- IRB Application Revisions
- New Common Rule
- Investigator/Reviewer Training
- Seaver IRB Calendar
- GPS IRB Calendar
- COVID-19 Updates
Date: Monday, November 22, 2021
To: Pepperdine Faculty
From: Katy Carr, Assistant Provost for Research
Subject: Revised IRB eProtocol Applications Coming December 18, 2021
The Pepperdine Institutional Review Board (IRB) has spent much of 2021 working with our external vendor Key Solutions to revise Pepperdine's exempt, expedited, and full board IRB applications on our eProtocol online platform. These revisions will reduce redundancy and burden for researchers and IRB reviewers, while remaining compliant and consistent with best practices based on the Office for Human Research Protections (OHRP) guidance and federal policy/guidelines, specifically the New Common Rule.
Pepperdine investigators with plans to submit IRB applications in the coming weeks should be mindful of the timeline below. Additionally, we ask that faculty advisors share this information with the appropriate student investigator groups.
From December 6 - 17, 2021, the Pepperdine IRBs will not be reviewing any new IRB submissions. The IRBs will use this time to process all pending submissions before the new application formats go live on December 18, 2021. Note: The update to the IRB eProtocol application forms may impact limited content within pending applications (any application without "approved" status), however no applications will be removed in their entirety or lose their place in the IRB review queue.
More information will be available on Pepperdine's IRB community webpage, and all available resources, including training videos, presentations, and forms will be updated accordingly. Please direct your questions to the Pepperdine IRB.
Updates to Pepperdine's IRB Manual
The revisions to the common rule are reflected in Pepperdine's IRB Manual.
Until January 21, 2019 institutions are required to comply with the pre-2018 Common Rule. The information below and on the linked pages is consistent with the Common Rule revisions that are set to go live on January 19, 2019. We will update the information on this page as applicable to keep Pepperdine's research community informed. Additional updates will be posted on a regular basis, as implementation guidance is issued by the federal government.
Beginning January 19, 2019, Pepperdine's eProtocol IRB system submission forms will be updated to reflect the revised Common Rule.
Overview of Common Rule Revisions
The Common Rule has been updated for the first time since it was issued in 1991. The Final Rule to update the current regulations at 45 CFR 46, Subpart A – "Federal Policy for the Protection of Human Subjects" (the Common Rule) was published by the U.S. Department of Health and Human Services (HHS) on January 19, 2017 in the Federal Register.
The most significant changes that affect research institutions, Institutional Review Boards (IRBs), and investigators are provided below. Some Final Rule changes were made in an effort to clarify how the pre-2018 Common Rule is applied. The most significant revisions are intended to "modernize, strengthen, and make more effective" the current system of oversight. The revisions propose to:
- Better protect human subjects
- Expedite research
- Increase trust in the research enterprise
- Reduce regulatory burden
The Common Rule revisions aim to better manage the many types of research (specifically including behavioral and social science research) that are being conducted today, as opposed to the research conducted in 1991. One of the Final Rule's main purposes is to facilitate the conduct of minimal risk research. It also recognizes the evolving technologies used today which have changed the scale and nature of information collected in modern research activities. Large databases, bio-specimen repositories, electronic health records, and clinical research networks have shifted research priorities.
Major Changes to the Common Rule
The following are some of the most significant changes that may affect our researchers:
Continuing Review: For new studies approved or determined exempt under the Revised Common Rule, continuing review will not be required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.
NOTE: If a study was reviewed under the pre-2018 Common Rule and was determined to require continuing review, continuing review is still required to stay compliant. The revised Common Rule permits the IRB to review existing research and determine if it can transition to comply with the Revised Common Rule.
Exemptions: The revised regulations created new exempt categories and modified some existing categories. Exempt research is research involving no greater than minimal risk and falls into specific categories identified in the federal regulations. Beginning January 19, 2019, Pepperdine's eProtocol IRB forms will adapt the exempt determination process to align with the revised exemption categories and to streamline the review process.
Limited IRB Review: The revised regulations also incorporate an alternate path of review for studies otherwise qualifying for exemption but working with identifiable information or biospecimens. An IRB member must conduct limited IRB review for these studies. The focus of the review is limited to determining that the research design includes adequate provisions to protect participant privacy and confidentiality.
Informed Consent: The revised regulations include new process requirements for the content, presentation, and organization of information so potential participants have all the information they need to make an informed decision. Consent forms will need to include key information at the beginning of the form and be presented at the outset of the consent discussion with participants to explain the research in an easy-to-understand and clear manner. Consent forms must be concise while also giving the full context of a study, including its risks and benefits. Consent forms will also need to include information regarding the potential for future use of de-identified data and biospecimens. Visit the IRB Forms webpage for approved form/templates.
What does this mean for me as a researcher?
- The new regulations go into effect on January 21, 2019, and Pepperdine will begin reviewing new studies under the revised Common Rule on that date.
- Pending applications for new studies will need to be reviewed under the new regulations if approval or an exempt determination has not been made prior to January 21, 2019. Researchers may need to work with Pepperdine IRB staff to address any adjustments to protocol materials needed to achieve compliance with the revised regulations.
- Pepperdine has purchased a new Collaborative Institutional Training Initiative (CITI) training module, "Revised Common Rule", to assist in this transition and we encourage researchers to complete it. Researchers can access the "Revised Common Rule" training module by logging in to their CITI profile.
- Researchers should check the Pepperdine IRB website frequently to ensure they are using the most currently available forms and information.
- Ask questions! We encourage you to contact any of Pepperdine's IRB administrative personnel (see left-hand menu) anytime.
Where can I learn more?
- The Office for Human Research Protections (OHRP), a division of HHS, is the lead agency who published the final rule. This site provides a news release and commentary on the revised common rule.
- The published version of the changes to the Common Rule in the Federal Register.
- Public Responsibility in Medicine & Research (PRIM&R) provides many helpful resources on their website.
Collaborative Institutional Training Initiative (CITI) Program offers a wealth of resources on its website.
Human subjects' training is required for all faculty, staff, and students conducting research involving human subjects at Pepperdine University. Proof of completion is required for your IRB application submission. Human subject training must be updated every three years.
The Human Subjects training is free for all Pepperdine students, staff and faculty.
Here are steps to register for the Human Subjects Training course:
- Go to: https://about.citiprogram.org/en/homepage/
- Click on "Register" (located on the top right corner of the screen)
- Proceed by entering the name "Pepperdine University" in the box. When the words "Pepperdine University" come up, click on that. Check the "I agree to the terms of services" box, as well as the box "I affirm that I am an affiliate of Pepperdine University."
- Finally, click on "Continue to Create Your CITI Program Username/Password" and continue to fill out all steps of the form with your information. State (unless told otherwise) that you are NOT interested in the option of receiving Continuing Education Unit (CEU) credit for completed CITI program courses.
- Provide your Pepperdine email address, your department and your role in your current research.
Once you have registered your account, choose the appropriate human subjects training course (see FAQ) and answer the rest of the questions in order to add and start your applicable CITI training course.
Special human subjects training pathways in CITI are required for the following:
- GSEP Education Students - Please select "GSEP Education Division - Social-Behavioral-Educational (SBE)"
- GSEP Psychology Students - Please select "Graduate & Professional Schools Psychology Division Human Subjects Training"
- Business DBA and MSOD Students - Please select "Business, Law, and Public Policy Students Human Subjects Training"
- Public Policy and Law Students - Please select "Graduate & Professional Schools - Business Law and Public Policy Students Human Subjects Training"
- GPS Faculty and Staff - Please select "Graduate & Professional Schools - Faculty Human Subjects Training"
- GPS IRB Members and Reviewers - Please select "Graduate & Professional Schools IRB Members and Reviewers" (note that this will supersede other training requirements based on your affiliation)
- Seaver IRB Members and Reviewers - Please select "Seaver Undergraduate IRB Members" (note that this will supersede other training requirements based on your affiliation)
- Seaver Students, Faculty, and Staff - Please select the one appropriate to your type of research below:
- "Seaver Undergraduate Biomedical Research Investigators" for biomedical studies that require expedited or full review
- "Seaver Undergraduate Social & Behavioral Research Investigators" for social and behavioral studies that require expedited or full review
- "Seaver Undergraduate Students, Faculty, and Staff (Conducting Minimal Risk Research)" for all studies that are designed exempt review or minimal risk
- Optional Training for All Students, Faculty, and Staff: Please select "Revised Common Rule" for the latest IRB policy changes
*Note that if you are serving as an IRB member or reviewer, you do not also need to complete training based on your affiliation (e.g., GSEP Faculty) as long as you complete the appropriate training for IRB members and reviewers.
Please click here to complete Human Subjects Training
The submission calendar below is for applications requiring full review of either archival or prospectively conducted research projects. Applications seeking confirmation of exempt status or expedited review of either archival or prospectively conducted research projects may be submitted to the IRB at any time and should reference the exempt/expedited review timeline on the IRB community homepage.
*NOTE: During the month of July, the Seaver IRB does not review any new (exempt, expedited, or full) applications. Also, the IRB will close for business in line with university holiday closures. Please be mindful of this as you make plans to submit an IRB application during these time periods.
|Proposal Submission Dates||Meeting Dates|
|August 24, 2022||August 31, 2022|
|September 21, 2022||September 28, 2022|
|October 19, 2022||October 26, 2022|
|November 23, 2022||November 30, 2022|
|No December Proposal Submission||No December Meeting|
|January 17, 2023||January 25, 2023|
|February 15, 2023||February 22, 2023|
|March 15, 2023||March 22, 2023|
|April 19, 2023||April 26, 2023|
|May 17, 2023||May 24, 2023|
|June 14, 2023||June 21, 2023|
|No July Proposal Submission||No July Meeting|
The submission calendar is for applications requiring full review of either archival or prospectively conducted research projects. Applications seeking confirmation of exempt status or expedited review of either archival or prospectively conducted research projects may be submitted to the IRB at any time and should reference the exempt/expedited review timeline on the IRB community homepage.
NOTE: During the month of August, the GPS IRB does not review any new (exempt, expedited, or full) applications. Also, the IRB will close for business in line with university holiday closures. Please be mindful of this as you make plans to submit an IRB application during these time periods.
|Submission Deadlines||IRB Review Meeting Dates|
|No August Proposal Submission||No August Proposal Submission|
|September 13, 2022||September 20, 2022|
|October 11, 2022||October 18, 2022|
|November 8, 2022||November 15, 2022|
|No December Proposal Submission||No December meeting|
|January 10 , 2023||January 17 , 2023|
|February 14,2023||February 21, 2023|
|March 14, 2023||March 21, 2023|
|April 11, 2023||April 18, 2023|
|May 9, 2023||May 16, 2023|
|June 13, 2023||June 20, 2023|
|July 11, 2023||July 18, 2023|
Office of the Provost
Thursday, May 06, 2021
Guidance and Requirements for Research Ramp-Up
Research activity at Pepperdine University is core to our mission and commitment to academic excellence. Our goal is to enable as much research activity where possible, while continuing to maintain adherence to local, state, national, and institutional requirements, as well as enhanced safety protocols. While the COVID-19 pandemic continues to impact our community and allowable on-campus and research activities, we are providing the below guidance and requirements to begin the gradual restarting of research operations.
The health and safety of our community remains our top priority, and we continue to adhere to public health guidance to mitigate the health and safety risks to our faculty, staff, and students, as well as the public and human and animal research subjects. Please continue to refer to Pepperdine's COVID-19 Protocols and Resources website for institutional protocols, restrictions, and guidance. Faculty, staff, and students should continue to work with their school-level COVID-19 processes.
It remains the case that all research/creative activities that can be conducted remotely should remain remote.
Limited research activities may be conducted on campus, at local field sites, and in the community. School-level approval from your divisional dean (as applicable) and dean are required to resume research activity.
Essential field work that involves domestic travel requires permission from your divisional dean (as applicable), dean, and/or Steering Team representative. Pepperdine continues to prohibit university-sponsored international travel; rare exceptions may be considered on a case-by-case basis.
Outside, non-essential visitors are not permitted on any of our campuses at this time and are prohibited from entering any research facilities or laboratories. Exceptions may be considered on a case-by-case basis and require the approval of your divisional dean (as applicable) and dean. In addition, campus access must be requested through the Office of Emergency Services and be sent at least 24 hours prior to the desired visit.
Researchers must follow all local (research site), state, national, and international guidelines from the Centers for Disease Control (CDC), the World Health Organization (WHO), and other official public health organizations with regard to in-person contact and travel, as well as Pepperdine's institutional policies.
Faculty remain responsible for providing direction and oversight of their projects, labs, and/or research sites, and any additional personnel including students and staff.
The health and safety of our community remains paramount. Faculty, staff, and students conducting research must feel safe. We encourage you to contact your divisional dean or dean with any concerns, non-compliance to safety protocols, or other grievances. You may also contact Lee Kats at email@example.com.
Laboratory and Studio Operations
Remote research and activity should be considered the default; only reserve in-person lab/studio time for activities that can only be accomplished with the equipment and materials in those spaces.
Use of these spaces will be limited and considered on a case-by-case basis. Procedures have been discussed and prepared with the relevant school deans, divisions, and divisional deans. Therefore we encourage you to contact your divisional dean or dean to receive school-level approval to gain access to these spaces.
Human Subject Research
Research with human subjects should be conducted remotely as much as possible. Changes to protocols to conduct the research remotely must be reviewed and approved by the Institutional Research Board (IRB) prior to implementation. These amendments will continue to be reviewed by the IRB as quickly as possible.
While researchers are encouraged to design protocols that include remote-only interactions, on a limited, case-by-case basis, the IRB will begin to review submissions for studies involving in-person interactions. In an IRB application for in-person research, researchers must include: a brief description of why the study cannot be done remotely, or why the study's methodology or expected results might be compromised without in-person interaction, a description the local (research site), state, national, and/or international guidelines they will adhere to in an effort to mitigate the health and safety risks to our faculty, staff, and students, as well as the public and human subjects. Researchers must include the specific methods/procedures involving in-person research that adhere to COVID-19 safety guidelines. For example, if the researcher is collecting a biological specimen (blood, urine), then the researcher must provide a step-by-step description of how the collection will occur within COVID-19 safety guidelines.
Human subjects (remote or in-person) cannot be conducted without the express approval of the IRB.
At this time, animal research does not require any additional prior approvals, other than from Pepperdine's Institutional Animal Care and Use Committee (IACUC).
Sponsored Projects and Grants
Research and Sponsored Programs (RSP) is fully operational and continues to support faculty, staff, and student research.
Many sponsors are considering the impact of COVID-19 on project timelines, and most federal sponsors allow for a one-time, no cost extension for 12 months. Please reach out to RSP with any questions or if you would like to file a request for a no cost extension.
At this time, our research support units (Research and Sponsored Programs, IRB, and Animal Care) continue to operate remotely. The University will continue to work to clarify the written guidelines for research activities and will provide updates when appropriate. Amid the evolving and unpredictable circumstances surrounding COVID-19, faculty and staff should remain prepared for a quick ramp-down of research activities should the need arise. If you have additional questions, please contact Katy Carr at firstname.lastname@example.org.
Rick R. Marrs