Forms

Initial Submission Forms

• Application for Full Committee Review of Human Subject Research
• Application for Expedited Review of Human Subject Research
• Application for Exempt Review of Human Subject Research
• Application for Review of Retrospective Human Subject Research
• Request for QI/QA Determination
• Request for Determination of Not Human Subjects Research

Here is the Departmental Scientific Review Checklist, if needed.

SUBMISSION INSTRUCTIONS (what is paper, what is electronic):  Click here

 

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Amendments/Changes to Previously Approved Studies

• Request for Amendment Form
  (used primarily for protocol, consent form and funding revisions)
• Request to Add or Revise Recruitment/Retention Materials
• Request to Update or Add and Investigator's Drug or Device Brochure
• Changes to External Study Personnel or Off-Site Changes
• Request for Changes to KUMC/KULC Study Personnel

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Continuing Review and Closing Studies

• Continuing Review Form 
  (This form is used for required recertification — annual or six-month — of non-exempt research)
• Closure Request
  (This form is used when a research study is completed or no longer pursued at KUMC)

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Problem Reports

Reporting timeframes are working days. Timeframes listed are the maximum.
Urgent information that impacts subject safety must be reported to the HSC within 24 hours.

Problem Report A - Internal Adverse Drug Event: This form is for an event that is unexpected and related to study participation (Internal events are those occurring to a subject at any site under the responsibility of the KUMC principal investigator).

• Reporting Timeframe: Death, 24 hours; Other, 5 days

Problem Report B - External Adverse Drug Event: This form is for an event at an external (non-KUMC) site that is unexpected and related to study participation.
• Reporting Timeframe: 20 days

Problem Report C - Unanticipated Adverse Device Event: This form is for internal and external events relating to devices that are unexpected and related to study participaton.
• Reporting Timeframe:  Internal Death, 24 hours; Internal Other, 5 days; External, 20 days

Problem Report D - Report of Non-Compliance: This form is for reporting deviations/violations of the study protocol.
• Reporting Timeframe:  5 days

Problem Report E - Study-Related Complaint: This form is for reporting subject-related complaints about the study.
• Reporting Timeframe:  5 days

Problem Report F - Monitoring/Audit Report: This form is for reporting monitoring/audit reports that indicate problems that could affect the safety of participants, influence the conduct of the study, or alter the HSC's approval to continue the study.
• Reporting Timeframe:  5 days

Problem Report G - Incarceration of a Study Participant
• Reporting Timeframe:  5 days

Problem Report H - Breach of Confidentiality/Loss of Data
• Reporting Timeframe:  5 days

Problem Report I - Other Problems: This form is for reporting all other problems including, but not limited to, equipment problems, availability of test articles/study materials or other availability of resources.
• Reporting Timeframe:  5 days

Report of New Information: This form is for reporting issues including, but not limited to, DSMB or DMC reports, safety reports, toxicology reports, or other interim findings; summaries of study-wide adverse events; suspension or termination of the study due to risk; publication that indicates an unanticipated change to the risk/benefit ratio of the study; an FDA alert, withdrawal from marketing, or other FDA information impacting the risk/benefit ration of the study.

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Supplemental Initial Submission Forms

• Application Addendum for Cancer and Cancer-Related Studies
• Instructions
• Nursing Impact Form
• Supplemental Application for Research Involving Pregnant Women, Fetuses or Neonates
• Research Request for Human Specimens (This form is used to request materials from the Biospecimen Repository Core Facility)
• Radiation Safety Form RS06 (required for all studies that involve any form of radiation or use of a radioisotope)