dLab Day 3 eProtocol Submissions. Diana Holt and Colleen Kohashi Office for the Protection of Human Subjects (OPHS). Today ’ s Agenda. eProtocol Essentials Short eProtocol Demo General Tips for Approval Common Submission Problems Question & Answer Period. eProtocol Essentials.
Diana Holt and Colleen Kohashi
Office for the Protection of Human Subjects (OPHS)
Berkeley eProtocol uses CalNet authentication. Anyone with a CalNet ID and password can access the system.
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 & to perform research involving human subjects.
Reviewed on a rolling basis // Usually a month or less for review and approval.
Reviewed on a rolling basis // Depending on the quality and completeness of the submission, approval can take up to 8 weeks or longer.
Full Committee Protocols:
Submit by the deadlines posted on the CPHS website. Note: Limited summer and winter holiday meetings.
*Non-Exempt forms are used for protocols reviewed by Expedited and Full Committee procedures.
Note: There is no Exempt to Non-Exempt application “conversion system.” If in doubt, call OPHS for a consultation.
Provide a comprehensive informed consent process.
See the Informed Consent Resources on the CPHS website, including Consent Builder (http://cphs.berkeley.edu/content/informedconsent.html).
Privacy refers to the individuals’ right to control access to themselves.
Confidentiality refers to how private information provided by individuals will be protected by the researcher from release.
**Describing how the confidentiality of research information will be maintained is an important element of the protocol & consent process.
eProtocol Quick Guides
For step-by-step instructions on how to check for completeness, submit the protocol, respond to comments, etc.
CPHS Guidance Documents
There are Guidance documents on specific topics that may be germane to your research including deception in research, subject recruitment, etc. (http://cphs.berkeley.edu/guideline.html)
Student Investigator Guide: A comprehensive step-by-step sheet to help with planning, completing the application and what to expect and when.(http://cphs.berkeley.edu/student.html)
Contact the Office:
We are available by phone, email and in-person meetings to assist investigators. (Contact information to follow at the end of the presentation.)
Subject Population & Recruitment
There are specific timeframes for reporting Unanticipated Problems and Adverse Events (see http://cphs.berkeley.edu/reviewtypes.html#adverse), as follows (copy into eProtocol application):
“An initial report will be made to the Director, Research Subject Protection, within no more than one week (7 calendar days) of the Principal Investigator learning of the incident. The report can be made by fax, mail/delivery, phone, or email. The initial report will be followed by a formal written report, submitted via eProtocol, within no more than two weeks (14 calendar days) of the Principal Investigator learning of the incident.”
When responding to comments: