Non-Affiliates and Outside Collaborations
Frequently Asked Questions
What if I will be engaged in human subjects research at another UC campus?
Principal Investigators (PIs) conducting human subjects research at another UC campus must either get IRB approval from UCB or have an active reliance (formerly NOITR or Notice of Intent to Rely on One UC IRB) under the UC MOU. For more information, see UC IRB Reliance Registry for Studies under the UC MOU.
What if I will be engaged in human subjects research at a non-UC institution?
PIs conducting human subjects research at a non-UC institution must either get IRB approval from UCB or enter into an Inter-Institutional Agreement (IIA) which allows UCB to rely on the other institution’s IRB review. For more information on inter-institutional agreements, see Collaborative Research.
What if I will be sharing data with non-UC Berkeley investigators/institutions?
Outgoing Data to Non-UC Berkeley Investigators/Institutions
Whenever UC Berkeley research data will be shared with non-UCB investigators/institutions, UCB investigators should abide by what participants (from whom the data was originally collected) agreed to during the informed consent process. Whenever possible, the data should be de-identified prior to transfer.
If you are seeking to send your data to another party, the Office of Technology Licensing (OTL) can assist you in putting together a data use agreement (DUA) to send the data. In order to ensure that the transfer of outgoing data from UC Berkeley meets University policies and safeguards you, your lab, your future rights, and the requirements of funding agencies, a DUA must be executed before sending the data. A DUA is similar to a confidentiality agreement in that it places restrictions on how the other party can use and disclose your non-public data. DUAs address important issues such as the recipient’s limitations on use of the data, obligations to safeguard the data, liability for harm arising from the use of the data, publication rights and restrictions, and privacy rights. An Outgoing Data Request form can be completed on the Berkeley IPIRA website.
For studies funded by NIH, investigators should be familiar with the NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources.
What if I am an unaffiliated researcher wanting to recruit subjects from the UCB community?
If you are a non-UCB researcher who wishes to recruit from the UCB community but are not collaborating with a UCB PI, then UCB is not engaged in the research and no IRB review is needed. An exception is the recruitment of subjects within UCB dormitories for which UCB IRB review is required. The non-UCB researcher is responsible for abiding by the policies of his/her home institution’s IRB and for obtaining appropriate permission to recruit from UCB groups and organizations.
What if I am collaborating on human subjects research at UCB?
Non-UCB researchers who wish to collaborate on research at UCB must have an eligible UCB principal investigator to serve as the sponsor who will submit a protocol to UCB’s IRB for approval. Non-UCB researchers are responsible for obtaining IRB approval from their home institutions.
Can volunteer research assistants help us in the lab?
Yes, it is quite common for volunteer research assistants to participate in lab work. PIs and/or lab managers should work with their HR department to ensure that a Worker’s Compensation Volunteer Registration Form is submitted for each volunteer.
PIs and/or lab managers are also responsible for ensuring that each volunteer receives adequate human subjects training, depending on his/her research responsibilities.
How should I use the “Working with Research Study Participants: An Overview” PowerPoint presentation in order to train non-UCB collaborators?
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Applicability: The PowerPoint may be used when UCB researchers elect to provide human subjects
research (HSR) training to eligible external collaborating staff (e.g., enumerators; non-profit agencies
which assist with recruiting, interviewing and/or running focus groups).
The presentation topics include the ethical principles of the Belmont
Report, recruitment, informed consent, and privacy and confidentiality.
Please note the following:
- This is an alternative to asking the collaborating staff to take the CITI or OHRP training modules.
- If external collaborators are affiliated with an institution that has an HSR training program in place, the collaborators should comply with the training requirements set by their home institution (i.e., the UCB PI is not responsible for providing the training).
- Training modality: The PowerPoint is designed for the UCB PI/designee to use during an in-person session or, if necessary, via a video chat service. This approach facilitates discussion and fosters team building.
- The PowerPoint presentation should not merely be forwarded to collaborators as a self-study tool.
- Uses: Adopt or adapt template content. Review the template content and customize it for the needs of the study, taking into account the individuals to be trained, their responsibilities, and the cultural setting of the study.
- The presentation template includes optional Speaker’s Notes and Presenter Tips for some (but not all) slides. To access these Notes/Tips, from the View menu, select Notes Page.
- Questions: Consult with OPHS as needed. Researchers who are unsure about whether the presentation is appropriate for a particular situation, or who have further questions about how to use this resource, should contact OPHS staff for guidance.
OPHS welcomes feedback regarding researchers’ experiences with using this PowerPoint presentation. We would also appreciate suggestions for future iterations.
I am a student investigator who will be withdrawing from enrollment in order to conduct my human subjects research. What are some considerations I need to make regarding my protocol?
As a student, you are required to have a faculty sponsor serve as the PI of your study. Before you withdraw from enrollment, you must ensure that your PI is willing to be responsible for keeping your protocol current in your absence because withdrawn students do not have access to eProtocol.
You and/or your PI will need to submit an Amendment in which your name/information is moved from the “Student/Postdoctoral Investigator” field to “Other Personnel” in the “Personnel Information” section before you withdraw. Additionally, any subsequent Amendments or Continuing Review applications that may be needed while you are on withdrawn status will need to be edited and submitted by your PI.