Date: / IR File#: / Protocol #:
Principal Investigator:
Study
Title:
Please complete the following questions to determine if the proposed research activity involves human subjects under DHHS/OHRP guidance:
- Does this research only involve de-identified human data or specimens obtained from a provider on the list of IRO Pre-reviewed Sources (e.g., ATCC, dbGaP, CHTN)? Complete list can be found at the following link -
Yes STOP.Research using only human data or specimens from IRO Pre-reviewed Source(s) source(s) is presumptively considered Not Human Subjects and does not need to be reviewed separately by the IRB.
No (continue to question #2)
- Is there any possibility that you could make a link to the identity of an individual even if you are using coded information?
YesNo (continue to question #3)
- Will any other investigator collaborating with you on this research be able to identify any human subject directly or indirectly through coding systems (this does not include the provider of the data or specimens if they are only providing data or specimensand they are prohibited by regulation, policy, agreement, or contract from releasing the identifiers to you)?
YesNo (continue to question #4)
- Will the activity involve the use of a drug other than the use of a marketed drug in the course of medical practice?
YesNo (continue to question #5)
- Will the activity involve determining the safety or effectiveness of a medical device?
YesNo (continue to question #6)
- Will the specimens or information/data support the marketing of a FDA regulateddrug/biologic/device?
(Note: If the research is conducted under an IND or IDE, this answer would be “yes”)
YesNo (continue to question #7)
- Will genotypic and/or phenotypic data derived from the de-identifed samples be submitted directly by Fred Hutch to dbGaP and/or any other public access repository?
YesNo
Not Human Subject Determination - IRB Submission Instructions:If you answered “Yes” to any question 2 through 7 above, the proposed study is Research Involving Human Subjects.
Please submit the appropriate New IRB Application for IRB review. If you need assistance regarding the appropriate application, please contact the IRO at 667-5900.
If you answered “No” to questions 2 through 7, please complete the flow chart on the next page and submit this form as part of the Application for Review Human Specimen or Data Research. Follow the instructions on the application form.
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NO YES
2.Is interaction
YES
NO
YES
NO
NO
YES
YES
YESNO
NO
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