Research Compliance

The Office(s) of the Vice President for Research will be CLOSED as follows during this holiday season:
Thursday and Friday, November 23 and 24 - Thanksgiving Holiday
Monday and Tuesday, December 24 and 25 - Christmas Holiday
Monday and Tuesday, December 31 - January 01, 2019

The Office of Research Compliance (ORC) is responsible for oversight, monitoring, development, and promulgation of policies and programs, and administration of review committees (where applicable) for the following compliance areas: 

Human Research Protections, Animal Research Protections, Use of Recombinant or Synthetic Nucleic Acid Molecules in Research,  Use of Stem Cells in Research,  Investigator Financial Conflicts of Interest, Laboratory Safety, Responsible Conduct in Research and Scholarship (RCRS), and Export Controls.

The ORC, through the Research Integrity Officer, receives allegations of research misconduct, and ensures compliance with University and federal policies and procedures governing such cases. 

Animal Use In Research

Biosafety in Research

Conflict of Interest

Controlled Substances In Research

Dual Use Research of Concern (DURC)

Export Controls

Government Classified and Controlled Unclassified Information

Human Subjects In Research

IRBNet

Radioactive Drug Metabolism Research

Research Misconduct

Responsible Conduct of Research and Scholarship

Stem Cells Research

Training

FAQs

As of April 17, 2017

  • Annual Certifications are due annually by May 1st
  • For new Investigators an initial Annual Certification should be submitted prior to the submission of any proposals

 

When Is It Required to Report a Change in External Interests?

  • Within thirty (30) days of discovering or acquiring a new FI or Obligation.
  • At the time of establishing a faculty owned company.
  • At the request of the DIO, where new FIs have come to the attention of the DIO.
  • For PHS/NIH funded investigators, applicable travel must be disclosed within thirty (30) days of said travel. Alternatively, travel that is anticipated can be disclosed anytime in advance and would satisfy the thirty (30) day requirement.

What External Interests Must be Reported?

  • Obligations
  • Financial Interests, where when aggregated for any one entity is greater than $5,000
  • Equity interests
  • Intellectual Property Rights and Interests, where royalty and other forms of payment are in excess of $5,000
  • Travel (for PHS/NIH only)

Note: The above include obligations and financial interest for both you and any Immediate Family Members.

Review the Definitions section of the Standard Operating Procedures for additional information and exclusions to what is considered a Financial Interest 

 

 

A Significant Financial Interest (SFI) is a Financial Interest (FI) that you (or your spouse or dependent children) hold that reasonably appears to be related to your institutional responsibilities.

Institutional Responsibilities are those duties you have and activities you do as part of your professional responsibilities at the University, including, e.g., research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.) 

…reasonably appears to be related to your institutional responsibilities…” means that if either your identified interests below, or the entity in which you have those interests, relies upon the same expertise utilized to carry out your Institutional responsibilities, it is considered an SFI. So, let's say you on a speaker's bureau for a company and present on topics related to the expertise you need to do your job at SBU. That would be a related interest. What if you were a paid board trustee for a religious organization? No, not related if you are an endocrinologist at the University. Yes, related if you are a faculty member in Religious Studies. Now let's say you are a paid member on a company's board. In this situation, it's not what you do for the company (serve as a board member, which may not be something you do at the University), but what the company's business is that must be considered in determining relatedness.  

Management Plan

For all identified FCOI’s and CO's, the DIO will develop and implement a Management Plan. If the University is unable to resolve a real or potential conflict of interest or the appearance of same, it will decline to perform the activity in question. Where human subjects are involved, the IRB may modify and/or add to the Management Plan. Where there is discrepancy or disagreement, the IRB's decision will supersede that of the DIO. The DIO sends the Management Plan to the Investigator. The Investigator must then provide concurrence and certification for compliance (signature) with the Management Plan in order for the award to be established or the unfunded agreement to be institutionally endorsed. The DIO will convey the notice of FCOI and/or CO and associated signed Management Plan to the Chair of the COI Committee, Assistant Vice-President of Research Compliance, Investigator, associated Chair, and associated Dean (the VPR will serve in this capacity when the investigator is a dean or vice president, or is otherwise conflicted).

Management Plan Compliance

The Investigator is required to comply with all terms of a Management Plan, including the submission of any resulting Publications via Huron Click.

Management Plan Monitoring

For all identified FCOI's and CO's, the DIO will monitor compliance with the Management Plan. Such monitoring will be documented.

The Institutional Animal Care and Use Committee works to ensure that research is conducted in a way that

  1. avoids or minimizes discomfort, distress, and pain in experimental animals consistent with sound scientific practices
  2. uses the minimum number of animals necessary to obtain valid results, and
  3. considers non-animal models wherever possible

Events and Training

There are currently no upcoming events.

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