Research Compliance

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

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.  

The fundamental research exclusion does not apply to shipping information and/or materials off campus, a license may be required to share this information with an international collaborator - even under a fundamental research project.

The fundamental research exclusion applies to INFORMATION that is made public; while the actual “item” that is the result of the research may require a license.

Key considerations when you have international collaborations - what are you sharing, who are you sharing with, why are you sharing.

A person who is NOT:

  • Granted permanent U.S. residence, as demonstrated by the issuance of a permanent residence card, i.e., a "Green Card"
  • Granted U.S. citizenship
  • Granted status as a "protected person" under 8 U.S.C. 1324b(a)(3), e.g., political refugees, political asylum holders, etc.
  • It also means any foreign corporation, business association, partnership, trust, society or any other entity or group that is not incorporated or organized to do business in the United States, as well as international organizations, foreign governments and any agency or subdivision of foreign governments (e.g., diplomatic missions)

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