APPLICATION/CERTIFICATION FOR USE AND DISCLOSURE
OF
PROTECTED HEALTH INFORMATION FOR RESEARCH
REQUESTING A WAIVER OF AUTHORIZATION
1. Name(s) of Investigator(s)
Department(s) of Investigator(s)
____________________________
_____________________________
____________________________
_____________________________
____________________________
_____________________________
____________________________
_____________________________
____________________________
_____________________________
2. Location and brief description of the Protected Health Information
[] UNTHSC Clinic Records _________________________________________
[] UNTHSC Research Records _______________________________________
[] UNTHSC Other Records (specify) __________________________________
[] OMCT Medical Records (specify) ___________________________________
[] OMCT Other Records (specify) _____________________________________
[] Other (specify)___________________________________________________
3. The investigator(s) seeks the use or disclosure of Protected Health Information
(PHI) located at sites indicated in #2, (check one):
[] Solely for Research on PHI of Decedents
(The investigator will be prepared to provide documentation of the individual’s
death)
[] Solely to review PHI to prepare a research protocol or for similar
purposes preparatory to research
(The investigator will not remove any PHI from UNTHSC or OMCT in the course
of the review)
[] To use or disclose existing PHI for other research purposes and
is requesting a waiver of consent and authorization.
4. How many individual patient records will you access for this protocol?
5. State how you will identify protected health information in your research
records? (i.e.: name of subjects, coded identifier, etc)
6. Will you be sharing PHI with anyone outside of UNTHSC or OMCT? __yes
__no
If yes, what PHI will be shared and how will it be identified? (i.e: name
of subjects, coded identifiers, etc.) ________________________________________________
[NOTE: If the PHI is shared outside of UNTHSC ot OMCT, additional documentation
may be necessary to account for the disclosure(s). Furthermore, the
sharing of PHI outside of UNTHSC or OMCT may require the outside party to
comply with federal requirements (HIPAA).]
7. Will the PHI you access and record include any of the following elements
(check all that apply)?
[] Patient/Subject Name
[] Device identifiers and serial numbers
[] Postal address information, other
[] Web Universal Resource Locators
than town or city, State & zip code
(URLs)
[] Telephone numbers
[] Biometric identifiers, including finger
[] Fax numbers
and voice prints
[] Electronic Mail addresses
[] Internet Protocol (IP) address numbers
[] Social Security Number
[] Full face photographic images and any
[] Medical record numbers
comparable images
[] Health plan beneficiary numbers
[] Account numbers
[] Certificate/license numbers
[] None of the above
[] Vehicle identifiers and serial
numbers, including license plate
numbers
8. State how the PHI will be protected from improper use and disclosure:
____________________________________________________________________________________________________________________________________
9. When will you destroy the PHI? (Be specific; state a date or event, such
as following data analysis, following publication, completion of protocol)
___________________________________________________________________
___________________________________________________________________
10. To justify a waiver of the requirement to seek informed consent and/or
HIPAA authorization from the subjects, you must be able to answer “YES” to
items (a)-(f) below. Insert explanations that support your request
for waiver.
a) Will the research involve no greater than minimal risk
to subjects or to their privacy? 0 yes 0
no
(Minimal risk means that the probability and magnitude of harm or discomfort
anticipated in the research are not greater than those ordinarily encountered
in daily life or during the performance of routine physical or psychological
examinations or tests.)
b) Is it true that the waiver will not adversely affect
the rights and welfare of subjects? 0 yes 0
no
(Consider the right of privacy and possible risk of breach of confidentiality
in light of the information you wish to gather.)
c) Is the risk to privacy reasonable in relation to benefits
to be gained or the importance of 0 yes 0
no
the knowledge to be gained?
d) Would the research be impracticable without the waiver?
0 yes 0 no
(If you checked “yes,” explain how the requirement to obtain consent would
make the research impracticable, e.g. are most of the subjects lost to follow-up
or deceased?).
e) Would the research be impracticable if you could not
record protected 0 yes 0 no
health information (PHI)?
(If you checked “yes,” explain how not recording PHI would make the research
impracticable).
f) When appropriate, do you have plans to provide subjects with pertinent
information 0 yes 0 no
after their participation is over? (e.g. Will you
provide details withheld during consent, or tell them if you found information
with direct clinical relevance for the subjects? This may be an uncommon
scenario)
I certify that the above information is correct, that it will apply throughout
the performance of the proposed research and that I will be responsible for
safeguarding the confidentiality of the human subjects who are involved.
I am aware of the confidential nature of the information obtained for the
purposes of this research. No protected health information (PHI) from
this research will be shared with or disclosed to others, for purposes other
than conducting the research as described above.
Printed Name: _______________________________________________
Signature: __________________________________________________
Date: ______________________________________________________
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