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 Who can use eProtocol? Who can be listed as Principal Investigator (PI) or Faculty Sponsor? Berkeley eProtocol uses CalNet authentication. Anyone with a CalNet ID and password can access the system.CalNet 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.

eProtocol Essentials // Designations 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 a significant manner. 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. Student or Postdoctoral Investigator (*must have faculty sponsor) The Student or Postdoctoral Investigator is an undergraduate or graduate student enrolled at UCB, or a postdoctoral scholar with a UCB appointment.

eProtocol Essentials // Compatibility Browser Make sure that you are using a web browser that is compatible with eProtocol: With Macs, use Safari With PCs, use Firefox (*eProtocol does not consistently support Chrome) Pop-up Blockers Make sure that your pop-up blocker is turned off

eProtocol Essentials // Plan Ahead Exempt Protocols: Reviewed on a rolling basis // Usually a month or less for review and approval. Expedited Protocols: 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. 12/21/2015 6

eProtocol Essentials // Forms Social Behavioral / Exempt Social Behavioral / Non-Exempt Biomedical / Exempt Biomedical / Non-Exempt *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.

eProtocol Tips // Informed Consent Provide a comprehensive informed consent process. Researchers should ensure that the consent documents are clear and concise Include translations Use waivers (e.g., unsigned consent) where appropriate See the Informed Consent Resources on the CPHS website, including Consent Builder ( 12/21/2015 8

eProtocol Tips // Confidentiality 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. 12/21/2015 9

eProtocol Tips // Anonimity Anonymous data collection means that no identifiable information (e.g., name, address, student ID number, , phone number, etc.) is connected to the data either directly or through a coding system, at any point in the study. Videotapes and photographs, audio recordings are considered to be identifiable; therefore the use thereof would not be considered anonymous. Multiple pieces of information, none of which are identifiable on their own, may identify a person when brought together. In this instance, the data would not be anonymous. 12/21/

eProtocol Tips // Resources 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. (

eProtocol Tips // Resources (con’t.) Student Investigator Guide: A comprehensive step-by-step sheet to help with planning, completing the application and what to expect and when. ( Contact the Office: We are available by phone, and in-person meetings to assist investigators. (Contact information to follow at the end of the presentation.) 12/21/

Commonly Requested Revisions Subject Population & Recruitment Include maximum total sample size. If unsure, over- estimate. Include recruitment details specific to the proposed study and provide copies of all recruitment documents (e.g., scripts, web postings, etc.). Data Collection Include copies of all data collection materials. Include interview guide(s). At minimum, include topics to be explored during the interview.

Commonly Requested Revisions (con’t.) Benefits: Include anticipated benefit to subject and society in the protocol. If there is no benefit to subject, state so. Attachments section: Include a PDF copy of the UCB CITI completion report for all students listed on the protocol. Complete Group 1 (bio-medical) or Group 2 (social-behavioral) for Research Investigators and Key Personnel. *The Responsible Conduct of Research will not suffice. 12/21/

Commonly Requested Revisions (con’t.) There are specific timeframes for reporting Unanticipated Problems and Adverse Events (see 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 . 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.”

Commonly Requested Revisions (con’t.) When responding to comments: Provide thorough but concise answers. Only include information relevant to the question posed. Be sure make the applicable revisions directly into the protocol as well. Be sure to click on the “submit to IRB” button to submit your responses and revisions. Once successfully sent, your dashboard will state “Responses Sent Cycle XX.”

For More Information & Assistance Call Monday to Friday, 8:30am-12pm, 1pm- 4:30pm Speak with the analyst who answers the phone In-person Meeting 2150 Shattuck Ave., Suite 300 Monday to Friday, 8:30am-12pm, 1pm- 4:30pm In-person assistance must be scheduled in advance Website