INSTITUTIONAL REVIEW BOARD APPLICATION – EXPEDITED REVIEW
For research involving the use of existing and CONFIDENTIAL data, records, or specimens
This application has been created specifically for retrospective research using confidential records, data, or specimens that are already in existence (on the shelf, in the files) at the time you submit your application for IRB review.
USE THIS FORM IF YOU CAN CHECK THAT ALL THREE BOXES APPLY. If any of three boxes do not apply to your research, contact the IRB staff (double click on link) to see which IRB application form to use for your research project. http://www.seattlechildrens.org/research/support-services/institutional-review-board/contact/
Your research will use only stored (archived or banked) records, data or specimens that currently exist. This means the records, specimens or data you want to use are already collected and stored at the time you submit your application for IRB review.
You need to record some data variables that are considered confidential and protected. A complete list of variables that are considered identifiers is provided in item 10.3 of this application (Table 1).
You are not planning to contact the individuals (or their parents) for any reason, e.g., to collect additional data or to obtain written permission/consent from the individuals’ or their parents to use their private health information (records, data, specimens) in your research. This will require that you meet the criteria for the IRB to approve a waiver of consent and waiver of authorization (HIPAA). These criteria are listed in items 9.1 –9.4.
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HOW TO SUBMIT THIS APPLICATION:
To expedite approval of this research application, send:
Ø One (1) electronic copy of the completed IRB application and all attachments to for review.
Please answer all the questions completely. DO NOT LEAVE BLANK ANSWERS; USE “N/A” WHEN NEEDED. Instructions and tips for completing the application are included in the application to assist you. Tips are shown in:
Ø Green, italicized font throughout the application or
Ø Comment boxes. Comment boxes are numbered and indicated by yellow highlighted text. When you place your cursor over the highlighted text, a comment box with tips or information will appear.
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PRINCIPAL INVESTIGATOR ASSURANCE
Principal investigator: Please review and confirm each statement by checking the box. Your signature acknowledges you will fulfill these requirements as the PI of this research study.
As principal investigator, I acknowledge:
I am responsible for the conduct of this research and that I will conduct the research project in compliance with the IRB’s conditions of approval.
I will provide the information necessary for complete review by the IRB.
I will not make changes to the research without prior approval from the IRB. For example, changes in research team members, changes in data fields being collected, changes in selection criteria.
I will report problems or protocol deviations that occur and will renew this application as required, but no less than annually.
I will not begin this research project, i.e., no confidential records, data or specimens will be collected for the research, until the research receives final approval from the IRB.
I confirm I will keep track of the patients whose protected health information is used in this research, if I checked No to item 10.9.
I will provide the IRB a final report to close the study when data analysis is complete and the research data has been de-identified as stipulated in items 10.11 and 10.12.
Principal investigator______Date______
1
IRB Expedited Review Application for Research Using EXISTING confidential data, records or specimens.
Revised June 2015
IRB APPROVAL IS VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED
IRB Chairperson’s Signature:______Date______
Approve Disapprove
Subject to the following conditions:______
______
Period of approval: From______through______
INSTITUTIONAL REVIEW BOARD APPLICATION - EXPEDITED REVIEW
For Research Involving the Use of existing and CONFIDENTIAL Data, Records, or Specimens
1.0 TITLE OF RESEARCH PROJECT:
2.0 PRINCIPAL INVESTIGATOR:
Name: / Degree:Position: / Dept/Division:
Telephone: / Pager (optional): / Email:
Mail Stop/Address:
Human Subjects Protections Training / Provide Date, Location and Type of Training:
Institutional Affiliation / Member of Children’s workforce (Children’s Employee, CUMG Employee, Resident or Fellow working at Children’s)? Yes No
If No, indicate institutional affiliation.
3.0 RESEARCH TEAM MEMBERS:
Name and Degree / Position / Dept/Division / Telephone
Number / Email / Mail Stop/
Address / Human Subjects Training* / Member of Children’s Workforce**
- Yes or No /
* Indicate the type, location and date of human subjects training
** Children’s workforce = Children’s employee, Children’s University Medical Group (CUMG) employee, Resident or Fellow working at Children’s.
4.0 CONTACT PERSON:
Name: / Degree:Position: / Dept/Division:
Telephone: / Email: / Pager (optional):
Mail Stop/Address:
5.0 FINANCIAL INTERESTS
5.1 Does any member of the research team or their immediate family have a significant financial interest that may be related to the research, its products or its sponsor? Yes No
If Yes, then list research team member(s) with SFI:
5.2 Is it possible that a commercial product or patent could derive from the research or use of research participants’ data or tissue? Yes No If Yes, then describe.
6.0 FUNDING SOURCES FOR THE RESEARCH PROJECT
The IRB is responsible for certifying to all funding agencies that the human subjects activities described in the funding application have been reviewed and approved by the IRB.
6.1 Do you have any pending or awarded funding proposals that support this research project?
No Check here and go to section 7.
Yes Provide one complete copy of each funding proposal, pending or awarded. Provide the funding information, A.-K., requested below for EACH funding proposal.
A. Name of principal investigator:
B. Title of proposal:
C. Type of proposal:
D. Proposal status:
E. Award status:
F. Type of funding agency:
G. Name of funding agency:
H. Agency’s number assigned to funding proposal, if known:
I. Funding dates of proposal:
J. Monies to be administered through:
If Other, provide name and address of the organization through with monies will be administered.
K. Is the research activity described in this IRB application described in the funding proposal?
Yes No. If No, explain why funding proposal is listed.
To conduct research using confidential (i.e., protected and private) health information from persons without their permission the IRB must find that you meet federal and state regulations. These include the federal regulations for waiver of consent; the HIPAA requirements for waiver of authorization; and Washington State law. The questions within this application provide the information the IRB needs to determine if this research meets federal, state, and institutional requirements.
7.0 RESEARCH DESCRIPTION, DESIGN AND METHODS
7.1 Provide a brief (one paragraph), non-technical description of the research study.
7.2 Briefly describe the background and significance of this research project (1-2 paragraphs). Cite previous work in the area by you, your co-investigators or others. Provide complete citation list for all work cited. If the list is long, attach as an appendix to application.
7.3 What specific question(s) (aims) does this research project attempt to answer?
7.4 Will you be using a control or comparison group? Yes No
If Yes, describe the control group.
7.5 Explain briefly how you plan to analyze and evaluate the data to answer the study question(s) stated in 7.3 above.
8.0 RESEARCH PARTICIPANTS
8.1 Indicate the approximate number and age range of research participants whose records, data or specimens will be used in this research. If there are different groups of participants, provide the number and ages for EACH group.
Number:
Age Range:
8.2 Define the inclusion criteria for EACH group of research participants whose records, data or specimens will be used in this research.
8.3 Define the exclusion criteria, if any, for EACH group of research participants that would exclude the use of these individuals’ records, data or specimens in this research.
8.4 Will gender, race, or ethnicity be used as variables in selecting individuals’ records, data, or specimens for use in this research? Yes No
If Yes, explain the rationale. The IRB’s concern is that research data include equitable gender and minority representation of individuals affected by the disorder or condition being studied.
8.5 Specify the time period in which these records, data or specimens were collected or created. To qualify for expedited review at Children’s, the data, records or specimens must be existing (on the shelf, in the record) at the time of IRB review of the research.
9.0 REQUEST FOR WAIVER OF CONSENT and WAIVER OF AUTHORIZATION (HIPAA)
9.1 Please explain why: The research involves no more than minimal risk to research participants and their privacy:
9.2 Please explain why: The waiver of consent and authorization will not adversely affect the rights, including the right to privacy, nor adversely affect the welfare of the participants whose records, data, or specimens are being used:
9.3 Please explain why: The research could not practicably be carried out without the waiver of consent and waiver of authorization:
9.4 Please explain why: The research could not practicably be carried out without access to protected health information:
10.0 RESEARCH DATA AND CONFIDENTIALITY
10.1 Identify ALL the sources of the data, records or specimens to be used in this research project.
10.2 Provide copies of the research data collection forms to be used or a COMPLETE list of data variables that will be collected.
10.3 Please check which of the following patient identifiers are recorded for the research study.
Table 1: The following are considered identifiers based on the federal privacy rule (HIPAA)
Names / Medical Record Numbers / Social Security Numbers / E-mail AddressesHealth Plan Beneficiary Numbers / Account Numbers / Telephone Numbers / Fax Numbers
All elements of dates (dates of birth, death, admission, discharge dates, service, e.g., surgery). All ages over 89 / Geographic subdivisions smaller than a state (street address, city, county, zip code) / Full face photographs or comparable images / Biometric identifiers – finger or voice prints
Vehicle ID and serial numbers including license plate numbers / Certificate and License Numbers (including driver’s license) / Device identifiers and serial numbers / Any other unique identifying number, characteristic or code
Internet Protocol Address Numbers / Web URL / Surgical pathology number
10.4 To comply with HIPAA you must use only the minimum necessary identifiers to achieve the purposes of this research. Explain why you need EACH of the identifiers checked in 10.3. above.
10.5 Check ALL the boxes below that indicate the steps you will take to maintain the confidentiality of the research data and privacy of the participants.
Study data will be coded with unique study code numbers. No direct identifiers, e.g., name, medical record number, pathology number will be listed on the research data collection forms or research data set.
The key to the study code will be retained in a secure place, separate from the research data. (The key links the study code number to the individual patient).
Research data will be stored on password protected, secure computers.
Research data will be stored in locked files in secure, locked offices.
Research data will be used only for the specific study aims listed in section 7.2 above.
All identifiers will be removed before any publication or presentation of the research data.
All members of the research team have received human subjects protections training.
Other, describe.
10.6 Where will you store the research data you are collecting and/or the specimens you will use?
10.7 Who is responsible for controlling access to the stored research data and/or specimens?
10.8 Will any persons not listed as PI or research team member (sections 2 and 3 above) receive or view research data with identifiers? Yes No
If Yes, explain who and what identifiers they will receive.
10.9 Are all members of the research team (PI and team members) part of Children’s work force?
Yes No If No, i.e., a member(s) of the research team is not part of Children’s work force, the use of protected health information (PHI) in this research is a “disclosure” under the federal privay rule (HIPAA). This means you must keep track of all patients whose PHI is accessed for the research. Page 8 of the IRB information sheet on HIPAA and research explains the tracking requirements for disclosures. http://irb.seattlechildrens.org/info_sheets/HIPAA_research.pdf. Children’s tracking forms are available at http://research.seattlechildrens.org/policies_forms/forms-irb-hipaa.asp
If you checked No, review and check the following:
As the Principal Investigator responsible for this research, I have read the HIPAA information sheet and understand the requirements for tracking. I confirm I will keep track of the patients whose protected health information is used in this research.
10.10 All members of the research team with access to confidential records, data or specimens collected for this research need to sign the appropriate institutional confidentiality agreement(s). Check all of the boxes below that apply to this research.
This research uses confidential records, data, or specimens of the University of Washington or Harborview Medical Center. Complete the University’s “Confidentiality Agreement” form. http://www.washington.edu/research/hsd/docs/393
This research uses the confidential records, data, or specimens of institutions other than Children’s, the University of Washington or Harborview Medical Center. If this box is checked, list the institutions and provide their IRB or Privacy Board approval, which confirms that the data will be released in a manner compliant with HIPAA.
10.11 To meet federal and state requirements the research data must be de-identified (made completely anonymous) AFTER the data analysis is complete. This means, when data analysis is complete and you are ready to close your IRB application, the IRB will need confirmation that all the research data collected has been made completely anonymous by removing all identifiers that were collected. Check ALL the boxes below that describe the steps you will take to de-identify research data after data analysis is complete.
All identifiers circled in 10.3 will be removed from the research data set and discarded.
All dates will be removed and discarded but some dates will be replaced with non-identifiers, e.g., date of XX will be changed to age at time of XX.