protocols & related
Protocol Paperwork Review Process
According to the Public Health Service (PHS) guidelines, protocols can only be approved for a three-year period, after which the investigator is required to submit a new protocol in order to continue the project. In order to comply with these guidelines and the requirements of the Animal Welfare Regulations (AWR), the Institutional Animal Care and Use Committee (IACUC) will review all protocols annually through the use of a Continuing (Annual) Review form and will require a new protocol submission every three years. e-Protocol will electronically notify the investigator at appropriate intervals when annual protocol updates are needed and/or when a protocol is approaching the expiration of its three-year approval limit.
Investigators are advised that because the University is a state institution, all protocols, Continuing (Annual) Reviews, amendments to the protocols, and related paperwork are considered public documents. Hence, this paperwork is subject to the Ohio Open Records laws.
e-Protocol is NEOMED’S electronic IACUC protocol submission system. e-Protocol is web-based, so it can be accessed from anywhere. You will need to use Firefox as your browser. A free browser download is available at: https://www.mozzilla.com. Follow the instruction for the download. e-Protocol can then be accessed at: https://eprotocol.neomed.edu.
Individuals will use their Windows/Office 365 credentials (NEOMED login and current password) to access the system. Each investigator will have their own dashboard”. The Investigator dashboard contains information related to e-Protocol, the IACUC, and/or other NEOMED compliance committees, etc. The dashboard also shows investigators all of their protocols, amendments, continuing reviews, etc. that they have submitted. Investigators and research staff will want to check their dashboard from time to time to see if there are any new messages.
If you have questions as to where the Protocol is in the review system, you can quickly check the “Event History”. This section keeps track of all the review cycles. The “E-mail History” keeps track of all the e-mail communications related to the protocol. These two items are located on the blue navigational bar located on the left-hand side of the Protocol, the Amendment or the continuing Review and can be accessed at any time.
A PDF guidance document is available to NEOMED staff on how to use e-Protocol on the IACUC-CMU shared drive. The guidance document is also available upon request. Feel free to contact the IACUC Regulatory Affairs Coordinator to request the PDF or with e-Protocol questions or concerns.
The NEOMED IACUC requires completion of all CITI-related training modules for all individuals working with animals. If a course is not available in CITI, individuals may be registered in the AALAS Learning Library (ALL) and provided with the course title. Within the Personnel Information section of e-Protocol, CITI will populate the current training for each individual listed on the protocol.
All research personnel will need to create an account within CITI (www.citiprogram.org). Individuals must register as a Researcher and affiliate with NEOMED. All fields within the CITI profile must be completed, with particular attention to two required fields within the CITI profile that must be completed: Institutional Username (NEOMED login credential) and Institutional e-mail address (NEOMED e-mail address). This is where NEOMED specific information needs to be entered. These fields must contain your NEOMED login credential and your NEOMED e-mail address respectively. If not, CITI training will not populate and will create delays in processing the e-Protocol submission.
If non-NEOMED individuals will be listed on the protocol as either a Co-PI or as a protocol participant, the following information must be sent to the IACUC Regulatory Affairs Coordinator in order to create a Banner account:
2.) Mailing address
3.) Phone number
Creation of a Banner account typically takes 5-7 business days. Non-NEOMED individuals will be notified, via e-mail, once their Banner account is set up and will be provided with their login credentials, how to reset their passwords, how to forward their NEOMED e-mail account to another e-mail account.
Please ensure all fields within e-Protocol are completed. The system will not allow you to submit the protocol until all relevant fields are completed. The submitted protocol will automatically go to the IACUC Regulatory Affairs Coordinator. A cursory review of the protocol submission is completed. The investigator will be notified if any relevant information is omitted.
All protocols involving a USDA-covered species, category E pain procedures, food and/or fluid restriction, prolonged restraint, death as endpoint, etc., will automatically be assigned for Full Committee Review (FCR). FCR means the protocol must be presented at a convened meeting of the IACUC.
Three primary reviewers (IACUC Chairperson or Vice Chairperson, the Attending Veterinarian, and an assigned monthly IACUC member) will review the protocol, as well as any other NEOMED regulatory compliance committee (e.g., Institutional Biosafety Committee-IBC; Institutional Safety Committee-ISC; Institutional Review Board-IRB; Radiation Safety Committee-RSC, etc.). The reviewers submit their comments within e-Protocol. Once all comments are received, e-Protocol will notify the investigator that the Cycle 1 review is complete and to check e-Protocol for comments related to the protocol.
The PI will revise the protocol according to the primary reviewer comments. Response to the primary reviewer comments must be made within the appropriate section of e-Protocol. Once all comments are responded to, the PI will submit the revised protocol through e-Protocol. The primary reviewers will review the revised protocol and will submit additional comments or concerns. This begins the Cycle 2 review. Review cycles will continue until the IACUC’s concerns are addressed.
If no additional concerns are communicated regarding pain category “C” (no more than momentary or slight pain or distress) and “D” (more than momentary or slight pain or distress for which analgesia, anesthesia or tranquilization is provided) protocols, the primary reviewers will Recommend for approval within e-Protocol indicating their approval. Pain category “E” (pain or distress which are not relieved by analgesia, anesthesia, or tranquilization) protocols must be presented at a convened IACUC meeting. The category “E” pain protocol must be approved by a quarum of the convened IACUC.
The PI and the Institutional Official (IO) are notified in writing on the IACUC’s decision regarding the approval status of the protocol. New protocols are added to the next month’s IACUC meeting agenda for either acknowledgement or approval. Approved protocols, with the reviewers’ comments and IACUC approval memo attached, are filed with the IACUC records.
Protocols involving potential pain or distress (Category D), which include adequate description of how any discomfort will be managed, are reviewed through the normal protocol review process. All protocols involving unrelieved pain or distress (Category E) are reviewed at a convened meeting of the IACUC and must be accompanied by a scientific justification provided by the principal investigator.
For new protocols involving unrelieved pain or distress (Category E), the IACUC assigns a sub-committee (i.e. IACUC chairperson, Attending Veterinarian, and one appointed IACUC member) the responsibility of monitoring the animals’ well-being during critical times throughout the study. The subcommittee and the principal investigator, if required, report their observations to the IACUC for further considerations. Once the IACUC has gained familiarity with the condition of the animals during the study, continued monitoring is carried out by the CMU Manager or by the Attending Veterinarian.
Continuing (Annual) Review
e-Protocol will notify investigators at 30 days and again at 15 days before the anniversary approval date of the protocol indicating that continuing (annual) review of the protocol is needed. Investigators will go to their Investigator Dashboard and click on the Protocol ID number. Investigators will then select Continuing Review from the available options. This will open the Continuing Review form. There are three sections to address. All three sections must be completed. Once completed, investigators will submit the form.
The Continuing (Annual) Protocol form will electronically come to the Regulatory Affairs Coordinator. for non-USDA covered species, the IACUC Office will administratively review and approved. For USDA-covered species, an assigned IACUC sub-committee will review and approved.
Please note: Any IACUC member can request a full committee review of the Continuing (Annual) Review by contact the IACUC Regulatory Affairs Coordinator. The review would then take place at the next scheduled IACUC meeting. If no additional concerns are communicated, the three primary reviewers will Recommend for Approval, indicating IACUC approval.
The PI and IO are notified, via e-mail, of the IACUC’s decision regarding the approval status. New Continuing (Annual) Reviews are added to the next month’s IACUC meeting agenda for either acknowledgement or approval. The approved form and e-mail notifications of approval are automatically logged and available within e-Protocol.
Amendment (Minor or Significant Protocol Changes)
An Amendment needs to be submitted when a change or addition to the protocol is proposed. These changes may include, but are not limited to, the species used, numbers of animals needed, experimental and/or surgical procedures to be performed, etc.
Changes must be approved by the IACUC before they are implemented. Amendments are to be submitted electronically via e-Protocol. If there are frequent modifications to a protocol, the IACUC may require submission of a new protocol.
Any IACUC member can request a Full Committee Review of the Amendment by contacting the Regulatory Affairs Coordinator. The review would then take place at the next scheduled IACUC meeting. If no additional concerns are communicated, the three primary reviewers will recommend for approval within e-Protocol.
The PI is electronically notified via e-Protocol of the IACUC’s decision regarding the approval status of the Amendment. The approved Amendment, with any reviewer comments, is electronically filed with the original protocol within e-Protocol.
Amendment (Addition of New Personnel)
All individuals who need to work with live animals must be included on an animal use protocol that is in good standing and are approved by the IACUC before they begin work with animals. Individuals who begin working with animals prior to this will create a non-compliance for the investigator and their protocol.
Listed below are the action steps that need to be completed by all research personnel in order to work with animals and to gain access to the Comparative Medicine Unit (CMU):
1.) Visit the CITI web site at www.citiprogram.org
2.) Create an individual account
3.) Affiliate with Northeast Ohio Medical University
4.) Register as a Researcher
***5.) ACTION REQUIRED: The “Institutional User Name” field within your CITI profile must contain your NEOMED login credential. (This field is a required field.)
***6.) ACTION REQUIRED: The “Institutional E-Mail Address” field within your CITI profile must contain your NEOMED e-mail address. (This field is a required field.)
The IACUC will require completion of the following CITI modules:
a.) Working with the IACUC
b.) Working with . . . (applicable species you will be working with)
c.) Reducing Pain and Distress in Laboratory Mice and Rats
d.) Aseptic Surgery (if applicable)
CITI will send the IACUC staff Completion Reports as each module is completed.
Investigators will need to submit an Amendment(s) within e-Protocol to add new research personnel to their current protocol(s). The Investigator must include the individuals training and/or experience at it relates to the procedures they will be performing on the protocol. It is acceptable for Investigator’s to include a statement that personnel will be trained by the investigative staff in those procedures relevant to the protocol.
In order to work with animals and to gain facility access, individuals will need to complete a facility tour. Please contact Jayne Poyer, CMU Supervisor, to schedule a mutually agreeable time for a facility tour. Jayne can be reached either by phone at X-6556 or at 330.325.6556 or by e-mail at email@example.com.
OCCUPATIONAL HEALTH & SAFETY:
In order to work with animals and to gain facility access, individuals will need to complete all occupational health and safety requirements. Please contact Jesse Zampedro in the EOHS Office to discuss occupational health and safety requirements. He can be reached either by phone at X-6496 or at 330.325.6496 or by e-mail at firstname.lastname@example.org.
Please Note: A facility tour and all occupational health and safety requirements must be completed before the IACUC can approve the Amendment.
Investigators will receive an electronic notification, by the system, once the Amendment to add new research personnel to their protocols is approved by the IACUC.
The IACUC Office will notify the NEOMED Police Department of facility access for the new research personnel. The notification will indicate the level of CMU access being provided to the individual.
Feel free to contact the Regulatory Affairs Coordinator with any questions or concerns.