Institutional Review Board at Tallahassee Memorial HealthCare, Inc.
Application for Approval of Retrospective Chart Review Research
THIS FORM MUST BE TYPED
HAND WRITTEN FORMS WILL NOT BE ACCEPTED.
IRB #:
Study Title:
(This could be a university, commercial sponsor, etc.)
Name of Principal Investigator:
(If this is a TMH only study, put the PI name here OR if this is a Multicenter Study, put the sponsor PI/Clinical Research Scientist name
here & the TMH PI name as the Intramural PI.)
Email:
Name of Intramural Principal Investigator (PI) at TMH:
Address:
Phone:
Fax:
Address:
Phone:
Fax:
Email:
Research Coordinator:
Phone #:
Email:
Fax:
Detail current funding sources, awards, grants (if applicable):
For projects that receive or have submitted application for federal funding, submit one complete copy
of the grant/continuation application/NIH Progress Report applicable to this study.
List the names of key personnel on this protocol. Indicate those who are obtaining informed consent from subjects.
Attach Human Subject Protection (HSP) Training certificate and a Resume/CV indicating the individual’s qualifications to
conduct research.
Obtaining
Informed
Consent
Name
(Complete this Section for New Studies Only)
HSP
Certificate
Resume/CV
Attached
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Proposed Start Date:
Funding source, if any:
If this is to be funded by a grant, attach a complete copy of the application.
1. What is the purpose of the study (protocol summary)?
2. Source of medical information that will be reviewed/studied (Check all that apply):
Entire Medical Record
Laboratory Results
Pathology Records
Radiology Records
Nursing Recourses
Billing Records (to determine cost/benefit)
Human Resources (employee/contractor info)
Survey/Questionnaires/Interviews
Organizational Improvement and Planning (special data reports to facilitate study)
Information Technology- (TMH information technology resources)
IRB Form 4d Rev. 4/13
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Institutional Review Board at Tallahassee Memorial HealthCare, Inc.
Others (Describe):
Please check that applies:
N/A
Research Qualifying for Expedited Review –
“Stop” Indicates Full Board Review Necessary
Research may qualify for expedited review if it: a) involves no more than minimal risk AND b) meets the following test of
eligibility. Research qualifying for expedited review may require written informed consent. Inclusion on this list merely
means that the activity may be eligible for review through the expedited review procedure when the specific
circumstances of the proposed research are considered it may be determined that a higher level of review is necessary.
Check the relevant boxes:
Yes-Stop
No Does this research project include abortuses, children (<18 years of age), decisionally impaired
persons, educationally/economically disadvantaged, employees, fetuses, human in vitro
fertilization, institutionalized persons, pregnant women, prisoners, students neonates, or any
population that would be considered vulnerable?
Yes-Stop
No Is it anticipated that any part of your research project will present more than the probability and
magnitude of harm or discomfort is greater in and of itself than any ordinarily encountered in daily
life or during the performance of routine physical or psychological examinations or tests?
Could identification of the subjects and/or their responses reasonably place them at risk of
Yes-Stop
No criminal or civil liability or be damaging to the subjects’ financial standing, employability,
insurability, reputation, or be stigmatizing?
Will reasonable and appropriate protections be implemented so that risks related to invasion of
Yes
No-Stop
privacy and breach of confidentiality is no greater than minimal?
Yes-Stop
No Does your research project involve classified human subjects research?
All of the human subject research in your project falls into one or more of the following expedited
Yes
No-Stop
review categories? (Check all that apply from the following list describing the eligible categories.)
This category encompasses some clinical studies of drugs and medical devices (investigational
new drugs or investigational new devices/equipment).
Is an investigational new drug application (21 CFR Part 312) required to
conduct this study?
Does the research on the marketed drug significantly increase the risks or
Yes-Stop
No decrease the acceptability of the risks associated with the use of the
product?
Is an investigational device exemption application (21 CFR Part 812)
Yes-Stop
No
required to conduct this study?
Is the medical device cleared/approved for marketing and being used in
Yes
No-Stop
accordance with its cleared/approved labeling in this study?
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
Yes-Stop
Category 1
No
a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subject, the
amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur
more frequently than 2 times per week; or
Category 2
Category 3
IRB Form 4d Rev. 4/13
b) from other adults and children, considering the age, weight, and health of the subjects, the
collection procedure, the amount of blood to be collected, and the frequency with which it will
be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml
per kg in an 8 week period and collection must not occur more frequently than 2 times per
week.
Prospective collection of biological specimens for research purposes by non-invasive means.
(Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of
exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine
patient care indicates a need for extraction; (d) excreta and external secretions [including sweat];
(e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing
gumbase or wax or applying a dilute citric solution to the tongue; (f) placenta removed at
delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during
labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is
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Institutional Review Board at Tallahassee Memorial HealthCare, Inc.
not more invasive than routine prophylactic scaling of the teeth and the process is accomplished
in accordance with accepted prophylactic techniques; (I) mucosal and skin cells collected by
buccal scraping or swab, skin swab, or mouth washing; (j) sputum collected after saline mist
nebulization).
Category 4
Category 5
Category 6
Category 7
Category 8
Collection of data through non-invasive procedures (not involving general anesthesia or
sedation) routinely employed by clinical practice, excluding procedures involving x-rays or
microwaves. Where medical devices are employed, they must be cleared/approved for
marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are
not generally eligible for expedited review, including studies of cleared medical devices for new
indications.) (Examples: (a) physical sensors that are applied whether to the surface of the body
or at a distance and do not involve input of significant amounts of energy into the subject or an
invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance
imaging; (d) electrocardiography, electroencephalogy, ultrasound, diagnostic infrared imaging,
doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing,
body composition assessment, and flexibility testing where appropriate given the age, weight,
and health of the individual).
Research involving materials (data, documents, records, or specimens) that have been collected,
or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
Collection of data from voice, video, digital or image recordings made for research purposes.
Research on individual or group characteristics or behavior (including, but not limited to, research
on perception, cognition, motivation, identity, language, communication, cultural beliefs or
practices, and social behavior) or research employing survey, interview, oral history, focus group,
program evaluation, human factors evaluation, or quality assurance methodologies.
The research was previously approved by the full Board; is permanently
closed to the enrollment of new subjects; all subjects have completed all
Yes-Stop
No
research-related interventions; and the research remains active only for
long-term follow-up of subjects.
The research was previously approved by the full Board; no subjects have
Yes-Stop
No
been enrolled and no additional risks have been identified;
The research was previously approved by the full Board; the remaining
Yes
No-Stop
research activities are limited to data analysis.
Research Qualifying for Exempt Review –
N/A
If no criteria are met, this indicates Expedited or Full Board Review is necessary.
45 CFR 46.101(b)(1)
Research conducted in established or commonly accepted educational settings, involving
normal educational practices such as (i) research on regular and special education
instructional strategies, or (ii) research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management methods.
45 CFR 46.101(b)(2)
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior
unless: (i) information obtained is recorded in such a manner that human subjects can be
identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the
human subjects' responses outside the research could reasonably place the subjects at risk
of criminal or civil liability or be damaging to the subjects' financial standing, employability,
or reputation.
45 CFR 46.101(b)(3)
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behavior
that is not otherwise exempt if: (i) The human subjects are elected or appointed public
officials or candidates for public office; or (ii) federal statute(s) require(s) without exception
that the confidentiality of the personally identifiable information will be maintained
throughout the research and thereafter.
45 CFR 46.101(b)(4)
Research involving the collection or study of existing data, documents, records, pathological
specimens, or diagnostic specimens, if these sources are publicly available or if the
IRB Form 4d Rev. 4/13
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Institutional Review Board at Tallahassee Memorial HealthCare, Inc.
information is recorded by the investigator in such a manner that subjects cannot be
identified, directly or through identifiers linked to the subjects.
45 CFR 46.101(b)(5)
Research and demonstration projects which are conducted by or subject to the approval of
department or agency heads, and which are designed to study, evaluate, or otherwise
examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or
services under those programs; (iii) possible changes in or alternatives to those programs
or procedures; or (iv) possible changes in methods or levels of payment for benefits or
services under those programs.
45 CFR 46.101(b)(6)
Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods
without additives are consumed or (ii) if a food is consumed that contains a food ingredient
at or below the level and for a use found to be safe, or agricultural chemical or
environmental contaminant at or below the level found to be safe, by the Food and Drug
Administration or approved by the Environmental Protection Agency or the Food Safety and
Inspection Service of the U.S. Department of Agriculture.
NB: The IRB or Designee is the final authority to determine the level of review required.
3. Where will the study be conducted? (List all locations under IRB at TMH review)
4. Current Informed Consent: Version & Date:
5. Study Population:
Males
Current Protocol: Version & Date Current:
Females
Children (<18 years)
Minoritie
(If the study is not gender/ethnic/racial/age group specific, the protocol must include justification for excluding
women and/or minorities or specific age groups.)
6. Age range of subjects:
7. Vulnerable populations (IRB Guideline - Section 4.3.2):
Students
Employees
Children (<18 years)
Children who are wards of the state
Decisionally impaired persons
Institutionalized Persons
Educationally/economically disadvantaged
Pregnant women
Abortuses
Prisoners (see note)
Other: Specify
Fetuses
Prisoners: The term “prisoner” includes those individuals involuntarily confined or detained in penal institutions
and/or other facilities as alternatives to criminal prosecution or incarceration in penal institutions, i.e., drug
treatment facilities, etc.
Please note, if a research subject is incarcerated or detained in an alternative facility after enrolling
In a study, the PI must notify the IRB immediately.
8. How will you obtain the list of subjects?
9. How many records will be reviewed?
10. Are the records hard copies?
Yes
No
11. Are the records electronic copies?
Yes
No
12. Who will review the charts (Provide name of the researcher)?
13. What is the clinical role associated with the source patients described in the records?
14. Who will maintain and/or store the data that contains PHI?
IRB Form 4d Rev. 4/13
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Institutional Review Board at Tallahassee Memorial HealthCare, Inc.
15. Check off any identifiers that you will be accessing, recording or disclosing among the following:
PHI Identifiers
Accessing
Recording
1
Patient/Subject Name
2
Address Street Location
Address Town or City*
Address State*
3
Address Zip Code*
Elements of date except year related to person, i.e., date of
birth, admission or discharge dates, date of death.
4
Telephone Number
5
Fax Number
6
Electronic Mail (email) address
7
Social Security Number
8
Medical Record Number
9
Health Plan Beneficiary Numbers
10
Account Numbers
11
Certificate/license Numbers
Vehicle identification numbers and serial numbers including
12
license plate numbers.
13
Medical Device Identifiers
14
Web URLs
15
Internet Protocol (IP) Addresses
16
Biometric Identifiers (finger and voice prints)
17
Full Face Photographic Images
18
Any unique identifying number, characteristic or code.
Disclosing
16. How will research data be collected and maintained?
17. How will information be recorded?
Data Collection Sheet (Provide a Copy)
Electronically (Provide template and explain procedure)
18. Describe your plan to protect identifiers from improper use or disclosure:
19. Will there be a link (code) to identifiers?
Yes
No
20. List all locations of records you are accessing:
21. List any outside entities, i.e., sponsor, insurance companies, regulatory agencies, data management groups,
etc., to whom PHI will be disclosed:
22. Describe how PHI will be kept confidential so, that those not materially involved will be unable to view or record
this information:
23. Are you obtaining authorization to use or disclose PHI?
Yes
No If NO, complete Sections I & II
24. Are you requesting a partial waiver of authorization for screening or recruitment?
Yes
No
If YES, complete Section III.
25. If, after collecting the data and returning the chart or data source to the appropriate location, you need to collect
any additional data or to verify any of the collected data for a subject, will it be possible for you to identify and
access the source data again based solely on the information recorded in your data sheet/database?
Yes
IRB Form 4d Rev. 4/13
No
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Institutional Review Board at Tallahassee Memorial HealthCare, Inc.
26. Charts will be accessed to review information dating from
(Give exact dates, i.e., 1/1/05 to 7/30/05).
to
27. How will confidentiality be protected?
28. What are the potential risks (including breach of confidentiality) and/or benefits to the subjects or society?
Attach a copy of the data collection form.
Authorization to Use and Disclose an Individual PHI
Section I Request
Yes
No
Waiver of HIPAA Authorization Notification Request
(If you are using a Limited Data Set, you do not need to request a Waiver of HIPAA Authorization.)
According to HIPAA Privacy Regulations, in order to use or disclose an individual’s PHI in the conduct of research
without the express authorization of the individual, the use or disclosure must not represent more than minimal risk to
the subjects. IRB approval of a waiver of HIPAA authorization will be contingent on the following:
a) Explain why the research could not practicably be conducted without the waiver:
b) Explain why the research could not practicably be conducted without the access to and use of PHI:
c) Will PHI be reused or disclosed to any other person or entity except as required by law, for authorized oversight of
the research project or other research for which the use or disclosure of PHI would be permitted by regulation.
Yes
No If YES, describe how/to whom:
Section II Request
Yes
No
Limited Data Set
The Privacy Rule allows a covered entity to use and disclose PHI included in a limited data set without obtaining an
authorization or documentation of a waiver or an alteration of authorization. Click here for complete guidance or visit
http://www.hhs.gov/hipaafaq/permitted/research/index.html.
Of the 18 PHI items listed in Section I, items with an (*) may be included and considered a “limited data set.”
Use of data under the provision of a limited data set requires the signing of a data use agreement by the researcher
(the recipient of the PHI in the limited data set.
Will you be using a limited data set for your study, i.e., you checked only those boxes with the items in red with
an asterisk *?
Yes
No If YES, attach a completed Data Use Agreement.
Section III Request
Yes
No
Partial Waiver of HIPAA Authorization for Screening/Recruitment Request
If it is impracticable to obtain a subject’s prior authorization, i.e., the researcher does not have access to the patient
records, the treating clinician is unable to approach patients on behalf of the researcher, etc., the researcher may ask
the IRB to grant a partial waiver of the patient’s authorization for screening recruitment purposes.
a) Describe how data will be collected and used:
Note: Information collected through a partial waiver for recruitment cannot be shared or disclosed to
any other person or entity.
b) Why do you need the PHI? (Check All That Apply)
IRB Form 4d Rev. 4/13
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Institutional Review Board at Tallahassee Memorial HealthCare, Inc.
Protected health information is required to determine eligibility.
Identifiers are necessary to contact the individual to discuss participation.
Other: Explain:
c) Why can’t the research practicably be conducted without the waiver? (Check All That Apply)
I don’t have access to the medical records/contact information of the targeted population.
There is no treating physician to assist in recruitment of the targeted study population.
The targeted study population will not be exposed to advertisements/media or any other institutional programs or
activities that would provide the opportunity for screening or recruitment.
Assistance from the treating clinicians has been historically minimal producing sub-par accrual.
Other: Explain:
Informed Consent – See IRB Guidelines Section 9 for Guidance
If you will be obtaining informed consent from subjects:
1. Where will informed consent be obtained?
Non-TMFM Physician’s/Researcher’s Office
TMFM Physician’s/Researcher’s Office*
Other
Clinic
Emergency Center*
N/A
Telephone
Tallahassee Memorial Hospital*
*Informed Consent must be documented in TMH medical record.
2.. Will consent be document by signature on a written consent form?
Yes
No
N/A
Request for Waiver/ Documentation/ Elements of Informed Consent Section:
Section I
Request
Yes
No
Waiver of Informed Consent
The IRB may waive the requirement to obtain informed consent, if one of the two sets of criteria is met:
Check the box next to the criteria that justifies your request for a waiver of informed consent. Provide a
detailed explanation in your protocol.
1. The research or demonstration project is to be conducted by or is subject to the approval of state or local
government officials and is designed to study, evaluate, or otherwise examine (i) public benefit or service
programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in
methods or levels of payment for benefits or services under those programs.
AND
2. The research could not practicably be carried out without the waiver or alteration.
Justification for request of waiver:
OR ALL OF THE FOLLOWING MUST BE MET.
IRB Form 4d Rev. 4/13
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Institutional Review Board at Tallahassee Memorial HealthCare, Inc.
1. Research involves no more than minimal risk to subjects.
2. The waiver or alteration will not adversely affect the rights or welfare of the subjects.
3.
The research could not practicably be carried out without the waiver or alteration.
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Justification for request of waiver:
Section II Request
Yes
No
Waiver of Documentation of Informed Consent
The IRB may waive Documentation of Informed Consent for some or all of the subjects if one of the following
conditions is met:
Check the box next to the criteria that justifies your request for a waiver of documentation of informed
consent. Provide a detailed explanation in your protocol.
The only record linking the subject to the research would be the consent document and the principal risk would be
the risk of breach of confidentiality. Provide the location of the detailed explanation in your protocol.
OR
Research involves no more than minimal risk of harm to the subjects and involves no procedures for which written
consent is normally required outside of the research context. Provide the location of the detailed explanation
in your protocol.
Section III Request
Yes
No
Waiver of Elements of Informed Consent
See IRB Guidelines Section 9.3 for guidance.
If it can be justified, the IRB may approve a consent procedure which does not include or which alters some of the
required elements of informed consent. Which elements of informed consent do you wish to be waived and why?
My research team and I will comply with the use and disclosure restrictions described above for the requested
waiver(s).
____________________________
(Principal Investigator’s Signature)
____________________
(Date)
__________________________
(Principal Investigator’s Name Printed)
Informed Consent
Required
Waived
Waiver HIPAA Authorization Notification
Required
Approved:
Date:
Waived
Yes
IRB Form 4d Rev. 4/13
No
For IRB Use Only
Documentation of Informed
Consent
Required
Waived
HIPAA Limited Data Set
Required
Waived
IRB Chair/Designee Signature:
Print:
Elements of Informed Consent
Required
Waived
Partial Waiver of HIPAA Authorization
for Screening/Recruitment
Required
Waived
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Institutional Review Board at Tallahassee Memorial HealthCare, Inc.
Statement of Compliance
If the Institutional Review Board approves this project, I agree to:
Initial
---- Execute the research plan as described in this application, including obtaining informed
consent from all subjects as deemed appropriate by the IRB.
---- Report to the IRB any research changes in the plan which may affect the use of human
subjects, prior to its implementation.
---- Report all internal, serious adverse events within one week of occurrence or
knowledge of event by the investigator.
---- Report within one week of notification by sponsor any problems, which arise in connection
with human subjects including any serious and adverse events.
---- Report progress to the IRB, as required, at least annually.
---- Report to sponsors and agencies as required.
---- Notify the IRB when the study is terminated.
---- Maintain records of the research, including consent documents, for a minimum of three
years beyond the termination of the study or longer as specified by the funding agency
or sponsor of the project.
---- Submit all recruitment materials, publications, notification of changes in key personnel to
the IRB approval prior to use.
---- Apply and comply with all Federal, State, Institutional regulations, the Belmont Report
Ethical Principals, Good Clinical Practice Guidelines (ICH), Helsinki Declaration and IRB
Guidelines governing this research.
---- Cooperate with the IRB.
There will be random audits of research protocols by the IRB.
Failure to comply with any of the above regulations may result in CLOSURE OF THE STUDY by
the IRB.
By signing below, I affirm that I am the
Intramural Principal Investigator
OR
Principal Investigator
(Check
Appropriate
Box)
and request approval of this project. I hereby assure compliance to the above and assume
responsibility for all activities, investigators and key personnel involved in this project.
___________ __________________________________________ ______________________
Date
Signature of Principal Investigator
Title
For Office of Research/IRB USE ONLY
Request for Exempt Review of Application for Approval of Retrospective Chart Review Research Reviewer’s Comments:
IRB Form 4d Rev. 4/13
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Institutional Review Board at Tallahassee Memorial HealthCare, Inc.
Project is exempt from IRB review. Identify the item number (regulatory citation) from the above list.
Project must be reviewed using
Expedited or
_________
Full Board review.
Request for Expedited Review of Application for Approval of Retrospective Chart Review Research Reviewer’s Comments:
Agree with criteria described above for Expedited approval of Application for new study.
Approve Application for new study. Do not agree with criteria described above for Expedited approval. Approve study
using expedited review guidelines using Category
_____________________________________.
Comments:
_________________________________________________________________________________
I certify that I have reviewed all documentation for this study. This Application for Approval of Retrospective Chart Review
Research new study application is approved using expedited review guidelines effective this date. The approval expires
(<364 days from approval).
Application for approval of new study IS NOT Approved for Expedited Review. Project requires Full Board review and
consideration.
Comments:
_________________________________________________________________________________
_________________________________________
IRB Chair or Designee
_________________
Date
The Office of Research/Institutional Review Board colleague has determined that this request for access to protected health
information (PHI) satisfies the requirements of the HIPAA Privacy Rule.
_____________________________________________
Office of Research/Institutional Review Board Colleague
IRB Form 4d Rev. 4/13
_________________
Date
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