eProtocol FAQs
1. Who can access eProtocol?
Berkeley eProtocol uses CalNet authentication. Anyone with a CalNet ID and password can access the system. Persons not affiliated with UC Berkeley must be entered in the Human Resources Management System and obtain a CalNet ID to access Berkeley eProtocol.
2. Who can create or edit a protocol?
Those listed in the protocol as Student or Postdoctoral Investigator, Administrative Contact, and Other Contact can create and edit a protocol, but will not be able to submit a protocol. Those listed as Other Personnel will only have viewing access to the protocol.
For instructions on how to create a protocol, see the eProtocol Quick Guide for Investigators.
3. Who can submit the protocol?
Only the person listed as Principal Investigator can submit a protocol using Berkeley eProtocol. This requirement exists as an electronic substitute for an ink signature from the Principal Investigator or Faculty Sponsor.
For instructions on how to submit a protocol, see the eProtocol Quick Guide for Investigators.
4. Who can be listed as Principal Investigator (PI) or Faculty Sponsor?
The person listed on the protocol as Principal Investigator (PI) must be an employee of UCB (usually with an academic appointment) who is eligible under University policy to submit proposals for extramural support of a research, training, or public service project, and to perform research involving human subjects.
As a general rule, the PI on the grant funding the research must be listed as PI on the CPHS application. All Academic Senate faculty members, and a few other categories listed in the policy, have PI status by title (i.e., as part of their appointment). Those who do not have PI status by title may be granted status by exception through the office of the Vice Chancellor for Research.
5. Why does eProtocol say that the PI listed is not eligible?
eProtocol checks the name of the PI on the protocol against a list of people who are eligible to be Principal Investigators. This list was initially taken from the contracts and grants database and it does not include all persons who have PI status. Your PI may need to be added to the list. If you receive a message that says "Please add a Principal Investigator or Faculty Sponsor who is eligible to be a PI" and you believe that it is an error, please contact IRB Manager Maria Savage at mcsavage@berkeley.edu.
6. How are the personnel roles in eProtocol defined?
Principal Investigator (PI)
The Principal Investigator is the person who has primary responsibility for the design, execution, and management of a research project and is involved in the project in a significant manner. The PI is also responsible for the protection of the rights and welfare of the human subjects and adherence by all study personnel to CPHS requirements, as well as applicable federal regulations and state statutes.
Faculty Sponsor
The Faculty Sponsor is a faculty member who has Principal Investigator status and agrees to sponsor the research of a student or postdoctoral investigator. The Faculty Sponsor is responsible for overseeing the protection of the rights and welfare of the human subjects and adherence to CPHS requirements, as well as applicable federal regulations and state statutes.
Student or Postdoctoral Investigator
The Student or Postdoctoral Investigator is an undergraduate or graduate student enrolled at UCB, or a postdoctoral scholar with a UCB appointment. Student/Postdoc Investigators are not considered by CPHS to be a PI on any research project unless granted exceptional PI status. Student or Postdoctoral Investigators who wish to perform human research at UCB must obtain the sponsorship of a faculty member with PI status.
A Student/Postdoc Investigator has primary responsibility for the design, execution, and management of her/his research project and is involved in the project in a significant manner. S/he is also responsible for the protection of the rights and welfare of the human subjects and adherence by all study personnel to CPHS requirements, as well as applicable federal regulations and state statutes.
Co-principal Investigator
The Co-principal Investigator is a principal investigator who shares the responsibility and authority for leading and directing a project on which there is more than one principal investigator.
Administrative Contact
The Administrative Contact is an individual who has some administrative responsibilities on the project and could also be one of the study personnel.
Other Contact
The Other Contact is any individual whom the PI would like to have listed as another contact.
Other Personnel
Other (Study) Personnel includes any individual who contributes in a substantive way to the design, conduct, and/or analysis of the data of a study at or on behalf of UCB. In particular, researchers and staff involved in obtaining informed consent from subjects are considered study personnel.
Please send any suggestions for additional FAQs to IRB Manager Maria Savage at mcsavage@berkeley.edu. |