Access to samples involves the investigator gaining IRB approval, and approval from the Biorepository Ethics and Scientific Review Commitees.
Outlined below are the steps required to submit a sample request to the University of Hawaii Biorepository and have your request fulfilled.
All of the forms are downloadable on this page.
PLEASE NOTE THAT THE REPRODUCTIVE BIOSPECIMEN REPOSITORY AND THE COMPREHENSIVE HUMAN ORGAN AND TISSUE BANK HAVE SEPARATE APPLICATION FORMS, although all other aspects of your application to either biobank are the same.
In brief, we require:
1)A completed application that describes your project and outlines the types of samples and clinical data you desire. Please follow all instructions on the downloadable application forms.
***If you are an investigator outside of the University of Hawaii system, we require that you have a UH-based co-PI.
The Biorepository staff would be happy to find you a collaborator with similar research interests.
2a) If you are a University of Hawaii investigator, you must apply to the UH Institutional Review Board (IRB) for exempt status and provide the Biorepository with the approval letter.
2b) If you are a non-UH investigator, you must acquire IRB-exempt approval from both your university’s IRB, as well as the UH IRB. Your UH co-PI can apply for exempt status here at UH. Both approval letters must be supplied to the Biorepository.
2c) Each investigator involved in the study must be certified with Collaborative Institutional Training (CITI) in research ethics. Verification that you have completed and passed the CITI training course is required by the IRB with your exempt research application.
4)If samples need to be shipped, we require approved Material Transfer Agreement forms
5)Payment for samples (cost recovery fees).
Please download the application and complete in full.
If there are any questions about the application please do not hesitate to contact the Biorepository Staff.
Upon receiving the completed application, your project will be reviewed for approval by both our Scientific and Ethical Review Boards (1-2 week turnaround time).
While our intent is distribute biospecimens as freely as possible, we must confirm that the proposal is a scientifically sound use of our samples, and does not stigmatize any ethnic or socioeconomic group. You may receive feedback from the review boards as compiled by our Director, and a revision of your proposal may be required.
IRB Exempt Approval and CITI research ethics training:
As required by law, the University of Hawaii follows government regulations on the protection of research subjects. These regulations apply to all research performed by UH faculty, staff or students or that use UH facilities or resources (e.g., data, etc.). Federal regulations permit some human subjects research to be exempt from IRB review, approval and oversight. Most projects using samples from the University of Hawaii Biorepositories will be considered exempt human subjects research as described by the IRB:
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (Note: Such materials must already exist at the time the research is proposed.)
Such human subjects research qualifies as exempt from IRB approval and from most of the federal human subjects regulations. Exempt research does require approval by the Human Studies Program.
If you are an investigator outside of the UH system, you must obtain IRB-exempt approval for your study from your university’s IRB, and your UH collaborator must do the same through the UH IRB. Both exempt approval letters will be required prior to sample distribution.
To apply for exempt approval from the UH IRB, please download the following form and visit their website for more details and instructions.
Downloadable UH IRB exempt application: UH IRB Exempt Application
Please read and fill out the IRB exempt application specific to your project. The following will apply to most IRB-exempt applications using the UH Biorepository’s samples:
On your IRB-exempt application, see…
I.“Is your Project Research?” Check the “Yes” box.
II.“Is Your Project Human Subjects Research?” In the first section, check the “No” box for 1 and 2. In the second section check the “Yes” box for 1 if applying for access to the Reproductive Biospecimen Repository and “No” if applying for access to the Comprehensive Human Organ and Tissue Bank (as these samples are from now deceased individuals), and the “No” box for 2 and 3.
III.Categories of Exemption. Check boxes 1 and 2 for Federal Category 4 (Research Involving the Use of Existing Data). Check “N/A” for the other Federal Categories in Section III.
IV.Description of Project will require explanations for #s 1, 2, 4, and 6.
Section V Attachments will require proof that all investigators associated with your project have completed the CITI-training in research ethics. Please see the UH IRB website for directions on how to complete the training:
Direct link to CITI website: https://www.citiprogram.org
If samples are to be shipped:
The UH Biorepository will initiate a Material Transfer Agreement, as outlined on the UH Office of Technology Transfer & Economic Development Website, to be agreed on by both parties.
Cost Recovery Fees:
We will be charging a dollar amount for the service of retrieving your sample/s.