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University Of TennesseeCollege Of Medicine SRC/ IRB
Initial Approval Request - Form A
(Form Must Be Typed)
INSTRUCTIONS:
Submissions to the IRB must contain all required materials. Incomplete submissions will be returned to the investigator without IRB review. A complete submission must contain the following:
1)A completed Research Proposal Check Sheet
2)A completed Form A with all signatures.
3)A formal research protocol, either prepared by the investigator or a sponsor of the research; (guidelines for writing a proposal are attached)
4)A proposed consent form containing all elements of informed consent
5)An “Investigator’s Brochure” for investigational new drugs or devices; and,
6)A copy of the Research Contract and Proposed Budget.
7)A copy of the Principle Investigator and Co-Investigator(s) current CV (unless already on file)
8)A copy of completion for the CITI On-line Human Subjects Protection Course for all Research Personnel.(unless already on file)
University Of Tennessee College Of Medicine SRC/IRB
Submission FoInitial Approval Request - Form A
(Form Must Be Typed)
Assigned: Expedited:_____ Full Board Review______
(Leave Blank)
GENERAL INFORMATION
Date: Department:
Principal Investigator
Co-Investigator(s)
Address:
Research Coordinator: Telephone Number: Fax Number: E-mail Address:
Other Key Research Personnel:
Title of Project
Is the Project Funded: Yes NoFunding Source
(If project is commercially sponsored, complete the IRB fee billing information below)
Estimated completion date of the research project: Estimated number of patients to be enrolled
ARE ANY OF THE TEST ARTICLES REGULATED BY FDA?
Does this study require an IND? Yes No If so what is the IND #Name of Drug:
(If the protocol involves an investigational drug a copy of the signed FDA 1572 form must be submitted)
Does this study require an IDE? Yes No If so what is the IDE # Name of Devise:
PROTOCOL SUMMARY (this information must be included or application will be returned)
Type a Brief Study Synopsis
TYPE OF REQUEST
Initial Full Review: Initial Expedited Review: Expedited Category (see page 4)
Protocol Version/dateThrough Amendment(s):
Investigator Brochure dated:Informed Consent Dated:
Advertisement/Posters:
Study Information:
Has this study been reviewed by another Institutional Review Board? Yes: No:
If so what was the outcome of that review: Approved: Disapproved:Pending
If disapproved or pending explain why:
Has your site ever been audited by the Food and Drug Administration (FDA) or the Office of Human Research Protection (OHRP) Yes No (Attach a copy of the audit report).
Conflict of Interest
- Yes No Is there a potential conflict of interest for the Principal Investigator or key research personnel?
If “Yes” check all that apply
- Compensation whose value could be affected by the study outcome.
- A proprietary interest in the tested product, including but not limited to, a patent, trademark, copyright or
licensingagreement, or the right to receive royalties from product commercialization.
- Any equity interest in the sponsor or product whose value cannot be readily determined through reference to
public prices (e.g., ownership interest or stock options).
- Any equity interest in the sponsor or product that exceeds $10,000, or 5%.
- Significant payments or other sorts with a cumulative value of $10,000 made directly by the sponsor to any of the
investigators as an unrestricted research or educational grant, equipment, consultation, or honoraria.
ADMINISTRATIVE APPROVAL OF PATIENT CARE AREAS INVOLVED WITH THE RESEARCH
(APPROPRIATE SIGNATURES MUST BE OBTAINED PRIOR TO IRB SUBMISSION)
I have reviewed this research and budget (if applicable) and authorize that it may be conducted in my responsible area
Director of Pharmacy ServicesSignature: Date:
Director of Nursing Services (specify area) Signature: Date:
Director of Pathology ServicesSignature: Date:
Director of Laboratory ServicesSignature: Date:
Director of Radiology ServicesSignature: Date:
Other (Specify area)Signature: Date:
Commercially Sponsored Trials IRB Fee Billing Information for: (1,800 Full Board Review; $500 Expedited Review)
Sponsor:Address:
Contact Name:Phone Number: Fax Number:
E-Mail Address:
Please answer the following questions for Investigator Initiated Projects
1. Is the research question clear Yes No
2. Is the background material pertinent and the rationale for the study clear Yes No
3. Has the most appropriate study design been utilized to maximize internal and external validity: Yes No
4. Are the research methods feasible and sufficiently detailed Yes No
5. Is there an appropriate sample size calculation Yes No
6. Are the appropriate statistical methods used and sufficiently outlinedYes No
SIGNATURES:
Signature of Principal Investigator : ______Date:______
Signature of Department Chairman :______Date:______
DO NOT WRITE BELOW THIS LINE
IRB ACTION:Approved Expedited_____; Full Board ______; With provision(s) _____; Referred For Board Review ______
COMMENTS:______
IRB Chairman Approval ______Date:______
GUIDELINES FOR DEVELOPING A RESEARCH PROTOCOLS:
PURPOSE OF THE STUDY. State concisely and realistically what the research in this proposal is intended to accomplish.
BACKGROUND AND CURRENT STATUS OF WORK IN FIELD.
CHARACTERISTICS OF SUBJECT POPULATION. Describe the characteristics of the subject population. Include the anticipated number of subjects to be studied (locally and in aggregate for multicenter studies), age ranges, sex, race, and health status. Identify the criteria for inclusion and exclusion. Justify the utilization of any special classes of subjects such as pregnant women, fetuses, children, mentally disabled, prisoners or others who are likely to be vulnerable. Estimate the time required to complete the entire study. Justify any planned exclusion of women.
METHOD OF SUBJECT SELECTION. Describe the method(s) to be employed in the identification/recruitment of potential subjects and attach any proposed advertising copies (posters, news ads, etc.).
STUDY SITE. State the location(s) where the study will be conducted.
METHODS AND PROCEDURES APPLIED TO HUMAN SUBJECTS. Describe the study design (e.g., randomized, blinded, placebo controlled, etc.) and all procedures (sequentially) to be applied to subjects. Clearly indicate which procedures and treatments are investigational (research) and those which are not.
POTENTIAL RISKS TO THE SUBJECT. Describe all potential risks: physical, psychological, social, legal or other associated with each procedure. Assess the probability, severity, potential duration and reversibility of each risk. Identify those risks which are minimal and those which are more than minimal. If there are no identifiable risks this should be so stated.
PROTECTION AGAINST RISKS. For all studies involving greater than minimal risk, describe the procedures utilized to prevent/minimize any potential risks.
POTENTIAL BENEFITS TO THE SUBJECT. Describe the potential benefits that may accrue directly to the subject. If there are none this should be so stated.
POTENTIAL BENEFITS TO SOCIETY. Describe the potential societal benefits of the study in terms of human health/welfare, the advancement of knowledge or the good of society.
RISK/BENEFIT ASSESSMENT. Justify the research study based on your evaluation of the risk/benefit assessment.
THERAPEUTIC ALTERNATIVES. For therapeutic studies describe any therapeutic alternatives available to the subjects.
CONFIDENTIALITY. Describe how confidentiality of data will be maintained. If data with subject identifiers will be released specify the person(s) or agency to whom this information will be released.
PAYMENT FOR PARTICIPATION. Describe any economic incentives or other rewards for participation and any prerequisite condition that must be fulfilled by subjects in order to receive compensation; including prorated payments for partial participation, if applicable.
FINANCIAL OBLIGATIONS. For all studies describe any costs to the subject as a result of the research procedures which are over and above what would be incurred by standard treatment, e.g., additional diagnostic tests, additional hospitalization, drugs, devices, etc. And, will the study medication be provided free of charge.
RESEARCH INJURIES. Describe the procedure for treatment of any research associated injury both in regard to the logistics of acute care and responsibilities for payment of costs associated with delivery of the care for such injuries. Specifically, describe the extent to which the sponsor of the research will be responsible for the costs associated with research related injuries.
INFORMED CONSENT. Describe the circumstances under which informed consent will be obtained, the process, and who will seek consent. If minors will be utilized as subjects, the process of assent should be described.
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