Compliance

Grant sponsored Human Subjects Research

NIH Extramural Nexus

Prior to proposal development: Listen to the first podcast in the human subject mini-series to confirm you're doing Human Subjects Research. Then tune in to the second episode in the series to develop a solid monitoring plan for your application. After you've been awarded: Check out the Post-Award Human Subjects Research for the latest episode.

Posted: 01/06/2021

Working with your IRB (the CPHS at CSUMB)

CITI Program Webinars (free)

This webinar will provide a discussion of effective communication strategies for students and faculty to work with their IRB. We will also talk about how to respond to an IRB request. Further, we will offer some tips on how to identify important deadlines and dates in the IRB review process. Finally, we will discuss what needs to be reported to the IRB and when it needs to be reported.

Posted: 10/7/2020

External Research Requests Temporarily Suspended

Due to the State of California's Executive Order EO-N-12-21, the CPHS has suspended processing External Researcher requests for an indefinite period of time.

Posted: 3/26/2020

Updated: 09/01/2021

Risk REDUCING Modifications

In response to COVID-19, changes to active, approved protocols which REDUCE the risk to subjects may be approved upon receipt by the CPHS.

Instructions and form link are at: https://csumb.edu/compliance/checklists-forms-policy > Post Approval Activities.

Posted: 3/24/2020

COVID-19 Recommendations

In response to questions regarding COVID-19 and Human Subjects Research, CSUMB makes the following recommendations to researchers.

• Closely follow university recommendations and announcements through CSUMB’s COVID-19 website - https://csumb.edu/health/coronavirus-information

• Please allow at-risk participant populations (e.g. elderly, those with underlying health conditions) to take proper precautions.

• Consider rescheduling in-person human subjects data collections that are not of immediate need. Allow research participants who indicate self-quarantine, illness, or at-risk status to continue their health-appropriate course of action.

In this time of public health concern, new measures are being encountered in everyday life. As a result, the following exceptions are temporarily deemed to be changes not requiring CPHS review. The CPHS will allow the following change without an amendment to the IRB protocol.

• Substitution of telephone, web conferencing, and secure electronic communication (such as Zoom: https://docs.google.com/document/d/12jPg2_B4dwuSzfkJ06yGJoMnX_xd-5a9cY4OLijYmDk/edit?ts=5e690d1e) to conduct data collection procedures normally done in-person. These methods may be added when possible and practical for mitigating research risks to subjects or others related to COVID-19. If there are questions about any changes to participant risk, please contact the CPHS at cphs@csumb.edu.

These changes will be in place until further notice and may expand as more information is known. If researchers choose to implement use of these practices, the revised documents must become part of the study file in the Principal Investigator’s records. To allow the IRB to have a record of the implementation, please send an e-mail message noting the study record title(s), PI name, and Kuali reference number(s) to cphs@csumb.edu within 10 business days of the implementation. The office will include this information in your study file in the Kuali system.

As necessary, the CPHS will communicate its recommendations with university public health leadership. For questions about the IRB review process or additional instances requiring insight on the topic above, please contact cphs@csumb.edu

Posted: 3/16/2020

Summer Schedule

The CPHS is comprised of faculty who are off-contract during the summer and staff who take scheduled vacations. This year, the CPHS skeleton crew is on duty July 3 through August 2, 2019. Questions and concerns should be directed to the Chair, Dr. Chip Lenno.

Posted: 7/3/19

Human Subjects Research Policy Update Posted

In compliance with the Revised Common Rule regulations, CSUMB's revised policy on Human Subjects Research is posted now.

Posted: 3/4/19

New regulations governing Human Subjects Research take effect January 21, 2019

January 21st, 2019, is the effective date for the revised Common Rule! Replace your OHRP-related bookmarks with 2018 Requirements and Revised Common Rule Educational Materials. Replace your CPHS-related bookmarks with Revised Common Rule Guidelines and Final (revised) Common Rule Resources.

The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))

Revised Common Rule Q&As

Posted: 01/18/19

Updated: 1/22/19

Effective Date for the Revised Common Rule Approaching FAST!

Starting January 21, 2019, CSUMB's IRB, the CPHS, will need to comply with the Common Rule revisions to 45 CFR 46: Protection of Human Subjects.

CPHS Guidelines compliant with the Common Rule revisions are at: https://sites.google.com/csumb.edu/cphs-guidelines-hsr-rev-rule.

Posted: 01/07/19

Protocol submission to the CPHS is now via Kuali Protocols!

This message is to let you know that the Committee for the Protection of Human Subjects (CPHS) has transitioned application submission to Kuali Protocols. Kuali Protocols is a module in our comprehensive electronic research administration (eRA) system: Kuali Research. So far, most of you have heard about "Kuali" because of the grant/contract signature official routing function in the Proposal Development module. Now we're rolling out another module!

Please bear with us as we iron out the wrinkles in Kuali Protocols (with use). Although we pilot-tested for two months, we still anticipate some bumps along the way as faculty and staff begin using it in earnest.

Learn more about preparing and submitting a protocol at: What goes into a protocol? Log into Kuali Protocols from SPOs website or from the CPHS website.

Posted: 12/19/2018

Emailed: 12/18/2018

Countdown to Regulatory CHANGES effective in January

It's looking more and more like the regulatory changes to the Common Rule will become effective January 20, 2019, as advertised. Read the detailed announcement on the Office of Human Research Protections website: Final Revisions to the Common Rule.

Please read the detailed announcement on the Office of Human Research Protections website: Final Revisions to the Common Rule. NOTE that we're NOT implementing Broad Consent or Limited IRB Review until further regulatory guidance is provided.

Get informed about the changes on the Collaborative Institutional Training Initiative (CITI)'s website: Final Rule Resources. NOTE that we're NOT implementing Broad Consent or Limited IRB Review until further regulatory guidance is provided.

Posted: 11/21/2018

3 Revised Common Rule changes effective TODAY

Changes to Continuing (annual) Review reporting requirements are effective today. If you're working on an active, approved, Expedited protocol, AND you are ONLY engaged in data analysis or manuscript development (i.e.: NO further interaction or intervention with human subjects and/or collection of identifiable data) you may "convert" your protocol to the new regulations which permits you to submit a close-out (non-extension request) Continuing Review even while you're still engaged in data analysis.

Pros/Cons of "converting" your protocol: The new regulations emphasize safety and privacy of subjects, especially vulnerable subjects. Your current protocol must meet this "higher bar" so you might be asked to clarify or even revise your safety and/or privacy monitoring procedures/plan in order to "convert" the protocol and take advantage of the Continuing Review change. Take a look at the Safety & Monitoring Plan Guidance to get a sense of the "higher bar". If you want to proceed with "converting" your protocol, contact the CPHS for assistance: cphs@csumb.edu.

See below for more details about two other rule changes that are perfunctory to CSUMB researchers.

Posted: 07/19/2018

Summer Schedule

The CPHS is comprised of faculty who are off-contract during the summer and staff who take scheduled vacations. This year, the CPHS skeleton crew is on duty July 9 through July 20, 2018. Questions and concerns should be directed to the Chair, Dr. Chip Lenno.

Posted: 07/02/2018

Expect Review Delays During the Summer

The CPHS is transitioning to an online submission system during the summer. Staff will be tasked with implementation while CPHS members are off-contract for the summer. Plan accordingly and submit early!

Posted: 06/20/2018

SOME elements of the Revised Common Rule become effective July 19, 2018 (the rest on January 21, 2019)

On June 18, 2018, HHS and 16 other federal departments and agencies issued a Final Rule to delay for an additional 6 months making the general compliance date of Revisions to the Common Rule while allowing the use of three burden-reducing provisions during the delay.

What does this mean for you?

After July 18, 2018:

• The CPHS' existing definition of "research" is codified and therefore broadly accepted. So, no change to our research community.
• The CPHS has the authority to determine when and if a continuing review status report is required in all Human Subjects Research approved by the CPHS. So regardless of the determined category of research (Exempt, Expedited, or Full Board Review) you may or may not be required to submit a continuing review status report annually or at any other schedule/increment. The CPHS will weigh the risk vs. benefits of each protocol and determine the requirement on a case-by-case basis.
• The CPHS' existing procedure of referring grant proposals (involving Human Subjects Research) to the Sponsored Programs Office is codified and therefore broadly accepted. So, no change to our research community.

The Final Rule has been put on public display by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2018/06/19/2018-13187/protection-of-human-subjects-delay-of-general-compliance-date.

Posted: 06/18/2018

Revised: See NEW effective date posted above.

Delay of the Revised Common Rule to July 19, 2018

On January 17, 2018, at 04:15 pm, an interim final rule was released delaying the effective and general compliance date of the revised Common Rule for six months to July 19, 2018.

What does this mean for you?

• No change for researchers:
  • Researchers continue to prepare (develop) protocols with the materials and references on Checklists, Forms & Policy.
  • CPHS Guidelines remain at: https://sites.google.com/a/csumb.edu/cphs-guidelines-on-conducting-human-subjects-in-research/. The revised guidelines are not applicable until further notice.
  • Categories of research set to change, remain the same (i.e.: Exempt and Expedited categories in the Revised Common Rule are NOT effective until July 19, 2018).

Revised: 06/18/2018

Originally posted: 01/18/2018

Students must submit under a faculty/staff Lead Researcher

In preparation for significant regulatory revisions effective in January 2018, the CPHS has begun implementing changes to conform to the new requirements. As such, student protocols must now be submitted under the direct supervision of a Lead Researcher who is faculty or MPP staff qualified to supervise Human Subjects Research.

What does this mean?

• Students may continue to prepare (develop) protocols, naming themselves as a Research Assistant and their faculty/staff supervisor as the Lead Researcher.
• Students may continue to first-author publications, lead-present at conferences, etc.
  
• Students may continue to carry out all research activities as directed by their faculty/staff supervisor.
  

Posted: 11/23/2017

Revised: See NEW effective date post above.

New regulations effective: January 19, 2018

Yes. After decades of input and revisions, in 2017 the U.S. Department of Health and Human Services (HHS), Office of Human Research Protections (OHRP) published the Final Rule, with changes to become effective January 19, 2018.*

Sixteen different federal agencies and departments have signed onto the Final Rule dubbing it the "Common Rule". While four additional agencies and departments are cooperatively abiding by the Final Rule, the U.S. Food and Drug Administration (FDA) is still not a signatory, nor are it's regulations harmonized with the Final Rule yet.

From the researcher's perspective the changes hinge largely on documenting the vulnerability (or lack thereof) of subjects, potential harms from a breach of subject's confidentiality, and Minimal Risk assessment. Researchers are still required to determine whether or not they need to prepare and submit a protocol ( is the research subject IRB review in the first place), and if so, prepare and submit an appropriate protocol for the research including all supplementary materials required for an IRB to ascertain the basic criteria for approval as well as any applicable additional criteria.

Read the detailed announcement on the Office of Human Research Protections website: Final Revisions to the Common Rule.

Get the gist of the changes on the Collaborative Institutional Training Initiative (CITI)'s website: Final Rule Resources.

Always check the Human Subjects Research website and CPHS Guidelines before you submit a protocol.

Revised: 01/18/2018

Originally posted: 01/18/2017