Registration is free and lunch is provided. This will be an ideal opportunity to get answers to your tough questions and to learn about the services provided by Research Affairs.  It will also put you in contact with other researchers on campus.

Since many more topics were suggested than could be accommodated in a single event, this session will by the kick-off for a series of lunchtime presentations on additional research related subjects. 

Click Here to Register

Registration is free and lunch is provided. This will be an ideal opportunity to get answers to your tough questions and to learn about the services provided by Research Affairs.  It will also put you in contact with other researchers on campus.

Since many more topics were suggested than could be accommodated in a single event, this session will by the kick-off for a series of lunchtime presentations on additional research related subjects. 

Click Here to Register

Investigators are invited to assist in the testing phase by submitting their disclosures in the new electronic system and providing feedback.  By submitting in this system, you will not need to submit the paper version of the research conflict of interest disclosure.  To access this system, log in to https://mylluint.llu.edu/researchaffairs/CoI/ with your institutional user name and password.  Since this is a testing phase, we understand there may be questions regarding submitting disclosures in the system.  Please use the contact list below to assist in any questions you may have.     

Contact:

• Sandra Figueroa for COI-related questions, (909) 558-8544 ext. 85794 or researchcoi@llu.edu.
• Sherie Donahue for questions or comments on the electronic system, sdonahue@llu.edu or x83911.
• LLU help desk for questions about your LLU ID or access issues, x48611.

Please note this is only a summary of the changes.  Investigators and other key research personnel are responsible for reviewing the complete, revised policy.  This policy will be available online after August 24, 2012.  To request a copy of the policy in advance, please contact Lorraine Sarmiento at ext. 49478 or lsarmiento@llu.edu. 

Policy H-29 Clinical Trials Registration has been revised.  Previously, the requirement was that all research studies meeting the ICMJE (International Committee of Medical Journal Editors) definition for clinical trials must be registered in an ICMJE-approved database, searchable to the public.  The revision now requires that only those trials meeting the clinicaltrials.gov registration requirements be registered at clinicaltrials.gov.  This will reduce unnecessary burden on investigators that are not required by law to register the trial.  It is encouraged, however, that investigators check any journal requirements if they intend to publish their research, since journals may have different registration requirements. 

Requirements for Maintaining IRB Approved Research (policy), Change Request (procedure), Continuing Review (procedure), Lapse in IRB Approval (procedure) are all new documents.  These documents outline requirements for research once it has received IRB approval.  Change requests must be submitted to the IRB for review prior to implementation (unless necessary to eliminate immediate hazard to a research subject).  Continuing review of research must be conducted appropriate to the degree of risk, but not less than once per year.  If a research study is not submitted for review prior to its expiration date, and it lapses, the principal investigator must notify the IRB if he/she wishes to continue the research, otherwise it will be subject to closure.  An explanation and a corrective action plan to prevent future lapses must be submitted for IRB review if the principal investigator does wish to renew the study.  Adverse events and unanticipated problems must be reported to the IRB in accord with the reduced requirements, as outlined in the study-specific matrix. 

If you have a study that has not yet received the study-specific adverse event/unanticipated problem reporting matrix, please submit a Change Request form and include the following information:  (1) Is the study sponsored? (2) Does the study require an IND or IDE?  If yes, is the PI acting as Sponsor-Investigator?  (3) Does the study use an independent DSMB/DMC for safety monitoring?  If no, is there sponsor-provided surveillance of safety data or is it monitored locally by the investigator and IRB? (4) Is the study minimal risk?  (5) Is the study federally funded?

Research Subject Injuries (policy) This policy outlines the responsibility of LLUAHSC with regards to research subject injuries on studies involving more than minimal risk.  When research is initiated and directed by an industry or a non-profit sponsor, it will be the responsibility of the sponsor to cover the cost of injuries resulting from study participation.  When research is initiated and directed by a government agency, it will be covered as stipulated in the terms and conditions of the government agency.  When research is initiated and directed by an LLU investigator, general and professional liability claims for injury or illness resulting from participation in a research study shall be reported to Risk Management (RM) and handled per RM guidelines.  If funding in this case comes from a government agency, it shall be covered per contract. 

As a reminder, all of these policies have been summarized.  Investigators and other research personnel are responsible for reading all policies and procedures in their entirety.  Research Affairs policies can be accessed at:  http://www.llu.edu/pages/handbook/lluahsc_policies/index.php?dir=H-Research%20Affairs/ 

If you need assistance locating a research policy, please contact Lorraine Sarmiento at lsarmiento@llu.edu.