Research Affairs has several new and revised policies for distribution. Policy H-35 Research Conflict of Interest has been revised. The most significant change is that our previous policy required investigators report potential conflicts of interest as they relate to a specific research project. The new law requires that investigators report significant financial interests as they relates to all their institutional responsibilities (clinical care, teaching, research, serving on review panels, etc.).
| Previous Requirement | New Requirement |
| Report potential conflicts of interest as they relate to a specific research project | Report all financial interests as they relate to your institutional responsibilities |
| No conflict of interest training requirement | Initial conflict of interest training required, which must be updated at a minimum, every 4 years |
| Interests must be reported for the previous 12 months and anything anticipated in the upcoming 12 months | Interests must be reported for the previous 12 months onl |
| Income $10,000 and above from privately held and publicly traded companies must be reported |
Income $5,000 and above from privately held and publicly traded companies must be reported. This includes income from non-profit agencies (See Limits of Disclosure) |
|
No travel reporting requirements |
All travel (sponsored or reimbursed) must be reported, unless it meets the exempt criteria (See Limits of Disclosure Document section 2.4) |
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.