: Addressing the Criteria for a Waiver of Consent/Authorization
damaging to the individual should it be wrongfully disclosed. The master list
containing PHI will be destroyed upon the completion of data collection.”

“This is a retrospective chart review and involves the use of PHI to ensure data
integrity and to match mother/infant pairs in the database. Name, date of birth and
medical record number, and dates of service will be collected, and used to generate
a database that contains only de-identified data. Data sheets used in the collection
of PHI and generation of the database will be destroyed after generation of the
database. All data analysis will be performed using only the de-identified database.
No data will be disclosed from the study. The information collected from the charts
would not be expected to be damaging should wrongful disclosure occur. The
database will be maintained in a password protected file on a computer with limited
access.”
2) This research could not be conducted without waiving or altering the
consent/authorization process.
Written informed consent/authorization should be obtained from each individual whenever
possible. Sometimes this is not feasible, such as when all patients have left the hospital. In
such cases a waiver of consent may be appropriate. Concern that patients will choose not to
participate is not reason enough to waive the informed consent requirement. The additional
time and costs associated with the informed consent process are not considered adequate
justification for demonstrating that informed consent is not feasible. Please explain why the
research could not be conducted without the waiver.
Sample Answers:
 “This research study requires comparing all emergency room admissions last year
for head trauma to determine if the severity of injury had an impact on length of stay.
All patients with a head trauma last year must be included in the data set to insure
valid data. Requiring written informed consent would limit the data set to individuals
we are able to contact which would potentially skew the data.”

“The retrospective chart review involves outcomes for very low birth weight infants.
In order to study neonatal mortality it is necessary to review charts going back for 10
years, and it is imperative to acquire information regarding all infants. Losing even a
small proportion of the cases due to inability to obtain consent (i.e. due to inability to
locate and contact individuals after a length of time) will significantly and adversely
impact the study, and invalidate the results.”
3) This research requires access to and the use of Protected Health
Information to conduct the study.
HIPAA requires that the minimum necessary standard be followed. This means collecting the
least amount of information needed to complete the task. If you are able to conduct the
research without collecting any, or very few, individual identifiers, this will make complying with
the HIPAA requirements easier.
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Instructions: Addressing the Criteria for a Waiver of Consent/Authorization
Identifiers may be necessary for obtaining information from multiple sources or for the on-going
collection of study data. In these cases it is important to utilize a unique identifier in order to
maintain data integrity. Please explain why access to or the use or disclosure of PHI is
necessary for this study.
Sample Answers:
 “This research activity requires matching data from four different sources. Name,
medical record number, and date of birth are essential to ensure that the data is
collected for the same individual.”

“The study requires matching information from the mother's chart with information
from the infant's chart for each maternal/infant pair for generation of the database.
PHI will be collected transiently, and used during the generation of the database for
the purpose of linking information from maternal and infant charts into mother/infant
pairs. Once this data is linked, the database will consist only of de-identified data--no
PHI will be retained in the database. No PHI will be used in analysis of the data.
Preliminary data sheets with PHI will be shredded once the de-identified data is
entered into the database. PHI will not be maintained in the database--it will contain
de-identified data only.”
4) This waiver or alteration will not adversely affect the rights and
welfare of the subjects.
It is important that research participants be given every opportunity to make informed decisions
about participating in a research activity. The informed consent process is a key component to
informing potential participants about what participation will involve and the potential risks and
benefits. The IRB must determine whether waiving or altering the informed consent process
will not adversely affect the rights or welfare of the subjects.
Please explain how the waiver/alteration will not have an adverse affect on the participants’
rights and welfare.
Sample Answers:
 “This is a retrospective study evaluating patient outcomes after surgery. No data will
be disclosed to another institution and all identifiers linking to the patient will be
destroyed after data collection is complete. There is no prospective participant
involvement or observation involved with this research activity.”

“This is a retrospective chart review. All identifiers linking the data to individual
patients will be destroyed after data collection. No data will be disclosed to another
institution. De-identified data from 3 different institutions will be combined into a
single database for analysis after PHI is removed from the database. There is no
prospective participant involvement or observation in this study.”
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Instructions: Addressing the Criteria for a Waiver of Consent/Authorization
5) The research participants will be provided with additional pertinent
information after participation, when appropriate.
Sometimes it is necessary not to provide full disclosure at the start of the research study
because full disclosure may bias the study. In these cases it is important to provide full
disclosure to the participant after his/her participation is complete. In other cases significant
clinical findings may warrant informing participants after participation.
Sample Answers:
 “The study is a retrospective chart review. The data available include only that
information which is already ascertainable from patient charts. In addition, since all
data will be de-identified, no information will be shared with the subjects subsequent
to the study.”
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