CreightonUniversityInstitutional Review Board

2500 CaliforniaPlaza, Omaha, NE68178 Phone: 402-280-3074  Fax: 402-280-4766

Checklist

Principal Investigator Responsibilities

General / See Policy:
 / With the assistance of the IRB office, determine whether IRB review is required for the proposed research. / IRB Policy 105
Section 4
 / Ensure that all investigators (principal investigator and all co-/sub-investigators) involved with human subject’s protocols complete the requirements for the CreightonUniversity Human Subjects Research Education Program. Please note, the IRB will not review a protocol until all investigators on the protocol have completed the education program and received their Initial Certification. / IRB Policy123
Sections 5.0 and 6.0
 / With the assistance of the IRB office, determine whether the project qualifies for exempt status, is eligible for expedited review, or requires full board review. / IRB Policy 105
Section 5.1
 / Prepare the protocol and address any special research issues. / IRB Policy 105
Section 6.1
 / Submit required documentation to the IRB. / IRB Policy 105
Section 8.0
 / Notify the IRB of any changes in the research protocol (e.g., amendments, addenda, administrative changes, etc.). / IRB Policy 122
Section 2.0
 / Submit a protocol summary and a status report on the progress of research according to the timeline determined by the IRB. Progress reports will be required at least once yearly. / IRB Policy 122
Section 5.4
 / Disclose financial conflict of interest to appropriate university officials and translate as necessary. / CU Financial Conflict of Interest Policy 3.1.10.
Informed Consent
 / Ensure information is presented in language that is understandable to the research subject. / IRB Policy 118
Section 2.4
 / Ensure there is no undue coercion or influence. / IRB Policy 118
Section 2.1
 / Obtain appropriate signatures on informed consent documents. / IRB Policy 118
Section 2.1
 / Ensure that content of informed consent forms is adequate. / IRB Policy 118
Section 5
 / Store and manage informed consent documents. / CU Policy, “Individual Departments or Responsible Areas/Parties for Research Records”
 / Submit any changes to informed consent document to the IRB for review prior to instituting. / IRB Policy 118
Section 10
Recruiting Subjects
 / Ensure recruitment methods and advertising follow appropriate guidelines for adequate protection of research subjects. / IRB Policy 113
Sections 3-7
 / If vulnerable research populations are involved, ensure all relevant guidelines are followed. / IRB Policy 116
Sections 2-4
IRB Policy 117 Section 6
Reporting Requirements
 / Promptly prepare and submit reports of adverse events (injury reports, unanticipated problems involving risk) to the IRB, Federal monitoring agencies, and sponsor. / IRB Policy 120
Section 3
 / Promptly notify the IRB of any procedures performed in variance with the protocol. / IRB Policy 120
Sections2 and 5
 / Prepare and submit termination reports. / IRB Policy 121
Section 10
Miscellaneous
 / Keep the following in mind when planning research:
  • Research considered to be in conflict with the Catholic nature of the University will not be approved (examples: embryonic stem cell research, abortion research, artificial birth control research)

  • Research requirements for birth control may not be limited to artificial methods

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Checklist: Principal Investigator Responsibilities

01/01/2010—12/31/2010

2010 Update