Procedures for Handling Research Integrity Issues

Research must be conducted in accordance with recognised research ethical norms and standards in all aspects of the research process, from planning to publication. Requirements for researchers to follow such norms and standards are regulated in the Research Ethics Act. According to this Act, all researchers are required to exercise due diligence, which means that each researcher is obliged to act with due care and to ensure that all research is done in accordance with recognised research ethical standards.

As a research institution, Oslo University Hospital (OUS) has an imposed responsibility for ensuring ethically sound research. This also implies a responsibility for dealing with all cases of possible breaches of recognised research ethics standards. In the following you will find information on how to proceed in cases of potential breach of research ethical norms and standards at OUS.

A joint research ombudsman scheme has been established for OUS, the Department of Clinical Medicine at the University of Oslo (UiO), and Akershus University Hospital (Ahus). Researchers and line managers can seek guidance from the research ombudsman before reporting breaches of research ethics norms.

The research ombudsman's tasks include:

• Advice and guidance in research ethics issues.
• Assist in resolving specific cases as early as possible and at the lowest possible level in the institution, including acting as a conflict resolver/mediator within the research ombudsman's mandate.
• Contribute as a resource person as part of the institutions' preventive measures, including courses and training.

The research ombudsman has no formal role in handling cases, but can assist line management when needed. For more information about the role and mandate, see the research ombudsman's website (UiO).

All employees who through their work at Oslo University Hospital (OUS) are made aware of possible violations of recognised research ethical standards have a responsibility to report this through their line manager. To ensure proper treatment, the report should be done in writing and with a description of:

• What the suspicion concerns
• Who is suspected
• In what contexts are breaches suspected, at which time point or during which period
• Whether the breach relates to results that are published and/or about to be published

Alternatively, an employee may request a meeting with the manager to explain the suspicion. In such cases, the manager shall keep minutes of the meeting.

Regional Research Support at OUS can provide advice and guidance in connection with notifications of possible violations upon request. Contact information can be found here.

A line manager, who receives notification of a possible violation of recognised research ethics norms, is obliged to investigate the case him/herself or to pass it on to senior manager if needed. The line manager always has the duty to keep the division’s research manager (forskningsleder) informed.

In cases where the employee believes there is a conflict of interest situation on the line manager’s hand, the employee may report directly to the head of division or research manager.

In cases where partiality or other conflicts of interest prevent proper follow-up in the division, Regional Research Support will assist in clarifying which division/research manager who can handle the case.

The manager who receives a notification is responsible for handling the case. The basic procedures include:

• Ensure that the case is adequately detailed
• Ensure that concerned parties are given the opportunity to comment
• Ensure that the matter is handled at a level where there is no partiality issues or other conflicts of interest
• Ensure that the parties' confidentiality is safeguarded

Anyone who files a case shall receive feedback within reasonable time about the proceedings. If the details of the case indicate discretion on grounds of privacy, this must be taken into account in the feedback. This also includes caring for involved parties in this type of case, both the person who is conveying a concern and those involved in the case.

A manager who has received and handled a report of suspected misconduct in research must prepare a written statement concerning the case. The statement shall contain at least:

• Whether it can be substantiated that a researcher has acted blameworthy
• If there are system errors that line management believes must be followed up
• Whether there is grounds for withdrawing an already published work as a result of the circumstances revealed

If however, during the course of the case, information is presented that provides grounds for assuming that there may be serious violations of recognised scientific norms ("scientific dishonesty"), the case shall be submitted to the division manager before a statement is made in the case. In such cases, the division manager, after consulting the line manager who has handled the case, may consider whether there is a basis for submitting this to “Redelighetsutvalget”. The division manager and/or research manager may also request assistance from Regional Research Support in assessing whether a case should be submitted to “Redelighetsutvalget”.

“Redelighetsutvalget” for research has been established in collaboration with the Department of Clinical Medicine at the Faculty of Medicine, University of Oslo, Oslo University Hospital HF and Akershus University Hospital HF.

The committee’s tasks are set out in its own mandate and and procedures available at their webpage. In principle, “Redelighetsutvalget” shall only deal with cases where there is a suspicion of "scientific dishonesty" pursuant to section 8 of the Research Ethics Act.

In accordance with the rules of procedure, the head of the committee has the opportunity to reject cases that he or she believes do not fall within the committee's mandate.

Preparation when sending a case to Redelighetsutvalget

Cases shall be reported in writing in a dedicated web form and shall follow the committee's case processing rules. For more information, see the Redelighetsutvalget website.

According to the committee’s procedures a case must be submitted in writing in a web-based notification form. For more information, see the website.