Posted: May 31, 2016
Revised Controlled Substances Policy and Forms Effective June 1, 2016
The Individual Investigator Use of Controlled Substances in Non-Therapeutic Research policy describes the responsibilities of the university, registrants, and authorized agents who use controlled substances in animal, cell culture, or in-vitro analytical laboratory research and, specifically, their responsibilities to comply with DEA and State of Ohio Board of Pharmacy requirements concerning the administration, handling, storage, destruction, and/or transfer of controlled substances used in such research.
The revision of the policy:
An overview of the University’s controlled substances program as well as the updated, required forms to be used for documenting the receipt, use, waste, loss/theft, transfer, or disposal of controlled substances in research as well as authorized agent lists are available on the “Controlled Substances” page of our Office of Research Compliance website: http://orc.osu.edu/regulations-policies/controlled-substances/.
For answers to frequently asked questions, visit http://orc.osu.edu/regulations-policies/controlled-substances/faqs/.
View the entire revised Individual Investigator Use of Controlled Substances in Non-Therapeutic Research policy here: http://policies.osu.edu/
Posted: March 29, 2016
2016 COI Disclosure will be available on April 25, 2016
Each year, The Ohio State University requires certain faculty, staff members, and students to complete an annual financial disclosure to comply with federal and state conflict of interest (COI) regulations, accreditation requirements, and OSU faculty and staff COI policies. This year, the new disclosure period begins April 25, 2016 with a required one-year look back period for 2016 going back to April 2015. COI disclosures should be completed by May 23, 2016 by going to http://go.osu.edu/coi.
All individuals required to complete a COI disclosure will receive an email, advising them that the new disclosure period has opened, and that their 2016 disclosure should be completed. Instructions on how to complete the disclosure, along with information regarding what needs to be disclosed and how the disclosure is reviewed and approved, will be provided in the email and upon logging into the e-COI system at http://go.osu.edu/coi.
If a 2015 disclosure form is on file, it will no longer be editable after April 25, 2016. Please note that the 2015 form will not expire until June 30, 2016. This provides individuals adequate time to complete the 2016 disclosure prior to expiration of the current disclosures. A reminder email will be sent in May to all individuals who are required to, but have not yet completed, the 2016 COI disclosure.
The Office of Research Compliance can be reached at 614-292-4284, or Conflictinfo@osu.edu
Posted: November 6, 2012
Article by Daniel Golden on the J. Reece Roth case
Posted: July 9, 2012
Posted: January 5, 2012
On August 25, 2011, the federal Department of Health and Human Services (HHS) enacted new, more stringent rules regarding financial conflicts of interest (FCOI) in research. As implemented, the regulations will substantially impact principal investigators (PIs) on research involving the use of human subjects, who have personal financial interests in the sponsor of their research, or in companies providing investigational drugs, devices or other financial support to their HHS-funded projects.
The most significant change for PIs in the new regulation is a reduction in the monetary interest considered to be a “significant” financial interest – from the current $10,000 threshold to $5,000 received within the past twelve (12) months. Under the new regulations, receipt of $5,000 or more from a research sponsor in consulting income, honoraria, stock or equity ownership, or personal payment of travel expenses by a sponsor will now be considered significant and require formal disclosure of the PI’s interest to HHS and a FCOI management plan. Additionally, the new regulations now cover financial interests received from any source (with the exception of federal and state agencies, U.S. colleges and universities, and academic medical centers), which may relate to all professional activities of an investigator – not just his/her research-related activities.
Importantly, the new rule may impact the ability of investigators with significant financial interests in companies or organizations providing financial support to their studies (including providing investigational drugs or devices) to remain as PIs on their current trials – or to function as PI on future human subjects research projects. Specifically, Ohio State follows best practice guidelines developed by the Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU) concerning investigators with financial interests involving human subject research. These AAMC/AAU guidelines include an express presumption that a PI with a significant financial interest in a company or organization cannot serve as PI on a human subject project, which is sponsored or financially supported by that company or organization. A financially-interested PI can only rebut this presumption by demonstrating facts that, in the opinion of the Ohio State University COI Advisory Committee (COIAC), constitute compelling reasons to allow the PI to conduct the research under conditions specified by the COIAC and approved by the responsible IRB. Additional information on the AAMC/AAU guidance can be found at https://www.aamc.org/download/75302/data/firstreport.pdf.
As a result of the more stringent federal requirements, we suggest that PIs with personal financial interests in sponsors or other organizations supporting their research strongly consider decreasing their interests well before the new regulations take effect on August 24, 2012, in order to stay below the lowered $5000 threshold for significant financial interests.
Please contact Ashlie Depinet, the University’s Conflict of Interest Administrator, at email@example.com to discuss the impact of the new federal conflict of interest regulations on your research.
|Change||Impact on Principal Investigators|
|The monetary threshold considered to be a “significant” financial interest will be reduced from the current $10,000 to a new threshold of $5,000 received in the twelve months preceding the annual disclosure; Any equity interest in a non-publicly traded company, i.e., a start-up company, will be automatically considered to be a “significant” financial interest;||Ohio State follows the AAMC/AAU best practice guidelines for Principal Investigators (PI) on research involving the use of human subjects. The guidance includes a presumption that any PI with a significant financial interest in a company cannot serve as PI on a human subject project sponsored or financially supported by that company – unless the University’s COI Advisory Committee finds s a compelling reason to allow the investigator to remain the PI. If you are currently a PI on a project and have or expect to receive $5,000 or more in the twelve (12) months preceding August 24, 2012 (the date the new rules take effect) from a company sponsoring or providing other support to the project, the new rule will impact your ability to remain PI.|
|PIs, co-investigators, and key research personnel will be required to disclose the occurrence of any reimbursed travel or sponsored travel related to his/her institutional responsibilities – not just research. The only reimbursed travel that is excluded from disclosure is that which is sponsored by a federal, state or local government agency or by a U.S. institution of higher education (an accredited college or university). This disclosure includes: the purpose of the trip, the sponsor/organizer, the destination and the duration.||Ohio State has not previously collected this detailed travel information. When it is disclosed, the University’s conflict of interest administrator and Conflict of Interest Advisory Committee will determine if additional travel information is needed and whether the sponsored travel represents a potential financial conflict of interest.|
|The new regulation requires that PIs, co-investigators and key research personnel update their annual e-COI disclosures within thirty days of acquiring a new significant financial interest.||Investigators will need to more frequently update their COI disclosures as new financial interests are received. If a significant new financial interest is acquired and not disclosed within 30 days, the new rules require that the University conduct a formal retrospective review of the investigator’s research and a formal mitigation plan will be required.|
|The federal regulations have a public accessibility requirement. The university will be required to make certain information available concerning identified financial conflicts of interests (FCOI) by a written response to any requestor within five business days of the request. The information required includes: the name of the faculty (or key research personnel), his/her position with respect to the research, the nature of the significant financial interest, and the range of the financial interest.||The Ohio Open Records law already provides public access to most investigator and research staff FCOI information on formal request. Public requests for information under the new federal requirements will be handled by the conflict of interest administrator and the conflict of interest advisory committee. This rule should have only a minor impact on PIs.|
|PIs, co-investigators and key research personnel will be required to complete formal FCOI training every four years.||The current Ohio State plan is to require investigators to complete on-line training through the Collaborative Institutional Training Initiative (CITI) of which Ohio State is a member. Investigators who have taken the CITI Human Subjects Training program within the last two (2) years will be ‘grandfathered’ for the first four years of this requirement. Ohio State investigators and key personnel who have not already taken CITI training must take the soon to be available CITI FCOI training module available at https://www.citiprogram.org before August 24, 2012.|
Posted: October 10, 2011
The National Institutes of Health (NIH) finalized financial conflict of interest (COI) rules on August 25, 2011 that contain a number of new requirements for researchers and research staff working on federally-funded projects. These new rules will go into effect on August 24, 2012.
The major changes from the current federal COI rules include:
For more detailed information on the new NIH rules, please see the summary of changes at http://grants.nih.gov/grants/policy/coi/
The Ohio State University’s existing COI disclosure process will continue to follow the current federal regulations; however, the institution will transition to a new COI reporting process next spring or early summer in order to comply with the new federal regulations. Detailed information will be provided about changes to the University process as they are developed. For additional specific information on how the rules may impact your research, please e-mail firstname.lastname@example.org or call (614)292-0057.
Posted: November 10, 2010
University of Tennessee Case: Perspectives and Lessons Learned from the J. Reece Roth Case