Student Investigators Guide
This guide page introduces students to the process of submitting an application to the Committee for Protection of Human Subjects (CPHS), UC Berkeley’s Institutional Review Board (IRB), including key information and associated content links to other areas of the CPHS website. The Office for Protection of Human Subjects (OPHS) is the administrative office that supports the Committee for Protection of Human Subjects. The OPHS staff team consists of friendly, knowledgeable professionals who are ready to assist you with human subjects research-related questions and concerns.
The guidance is organized into four parts:
- Part 1 focuses on when CPHS review is needed (not all projects constitute human subjects research as defined by the federal regulations).
- Part 2 addresses pre-submission steps and planning.
- Part 3 covers submitting an application to CPHS and the CPHS review cycle.
- Part 4 provides post-approval tips for maintaining a CPHS-compliant protocol.
Start the process early! If your project needs CPHS review, you should submit your application at least eight weeks in advance of when you plan to begin the research. We receive a high volume of applications, and most need adjustments before they may be considered review-ready. Please plan accordingly.
Part 1: Determine if you need to submit an application to CPHS
Go to What Needs Review for general guidance and helpful examples of activities that may or may not trigger the requirement to submit an application for CPHS approval. In particular, note that while some Undergraduate-Initiated Research Activities (UIRA) involving human subjects may require approval by CPHS, many others do not. This is discussed in the CPHS guidance document Ethical Issues in Undergraduate Research Activities with Human Subjects.
If you are an undergraduate student planning to conduct a UIRA project, be sure to read the Ethical Issues document referred to in #1 above as well as Guidance on Designing Undergraduate-Initiated Research Activities. These guidance documents were written specifically to assist undergraduate students and their faculty mentors with UIRA projects.
If it appears that you need to submit a CPHS application, go to Types of Review and read the descriptions for new Exempt and new Non-Exempt applications. This information will help you determine which type of application is appropriate for your research.
After reviewing the descriptions, if you are still unsure whether to submit or which type of application to submit, email OPHS, or call us at (510) 642-7461. Our phone consultation hours are 1 – 4:30 pm, Monday through Friday. OPHS staff are also available for in-person consultation, by appointment only. To schedule an appointment, email OPHS.
Part 2: Pre-submission steps and planning
1. In order to submit an application to CPHS, you need to work with a Principal Investigator (PI). Student Investigators who wish to conduct human subjects research at UCB must obtain the sponsorship of a UCB faculty member with PI status. Make sure that your faculty sponsor has PI status. If this is not the case, contact OPHS for further guidance.
2. Human subjects training requirement. UCB faculty (with some exceptions), staff, and students engaged in human subjects research must complete the online Human Subjects Curriculum CITI course (UCB-course sequence).
- When you register online, be sure to select UC Berkeley as your institution.
- Depending upon your research activity, select one of the following courses:
- Biomedical Research Investigators and Key Personnel (Group 1) OR
- Social and Behavioral Research Investigators and Key Personnel (Group 2).
- Save a pdf of your CITI completion report; you will need to upload it to the CPHS eProtocol application.
Note: The CITI Responsible Conduct of Research (RCR) curriculum is not required for the CPHS approval process. However, student researchers who are personnel on a National Science Foundation (NSF)-funded study will need to complete RCR training in order to fulfill the NSF requirements (see Responsible Conduct of Research for additional information).
1. CPHS Guidance on specific topics. Before you start the CPHS application, review the guidance topics listed, many of which will be helpful to first-time researchers (e.g., recruitment, informed consent, parental permission and child assent, data security, secondary analysis of existing data). The guidance documents will provide you with a framework for what to include in the application.
- If your research is non-exempt and involves direct contact with human subjects, review the Informed Consent Guidelines, then the consent document templates and samples, and locate the one(s) most suitable for your research. Create your consent document(s) using our online resource, Consent Builder. By entering your study variables into the program, you can create Word documents, with CPHS-recommended language and format, to save to your desktop. You can then tailor the form(s) as needed before attaching as a pdf to your CPHS eProtocol application.
- If you plan to submit an Exempt application, consent documents are not needed for review. However, you should follow consent guidance outlined in Section D, Respect for Persons and Informed Consent, of the CPHS guidance on Exempt Research.
2. Off-site recruitment permissions. In order to recruit subjects at an off-site location (e.g., another UC campus, a clinic, a school), you will need to obtain advance letters of permission/cooperation from each site and upload them to the CPHS application. Note: This applies to certain UC facilities as well (e.g., UCB-affiliated preschools, residential units, etc.)
3. Research collaborations involving an external institution, or another UC. Research involving external collaborations will require additional planning and coordination. If your external colleagues are engaged in the research, this may also involve IRB review at the other institution, or a process whereby one IRB relies upon the review of another IRB. If this applies to you, seek consultation from your PI and/or OPHS immediately.
Part 3: Submitting a protocol to CPHS / the CPHS review cycle
1. eProtocol is the CPHS online application system. Before you begin the application, review the instructions and FAQ pages. Be sure to select the most appropriate form for your research. If in doubt, contact OPHS for assistance.
- When you are ready to start, go to the Quick Guides tab and select the Create a Protocol document. It includes helpful screenshots to orient you to the eProtocol system.
- The Quick Guide Submit a Protocol Application will also be helpful to you.
2. The Review Cycle. Submitted eProtocol applications are triaged to an appropriate review panel (i.e., exempt, non-exempt expedited, or full CPHS Committee). Exempt and non-exempt protocols are reviewed on a rolling basis, and in the order received. Protocols that require full Committee review are assigned to the appropriate panel for review at the next available meeting.
- You will receive an eProtocol-generated email informing you of the name of the panel manager. Your protocol will be held in the review queue and pre-reviewed by staff as soon as possible. Protocols are reviewed in the order in which they are received.
- Exempt review applications. The panel manager/assigned staff reviewer will send comments in eProtocol (the system will issue an email to let you know when comments are available). Respond to comments in eProtocol as soon as possible. Sometimes response clarifications generate more questions, and therefore more rounds of eProtocol comments/ responses; it is all part of the process. Once the review is complete, you will be informed of the outcome (i.e., exempt determination; not human subjects research as defined by the federal regulations; does not fit exempt criteria/submit non-exempt application).
- Non-exempt expedited review applications. The panel manager/assigned staff reviewer will send comments in eProtocol (see information for Exempt, above). Once the pre-review process is complete, the protocol will be submitted to the CPHS reviewer(s). Unless a CPHS reviewer has additional concerns, this last step in the approval process is typically completed within one week.
- Full Board review applications. The panel manager/assigned staff reviewer will pre-review the application (see information for Exempt, above). If there are any missing documents (e.g., consent forms) necessary for the review, the panel manager/staff will either submit eProtocol comments or contact you outside of the system, as appropriate to the situation/ timeline. Following the meeting, you will be notified of the vote outcome (e.g., full approval, conditional approval, deferral to another convened meeting). Post-meeting comments are sent in eProtocol to you and the Principal Investigator as soon as possible, usually within two weeks of the meeting date.
Part 4: Post-approval tips for maintaining a CPHS-compliant protocol
Once you have your CPHS approval (congratulations!), be sure to review the following information so that you remain alert to your ongoing responsibilities as a UCB Student Investigator. Communicate regularly with your PI/research team throughout the implementation of the study. Contact OPHS at any time if you have any questions or concerns.
Approval Period. Unless you were granted an Exempt determination (no expiration date), the CPHS approval letter will include an effective date and an expiration date. Be sure to make a note of the expiration date. Additionally, review the Study Renewal/Continuation section below.
- Study Renewal/Continuation. Federal regulations require that IRBs review continuing research until the time of study closure. At UCB, most protocols are assigned either a ten-year or a one-year approval period. (In some circumstances, CPHS may designate a shorter approval period.)
- Ten-year approval period. To qualify, the research must:
- involve no more than minimal risk to participants (as defined by 45 CFR 46.102);
- not be supported by federal funds;
- not be subject to federal oversight; and
- other restrictions listed at Ten-Year Approvals.
- One-year approval period. Unless a protocol qualifies for a ten-year approval period, in most circumstances it is given a one-year approval period.
- Ten-year approval period. To qualify, the research must:
- Several months before the expiration date, you will start to receive eProtocol-generated courtesy reminders. Applications for continuation review should be submitted eight weeks prior to the expiration date to allow sufficient time for the renewal process. It is a Principal Investigator /Student Investigator responsibility to submit for renewed approval in a timely manner. In keeping with federal regulations, if approval expires, all human subjects research activities—including data analysis—must cease until re-approval from CPHS is received.
- Amendments/Modifications. eProtocol amendment applications must be submitted to and approved by CPHS prior to implementation. This requirement pertains to all proposed modifications/changes to exempt and non-exempt currently approved protocols. Amendments include (but are not limited to): Requests to increase the approved total subject sample size; changes or additions to subject contact materials/consent documents; consent document translations; study personnel changes; changes in funding sources; study design modifications.
- Unanticipated Problems and Adverse Events. Discuss any issue promptly with the protocol PI. Together, you will need to determine if it triggers the need for a prompt report to CPHS.
- Any unanticipated problem involving risks to subjects or others, and/or a serious adverse event, must be reported promptly to CPHS within no more than one week (7 calendar days), by phone, email, or mail/delivery.
- A written report (via eProtocol) must be sent within two weeks (14 calendar days), of the Principal Investigator becoming aware of the event.
- Protocol Deviations (includes noncompliances). Any deviation from an approved Non-Exempt protocol or Exempt protocol must be reported to CPHS/OPHS promptly. The IRB will review the report to determine whether the incident was a serious or a minor noncompliance and assess whether any corrective actions or substantive changes are needed in order to protect the safety, welfare, and rights of subjects or others.