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The Office of Research Support (ORS) does not administer or oversee HOP policy 5-2011* or training related to the policy. ORS administers HOP policy 7-1210, “Promoting Objectivity in Research by Managing, Reducing or Eliminating Financial Conflicts of Interest” so if you conduct research and have:

  1. Not submitted a Financial Interest Disclosure (FID), you will need to complete mandatory training and file a FID. Instructions for completing these requirements are located at http://www.utexas.edu/research/rsc/coi/training.html.
  2. Previously submitted a FID, you are not required to complete additional training nor re-disclose the same information to comply with the UTS 180/HOP 5-2011 policy requirements.   However, you may have other responsibilities under that policy.

*If you have questions concerning the other policy, HOP policy 5-2011, “Conflicts of Interest, Conflicts of Commitment, & Outside Activities,” you should contact the Provost’s Office evpp_coi@austin.utexas.edu.

Unanticipated Problems

An “unanticipated problem involving the risks to participants or others” is an event that meets the following three criteria. The event was:

  • Unforeseen,
  • Related to the research, and
  • Caused harm or increased the risk of harm to the participants or others

The Institutional Review Board (IRB) requires PIs to report an unanticipated problem within five days of becoming aware of the problem.

Examples of unanticipated problems include:

  • An actual unforeseen harmful or unfavorable occurrence to participants or others that relates to the research protocol (injuries, side effects, etc.);
  • An unforeseen development that potentially increases the likelihood of harm to participants or others in the future;
  • A problem involving data collection, data storage, privacy, or confidentiality;
  • A participant complaint about approved research procedures;
  • New information about a research study that indicates a possible change in the research risks to participants (sources may include a publication in the literature, interim findings, safety information released by the sponsor or regulatory agency, or the safety monitoring report);
  • Changes in approved research initiated without review and approval to eliminate apparent immediate hazards to the participants.

Section 9 of the IRB Policies and Procedures Manual provides further information regarding the review of unanticipated problems.