Guidance

This guidance document outlines information that should be shared with participants during the informed consent process relating to the 1) disclosure of confidential information of reportable diseases; 2) disclosure of abusive situations; and 3) disclosure of information about harming others or themselves. In some cases, the disclosure of confidential information is mandatory (by law or University policy) and in other cases, the researcher may have a professional duty to make such disclosures.  For the citations of applicable laws, please see the University of Utah Board Member Guidance Series: Applicable State Laws.

Reportable Diseases

Local and state health departments require certain diseases be reported in the interest of public health. These diseases are called “reportable diseases”. Cases of reportable diseases are required to be reported to local and state health departments by health care providers, hospitals or laboratories. By complying with reporting requirements, state and local health departments can improve public health through prevention services, treatment and care, and disease control. Each state has its own laws and regulations defining reportable diseases. The list of reportable diseases may vary over time.

Investigators should be familiar with the local reporting requirements because reporting requirements will vary based on location. You may refer to Utah Department of Health website for a current list (rev. 7/2020) of Utah’s reportable diseases, including the reporting time frame and how to report.

If a reportable disease may be detected, diagnosed or treated during the course of a research study at the University of Utah, the IRB may request the following:

1. The informed consent document states the intent to test for the reportable disease.
2. The informed consent document states the investigator’s responsibility to report to the appropriate agency and how the reporting will affect confidentiality.
3. If a positive result and the notification to the appropriate health department may result in partner notification activities, this should be stated in the confidentiality section.
4. The informed consent document describes opportunities for follow-up counseling or medical care, as applicable.

Please see Appendix A of this document for more information regarding requests for exemption of mandatory reporting of AIDS and HIV infection in Utah.

Abuse

In some cases, mandatory reporting of confidential information may be required. If researcher is legally obligated to reveal instances of child abuse, elder abuse, or abuse of the disabled, a disclosure should be given during the informed consent process. If your study involves the possibility of disclosure of abusive situations, mandatory language must be included in the consent document. See the Supplemental Elements tab on the Consent Document Checklist found on the IRB website.

Sexual Misconduct and Discrimination

Under University of Utah policy, most University employees (including researchers) are required to report situations involving sexual misconduct and discrimination to the Office of Equal Opportunity and Affirmative Action (OEO/AA). This includes research activities that may result in a participant who is a University of Utah student disclosing alleged sexual violence. The PI/study team member to whom incidents of this alleged sexual violence is disclosed is considered a “mandatory reporter” and has an obligation to report these incidents to the University of Utah Office of Equal Opportunity, Affirmative Action, and Title IX (OEO). If the research is such that participants may divulge experiences with sexual violence and participants are adult students (18+) at the University of Utah, the consent document should include language that outlines this required reporting. See Supplemental Elements tab on the Consent Document Checklist found on the IRB website.

Threat to Self or Others

In some cases, a researcher may have a duty to disclose information necessary to prevent a serious and imminent threat to the health or safety of the patient or others. If a study involves the possibility that participants may disclose information about harming themselves or others, investigators should include a statement about the potential breach of confidentiality. Suggested language for the consent document can be found under the Supplemental Elements tab on the Consent Document Checklist found on the IRB website.

Documents and References

BMGS: Applicable State Laws: https://irb.utah.edu/investigator-guidance-series/

University of Utah Consent Document Checklist – Supplemental Elements Tab: https://irb.utah.edu/informed-consent/consent-document-checklist/

University of Utah Office of Equal Opportunity (OEO/AA): https://oeo.utah.edu/

Utah Department of Health Bureau of Epidemiology: Disease Reporting:  http://health.utah.gov/epi/reporting/

Utah Department of Health Reportable Disease List (Rev. 7/2020) http://health.utah.gov/epi/reporting/Rpt_Disease_List.pdf

Points to Consider

Appendices