Institutional Review Board at Tallahassee Memorial HealthCare, Inc.
Application for Approval of Retrospective Chart Review Research
THIS FORM MUST BE TYPEDHAND WRITTEN FORMS WILL NOT BE ACCEPTED.
IRB #: / Study Title:
Name of Principal Investigator:
(If this is a TMH only study, put the PI name here OR if this is a Multi-center Study, put the sponsor PI/Clinical Research Scientist name here & the TMH PI name as the Intramural PI.)
Email: / (This could be a university, commercial sponsor, etc.)
Address:
Phone:
Fax:
Name of Intramural Principal Investigator (PI) at TMH:
Email: / Address:
Phone:
Fax:
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)
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?
Yes-Stop No / Could identification of the subjects and/or their responses reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing?
Yes No-Stop / Will reasonable and appropriate protections be implemented so that risks related to invasion of privacy and breach of confidentiality is no greater than minimal?
Yes-Stop No / Does your research project involve classified human subjects research?
Yes No-Stop / All of the human subject research in your project falls into one or more of the following expedited review categories? (Check all that apply from the following list describing the eligible categories.)
Category 1 / This category encompasses some clinical studies of drugs and medical devices (investigational new drugs or investigational new devices/equipment).
Yes-Stop No / Is an investigational new drug application (21 CFR Part 312) required to conduct this study?
Yes-Stop No / Does the research on the marketed drug significantly increase the risks or decrease the acceptability of the risks associated with the use of the product?
Yes-Stop No / Is an investigational device exemption application (21 CFR Part 812) required to conduct this study?
Yes No-Stop / Is the medical device cleared/approved for marketing and being used in accordance with its cleared/approved labeling in this study?
Category 2 / Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
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
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.
Category 3 / 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 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 / 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).
Category 5 / 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).
Category 6 / Collection of data from voice, video, digital or image recordings made for research purposes.
Category 7 / 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.
Category 8 / Yes-Stop No / The research was previously approved by the full Board; is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects.
Yes-Stop No / The research was previously approved by the full Board; no subjects have been enrolled and no additional risks have been identified;
Yes No-Stop / The research was previously approved by the full Board; the remaining research activities are limited to data analysis.
N/A Research Qualifying for Exempt Review –
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 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: Current Protocol: Version & Date Current:
5. Study Population: Males 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 Pregnant women Fetuses
Children (<18 years) Children who are wards of the state Abortuses
Decisionally impaired persons Institutionalized Persons Prisoners (see note)
Educationally/economically disadvantaged Other: Specify
Prisoners: The term “prisoner” includes those individuals involuntarily confined or detained in penal institutionsand/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?
15. Check off any identifiers that you will be accessing, recording or disclosing among the following:
PHI Identifiers / Accessing / Recording / Disclosing1 / Patient/Subject Name
2 / Address Street Location
3 / Address Town or City*
Address State*
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
12 / Vehicle identification numbers and serial numbers including 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.
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