IRB Application: Anti-Kell Project

Does the subject group include healthy volunteers? __Yes __No _x   N/A

Does the subject group include ill persons? __Yes __No _x_ N/A

Are subject groups excluded for medical reasons? __Yes __No _x_ N/A

Are there vulnerable subject groups? __Yes __No   x   N/A

If yes, is the exclusion criteria for the study specified? __Yes __No   x   N/A

Are any subjects under the age of 18? __Yes __No   x   N/A

Are any subjects under the age of 12? __Yes __No   x   N/A

Are any subjects over the age of 70? __Yes __No   x   N/A

A.                                                        APPLICATION FORM

The application form must be filled out completely so committee members may have a clear understanding of the nature and human subject implications of the research proposal.  A summary paragraph for each section is sufficient.  A statement referring to the attached materials is not sufficient and will not be accepted.  Applications submitted with incomplete forms will be returned without consideration of the proposal.

1. TITLE

Comparison Study of Gel Method vs. the Traditional Tube Method in Detecting Anti-Kell Antibody

2. DESCRIPTION OF THE STUDY

The researchers plan to receive at least 50 patient serum specimens with the anti-Kell antibody from various local hospitals.  Through a blinded independent study, we will test each specimen for the anti-Kell antibody in three ways:  by the gel method, by the tube method with PEG enhancement, and by the tube method with LISS enhancement.  Several specimens will be duplicated without researcher’s knowledge in order to create an internal control.  The purpose of this research is to determine the sensitivity of detection for anti-Kell antibodies by the Ortho-gel method.  Anecdotal evidence shows that some anti-Kell antibodies have been missed using the gel method, which could lead to a possible transfusion reaction. 

3. DURATION OF THE STUDY

The duration of this study will be from November 2005 through April 2006.

4. MULTICENTER STUDY

This is NOT a multi-center study.  All specimens will be donated from various local hospitals, however all testing will be done at the Weber State University Clinical Laboratory Sciences Blood Bank.

5. NUMBER OF SUBJECTS

            At least 50 patient sera will be tested.

6. HEALTH STATUS OF THE SUBJECTS

All patient information will be unknown to the researchers

7. SUBJECT GROUPS EXCLUDED

All patient information will be unknown to the researchers

8. AGES OF THE SUBJECTS

All patient information will be unknown to the researchers

9. DESIGN OF THE STUDY

This will be a blind control study.

10. RISKS TO SUBJECTS

There is no risk to patients from whom the samples were obtained. These samples were obtained prior to our research by various hospitals.  The researchers will have no contact with the patient whatsoever.                       

ANY MODERATE OR HIGH RISK STUDY MUST GO THROUGH A SEPARATE REVIEW PROCEDURE WHICH INCLUDES THE APPROPRIATE ADMINISTRATIVE OFFICER AND THE UNIVERSITY ATTORNEY.

11. BENEFITS TO SUBJECTS AND OTHERS

The researchers want to help those facilities that are using this technology in their lab avoid a serious transfusion reaction if the Ortho-gel method proves to be inadequate.

12. COSTS TO BE BORNE BY SUBJECTS

There will be no cost to the subjects.

13.  IS CONFIDENTIALITY ASSURED

Patient information will be removed and replaced with an accession number.  Researchers working on this project will not have access to actual patient information.  All confidentiality of all patient information will be enforced and privacy of all subjects will be maintained.

14. CONTRACT OR GRANT NUMBER

A grant proposal has been submitted to the WSU Undergraduate Research Office and is currently under evaluation.

15.  NAME OF PRINCIPAL INVESTIGATOR AND DEPARTMENT

The investigator is Bill Zundel from the Clinical Laboratory Sciences Department at Weber State University.                                                      

B.                                            DESCRIPTION OF THE STUDY

1.  BACKGROUND INFORMATION

Considering the fact that the Ortho-Diagnostics Gel method is still fairly new, research has yet to be performed in this area.  We found a great deal of literature on the advantages of Ortho-Gel, however, there was not much data about the disadvantages that occur with using this technique with anti-Kell.  Anecdotal evidence suggests that Ortho-Gel has missed some Anti-K antibodies in routine antibody screenings.  This is clinically significant, because overlooking this antibody could cause an adverse transfusion reaction.  Through a blinded independent study, at least 50 samples will be tested using gel technology, tube method with PEG enhancement, and tube method with LISS enhancement.  Data will then be collected and a comparison between the three will be evaluated to determine the sensitivity of each method in detecting anti-Kell.  Through this study, researchers expect to make those who implement the Ortho-Diagnostic Gel cards in their facilities aware of the potential risk involved when performing an antibody identification of anti-Kell. 

C.                                                        INFORMED CONSENT

                        No informed consent is needed because the researchers are not dealing with the patients. They are only dealing with saved samples from various hospitals in Utah.