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Institutional Review Board (IRB)
Human Research Protections Program
1600 S. Andrews Avenue, Ft. Lauderdale, FL 33316 (954) 355-4941 FAX (954) 355-4930
Request for Exempt Research & Protected Health Information IRB Use Only
Application IRB CPA
Submission Type: [ ] New Request [ ] Renewal [ ] Change in activities
How long with this study last?______________
Project Title:
To qualify for exempt status project activities may not be more than minimal risk, Minimal risk mean
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.
Research activities conducted under the jurisdiction of the Food and Drug Administration (FDA) does
not qualify for exempt status.
Project Investigator(s)
Name (Last name, First name MI): Professional/ Degree Title:
Mailing Address: Office Phone Number:
Pager or Cell Phone Number:
Fax:
Are you a Broward Health Employee? Email:
If yes, facility where you work: Department (if applicable):
Occupational Position:
Broward Health Staff Affiliate Physician Nursing Research Student Research Other: :
Training is required prior to the initiation of research activities
Indicate type research training / education received:
Human Subjects Training HIPAA Training Module (required) Data/ Collection Module (required) –To
obtain training visit CITI On Line Training Modules at http://www.CITI Program.org
*Submit training certificate(s), licenses, resume / curriculum vitae with this application
1
Facility / Departmental Project Clearance is Required
Check Facility where you intend to recruit patients, collect data, and or use institution resources
(√)
facility
Broward General Medical Center / Chris Evert Children’s Hospital
North Broward Medical Center
Imperial Point Medical Center
Coral Springs Medical Center
Children’s Diagnostic and Treatment
Community Health Services
Physician Practices
FINANCIAL CONFLICT OF INTEREST
Does project investigator (including key personnel, or their immediate family members have a financial Yes
interest (including salary or other payments for services, equity interests, or intellectual property rights) that No
would reasonably appear to be affected by the research, or a financial interest in any entity whose financial
interest would reasonably appear to be affected by the research?
List other researchers involved in this project.
Are there other researchers involved in this research study? [ ] Yes [ ] No
If yes, please list research team members who will be involved in this project.
Project Team Member(s) Name Job Title Phone Number CITI Training
Yes or No
Student / Resident Research (additional information required)
Name of University / College:
(Submit Letter of Support)
Advisor / Preceptor (Last name, First name MI): Department
Mailing Address: Phone Number:
Email:
_____________________________________ __________________________________
Signature of Advisor / Preceptor Date
1. Does this project involve the following vulnerable populations?
[ ] Yes [ ] No Children, adolescents
[ ] Yes [ ] No Prisoners, fetuses, pregnant women, or human in vitro fertilization
[ ] Yes [ ] No Cognitively impaired subjects
2. Is this project a systematic investigation designed to develop or contribute to generalizable knowledge?
Yes ______ No ____
3. Are the human subjects in this study living individuals? Yes ______ No ____
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4. If you answered yes to question 2 and 3 STOP here. This study is not “Exempt” from further IRB review.
You cannot use this form: Unless, the research and/or demonstration projects will be conducted by appropriate Federal
Department or Agency heads which are designed to study, evaluate, or otherwise examine public benefit or service programs; or
procedures for obtaining benefits or services under those programs;
5. What is your research question, or the specific hypothesis?
6. What are the potential benefits of the proposed project to the field?
7. What are the potential risks of the proposed project to the field?
8. Describe your research population –
Sample Size
Age Range
Gender
Race
9. Provide description of the proposed activity – submit full copy of project proposal. (Include data, survey
instruments, and all materials that will be used to conduct this project).
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Check Appropriate Categories of Research which are Exempt
Research conducted in established or commonly accepted educational settings, involving normal
Category
educational practices, such as:
B1:
_______
(√) if apply 1. research on regular and special education instructional strategies, or
2. research on the effectiveness of or the comparison among instructional techniques, curricula, or
45 CFR 46.101 classroom management methods.
(b)(1)
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or observation of public behavior unless:
Category
B2: 1. information obtained is recorded in such a manner that human participants can be identified,
directly or through identifiers linked to the participants; AND,
_______ 2. any disclosure of the human participants' responses outside the research could reasonably place
(√) if apply the participants at risk of criminal or civil liability or be damaging to the participants' financial
45 CFR 46.101 standing, employability, or reputation.
(b)(2)
NOTE: Survey and interview techniques that include minors are not exempt, EXCEPT observation of the
public behavior of minors, if the researcher is not a participant, is exempt.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of public behavior that is not exempt under Category 2,
Category
B3: IF:
_______
(√) if apply 1. the human participants are elected or appointed public officials or candidates for public office, OR
45 CFR 46.101 2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable
(b)(3) information will be maintained throughout the research and thereafter.
Category
B4: 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 participants cannot be identified directly or through identifiers linked to the
(√) if apply participants.
45 CFR 46.101
(b)(4)
Category
B5: Research and demonstration projects which are conducted by or subject to the approval of appropriate
Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
_______ 1. public benefit or service programs; or
(√) if apply 2. procedures for obtaining benefits or services under those programs; or
3. possible changes in or alternatives to those programs or procedures; or
45 CFR 46.101 4. possible changes in methods or levels of payment for benefits or services under those programs.
(b)(5)
Taste and food quality evaluation and consumer acceptance studies,
Category
B6:
1. if wholesome foods without additives are consumed, or
_______ 2. if a food is consumed that contains a food ingredient at or below the level and for a use found to be
(√) if apply 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
45 CFR 46.101 Food Safety and Inspection Services of the U.S. Department of Agriculture.
(b)(6)
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Privacy and Protected Health Information
1. Will you obtain data through intervention or interaction with individuals? ___YES
____NO.
(Note: “Intervention” includes both physical procedures by which data are gathered [for example,
measurement of heart rate or venipuncture] and manipulations of the subject or the subject’s
environment that are performed for research purposes. “Interaction” includes communication or
interpersonal contact between the investigator and subject [for example, surveying or interviewing].)
2. Will you obtain identifiable private information about these individuals? ___YES
____NO.
(Note: "Private information" includes information about behavior that occurs in a context in which an
individual can reasonably expect that no observation is taking place, or information which the
individual can reasonably expect will not be made public [e.g., a medical record]. "Identifiable" means
that the identity of the subject may be ascertained by the investigator or associated with the
information [e.g., by name, code number, pattern of answers, etc.].)
3. Is this proposal a student research project defined as a project which is a normal part of
the student's course work; is supervised by a faculty member; and its primary purpose is the
development of the student's research skills; does not present more than minimal risk to participants;
does not deal with issues of a sensitive nature; and is not genuine research? ___YES ____NO.
4. Is this proposal a quality assurance project designed to improved performance supervised
by a manager/ employee or designee of Broward Health; with its primary purpose to improve quality
care methods and procedures conducted in the organization; does not present more than minimal
risk to participants? ___YES ____NO.
PRIVACY OF PARTICIPANTS
a. Does this project require access to personally identifiable private information?
Yes No
If Yes Describe the personally identifiable private information involved in the research. List the
information source(s) (e.g., educational records, surveys, medical records, etc.).
b. People or organization who may receive this information?
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CONFIDENTIALITY OF DATA
a. Explain how information will be handled, including storage, security measures (as necessary), and
who will have access to the information. Include both electronic and hard copy records.
b. Indicate what will happen to the identifiable data at the end of the study.
Identifiers permanently removed from the data and destroyed (de-identified)
Identifiable/coded (linked) data are retained
Identifiable data not collected
HIPAA Waiver
Will individually identifiable Protected Health Information (PHI) subject to the HIPAA Privacy Rule
requirements be accessed, used, or disclosed in the research study? ___Yes _____ No
Yes No Check all that apply:
1. The use or disclosure of PHI involves no more than minimal risk to the participants.
2. Granting of waiver will not adversely affect privacy rights and welfare of the individuals whose
information will be used.
3. The project could not practicably be conducted without a waiver.
4. The project could not practicably be conducted without access to and use of the PHI.
5. The privacy risks are reasonable relative to the anticipated benefits of the research.
6. An adequate plan to protect identifiers from improper use and disclosure is included in the
research proposal.
7. An adequate plan to destroy the identifiers at the earliest opportunity, or justification for
retaining identifiers, included in the IRB approved research proposal; or such retention is
otherwise required by law.
8. Whenever, appropriate, the subjects will be provided with additional pertinent information
after participation.
9. This project includes written assurances that PHI will not be re-used or disclosed to any other
person or entity for any purpose than that approved by the IRB as part of this research, except as
required by law.
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Statement of assurance
By signing this statement I am providing written assurance that only information essential to the purpose
of this research project will be collected, and access to the information will be limited to the greatest
extent possible. Protected health information will not be re-used or disclosed to any other person or
entity.
I have evaluated this protocol and determined that I have the resources to conduct this project. I will
seek and obtain prior written approval from the IRB for any substantive modifications in the proposal,
including changes in procedures, co-investigators, funding agencies, etc. I will promptly report any
unexpected or otherwise significant adverse events or unanticipated problems or incidents that may
occur in the course of this study. I will report in writing any significant new findings, which develop during
the course of this study which may affect the risks and benefits to participation. I will not begin my
research until I have received written notification of final IRB approval. I will comply with all IRB requests
to report on the status of the study. I will maintain records of this research according to IRB guidelines.. If
these conditions are not met, I understand that approval of this project may be suspended or terminated.
__________________________________________________________
Print name of Project Investigator
Signature of Project Investigator Date
Broward Health Official Use Only
[ ] APPROVE [ ] PEND [ ] DENY
Facility ID: Broward General Medical Center ( ) Christ Evert Children’s Hospital ( ) North Broward Medical Center
( ) Imperial Point Medical Center ( ) Weston Regional ( ) Community Health Services ( ) Children’s Diagnostic and
Treatment Center ( )
____________________________________________ _____________________
Administrator /Regional Manager Date
____________________________________________ ______________________
Departmental Manager Date
____________________________________________ _____________________
Human Protections Administrator Signature Date
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