Completing your IRB Submission - Medical Intervention Committee A1 and A2
This information is intended to provide guidance to completing your IRB Application for Medical Intervention protocols. When completing your application it is important to submit all required documentation accurately and in a timely manner. The links below will direct you to the current forms maintained on the IRB Web-site. It is important to access the most current forms prior to each IRB submission as these forms periodically change.
To begin your IRB Submission there are 6 elements to consider to ensure your application meets the requirement for an IRB Review by the Medical Intervention committee's as detailed by the IRB.
Submit To the Temple IRB Manager for all Research Protocols at Temple
Frequently used Information:
IRB Submission Memo and Checklist Form- Form developed by the Office of Clinical Trials for guidance to the submission process for medical intervention protocols
All training certificates are valid for 2 years from the date of training. For University Memorandum detailing the training requirements click here.
2.
You will need to know have all study team members AccessNet Login Information and Temple University Employee ID Number available for the
IRB Submission process.
Step #2: Determine Level of Review and Submission Requirements - For more information about review information you can click on the links within the chart below indicated by Blue Text
(46101(a))
All research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research.
The IRB shall review and have authority to approve, require modifications in (to secure approval) or disprove all research activities.
Review procedure for certain kinds of research involving no more than minimal risk and for minor changes in approved research. Click here for categories
Subject to review by IRB Chairman or Qualified Designee.
Complete IRB Submission Documentation. Original plus 1 copy. Maintain 1 copy for yourself
46.101(b)-
Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy
IRB chairman has final determination
Submit IRB Request for protocol review page plus description of the project
Ongoing reviews typically within 5-7 days
The Chairman of the Institutional Review Board has final determination regarding the review category that the research protocol is eligible. If you have questions or ar seeking additional guidance please call the IRB at 215 707-3390.
Step #3: Determine which IRB will review your protocol, answer the following questions:
1. Does this research meet the PHS definition of a clinical trial?*
YES
NO
2. Is the protocol designed and written by the sponsor?
YES
NO
3. Is the sponsor of the research a for-profit entity/company?
YES
NO
4. Is the protocol a phase III or phase IV clinical study?
YES
NO
5. Is this an Oncology protocol?
YES
NO
Temple University IRB
TIRB
Any questions 1-4 Answered NO
Question 5 answered NO
Western IRB
WIRB
All questions 1-4 Answered YES
Question 5 Answered NO
Fox Chase IRB
FIRB
Question 5 is YES
*The code of Federal Regulations defines research as, “a systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalizable knowledge.” As examples, the following are human research; case reports, retrospective evaluation, case-controlled evaluation of disease incidence, prospective randomized trials and data collection to support an application to the FDA.
OR
A clinical trial is defined by the Public Health Service as, “A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.”
Step #4: Determine if Additional Committee Approvals are Required?
Medical Radiation Sub Committee -Evaluate all proposal for research, diagnostic, and therapeutic use of radioisotopes and radiation producing (ionizing and non-ionizing) devices anywhere within Temple University involving application or administration of radiation or radoactive materials to humans.
Approval from the committee is required for all research protocols involving radiation exposure to humans that is outside the practice of standard of care
Contact person is Kurt Bodison Assistant Director, Environmental Health & Radiation Safety Phone: 215-707-7646 Email: kurt.bodison@temple.edu.
Temple and Fox Chase IRB Protocols approvals - MRC approval maybe obtained at the same time as the IRB Submission
WIRB IRB Protocol approvals - MRC approval must be obtained prior to sending the protocol to WIRB
Fox Chase Research Review Committee- Submission, Review and Approval must be obtained from the Fox Chase RRC prior to the IRB submission and review. The RRC web-site contains the most current information regarding the committee requirements and contact information.
The submission guidelines for completing a proposal to the Fox Chase Research Review Committee. These guidelines provide current instructions and process for a new protoocl reveiw at FCCC.
Institutional BioSafety Committee -The Temple University Institutional Biosafety Committee (IBC) is responsible for the regulation and monitoring of all University research that involves recombinant DNA, infectious agents, and other biohazards.
Pharmacy And Therapeutics - If an Investigational Drug is used submit a copy of the IDDS form to theTUH Investigational Pharmacy. You can contact Investigational Drug Services Pharmacist Christine Fitzgerald at 215 707-9346.
Step #5: Complete Required Documentation for the IRB Submission!
Please be sure to utilize the most current version of all submission forms as found on the IRB web site forms are subject to revision at any time. The links below do go to the IRB Web-site forms and are the current versions. The IRB is available to assist with guidance on the required submission materials. Temple University IRB review protocols must be received by the IRB Office 2 weeks prior to the scheduled IRB Meeting Date!
Mandatory Primary Elements for a Medical Intervention IRB Submission: These forms must be collated into individual packets and will be distributed to all committee members on the IRB for review.
