The purpose of this checklist is to provide support for irb staff conducting Pre-review. This checklist is to be completed by the irb staff, signed, dated, and


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NameThe purpose of this checklist is to provide support for irb staff conducting Pre-review. This checklist is to be completed by the irb staff, signed, dated, and
A typeDocumentation


CHECKLIST: Pre-Review
NUMBER

DATE

PAGE
HRP-401

2/19/2013

of


The purpose of this checklist is to provide support for IRB staff conducting Pre-review. This checklist is to be completed by the IRB staff, signed, dated, and retained.

IRB Number:

     

Protocol Name:

     

Investigator:

     




Regulatory Oversight (Check all that apply)



(DHHS)



(DOD)



(DOJ)



(EPA)



ICH-GCP



(FDA)



(DOE)



(ED)



Other Federal Agency









Restrictions (Check if applicable)



Principal investigator is Restricted




Missing Materials

     




Special Determinations (Check all that apply)



Children



Not significant risk device (FDA)



Waiver/alteration of the consent process



Wards



Non-viable neonates



Waiver of HIPAA authorization



Pregnant women



Neonates of uncertain viability



Waiver of consent documentation



Prisoners



Cognitively impaired adults



Waiver of consent for emergency research



Minimal risk







Protocol Tracking (Check all that apply)



Social/Behavioral/Education



Biomedical/Clinical







Final Contingencies

     




STUDY CLOSURE



Research can be closed.




Sign

     

Date

     




The purpose of this checklist is to provide support for IRB staff conducting screening of submission materials.

  1. ALL REVIEWS

Determine the laws that apply to the Human Research and indicate these in the “Regulatory Oversight” section.

Determine whether any investigators or research staff are Restricted. If so, list their names and the reasons these in the “Restrictions” section.

If there is a HIPAA authorization, review using “WORKSHEET: HIPAA Authorization (HRP-330)”

If a HIPAA waiver of authorization is required, grant using “CHECKLIST: HIPAA Waiver of Authorization (HRP-441)”

Note any missing materials necessary for review in the “Missing Materials” section:

Application & appendices A (external sites), B (drugs and devices)

Investigator Protocol

Consent document(s) or script(s)

Data collection instruments

Written material to be seen or heard by subjects

Local Oversight review authorization

  1. INITIAL REVIEW and MODIFICATION (when the modification affects one of the following)

If the research involves the use of a drug use the “WORKSHEET: Drugs (HRP-306).”

If the research involves the use of a device (including an humanitarian use device) use the “WORKSHEET: Devices (HRP-307)”

Note any special determinations that need to be made by the convened IRB or Designated Reviewer in the “Special Determinations” section.

If the device meets the abbreviated IDE requirements, note “Non significant device determination” in the “Special Determinations” section.

Note any missing materials necessary for review in the “Missing Materials” section:

Qualifications of the key personnel

Grant application

Complete sponsor protocol (including DHHS protocol)

DHHS-approved sample consent document

Investigator brochure for investigational drug

Package insert for marketed drugs

Product information for medical devices

Feasibility process conducted by external IRB

For the Department of Energy (DOE) research: “Checklist for IRBs to Use in Verifying that HS Research Protocols are In Compliance with DOE Requirements”

For the Department of Education (ED) research ensure that a permission letter has been submitted attesting compliance with FERPA and PPRA.

Note missing/inappropriately answered Investigator Protocol sections in the “Missing Materials” section:

IRB Review History

Objectives

Background

Setting

Resources Available

Prior Approvals

Study Design

Recruitment Methods

Inclusion/Exclusion Criteria

Compensation for Injury

Local Number of Subjects

Total Number of Subjects

Study Timelines

Study Endpoints

Procedures Involved

Data and Specimen Banking

Data Management

Confidentiality

Provisions to Monitor Data

Withdrawal of Subjects

Risks to Subjects

Potential Benefits to Subjects

Provisions to Protect Privacy

Economic Burden to Subjects

Consent Process

Consent Documentation

Vulnerable Populations

Drugs or Devices

Multi-Site Research

Community-Based Participatory Research

Sharing of Results

Final Contingencies” section:

Research is subject to regulations not overseen or conducted by the organization

Positive financial declaration without a Conflict of Interest report

Protocol information relates to an item in the list of institutional financial interests

An IND is required and there is no IND

An IND is required and there is insufficient documentation

If an IDE/HDE is required and there is no IDE/HDE

An IDE/HDE is required and there is insufficient documentation

There are inadequate provisions to control the drug(s)

There are inadequate provisions to control the device(s)

There are inadequate provisions for an investigator held IND

There are inadequate provisions for an investigator held IDE

External site(s) getting federal funds from the organization does not have a federalwide assurance (FWA)

The research involves adults unable to consent and statements by the investigator and legal regarding which individuals are legally authorized representatives do not match.

The research involves children and statements by the investigator and legal regarding which persons individuals are legally authorized representatives do not match.

  1. CONTINUING REVIEW

Determine whether any new information has been provided. (For example, a new risk.) If so, follow “SOP: New Information (HRP-024).”

Note missing Continuing review form in the “Missing Materials” section:

  1. MODIFICATION

Determine whether any new information has been provided. (For example, a new risk.) If so, follow “SOP: New Information (HRP-024).”

Note missing modification form in the “Missing Materials” section

  1. STUDY CLOSURE

Confirm that the research meets the criteria for closure and note in the Study Closure Section.

Determine whether any new information has been provided. (For example, a new risk.) If so, follow “SOP: New Information (HRP-024).”



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