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You are here:
>
IRB
>
Non-Medical IRB
Non-Medical IRB
GO TO:
Institution's Assurance
Non-Medical IRB Letter to Faculty
Non-Medical IRB Guidelines and Process
Human Subjects Research Regulatory Binder
Exempt Review Submissions
Expedited Review Submissions
Full Review Submissions
Periodic Report for Continuing Review or Final/Policy
Adverse Event Reporting
Policy on Substituted (Surrogate) Consent
Requirements for Preparing Consent Forms in Foreign Language
Durable Power of Attorney
Research Involving Private Information or Biological Samples
Policy on Human Subject Research Violations and Reporting
Protocol Deviation Reporting
Policy and Form for Case Reports and Case Studies
Guidance for Web Posting of Clinical and Basic Research
Guidance for Securing Waiver of Consent From IRBS
IMPORTANT! - ClinicalTrials.gov Registration Process
ClinicalTrials.gov Registration Proccess [
MS WORD
]
Institution's Assurance
Drexel University's Federal-Wide Assurance # 00001852 [
PDF
]
Drexel University College of Medicine's Federal Wide Assurance, # 00005917 [
PDF
]
Non-Medical IRB Letter to Faculty
Non-Medical IRB Letter to Faculty [
PDF
]
Non-Medical IRB Guidelines and Process
Non-Medical IRB Guidelines, approved 09/26/2002 [
PDF
]
IRB Review Process Flowchart [
JPG
]
Human Subjects Research Regulatory Binder
Human Subjects Research Regulatory Binder [
PDF
]
I. Exempt Review Submissions
PLEASE NOTE: WE ARE BETA TESTING NEW FORMS. THESE FORMS ARE TAILOR-MADE FOR EACH OF THE CATEGORIES OF REVIEW LEVELS WITH MANY OF THE SUB-FORMS EMBEDED IN THE PRIMARY APPLICATION. WE WILL CONTINUE TO ACCEPT THE CURRENT FORMS UNTIL FURTHER NOTICE.
Submit original and 2 copies of the following:
Proposal Submission Checklist [
MS Word
]
Project Submission Transmittal Form [
PDF
]
Exempt Review Form.
Complete one of the forms below that is applicable to your research.
Exempt Review Category 1 [
MS Word
]
(Applicable to research involving normal educational practices – Consent may be required)
Exempt Review Category 2 [
MS Word
]
(Applicable to research using educational tests, surveys and interviews)
Exempt Review Category 3 [
MS Word
]
(Applicable survey and interview public officials)
Exempt Review Category 4 [
MS Word
]
Applicable to research involving existing records/data/biological samples)
Exempt Review Category 6 [
MS Word
]
(Applicable to research involving taste and food quality evaluations)
Co-Investigator Form
Use this form if you have more than 2 co-investigators [
MS Word
]
Conflict of Interest Form [
MS Word
]
Research Proposal with appropriate references (Copy of the Grant, Masters or Ph.D. research proposal.
Data Collection Instruments such as the information you will recording from the source or survey instruments, images if they are the objects of the study, advertisements, surveys and questionnaires
II. Expedited Review Submissions
PLEASE NOTE: WE ARE BETA TESTING NEW FORMS. THESE FORMS ARE TAILOR-MADE FOR EACH OF THE CATEGORIES OF REVIEW LEVELS WITH MANY OF THE SUB-FORMS EMBEDED IN THE PRIMARY APPLICATION. WE WILL CONTINUE TO ACCEPT THE CURRENT FORMS UNTIL FURTHER NOTICE.
Submit original and 3 copies of the following:
Proposal Submission Checklist [
MS Word
]
Project Submission Transmittal Form [
PDF
Expedited Review Application for Research involving Pathological Samples with Identifiers
Expedited Review for Charts [
MS Word
]
Full Review/Expedited Review Combined Form [
MS Word
]
Expedited Certification Form [
MS Word
]
Co-Investigator Form – Use this form if you have more than 2 Co-investigators [
MS Word
]
Conflict of Interest Form (Use this form if there is more than 1 collaborator who has a conflict of interest) [
MS Word
]
Informed Consent Non-medical Without HIPAA Authorization [
MS Word
]
Assent Form Template [
MS Word
]
Request for Consent Waiver [
MS Word
]
Research Proposal (Thesis or Grant)
Data Collection Instrument
Internal Indemnification Form (Not applicable for Chart Reviews) [
MS Word
]
HIPPA Waiver of Authorization(If applicable) [
PDF
]
III. Full Review Submissions
PLEASE NOTE: WE ARE BETA TESTING NEW FORMS. THESE FORMS ARE TAILOR-MADE FOR EACH OF THE CATEGORIES OF REVIEW LEVELS WITH MANY OF THE SUB-FORMS EMBEDED IN THE PRIMARY APPLICATION. WE WILL CONTINUE TO ACCEPT THE CURRENT FORMS UNTIL FURTHER NOTICE.
Submit 1 original and 6 copies of the following:
Proposal Submission Checklist [
MS Word
]
Project Submission Transmittal Form [
PDF
Full Review/Expedited Review Combined Form [
MS Word
]
Co-Investigator Form – Use this form if you have more than 2 Co-investigators [
MS Word
]
Conflict of Interest Form (Use this form if there is more than 1 collaborator who has a conflict of interest) [
MS Word
]
Informed Consent Non-medical Without HIPAA Authorization [
MS Word
]
Assent Form Template [
MS Word
]
Request for Consent Waiver [
MS Word
]
Data Collection Instrument (e.g. Questionnaires)
Internal Indemnification Form (Not applicable for Chart Reviews) [
MS Word
]
HIPPA Waiver of Authorization(If applicable) [
PDF
]
Investigators brochure or pertinent information documents (Patient Information Supplement) if research involves the use of a drug/device/interventional procedure (Mandatory)
Research Proposal with appropriate references (Copy of the grant, Masters or Ph.D. research proposal).
IV. Periodic Report for Continuing Review or Final Summary
Guidelines for preparing the report [
MS Word
]
Continuing Review Form and Progress Report (Must be downloaded and filled out electronically - NO HANDWRITTEN SUBMISSIONS WILL BE ACCEPTED)
[
MS Word
]
Policy for Continuing Review [
MS Word
]
V. Adverse Event Reporting
Adverse Event Reporting Form [
MS Word
]
VI. Policy on Substituted (Surrogate) Consent
Substituted consent policy [
PDF
]
Verification of spouse or domestic partnership status form [
PDF
]
Self-certification of surrogate decision in research study form [
PDF
]
VII. Requirements for Preparing Consent Forms in Foreign Language
Requirements for Preparing Consent Forms in Foreign Language [
PDF
]
VIII. Durable Power of Attorney
Durable Power of Attorney Form [
PDF
]
IX. Research Involving Private Information or Biological Samples
Research Involving Private Information or Biological Samples Policy [
PDF
]
X. Policy on Human Subject Research Violations and Reporting
Policy on Human Subject Research Violations and Reporting [
PDF
]
Policy for Reporting Protocol Deviations [
MS Word
]
Protocol Deviation Reporting Form [
MS Word
]
XI. Policy and Form for Case Reports and Case Studies
Policy for Case Reports and Case Studies [
MS Word
]
IRB Application Form for Case Reports and Case Studies [
MS Word
]
XII. Policy on Human Subject Research Violations and Reporting
Policy on Human Subject Research Violations and Reporting [
PDF
]
Policy for Reporting Protocol Deviations [
MS Word
]
Protocol Deviation Reporting Form [
MS Word
]
XIII. Amendment/Changes or Project Termination FORM
Amendment/Changes or Project Termination FORM [
MS Word
]
XIV. Policy and Form for Case Reports and Case Studies
Policy for Case Reports and Case Studies [
MS Word
]
IRB Application Form for Case Reports and Case Studies [
MS Word
]
XV. Guidance for Web Posting of Clinical and Basic Research
Guidance for Web Posting of Clinical and Basic Research [
PDF
]
XVI. Guidance for Securing Waiver of Consent From IRBS
Guidance for Securing Waiver of Consent Form IRBS [
MS Word
]
Request for Consent Waiver [
MS Word
]