IRB and Human subjects requirements
This forum is a is a work in progress, meant to stimulate discussion and collaboration. Include your voice! moderator
Does my student need IRB approval from BOTH UCSF and its Partner University?
Student researchers at non-affiliate sites may qualify for a waiver if:
1) Their mentor (PI) is not UCSF faculty; 2) They already have an IRB approval from the other institution; and 3) They are not accessing UCSF facilities, medical records, patients or personnel. [guidelines]
Country Specific Requirements
Every country has its own IRB requirements! Where can I find the requirements for countries I plan to work in?
There is a clearing house of IRB requirements posted here. Remember that there are often OTHER requirements, such as state or district regulations, which must be met. We strongly suggest that anyone planning a project in a new site take advantage of the expertise of researchers who have already worked in an area, read the advice page linked at the top of this forum, and take advantage of CTSI's Global Health Consultants
Conflicts in requirements
Reading the IRB requirements, it looks as though I need to maintain patient records at UCSF, but the country I work in wont let me take the records out of country. Who mitigates?
You are not alone! The IRB committess have seen this type of situation before. Write them a note, they are very committed to fostering the independence of the IRBs in our partner institutions, and will work with you to develop a solution.
NIH changes to human approvals
_I heard the NIH made some changes to the approval requirements? Current NIH policy requires prior approval from the NIH awarding Institute/Center (IC) for a change in scope . One of the potential indicators of a change in scope is a change from the approved involvement of human subjects. There is guidance in this document
I'm working with a stigmatized population that avoids paper records. I need consents for my IRB, how do researchers deal with this?
Fingerprinting is the most common work around. There is a discussion on electronic fingerprinting linked to encryption or auto-destruct software to safe-guard at risk populations.[JOIN discussion ]
Funded start date
NIH grants require IRB approvals before releasing funds. However, IRBs in foreign countries (Uganda) require payment of IRB application fees before releasing the initial review approval. What solutions have been found at UCSF to solve this catch-22?
NIH allows for funding of project related expenses up to 90 days prior to the start of the award. If approved for award, the IRB application fees would be allowed as a pre-award costs. In addition, UCSF has a process in place for the setup of the fund prior to award setup with approval from the Department. Guidelines for Fund advance request and setup can be found at the Office of Sponsored Research
My project is close to close-out. My partner institution is responsible for transitioning participants into other care structures. What kind of oversight should I provide? [reply]