Human Subjects and Ethical Research Policy

Purpose and Scope

1. Northeastern University London (the University) is committed to the ethical conduct of research and strives to adhere to the highest ethical standards for the protection of human and living subjects, consistent with the principles of the Nuremberg Code, the Concordat on Research Integrity, the UKRIO Code of Practice on Research, and – when conducting work in the US with other Northeastern Colleges -, the Belmont Report. Accordingly, the University will designate a committee or similar body (‘the designated body’) from time to time that provides a procedural framework for meeting the ethical and legal requirements, that the rights and welfare of living and human subjects receive adequate protection, and that ethical standards in research are met. 
2. This policy applies to all research and scholarship involving human or living subjects, and to all research and scholarship with ethical implications, conducted by faculty, staff, and/or students at the University. Students in their classes should not be subjects of their research.

Definitions

3. For purposes of this policy:
   1. Research: a systematic investigation, including research, development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a programme which is considered research for other purposes. For example, some demonstration and service programmes may include research activities, as may activities conducted under Scholarship.
   2. Human Subjects: includes an individual about whom an investigator (whether professional or student) conducting research obtains:
      1. data through intervention or interaction with the individual, or 
      2. identifiable personal information.
   3. Investigator or principal investigator: any individual who is involved in conducting human subjects research studies, or research studies with any other implications for research ethics, without limitation.

Policy

4. It is the policy of the University that no activity involving human or living subjects, or with implications for research ethics, be undertaken until those activities have been reviewed and approved by the designated body. Accordingly, all proposals for university research involving human or living subjects or with implications for research ethics must first be submitted to the designated body for review and approval. 
5. In addition, the University requires completion of training, as directed from time to time, on the protection of human subjects and the ethical principles of research for all human or living subject research and all research with ethical implications, regardless of whether or not investigators have received funding to support their project. This training is mandatory for all faculty, staff, and students who conduct/supervise research involving human subjects whether on campus or off-campus, whether funded or unfunded. 
6. The principal investigator is responsible for the protection of participants, subjects, or persons referred to in human or living subjects’ research. Safeguarding the participants, subjects, or persons referred to from undue risk is the ethical responsibility of each person who is involved, either directly or indirectly, in conducting research at the University. Principal Investigators must require that each member of the research team carries out all research procedures in accordance with ethical principles of research. 
7. The designated body has the authority to suspend or terminate approval of research that is not being conducted in accordance with its requirements or that has been associated with harm to subjects. Investigators whose research does not comply with University policies may not obtain review or approval for other human or living subjects research activities, or for research activities with ethical implications, for themselves or their students until the compliance issues have been cleared. Regulations require that the designated body report violations of university policies or the law to the appropriate officials. 
8. Information regarding approval procedures and other necessary guidelines for human research at the University are provided through instruction from time to time. Investigators are responsible for adhering to the guidelines provided and should read all relevant policies and procedures prior to submitting an application for review.

Additional Information

9. Performing research with human or living subjects, or with ethical implications, without prior approval by the designated body is unethical and may be illegal. It will jeopardize the reputation and standing of the University.
10. A project that is conducted without approval by the designated body is subject to termination and/or other action by the University, and may be subject to disciplinary action, and/or criminal or civil legal action.

Contact Information

11. The University will designate from time to time an officer who can provide information and advice about human or living subjects research, and for research with ethical implications, and the procedures for applying for ethical review. The contact details will appear on the University website.
12. The University will designate from time to time an officer who has overall responsibility for research ethics, and who will provide the Board with an annual report on research integrity. The contact details will appear on the University website.
13. The University will designate from time to time an officer or officers to whom allegations of research misconduct may be made. The contact details will appear on the University website. 
14. Alongside these contact details, the University will provide information on its Public Interest Disclosure (‘whistleblowing’) Policy.

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