Announcements

Updates to Pepperdine's IRB Manual

The revisions to the common rule are reflected in Pepperdine's IRB Manual

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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:

  1. Go to: https://about.citiprogram.org/en/homepage/
  2. Click on "Register" (located on the top right corner of the screen)
  3. 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."
  4. 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.
  5. 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 - Social-Behavioral-Educational Human Subjects Training
  • Faculty/Staff - Faculty/Staff Human Subjects Training
  • MSOD - MSOD Human Subjects Training
  • GSEP Psychology Students - Psychology Human Subjects Training
  • Business/Public Policy/Law Students - Graduate & Professional School Human Subjects Training 

Please click here to complete Human Subjects Training

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.

Proposal Submission DatesMeeting Dates
August 21, 2019 August 28, 2019
September 18, 2019 September 25, 2019
October 9, 2019 October 16, 2019
November 6, 2019 November 13, 2019
No December Proposal Submission No December Meeting
January 22, 2020 January 29, 2020
February 5, 2020 February 12, 2020
March 11, 2020 March 18, 2020
April 8, 2020 April 15, 2020
May 6, 2020 May 13, 2020
June 10, 2020 June 17, 2020
No July Proposal Submission  No July Meeting
August 19, 2020 August 26, 2020

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.

Submission DeadlinesIRB Review Meeting Dates
September 2, 2019 September 10, 2019
September 30, 2019 October 8, 2019
November 4, 2019 November 12, 2019
No December Proposal Submission No December Meeting
January 6, 2020 January 14, 2020
February 3, 2020 February 11, 2020
March 2, 2020 March 10, 2020
April 6, 2020 April 14, 2020
May 4, 2020 May 12, 2020
June 1, 2020 June 9, 2020
July 6, 2020 July 14, 2020