RICRO COVID-19 Notices for Research Practices

As a reminder, you can find general CSU information about COVID-19 at:  https://safety.colostate.edu/coronavirus/ and CSU Research information about COVID-19 at: https://www.research.colostate.edu/covid19/

Our office is receiving questions from researchers about the appropriate process for making changes to their studies/protocols in response to the current COVID-19 pandemic.  Below are online resources and information for CSU researchers.

IACUC

Reminder—the IACUC has an amendment review process to facilitate quick turnarounds should you need to amend your protocols.  Some of you are familiar with it—Veterinary Verification and Consultation (VVC).  Only certain amendments are eligible for VVC.  If you need to amend your protocol and want to know if it is eligible for VVC, then:

  • Submit an amendment in eProtocol.
  • REPLY ALL to the email you receive from eProtocol to send an email to RICRO IACUC Staff and ask if it is eligible for VVC, as well as the desired timeline.
  • Someone from the RICRO IACUC team will reply after they review your amendment request.
  • RICRO IACUC Group Email

If you currently have an active, approved IACUC protocol, then you are included on the Animal Users listserv.  If you are not sure, go to Animal Users Email Listserv.  You can subscribe and will receive emails should there be any impact on LAR facilities or other aspects of the Animal Care and Use Program.

IBC

Reminder—IBC protocol review has an amendment review process to facilitate quick turnarounds should you need to amend your procedures as a result of COVID-19 impacts on research. You may either submit your amendment via the Online IBC Database or by sending an email to RICRO_IBC@mail.colostate.edu.

Unsure what happens to your experiments involving biohazardous materials during a CSU shutdown or quarantine? Contact Robert.Ellis@colostate.edu, or your Research Associate Dean, department chair, or Karen.Dobos@colostate.edu for guidance on access to your lab.

For Biosafety Incidents during a CSU shutdown or quarantine, follow all standard protocols indicated in the link. Please make sure you update your cell phone contact lists for urgent communications within your laboratory.

IRB:

Reminder – § 45 CFR 46.108 and §21 CFR 56.108(a)(4) require that each IRB shall….”Follow written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to human subjects.”

If an investigator needs to change research plans in order to eliminate apparent immediate hazards to research participants, these changes can be made and then reported to the CSU IRB within 5 business days. Eliminating immediate hazards may include actions to reduce potential exposure to COVID-19 such as: decreasing the number of protocol-mandated in-person study visits or moving to remote study/teleconferencing study visits; delaying study visits to outside the study defined schedule to ensure participants are not traveling unnecessarily; among other options.

If your project received an Expedited or Full Board APPROVAL:

Submit an Amendment.

Given these unique circumstances, the IRB will accept eProtocol submitted amendments to document these changes after implementation. The notification of the change in research plans may, also, be a memo, letter, or other document that explains the changes being made, provides enough information for the IRB to assess the risks resulting from the changes. Any documentation submitted will proceed with IRB review as per the usual process.

If your project received an Exempt DETERMINATION:

Document for your own records.

Under this circumstance you are not required to submit a formal amendment to document a change from in-person to virtual participant interactions or delaying/altering study visits to outside the defined schedule.  Instead, please save a copy of this notification along with a brief overview of your protocol changes for your own records.  The IRB may ask for your documentation with future renewals or amendments.  If changes fall outside of the parameters outlined here, submit an amendment through eProtocol as described above.

  1. How do I tell if I received an Expedited or Full Board APPROVAL or an Exempt DETERMINATION?

On your eProtocol homepage dashboard you will see a section for Approved Protocols.  Under Review Decision it will list one of the following:

  • Full Review (APPROVAL)
  • Designated Review (APPROVAL)
  • Exempt Review (DETERMINATION)
  1. Special Circumstance: If you received an exempt determination and are currently recruiting from a CSU Research Participant Pool (PSYCH Pool, Business Pool, HDFS Pool) and need to change your recruitment method, population, or compensation, you do not need to submit an amendment.  Please update all relevant documents to include the updated information (recruitment, consent, etc.).  Save a copy of this notification along with a brief overview of your protocol changes for your own records.
  1. Examples:
    • I am currently recruiting from the CSU PSYCH Pool for an in-person experiment. Since students will not be on campus, can I change my recruitment pool to a different participant pool?

YES.  Although this does not clearly align with the allowances “to eliminate apparent immediate hazards to human subjects,” if the participants voluntarily choose to participate this is still considered everyday living risk.

  • I am currently recruiting from the CSU PSYCH Pool for an online experiment. Since students will not be on campus, I anticipate that I will not get the same amount of enrollment.  Can I change my recruitment pool to a different online platform (Qualtrics, etc.) and offer monetary compensation instead of research credit?

YES.  The change of recruitment pool and compensation method will not alter the risk to participants.

IRB personnel will be available to address general concerns, questions, etc. Please use RICRO_IRB@colostate.edu for the most efficient responses to your needs.

Quality Assurance:  Special considerations for studies requiring GLP/GCP/QA compliance

Due to current challenges facing the health of our staff and communities, the following are some thoughts regarding managing our regulated research:

  1. If study deviations occur or you need to amend your studies due to staffing or other related concerns, be sure to do so.  As per normal, document any changes to the GLP/GCP study protocol as soon as possible in accordance with your SOPs.  If amendment/deviation or other study Forms are unavailable for some reason, remember a simple but complete Note to File is an acceptable method of documenting protocol changes or even data in emergency situations. Don’t forget ALCOA, so date and sign all entries.
  2. Remember when changes occur to approved GLP/GCP protocols, be sure to thoroughly consider and document the impact on study conduct and objectives.  A well thought out assessment on study impacts and risks could allow you to better prioritize which steps to take and which can be better skipped if your resources are or become limited.  Contacting your Sponsor Representative/Monitor can also be of assistance in prioritization.
  3. Be sure to communicate the study needs well to staff and QA, especially if there are changes in procedure or schedule.
  4. I (Cat Bens) will be available by email or phone so don’t hesitate to contact me if I can be of assistance.

Finally, this office will remain staffed through any shutdown to address any urgent concerns. Please do not hesitate to use the email lists provided above, or if time is of the essence, contact the RICRO Director (Karen Dobos) directly via cell phone: 970-290-7842.