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Medical IRB

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Institution's Assurance
Medical IRB Guidelines and Process
Human Subjects Research Regulatory Binder
Submission of IRB Application Forms
Exempt Review Submissions
Expedited Review Submissions
Full Review Submissions
Periodic Report for Continuing Review or Final/Policy
Adverse Event Reporting
Amendment/Changes or Project Termination FORM
Policy on Substituted (Surrogate) Consent
Requirements for Preparing Consent Forms in Foreign Language
Durable Power of Attorney
Radiation Exposure to Human Subjects
Good Clinical Practice
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
Emergency Use of Drugs/Biologics and Devices
Human Tissue and Specimen Procurement
 
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 ]
Medical IRB Guidelines and Process
Medical IRB Guidelines, revised November 6, 2009 [ PDF ]
IRB Review Process Flowchart [ JPG ]
Investigator's Responsibilities [ MS Word ]

Human Subjects Research Regulatory Binder
Human Subjects Research Regulatory Binder [ PDF ]

Submission of IRB Application Forms
We are now using the new forms below. Kindly update any local copies you may have and discontinue use of the old forms. We appreciate your comments going forward as we continue to improve these forms.
I. Exempt Review Submissions
PLEASE NOTE: THESE FORMS ARE TAILOR-MADE FOR EACH OF THE CATEGORIES OF REVIEW LEVELS WITH MANY OF THE SUB-FORMS EMBEDED IN THE PRIMARY APPLICATION.

Submit original and 1 copy of the following:
  1. Proposal Submission Checklist [ MS Word ]
  2. Project Submission Transmittal Form [ PDF ]
  3. 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)
  4. Co-Investigator Form
    Use this form if you have more than 2 co-investigators [ MS Word ]
  5. Conflict of Interest Form [ MS Word ]
  6. Research Proposal with appropriate references (Copy of the Grant, Masters or Ph.D. research proposal.
  7. 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: THESE FORMS ARE TAILOR-MADE FOR EACH OF THE CATEGORIES OF REVIEW LEVELS WITH MANY OF THE SUB-FORMS EMBEDED IN THE PRIMARY APPLICATION.

Submit original and 3 copies of the following:
  1. Proposal Submission Checklist [ MS Word ]
  2. Project Submission Transmittal Form [ PDF
  3. Expedited Review Application for Research involving Pathological Samples with Identifiers [ MS Word ]
  4. Expedited Review for Charts [ MS Word ]
  5. Full Review/Expedited Review Combined Form [ MS Word ]
  6. Expedited Certification Form [ MS Word ]
  7. Co-Investigator Form – Use this form if you have more than 2 Co-investigators [ MS Word ]
  8. Conflict of Interest Form (Use this form if there is more than 1 collaborator who has a conflict of interest) [ MS Word ]
  9. Informed Consent A WITH HIPAA Authorization DU DUCOM [ MS Word ]
  10. Informed Consent B WITHOUT HIPAA Authorization DU DUCOM [ MS Word ]
  11. Informed Consent A WITH HIPAA Authorization SCHC [ MS Word ]
  12. Informed Consent B WITHOUT HIPAA Authorization SCHC [ MS Word ]
  13. Assent Form Template [ MS Word ]
  14. Request for Consent Waiver [ MS Word ]
  15. Research Proposal (Thesis or Grant)
  16. 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 or questionnaires.
  17. Internal Indemnification Form (Not applicable for Chart Reviews) [ MS Word ]
  18. HIPPA Waiver of Authorization(If applicable) [ PDF ]
III. Full Review Submissions
PLEASE NOTE: THESE FORMS ARE TAILOR-MADE FOR EACH OF THE CATEGORIES OF REVIEW LEVELS WITH MANY OF THE SUB-FORMS EMBEDED IN THE PRIMARY APPLICATION.

Submit 1 original and 3 copies of the following:
  1. Proposal Submission Checklist [ MS Word ]
  2. Project Submission Transmittal Form [ PDF
  3. Full Review/Expedited Review Combined Form [ MS Word ]
  4. Co-Investigator Form – Use this form if you have more than 2 Co-investigators [ MS Word ]
  5. Conflict of Interest Form (Use this form if there is more than 1 collaborator who has a conflict of interest) [ MS Word ]
  6. Informed Consent A WITH HIPAA Authorization DU DUCOM [ MS Word ]
  7. Informed Consent B WITHOUT HIPAA Authorization DU DUCOM [ MS Word ]
  8. Informed Consent A WITH HIPAA Authorization SCHC [ MS Word ]
  9. Informed Consent B WITHOUT HIPAA Authorization SCHC [ MS Word ]
  10. Assent Form Template [ MS Word ]
  11. Request for Consent Waiver [ MS Word ]
  12. Investigators brochure or pertinent information documents (Patient Information Supplement) if research involves the use of a drug/device/interventional procedure (Mandatory)
  13. Research Proposal with appropriate references (Copy of the grant, Masters or Ph.D. research proposal).
  14. Internal Indemnification Form (Not applicable for Chart Reviews) [ MS Word ]
  15. HIPPA Waiver of Authorization(If applicable) [ PDF ]
IV. Periodic Report for Continuing Review or Final Summary
  1. Guidelines for preparing the report [ MS Word ]
  2. Continuing Review Form and Progress Report (Must be DOWNLOADED and filled out electronically - NO HANDWRITTEN SUBMISSIONS WILL BE ACCEPTED)
    [ MS Word ]
  3. Policy for Continuing Review [ MS Word ]
V. Adverse Event Reporting
  1. Adverse Event Regulations/Definitions/Responsibilities [ MS PowerPoint ]
  2. On-Site Adverse Event Reporting Form [ MS Word ]
  3. Off-Site Adverse Event Reporting Form [ MS Word ]
  4. Adverse Event Reporting for WIRB approved protocols [ MS Word ]
VI. Amendment/Changes or Project Termination FORM
Amendment/Changes or Project Termination FORM [ MS Word ]

VII. Policy on Substituted (Surrogate) Consent
  1. Substituted consent policy [ PDF ]
  2. Verification of spouse or domestic partnership status form [ PDF ]
  3. Self-certification of surrogate decision in research study form [ PDF ]
VIII. Requirements for Preparing Consent Forms in Foreign Language
Requirements for Preparing Consent Forms in Foreign Language [ PDF ]

IX. Durable Power of Attorney
Durable Power of Attorney Form [ PDF ]

X. Radiation Exposure to Human Subjects
Guidelines for Human Research Involving Radiation Exposure [ PDF ]
Application for Administration of Radioactive Materials or Radiation to Human Research Subject [ DOC ]
XI. Good Clinical Practice
Good Clinical Practice Standards [ MS PowerPoint ]

XII. Research Involving Private Information or Biological Samples
Research Involving Private Information or Biological Samples Policy [ PDF ]
XIII. Policy on Human Subject Research Violations and Reporting
  1. Policy on Human Subject Research Violations and Reporting [ PDF ]
  2. Policy for Reporting Protocol Deviations [ MS Word ]
  3. Protocol Deviation Reporting Form [ MS Word ]
XIV. Policy and Form for Case Reports and Case Studies
  1. Policy for Case Reports and Case Studies [ MS Word ]
  2. IRB Application Form for Case Reports and Case Studies [ MS Word ]
XV. Guidance for Web Posting of Clinical and Basic Research
  1. Guidance for Web Posting of Clinical and Basic Research [ PDF ]
XVI. Guidance for Securing Waiver of Consent From IRBS
  1. Guidance for Securing Waiver of Consent Form IRBS [ MS Word ]
  2. Request for Consent Waiver [ MS Word ]
XVII. Emergency Use of Drugs/Biologics and Devices
  1. Form and Guidance to Request for the Emergency Use of Drugs/Biologics and Device [ PDF ]
  2. Form and Guidance to Request for Humanitarian Use Device [ PDF ]
XVIII. Human Tissue and Specimen Procurement
  1. Policy:
    1. Registration for Procurement of Human Specimens
    2. Research Involving Private Information or Biological Samples

  2. Training:

    3. CAP Lab, Lab Safety, Bloodborne Pathogen and Infectious Substance Shipping Training

    Directions and FAQs

    1. Laboratory Safety and Bloodborne Pathogen Training Homepage
    2. Shipping of Biological and Hazardous Materials

  3. DIRECTIONS, FAQs and FORMS:

    4. DIRECTIONS and FAQs
    1. Human Specimens Study Registration Form (University Biosafety Registration)
    2. Exempt Category 4 (Research involving the collection or study of EXISTING pathologic or diagnostic specimens)
    3. Registration to Obtain Cell Lines and Commercial Blood